NJ Psychological Association challenges APA Clinical Practice Guideline for the Treatment of PTSD


quick takes

ptsd guidelinesThe APA guidelines can be found here 

From: Charity Wilkinson <wilkinson.charity@gmail.com>

Subject: [abct-members] APA PTSD Clinical Practice Guideline Being Questioned by NJPA

Date: December 22, 2017 at 7:44:44 PM CST

To: ABCT Member List <abct-members@lists.abct.org>

Reply-To: ABCT Member List <abct-members@lists.abct.org>

Dear Colleagues,

I’m writing to bring to your attention that the NJ Psychological Association issued statement today indicating that they sent a message to the APA expressing concern about the Clinical Practice Guideline for the Treatment of PTSD. This action was taken when a group of over 75 psychologists in NJ signed a letter opposing the Guideline. Though many of us sent statements to the NJPA supporting the Guideline, our statement was ignored.

The NJPA’s statement advocates for psychologists practicing from psychodynamic and other orientations who believe that their work has been wrongfully excluded. They have indicated that they fear the loss of their livelihood, insurance companies not funding their work, and the opportunity for clients to receive psychodynamic and other treatments that were not included. The statement also suggests that all treatments yield results and that RCT’s should not have been as strongly considered in the development of the Guideline.

I would ask that ABCT members and perhaps leadership create a statement in support of the APA PTSD Guideline.

Thank you for your consideration.


Charity Wilkinson-Truong

This is why APA has been so reluctant to take a stand and set guidelines about what is evidence-based psychotherapy and what is not.

See my post of a while ago (2012)

Troubles in the Branding of Psychotherapies as “Evidence Supported”


Unfunny 2017 BMJ Christmas articles not in the same league with my all-time favorite

Which is: A systematic review of parachute use to prevent death and major trauma

I agree with Sharen Begley’s assessment in Stat of this year’s BMJ Christmas issue as a loser.

tenorA BMJ Christmas issue filled with wine glasses, sex, and back pain brings out the Grinch in us

Bah! … humbug. Is it just us, or is the highly anticipated Christmas issue of the BMJ (formerly the British Medical Journal) delivering more lumps of coal and fewer tinselly baubles lately?

Maybe it’s Noel nostalgia, but we find ourselves reminiscing about BMJ offerings from Yuletides past, which brought us studies reporting that 0.5 percent of U.S. births are to (self-reported) virgins, determining how long a box of chocolates lasts on a hospital ward, or investigating Nintendo injuries.

I agree with her stern:

Note to BMJ editors: Fatal motorcycle crashes, old people falling, and joint pain — three of this year’s Christmas issue studies — do not qualify as “lighthearted.”

My all-time favorite BMJ Christmas article

Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials


With its conclusions:

As with many interventions intended to prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation by using randomised controlled trials. Advocates of evidence based medicine have criticised the adoption of interventions evaluated by using only observational data. We think that everyone might benefit if the most radical protagonists of evidence based medicine organised and participated in a double blind, randomised, placebo controlled, crossover trial of the parachute.

The brief article is actually a great way to start a serious discussion of randomized trials with a laugh.

Parachutist-splashWe can all agree that we wouldn’t participate in a randomized trial of parachutes. Any effort to conduct a systematic review and meta-analysis of such studies would answer up , formally speaking, as a failed meta-analysis. We we could start with a rigorous systematic search, but still end up with no studies to provide effect sizes. That’s not a bad thing, especially one as an alternative to making recommendations on weak or nonexistent data.

I would like to see a lot more formally declared failed meta-analyses by the Cochrane collaboration.  Clearly labeled failed meta-analyses much preferable to recommendations consumers and policymakers for treatments based on a small collection of methodologically weak and underpowered trials. It happens just too much.

If the discussion group were ripe for it, we could delve into when randomized trials are not needed or what to do when there aren’t randomized trials. I think one or more N = 1 trials not using a parachute or similar device would be compelling, without a nonspecific control group. On the other hand, many interventions that have been justified only by observational trials turn out not to be effective when RCT is finally done.

Keep a discussion going long enough of when RCTs can’t provide suitable evidence, and you end up in a predictable place. Someone will offer a critique of RCTs as the gold standard for evaluating interventions or maybe of systematic reviews meta-analyses of RCTs being a platinum standard. That can be very fruitful too, but sooner or later can get someone proposing alternatives to the RCT because their pet interventions don’t measure up in RCTs. Ah, yes, RCTs can capture the the magic going on long-term psychodynamic psychotherapy.

[For review of alternatives to RCTs that I co-authored, see Research to improve the quality of care for depression: alternatives to the simple randomized clinical trial ]

Ghosts of Christmases Past

Searching for past BMJ Christmas articles can be tedious. If someone can suggest an efficient search term, let me know. Fortunately the BMJ last year offered a review of all-time highlights

Christmas crackers: highlights from past years of The BMJ’s seasonal issue

BMJ 2016; 355 doi: https://doi.org/10.1136/bmj.i6679 (Published 15 December 2016)

Cite this as: BMJ 2016;355:i6679

For more than 30 years the festive issue of the journal has answered quirky research questions, waxed philosophical, and given us a good dose of humour and entertainment along the way.

A recent count found more than 1000 articles in The BMJ’s Christmas back catalogue. A look through these shows some common themes returning year after year. Professional concerns crop up often, and we seem to be endlessly fascinated by the differences between medical specialties. Past studies have looked at how specialties vary by the cars they drive,7 their ability to predict the future,8 and their coffee buying habits.9 Sometimes the research findings can challenge popular stereotypes. How many people, “orthopods” included, could have predicted that anaesthetists, with their regular diet of Sudoku and crosswords, would fare worse than orthopaedic surgeons in an intelligence test?1

It notes some of the recurring themes.

Beyond medical and academic matters, enduring Christmas themes also reflect the universal big issues that preoccupy us all: food, drink, religion, death, love, and sex.

This broad theme encompasses one of the most widely accessed BMJ Christmas articles of all times

In 2014 Ben Lendrem and colleagues explored differences between the sexes in idiotic risk taking behaviour, by studying past winners of the Darwin Awards.4 As the paper describes: winners of these awards must die in such an idiotic manner that “their action ensures the long-term survival of the species, by selectively allowing one less idiot to survive.”

There is also an interesting table of the four BMJ Christmas papers that won Ig Noble prizes:

Christmas BMJ papers awarded the Ig Nobel prize

  • Effect of ale, garlic, and soured cream on the appetite of leeches (winner 1994)15

  • Magnetic resonance imaging of male and female genitals during coitus and female sexual arousal (1999)13

  • Sword swallowing and its side effects (2006)16

  • Pain over speed bumps in diagnosis of acute appendicitis (2012)17




Unethical: Why Bristol University SMILE trial should not have been conducted with chronically ill children

If it should have been conducted at all, the first clinical trial of Lightning Process should not have been conducted with chronically ill children. Safety and efficacy had neither been established with adults, nor healthy children.

Phil Parker, developer of the trademarked, commercial Lightning Process package claims that is not a psychological treatment, but a physical one. He further claims its scientific basis is an amalgamation of neurolinguistic programming, osteopathy, and life coaching.

not psychologicalThere is no plausible scientific mechanism by which Lightning Process would work. A small minority of vulnerable adult and child patients with chronic fatigue syndrome are drawn to the false claims of the health benefits lightning process, which the UK Advertising Standards Authority now forbids posting on the web. This is a truth-in-advertising-problem, not justification for launching a clinical trial. 

Researching the Lightning Process is no more ethically and scientifically justified than researching Prince Charles’s claims that (organic) coffee enemas can slow progression of cancer. Yet, the logic is the same that has been used to justify the SMILE trial.

Protecting-children-520x350Pediatrician Esther Crawley should undergo remedial ethics training and I recommend an excellent source below.

No parents should consent to their children participating in clinical trials of Bristol University, until a transparent independent inquiry reports how and why the SMILE trial was approved.

A belated praise to the parents who stood up against Professor Esther Crawley and all her nastiness. She should apologize to you.

Required reading for Professor Crawley and relevant administrative staff of Bristol University

Ethical Conduct of Clinical Research Involving Children. Edited by Marilyn J. Field and Richard E. Behrman. 448 pp., illustrated. Washington, D.C., National Academies Press, 2004. $57. ISBN 0-309-09207-8

Although the price is listed as US$57. A free downloadable PDF is available here 

No excuse, Professor Crawley, overcoming your being ethically challenged can start with some free reading.

An excellent summary is here Institute of Medicine (US) Committee on Clinical Research Involving Children; Field MJ, Behrman RE, editors. Ethical Conduct of Clinical Research Involving Children. Washington (DC): National Academies Press (US); 2004. Summary.

Ethical Conduct of Clinical Research Involving Children.






Some key excerpts

The special ethical and regulatory protections for children may preclude potentially important clinical studies that would be approved for adult participation. This prospect can put pressure on those involved in developing or reviewing studies that include infants, children, or adolescents. A strong system of protections for adult and child participants in research will provide support and guidance for all involved to help them fulfill their legal and ethical responsibilities in such situations.


Notwithstanding the expected benefits of policies to increase the amount of research involving infants, children, and adolescents, some caution is appropriate. Unlike most adults, children usually lack the legal right and the intellectual and emotional maturity to consent to research participation on their own behalf. Their vulnerability demands special consideration from researchers and policymakers and additional protections beyond those provided to mentally competent adult participants in research.


As discussed later in this chapter, instances of unethical research practices involving children have prompted public criticism and concern that has contributed to the development of current federal regulations to protect both child and adult participants in research. Since the 1960s, policymakers, researchers, research institutions, and research sponsors have taken a number of steps to strengthen ethical standards and policies for human research and to create formal programs, including institutional review boards (IRBs), to approve and monitor research. Clinical studies funded, conducted, or regulated by the government are now subject to a (mostly) common set of provisions for the protection of human participants in research, including special protections for children. One result is that some potentially important clinical studies that would be approved for adult participation cannot be approved for participation by children.

a9062388703d9f42237ea708b2e088f1--protective-boyfriend-quotes-protective-quotesParents’  “intimate and profound duty to protect and promote their child safety and well-being in research”

…The committee recognizes the important role of parents. They have a most intimate and profound duty and desire to protect and promote their child’s safety and well-being in research, as in all realms of life. Chapter 5, in particular, has discussed how investigators, IRBs, and others can effectively and compassionately support parents in fulfilling their responsibilities and, thereby, help them to feel that they have done the right thing for their child, whatever their choices about the child’s participation in research. Once parents have agreed to their child’s participation in research, they—and older children and adolescents—may sometimes have crucial responsibilities for following the research protocol (e.g., administering medicines or bringing the child in for research appointments). Investigators need to make sure that parents and older children and adolescents understand any such responsibilities before they agree to research participation and that they have appropriate support in adhering to the protocol during the course of the research

Selected Recommendations

Recommendation 4.1: In evaluating the potential harms or discomfort posed by a research protocol that includes children, investigators, and reviewers of research protocols should

Interpret minimal risk in relation to the normal experiences of average, healthy, normal children;

Focus on the equivalence of potential harms or discomfort anticipated in research with the harms or discomfort that average, healthy, normal children may encounter in their daily lives or experience in routine physical or psychological examinations or tests;

Consider the risk of harms or discomfort in relation to the ages of the children to be studied; and

Assess the duration as well as the probability and magnitude of potential harms or discomfort in determining the level of risk.

In Section 406 of 45 CFR 46, federal regulations permit research that involves a minor increase over minimal risk without the prospect of direct benefit if the research involves children with a disorder or condition, is likely to yield vital knowledge about that disorder or condition, and entails research experiences that are reasonably similar to those that such children encounter in certain other situations. Consistent with the interpretation of minimal risk, the interpretation of this level of research risk should not allow a higher threshold of risk for children who are exposed to more risk in other aspects of their lives (Recommendation 4.2). Also, consistent with the language of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which defined this standard in 1977, the risk allowed under this category can be only slightly above minimal risk.

Recommendation 4.3: In determining whether proposed research involving a minor increase over minimal risk and no direct benefit can be approved, the term condition should be interpreted as referring to a specific (or a set of specific) physical, psychological, neurodevelopmental, or social characteristic(s) that an established body of scientific evidence or clinical knowledge has shown to negatively affect children’s health and well-being or to increase their risk of developing a health problem in the future.

Recommendation 4.1 In evaluating the potential harms or discomfort posed by a research protocol that includes children, investigators, and reviewers of research protocols should

Interpret minimal risk in relation to the normal experiences of average, healthy, normal children;

Focus on the equivalence of potential harms or discomfort anticipated in research with the harms or discomfort that average, healthy, normal children may encounter in their daily lives or experience in routine physical or psychological examinations or tests;

Consider the risk of harms or discomfort in relation to the ages of the children to be studied; and

Assess the duration as well as the probability and magnitude of potential harms or discomfort in determining the level of risk.

Parents should have been warned about unprofessional providers in Esther Crawley’s SMILE trial

The providers of Lightning Process in the SMILE trial were not credentialed health professionals and are not bound by ethical codes.

giphyEsther Crawley’s overdue publication of results from the SMILE trial  deserves close scrutiny for lots of reasons. But especially for what is said about the supervision and qualifications of Lightning Process practitioners who delivered the treatment.

Readers can easily gloss over a seemingly straightforward description of these practitioners in the paper. Yet, a little probing and checking of sources should cause some alarm among the parents who agreed to their children participating in the trial.

The details are alarming enough to cause worry about participating in any clinical trial involving Esther Crawley. She does not look after the safety and rights of children in her care.

This trial was approved by a number of committees at Bristol University. Assured by those well-publicized approvals, parents undoubtedly assumed that their children were protected from risks and needless exposure to quack treatments or providers not bound by enforceable ethical codes. The children did not have these protections, which should give pause to anyone contemplating allowing their children to participate in a trial regulated by Bristol University.

What was said in the published paper

LP practitioners have completed a diploma through the Phil Parker Training Institute in Neurolinguistic Programming, Life Coaching and Clinical Hypnotherapy. This diploma is examined through written and practical examinations and is accredited by the British Institute of Hypnotherapy and NLP. Following the diploma, LP practitioners undertake a further course to learn the tools and delivery required for the LP after which they must pass both a practical and written examination. Practitioners undertake supervision and continuous professional development in order to further develop their skills and knowledge. They are regulated by the register of LP practitioners, adhere to a code of conduct and there is a Professional Conduct Committee that oversees complaints and professional practice issues.

Let’s isolate and probe some of these statements.

LP practitioners have completed a diploma through the Phil Parker Training Institute in Neurolinguistic Programming, Life Coaching and Clinical Hypnotherapy.

advanced practitionerComment: This is does not represent anything approaching a degree from an accredited university or training institute. Phil Parker has been sanctioned by the UK Advertising Standards Authority for false claims about treating and even curing complex medical conditions. Yet the SMILE trial presented the Lighting Process as a treatment to the parents and children.

It would be fascinating to debrief the parents to discover what they assumed in consenting to their children’s participating in the trial. Did they think the children were being treated? Were they informed that the ASA forbade billing Lightning Process as a treatment? That the treatment providers were not chartered or qualified medical or mental health providers?

Neurolinguistic Programming has been widely discredited as quackery and is no longer is discussed in the scientific or clinical literatures.

Life Coaching is so vague a term as to be meaningless. There is no regulation or consistent specification of what is done or forbidden to be done in life coaching.

Clinical Hypnotherapy is not a restricted, independently recognized, nor chartered class of provider. Anyone can call themselves a clinical hypnotherapist. Phil Parker’s institute issues meaningless certificates that be hung on providers’ walls to confuse consumers.

This diploma is examined through written and practical examinations and is accredited by the British Institute of Hypnotherapy and NLP.

 Comment: Sounds impressive, huh? The ‘written and practical examinations’ involve showing adeptness in delivering a quack treatment that involves making false claims and offering pseudoscientific explanations to patients- messages defined by those who sell the training products.  Ability to meet these criteria involves taking trademarked training courses in quackery. Any deficiencies in knowledge or practice that examiners perceive are remedied by taking more courses. Essentially, this is a pyramid scheme from which Phil Parker benefits financially.

Reassured that providers are accredited by “British Institute of Hypnotherapy and NLP?” Go visit the website and you can readily see that it is an extension of Phil Parker’s marketing effort, not something independent or otherwise chartered or regulated. The site offers courses in referrals to people who have completed courses.

At the website a rotating variety of pseudoscientific explanations are provided with claims of dramatic effects of hypnosis that are at odds with the evidence. Visitors are led to believe that hypnotherapy is effective for reducing blood pressure and stopping smoking:

Hypnotherapy can help you kick the habit of smoking into touch for good.

Compare that to what is said by the Cochrane Collaboration:

Does hypnotherapy help people who are trying to stop smoking?

We have not shown that hypnotherapy has a greater effect on six-month quit rates than other interventions or no treatment. There is not enough evidence to show whether hypnotherapy could be as effective as counselling treatment. The effects of hypnotherapy on smoking cessation claimed by uncontrolled studies were not confirmed by analysis of randomized controlled trials.

The site also falsely claims that hypnotherapy can reduce blood pressure. The site is basically an advertisement for exaggerated claims about hypnosis backed by pseudoscientific explanations of how it works.

Hypnotherapists now understood neurology and physiology of using hypnosis and have the evidence of neurosciences support this understanding.

not psychologicalNonsense. This British Institute of Hypnotherapy and NLP is set up and run by a guy who claims neuroscience, osteopathy and neurolingustic programming explain the effects of the Lightning  Process, which are claimed to be physiological, not psychological. Who believes these additional claims about hypnosis are valid?

Consumer beware.

Practitioners undertake supervision and continuous professional development in order to further develop their skills and knowledge.

But the supervision is in use of a commercial product with a pseudoscientific explanation. So, apparently practitioners are supervised in their willingness and ability to adhere to the scripts they have received as part of products they have purchased. The “continuous professional development” is taking a steady stream of Phil Parker’s training courses. Because his materials are trademarked, no one who is not authorized by Parker to sell his merchandise.

They are regulated by the register of LP practitioners, adhere to a code of conduct and there is a Professional Conduct Committee that oversees complaints and professional practice issues.

There is a financial conflict of interest in Phil Parker offering courses and training and what the ASA has said cannot be described as treatment and then setting up a professional conduct committee is tied directly to his products.

What should parents be able to expect in bringing their children to a recognized, regulated healthcare site, like the NHS? The treatment providers should be professionals licensed by a governmental or independent body separate from any marketing of training. If not fully licensed or regulated professionals, they should be supervised by professionals, such as medical or mental health clinicians.

The class of providers should also be licensed or chartered so that sanctions with legal consequences can be applied for misconduct or unethical behavior. Providers working with children should be held to some ethical standards in terms of the safety and rights of both children and their parents.

None of these features are present in the treatment provided in the SMILE trial.

Christine Fenton, a retired Deputy Head of two high schools in the UK notes she was responsible for child protection in those roles. She expressed this concern about the basic conflict of Lightning Process and tenets of childhood protection:

LP participants are directed to not talk to others about it – keep secrets – to report positively regardless of their internal view is appalling to me. Child Protection has a key tenet ‘secrets are not ok’ – if an adult tells a youngster to keep a secret it is a form of control & creates an environment in which abuse can occur more easily.

Teachers, like other professionals coming in contact with children are required to take courses about child protective services and the duty to report abuse. They are held legally responsible for violation of the associated rules. However, legally, providers of the lightning process are only ordinary citizens, not professionals and are not held responsible in this manner.

In obtaining approval for the conduct of the SMILE trial from Bristol University, Pediatrician Esther Crawley claimed that sessions of the writing process were taped and that she had responsibility for reviewing the tapes. It strains credibility to claim that she actually listened to all the tapes from the study.

But what does it mean for a physician to supervise a quack treatment provided by quack providers who are not being allowed to call what they do treatment? How does Crawley react when physically ill, impaired children are instructed to deny their fatigue and pain to authority figures such as teachers and parents?

Truly mind-boggling to consider.

Bristol University should start cleaning up its clinical trial registries by publishing two psychosocial intervention studies

A story in the feisty Bristol Cable revealed Bristol University ignores its responsibilities to publish results of clinical trials. A follow up story announced the university’s pledge to remedy the situation.

The investigation of hidden data involved drug and medical device trials and excluded psychotherapy or psychosocial intervention trials. But here are two trials for which publication is overdue.

One of the trials evaluates a quack treatment, which the Advertising Standards Authority (ASA) advises cannot make claims about health benefits. Its promoter was paid handsomely for the treatment provided in the trial. He capitalized heavily on the trial to advertise his treatment as being evaluated in a clinical trial. Was the trial simply a lucrative infomercial for his discredited product?

box score

There is some evidence that these trials did not go as planned, but that is all the more reason to publish results so that we can understand what went wrong.

lack of transparency

The situation is sufficiently problematic for me to recommend:

Patients should not enroll in psychotherapy trials associated with Bristol University until results of these trials are published.

Patients should be advised that the burden and inconvenience of participating in research is not warranted if the results remain unpublished. You are not obligated to participate in research. Don’t let anyone tell you differently.

A headline in the investigative journalism platform Bristol Cable read:

Medical research in Bristol violates international transparency …

A joint investigation by TranspariMED and the Bristol Cable shows that the University of Bristol has not posted summary results for a single clinical trial onto registries. On the main European trial registry, the university is listed as the sponsor of 14 drug trials involving over 1,600 healthy volunteers and patients. Three trials that ended in 2009, 2011 and early 2016 have still not posted results there. Most of the remaining 11 trials also seem to have been completed, but are still listed as ‘ongoing’, suggesting that the university is not keeping its medical research records up to date.

On Clinicaltrials.gov, the main American registry, the university has registered 16 research projects; it has posted summary results for none of them.

A follow up headline read

Bristol University pledges clinical trial registry cleanup

A spokesperson for the university responded that Bristol had recently started adding results to the European registry. He also explained that until last year, “anyone could set up an account naming the University as the umbrella organisation” on Clinicaltrials.gov. The university has now assumed central control over those registry entries and is working to clean up its data, the spokesperson said.

The founders of the Bristol Cable told The Guardian: ‘We’re holding people to account for their actions’

The investigation was part of a larger international effort to uncover and correct a scandal: results of many drug trials are never published. Or published reports switch outcomes to make the manufacturers’ drugs appear more effective than they actually were in the trials.

Psychotherapy trials are excluded from these investigations. Yet, publishing results of psychotherapy trials consistent with the originally planned outcomes is undoubtedly less common because of lack regulatory oversight of psychotherapy trials. The confirmation bias in published of psychotherapy trials could even be stronger than with drug trials.

But we really cannot get a precise estimate of how many results of psychotherapy trials are being kept out of view. Many psychotherapy researchers do not even register their trials – or register only after they have already peeked at some of their results and can revise what were the originally intended outcomes being investigated.

This situation is unacceptable because it allows the promotion of ineffective and even harmful treatments.

Moreover, investigators have a moral and ethical responsibility to patients who consent to participate in clinical trials. In a trial comparing an intervention the investigators expect to be effective to a control group, half of the patients will not be randomized to the intervention. In many trials, this means the patients will be assigned to the no-treatment control group and get nothing. But these patients will be burdened with extra visits to complete the outcome assessments needed to evaluate the active treatment given to the patients in the other group.

Presumably, if the patients assigned to the control group are not simply confused or misinformed, they voluntarily continue to show up because they believe they are contributing to science and to knowledge that will help others in their predicament, if not themselves.


The first trial

The trial registration is ISRCTN72645894 DOI 10.1186/ISRCTN72645894

Early intervention in fatigue: a feasibility study

Study hypothesis

The overall aim of this study is to investigate the feasibility and acceptability of conducting a randomised controlled trial (RCT) to investigate the effectiveness and cost effectiveness of early intervention for chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME) compared with standard medical care in primary care.


Early intervention for fatigue. The intervention is based on the principles of cognitive, behavioural and graded exercise and is delivered by a trained therapist in an individual face-to-face session with telephone follow-up sessions. Follow up length: 6 month(s); Study entry: single randomisation only

Primary outcome measure: Recruitment, adherence and follow up. Timepoint(s): 3 and 6 months

Secondary outcome measures: Not provided at time of registration

Note that the primary outcomes are not patient clinical outcomes, i.e., whether patients benefited from being assigned to active treatment versus control. The study was explicitly described as a feasibility and acceptability study.

Psychotherapy studies are commonly described in the literature as pilot and feasibility studies, mainly to escape the criticism that the study was small and underpowered.  But, if so, effect sizes for patient outcomes should be presented because they are likely to be exaggerated and not generalizable to what would occur in a larger, better controlled study or in routine practice.

I wonder if the consent forms provided to patients indicated that the investigators were not interested in whether they benefited from treatment.

What results of a freedom of information act request revealed

Feasibility: We aimed to recruit 100 participants to this study, but were only able to recruit 44.  In addition, 9 (32%) who should have received EI did not have all the sessions offered.

Acceptability: Although 12 of the participants told us that some of EI was useful, 11 of these participants also found some parts unacceptable. Four participants were still experiencing fatigue after completing EI and two felt they wanted more help at the end. Four of those we talked to did not find EI acceptable and withdrew. Reasons included: not liking the treatment model, or the way it was delivered.

Fatigue, pain, mood and work status were no different between the two groups at the end of the study however the study was not large enough to show an effect.

Our results show that this type of study is not feasible and EI was not acceptable to a lot of participants

It is a disservice to the patients who participated in the trial that there is no published acknowledgement that the study did not reach its accrual goal because patients did not wish to participate.  Patients who consented to treatment did not generally find it helpful.  Publication of this study could serve as a warning that most primary care patients suspected of having chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME) are not interested in treatment based on the principles of cognitive, behavioural and graded exercise. The minority who consented to participate did not find the experience helpful.

The second trial: SMILE

 The trial registration is http://www.isrctn.com/ISRCTN81456207

The study protocol:

Crawley E, Mills N, Hollingworth W, Deans Z, Sterne JA, Donovan JL, Beasant L, Montgomery A. Comparing specialist medical care with specialist medical care plus the Lightning Process® for chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME): study protocol for a randomised controlled trial (SMILE Trial). Trials. 2013 Dec 26;14(1):444.

An overlapping pilot study

This protocol is also cited for a pilot for which no full report was published, only a summary. The results of this pilot study resulted in the outcomes being switched for the main study.

Crawley E, Mills N, Beasant L, Johnson D, Collin SM, Deans Z, White K, Montgomery A. The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study). Trials. 2013 Dec 5;14(1):415.

Was this really a separate pilot study or an abortive failed start to the study described in the protocol? We can’t tell.

Among the  sparse details from the pilot study:

Recruitment rates were lower than anticipated, meaning that recruitment continued for longer than planned. This was mainly due to an underestimate of the number of eligible patients at the start of the study (nearly half were not eligible). However, a recruitment rate of 35.9% does not preclude a full study.


In addition to the difficulty measuring change in school attendance for those transitioning from GCSEs to A levels, it may be a poor outcome measure for those who do not consider school attendance their primary goal. We suggest that a full study uses other primary outcomes, such as the SF-36 or the Chalder Fatigue Scale and uses school attendance as a secondary outcome.

So, at a time when other evaluations of interventions for ME/CFS were undergoing coordinated switching of outrcomes because of null findings from the FINE trial with the original scoring, the SMILE trial seems to have switched outcomes as well.

The treatment being evaluated in the main study is described as:

The Phil Parker Lightning Process® (LP) is a trademarked intervention that is used for a variety of conditions including CFS/ME. It has been developed from osteopathy, life coaching and neuro-linguistic programming. The intervention includes three group sessions on consecutive days where young people are taught skills that they can try out for themselves including looking at their sitting and standing posture. Families currently pay approximately £620 to attend the LP course.

Even though over 250 children and young people a year use the LP as an intervention for their CFS/ME, there are currently no reported studies investigating the effectiveness or possible side effects (for example serious adverse events) of the LP.

This is an exceedingly weak rationale for inflicting a quack treatment on unsuspecting children. Ethically, there must be a scientific rationale for exposing children to an unproven treatment that might be ineffective or even harmful.

The Advertising Standards Authority (ASA) guidance has ruled that LP cannot be advertised as a treatment:

To date, neither the ASA nor CAP [Committee of Advertising Practice] has seen robust evidence for the health benefits of LP. Advertisers should take care not to make implied claims about the health benefits of the three-day course and must not refer to conditions for which medical supervision should be sought.

Yet, the information sheet for the trial is describing it as a treatment to patients.

The materials patients must read as part of participating in the trial reek of pseudoscientific misinformation.

LP trains individuals to recognize when they are stimulating or triggering unhelpful physiological responses and to avoid these, using a set of standardized questions, new language patterns and physical movements with the aim of improving a more appropriate response to situations.

* Learn about the detailed science and research behind the Lightning Process and how it can help you resolve your issues.

* Start your training in recognising when you’re using your body, nervous system and specific language patterns in a damaging way

 What if you could learn to reset your body’s health systems back to normal by using the well researched connection that exists between the brain and body?

The Lightning Process does this by teaching you how to spot when the PER is happening and how you can calm this response down, allowing your body to re-balance itself.

 The Lightning Process will teach you how to use Neuroplasticity to break out of any destructive unconscious patterns that are keeping you stuck, and learn to use new, life and health enhancing ones instead.

 The Lightning Process is a training programme which has had huge success with people who want to improve their health and wellbeing.

The intervention imposes strange demands on patients that encourage dishonesty, including in completing the outcome evaluations:

  1. Responsibility of patients:

Believe that Lightning Process will heal you. Tell everyone that you have been healed. Perform magic rituals like standing in circles drawn on paper with positive Keywords stated on them. Learn to render short rhyme when you feel symptoms, no matter where you are, as many times as required for the symptoms to disappear. Speak only in positive terms and think only positive thoughts. If symptoms or negative thoughts come, you must stretch forth your arms with palms facing outward and shout “Stop!” You are solely responsible for ME. You can choose to have ME. But you are free to choose a life without ME if you wish. If the method does not work, it is you who are doing something wrong.

Bristol University at first rejected a freedom of information act requests for how much developers of the treatment were paid but on appeal revealed mean cost of a course for trial participants was £567. This means £14,000 wasted on a junk intervention in the pilot study and much more was paid for the full trial.

Special thanks to John Peters for his assistance and his excellent detective work and use of the Freedom of Information Act.

See his blog posts here:

THE SMILE TRIAL (part 1): Why the trial should never have been allowed in the first place.

THE SMILE TRIAL (part 2): A trial so flawed as to be worthless.

THE SMILE TRIAL (part 3): The only one to benefit is Parker. 

And also my post


Parker start your journey


Beware of the pinkwashing of suicide prevention

Cause marketing of cosmetics to prevent suicide could mark the return of exploitation of a good cause for profit.

Just as with we learned with Breast Cancer Pink Ribbon campaigns, we need to ask questions about what is being accomplished, where the profits are going and whether we should object.

Two companies announced special deals on cosmetics to reduce suicide.

Brandt Skincare ‘s $38 limited-edition #sayiloveyou skin-care kit

brandt kit with tattooBrandt skin care announced it was launching a special deal in #sayiloveyou skin-care kit for suicide awareness month


After renowned celebrity dermatologist Dr. Fredric Brandt died by suicide in 2015, his friends and colleagues (given that he was known for being unfailingly warm and outgoing, the two often overlapped) started the Dr. Brandt Foundation in his honor to raise awareness by encouraging meaningful, empathetic conversations around mental illness and provide a support system for those whose lives have been affected by its devastating effects.

This Sunday, to coincide with Suicide Prevention Awareness Month, the Foundation is set to launch a new social media campaign to help raise money, promote understanding, and encourage fans and followers to join the fight against suicide and depression. Getting involved is easy: For every image of a heart posted to Instagram with the hashtag #sayiloveyou, the Foundation will donate $1 to its suicide prevention project up to $100,000.

Dr. Brandt Skincare will also offer a $38 limited-edition #sayiloveyou skin-care kit, available September 10, that includes a collection of the brand’s best-selling products, a signature tote bag, and a temporary heart tattoo (yes, for the ‘gram), with a percentage of the proceeds going to the Dr. Brandt Foundation. (Of course, you can always donate directly to the cause, too.)

Not to be outdone, NYX announced #LuvOutLoud

way to go

NYX’s #LuvOutLoud donates $6,000 to The Trevor Project, a non-profit that helps provide support and suicide prevention for LGTBQ youth.

Whether it’s black lipstick, bold brows, or something as simple as faux freckles, makeup can send a meaningful message about who you are, what you stand for, and the way you want to be seen. But the process of turning your personal beauty choices into part of your identity can start even before it makes its way to your face, like when you buy a tube of Luv Out Loud, a new collection of liquid lipsticks from NYX Professional Makeup,.


The lipsticks don’t just represent the NYX mantra of “inclusivity, acceptance, and artistry for all” in name alone: The brand teamed up with makeup artist and social-media influencer Angel Merino, aka @mac_daddyy, to donate $6,000 to The Trevor Project, a non-profit that helps provide support and suicide prevention for LGTBQ youth.

NYX’s new lipstick line supports the LGBTQ+ community 

Makeup for the win!

NYX has new matte lipsticks coming out — and they benefit a beautiful cause. It’s always great when our makeup addictions serve a higher purpose, right?

The brand has partnered with celebrity makeup artist Angel Merino to raise money for the LGBTQ+ community with its Luv Out Loud collection.

NYX and Angel will donate $6000 to The Trevor Project — an organization that fights to keep suicide rates down among LGBTQ+ youth.

The brand is also hosting a contest that allows people to enter to win $10,000 that will be donated to the charity of their choice.

All you have to do is post a video of yourself talking about how a part of your life represents one of the empowering shade names in the new collection.

“It’s déjà vu all over again.” – Yogi Berra 


Pinkwashing was first applied to:

The practice of a company using support of breast cancer-related charities to promote itself and its products or services.

But then became:

(LGBT) The practice of a state or company presenting itself as gay-friendly and progressive, in order to downplay their negative behavior.

Pink Ribbon Blues

folgersBreast Cancer, Concept Brand with Pink Ribbon Logo Breast Cancer, Concept Brand with Pink Ribbon Logo

Gayle Sulik, author of Pink Ribbon Blues: How Breast Cancer Culture explained:

A brand must inspire people to spread the word about your “product.” One of most powerful ways to do this is through an emotional connection that encourages consumers to identify with the brand message.

Nike’s “Just Do It” slogan with accompanying “swoosh” logo dared consumers to take action and challenge themselves. Igniting a purpose beyond the mere purchase of athletic gear, the company tapped into an American belief about the importance of hard work and getting ahead. Many brands are designed to influence how people think of themselves. Am I classic, trendy, healthy, conscientious, rugged, interesting? In the context of Nike’s product line, “doing it” also meant engaging in physical activity that likely required Nike gear. But it was the message not the product that led to sales.

The pink ribbon works in a similar way. It functions as a logo for a “set of expectations, memories, stories and relationships that, taken together, account for a consumer’s decision to choose” the breast cancer brand.

The breast cancer brand draws from a collection of symbols, images, and meanings within pink ribbon culture to maintain the principal message that breast cancer is a vitally important cause, and that supporting it indicates good will toward women. The brand encourages people to buy and display pink in the name of increased awareness, improvement in women’s lives, faith in medical science, and hope for a future without breast cancer. The brand capitalizes on emotional responses related to fear of the disease, hope for a cure, and the goodness of the cause.

pinkwashed productsThe movie Pink Ribbon Blues, Inc slammed “pink-washing” in breast cancer marches and awareness campaigns

The film questioned

the priorities of the campaigns and the broad use of the pink-ribbon logo as a fight-breast-cancer addition to products as diverse as T-shirts, toilet tissue and handguns.



“For me, pink ribbons were something very innocent,” said Lea Pool, director of the made-in-Canada documentary, which emphasizes the corporate sponsors of many of the events.

“I think it’s still not a bad idea, but I was very afraid of all the corporations and how they hijacked the disease and how they made profits out of that, and how there is pink-washing in the process of doing fund-raising.”


“It’s not about raising money it’s asking the question about where that money is going,” said Pool. Coining a phrase from an activist web site, she added: “Think before you pink.”

Think Before You Pink

Breast Cancer Action launched an effective campaign to get people asking questions before they participated or donated to a breast cancer walk.

Each year, hundreds of thousands of people come together to participate in breast cancer walks and runs across the U.S. Since the first breast cancer walks began in the 1980s, they have become one of the most common ways for people to try to do something about breast cancer.

Some of these walks have become huge affairs that are hosted by multi-million dollar charities and sponsored by multi-billion dollar corporations that raise millions to “end breast cancer.” And yet each year, 250,000 women are diagnosed with breast cancer and 40,000 women die of this disease.

NFL cheerleaderThe NFL Pink October, A Perfect Catch was launched and  came under particular scrutiny

NFL’s A Perfect Catch

Overview of the NFL’s Fundraising Efforts for the American Cancer Society

The NFL does not profit from the sale or auction of breast cancer awareness-identified (“Pink”) merchandise. Since 2009, the first year of the NFL’s “A Crucial Catch” campaign, the NFL’s work has raised approximately $4.5 million for the American Cancer Society, with the majority of the contribution coming from the sale of Pink items at retail and via the NFL Auction website. Beginning with the 2011 “A Crucial Catch” Campaign, money raised via the campaign supports the American Cancer Society’s Community Health Advocates National Grants for Empowerment (CHANGE) program. This program promotes health equity and addresses cancer screening disparities through community based cancer prevention and early detection programs that increase access to breast cancer screenings. The program officially launched in 2012 within 17 communities across the country (each within 100 miles of an NFL city) where data showed that the population had lower breast cancer screening rates and higher mortality rates relative to other communities. The goal of the program is to add multiple locations in 2013 and beyond; and assist even more women in their efforts to prevent cancer and find cancer early.

buy pink nfl

Here’s why the NFL’s annual pink campaign does almost nothing to fight breast cancer

The NFL has its own perilous health issues that the league has attempted to cover up. And in fact, they toned down all the pink last year in what appeared to be an effort to avoid looking too hypocritical – after the league bungled several domestic violence cases involving players.

The issue with football’s self-congratulatory awareness month goes beyond pink pom-poms, pink penalty flags and pink cleats. Hardly any of the money raised during this month even reaches the American Cancer Society. But the criticism – many from breast cancer survivors – hasn’t phased the NFL or many of its partners.


Business Insider wrote in 2013 that just 8.01 percent of money from NFL Breast Cancer Awareness merchandise goes to research efforts. Even worse, VICE Sports reported last year that none of that money goes toward cancer research programs. A spokeswoman for the American Cancer Society told VICE the NFL donations go to awareness, education and screenings.

The NFL program promoted breast cancer screening without regard to the evidence questioning its effectiveness and risks versus benefits, especially among younger women.

“Screening doesn’t save lives and screening mammography … is different from diagnostic mammography,” Jagger says. “The NFL has no business providing medical advice to women that is outdated, unproven, and misguided.”

Jagger quotes well-regarded and independently conducted research that shows screening mammography has no overall impact on survival rates of women with the disease.

The NFL Won’t Turn Pink In 2017


After eight straight Octobers of painting fields, cleats, and helmets with pink ribbons, the NFL has decided to discontinue its “pink October” initiative, The MMBQ reports.

Since 2009, NFL games in the month of October have featured football players wearing pink in support of awareness and screening initiatives alongside the American Cancer Society. However, the league will now expand the campaign in an effort to raise awareness and screening for other forms of cancer as well.

The new campaign, which will keep the original name of “A Crucial Catch,” will allow individual teams to choose the cause that they’ll champion during a three-week window in October.

The move comes after years of criticism that the NFL’s “pinkwashing” actually does very little for breast cancer patients in terms of funding research for the cure. The new campaign will still focus on education and screenings, instead of raising funds for research.

I am offering e-books providing skeptical eBook_Mindfulness_345x550lookseBook_PositivePsychology_345x550at mindfulness and positive psychology, and arming citizen scientists with critical thinking skills so they dan decide for themselves. I am also offering scientific writing courses on the web as I have been doing face-to-face for almost a decade. I want to give researchers the tools to get into the journals where their work will get the attention it deserves.

Sign up at my website to get advance notice of the forthcoming e-books and web courses, as well as upcoming blog posts at this and other blog sites. Get advance notice of forthcoming e-books and web courses. Lots to see at CoyneoftheRealm.com.

Acceptance and Commitment Therapy and Positive Psychology: Theoretical integration or product line expansion?

doritosDoes combining ACT and positive psychology yield something like a Nacho Cheese Doritos® Locos Tacos Supreme? A product line expansion for ACT?

As documented in a previous blog post, the founders of Acceptance and Commitment Therapy seem to be crafting themselves as workshop gurus. This is at the expense of attending to the pressing need to develop a base of evidence appropriate to the claims being made for the efficacy of ACT.

By the usual standards, the evidence is weak that ACT is an effective treatment for any of a range of clinical problems. There is no evidence that ACT is superior to the already disseminated psychotherapies its promoters would replace.

ACT joining forces with the huge  positive psychology movement could be a strategic next step, if expanding the market for ACT products is the goal. There are obvious theoretical differences between ACT and positive psychology, but signs are that these differences are sidestepped in joint marketing ventures. Press releases are on the web for a “historic “captains of both ships” Barbara ‘Positivity’ Fredrickson and Steven ‘ACT’ Hayes having a “historic meeting in Berlin.

Talks by Fredrickson and Hayes are also jointly being promoted here. 

A historic meeting of Positive Psychology and ACT

Zegers Hein interviews  Barbara Fredrickson & Steven Hayes

Some excerpts from the article and interview:

Positive Psychology and ACT (Acceptance and Commitment Therapy) are different movements within psychology. Yet they also have quite a lot in common. We witnessed the two captains of both ships meet for the very first time: Barbara ‘Positivity’ Fredrickson and Steven ‘ACT’ Hayes. Here is an exclusive report of this historic meeting in Berlin, Germany1. This meeting is indicative of Positive Psychology 2.0, the so-called ‘second wave positive psychology’ that embraces ‘negative’ emotions. Questions are raised that are highly relevant for this MOOC, such as: Would you prefer to feel all kinds of emotions or just to be happy? Can ‘negative’ emotions be positive?

Positive Psychology and Acceptance and Commitment therapy (‘ACT’ for short, pronounced as one word) both appeared at about the same time within the history of psychology. Since its inception, Positive Psychology has always held ‘The Meaningful Life’ as a central pillar. Similarly, within ACT, moving towards meaningful ‘Valued Living’ is a core process. What, then, are the differences between both movements?

Positive’ Psychology vs. ‘Dark’ ACT?

Fredrickson: ‘Positive Psychology, to me, is not a separate domain of psychology. It’s an emphasis, a leaning, a call within psychology to also focus on positive aspects.’ But isn’t this positive emphasis different from what ACT proclaims?

Hayes: ‘When ACT first got popular attention with a story in ‘Time’, this story was titled ‘Happiness is not normal’. Which is of course something we’d never said, but some reporter wrote down. Another headline of that time was ‘Hello Darkness’. And I get that (laughs). From the beginning, we’ve cared about meaning and purpose and values-based action. Constructing the sort of lives that make life worth living.’ Turning towards his neighbor: ‘And Barbara has, throughout her career, really focused on the relationship between positive emotions and behaviour. And that is of central importance, I think, to ACT.’

Sweet Sadness

ACT consciously tries to avoid labeling emotions ‘positive’ or ‘negative’. How would you define positive emotions for ACT? Hayes: ‘It seems to be so contextually bound, that you can flip it. Take for instance sadness, is that negative? Clearly not. If my mother died last spring, sadness is what I would want, right? Is that a negative emotion? No, it’s not a negative emotion. In fact, are there any negative emotions (that are not contextually bound)? If you live them fully, and put them into your life that leads you in a values-based direction?’

So what ‘negative’ are we talking about here? Fredrickson: ‘I think that, as a field, we’ve inherited some language in terms of calling classes of emotions ‘positive’ and ‘negative’, and there’s so much levels at which you could define that ‘positive’ and ‘negative’. I think that what’s meant by it, is this: ‘If all other things were equal, would this be a wanted state? Would you want the state to continue?’ Hayes nods in agreement when Fredrickson continues: ‘Negative emotions are useful if connected to context, but become negative if disconnected from context.’

When pressed for a further clarification of this distinction, Fredrickson continues: ‘I think of it as a can opener. Positive emotions, or hedonic well-being, is a way to open people up, in a way so they can see and appreciate more meaning. And experiencing meaning more is in itself an emotional uplift too’.

‘By the way, speaking of opening up’, Fredrickson smiles, ‘another illustration may be the licence plate I have chosen to put on the car I drive. The licence plate on my car reads: “Be Open”.’

Choose to feel

Hayes: ‘Exactly. Be Open. And for me, that includes openness to sadness. The point is that openness to sadness – including seeing the suffering of others, and being moved by it – is critical to compassion and happiness. Said in another way, the poets are right: it is our tears that scoop out a place for our laughter to reside.

But Barbara’s license plate on her car is right on: ‘Be Open’. Note, it is not “Be Happy.” It’s “Be Open”’, Hayes points out. ‘I have a similar sign on the wall of my office: “Choose to Feel.”

None of this is in any way theoretically clear, but maybe it is unfair to apply the standards of an entirely different form of discourse.  “Pepsi’s the One”  is advertising, not a theoretical propositon or an evidence-bassed statement. Probably the same for some of the sloganeering in this interview. But was does this do for the credibility of Hayes and Fredrickson when they want to speak more seriously?

I can’t wait for next year’s model, Positive Psychology 2.0, or did I miss it and  now have to wait for the fall release of Positive Psychology 3.0?

Personally, I am a great fan of traditional tacos and all their regional Latin Amercian variations. Some neuva ola and fusion tacos are tasty, too. But  I can’t bring myself even to go near a Nacho Cheese Doritos® Locos Taco Supreme. Just not authentic enough and the fake cheese is gross.

eBook_PositivePsychology_345x550I will soon be offering e-books providing skeptical looks at positive psychology and mindfulness, as well as scientific writing courses on the web as I have been doing face-to-face for almost a decade.

Sign up at my website to get advance notice of the forthcoming e-books and web courses, as well as upcoming blog posts at this and other blog sites. Get advance notice of forthcoming e-books and web courses. Lots to see at CoyneoftheRealm.com.

Psychological interventions do not reduce pain, despite claims of proponents

A provocative review finds a “lack of strong supporting empirical evidence for the effectiveness of psychological treatments for pain management.”

The open access paper

Georgios Markozannes, Eleni Aretouli, Evangelia Rintou, Elena Dragioti, Dimitrios Damigos, Evangelia Ntzani, Evangelos Evangelou and Konstantinos K. Tsilidis. An umbrella review of the literature on the effectiveness of psychological interventions for pain reduction, BMC Psychology https://doi.org/10.1186/s40359-017-0200-5

This article received open or public peer review . The three versions, reviewers’ comments, and author responses are available here 

Why this review was needed

According to the review:

Psychological interventions were introduced over 40 years ago and are now well established in clinical practice [5]

…the effect sizes across all meta-analyses are modest, only rising above a medium-size effect (i.e., standardised mean difference larger than 0.5) in lower quality studies [4].

… Because of the wide implementation of psychological interventions in pain management and the elevated likelihood for biases in this field as shown in prior relevant empirical research [19, 20], we used an umbrella review approach [21, 22] that systematically appraises the evidence on an entire field across many meta-analyses. In the present study we aimed to broaden the scope of a typical umbrella review by further evaluating the strength of the evidence and the extent of potential biases [23, 24, 25, 26, 27] on this body of literature.

What is an umbrella review?

 A key source defines an umbrella review:

Ioannidis JP. Integration of evidence from multiple meta-analyses: a primer on umbrella reviews, treatment networks and multiple treatments meta-analyses. CMAJ. 2009;181(8):488–93.

Umbrella reviews (Figure 1) are systematic reviews that consider many treatment comparisons for the management of the same disease or condition. Each comparison is considered separately, and meta-analyses are performed as deemed appropriate. Umbrella reviews are clusters that encompass many reviews. For example, an umbrella review presented data from 6 reviews that were considered to be of sufficiently high quality about nonpharmacological and nonsurgical interventions for hip osteoarthritis. 9 Ideally, both benefits and harms should be juxtaposed to determine trade-offs between the risks and benefits. 10

ioannidis umbrella review

Ioannidis provides the following caveat about umbrella reviews and data syntheses more generally:

Integrating data from multiple meta-analyses may provide a wide view of the evidence landscape. Transition from a single patient to a study of many patients is a leap of faith in generalizability. A further leap is needed for the transition from a single study to meta-analysis and from a traditional meta-analysis to a treatment network and multiple treatments meta-analysis, let alone wider domains. With this caveat, zooming out toward larger scales of evidence may help us to understand the strengths and limitations of the data guiding the medical care of individual patients.

Discrepancy of this review with past evaluations

Our results come in discordance with the generally strong belief in the literature that psychological therapies are universally effective on a variety of pain conditions [76, 77, 78]. However, this belief is mainly established based on a limited number of small primary studies, and future larger studies are warranted. Notably, the median number of individuals in the intervention and control groups in each individual study included in our systematic evaluation was only 33 and 28 respectively, whereas the median number of studies included in each meta-analysis was only three. Our evaluation revealed that the reported effectiveness is usually overstated in the existing studies. The nominally statistically significant associations between psychological interventions and pain were confirmed in less than half of the examined meta-analyses. In addition, the random effects estimates were statistically significant in only 20% of the meta-analyses, when a P-value threshold of 0.001 was applied. Furthermore, in only nine meta-analyses the prediction interval excluded the null value, thus suggesting that only 6% of future studies are expected to demonstrate substantial “positive” (i.e. not null) associations between psychological interventions and pain treatment.

The punchline and the remedy

In conclusion, the present findings support that the effectiveness of psychological treatments for pain management is overstated and the supporting empirical evidence is weak. The present findings combined with the fact that psychological intervention trials are still at an early research stage and fall short compared to drug trials [87] underline the necessity for larger and better-conducted RCTs [85] Future research should further focus on building networks involving all stakeholder groups to achieve consensus and develop guidance on best practices for assessing and reporting pain outcomes [88, 89]. The use of standardized definitions and protocols for exposures, outcomes, and statistical analyses may diminish the threat of biases and improve the reliability of this important literature.

ebook_mindfulness_345x550I will soon be offering e-books providing skeptical looks at mindfulness and positive psychology, as well as scientific writing courses on the web as I have been doing face-to-face for almost a decade.

Sign up at my new website to get advance notice of the forthcoming e-books and web courses, as well as upcoming blog posts at this and other blog sites.  Get advance notice of forthcoming e-books and web courses. Lots to see at CoyneoftheRealm.com.

A longer than needed look at ’11 minutes of mindfulness can reduce drinking by bottle of wine a week.’

Why University College, London issued embargoed press release for an already published mindfulness study is more interesting than the insipid study itself.

The study is actually provides an excellent teaching example of what can happen when a recipe for hype-worthy mindfulness study is mindlessly followed.

University College, London should put more money into providing competent methodological and statistical consultations than orchestrating publicity campaigns promoting studies of mindfulness laced with pseudoscience.

A journalist sent me an embargoed press release from University College, London. At first I couldn’t make sense of why there was embargo, because the study itself was already available on the web.

embargoed for release

Apparently UCL was trying to coordinate a media campaign for a mediocre study by coordinating churnaling – essentially plagiarizing by journalists – in the media like a chorus of quacking ducks..

Not surprising, sources, like The London Times and Time complied fabulously.


How A Short Meditation Can Help People Drink Less

times mindfulness


New sources churnaled the press release, which said:

Brief training in mindfulness strategies could help heavy drinkers start to cut back on alcohol consumption, finds a new UCL study.

After an 11-minute training session and encouragement to continue practising mindfulness — which involves focusing on what’s happening in the present moment — heavy drinkers drank less over the next week than people who were taught relaxation techniques, according to the study published in the International Journal of Neuropsychopharmacology.

“We found that a very brief, simple exercise in mindfulness can help drinkers cut back, and the benefits can be seen quite quickly,” said the study’s lead author, Dr Sunjeev Kamboj (UCL Clinical Psychopharmacology Unit).


“We used a highly controlled experimental design, to ensure that any benefits of mindfulness training were not likely explained by people believing it was a better treatment,” said co-author Dr Tom Freeman (Senior fellow of the Society for the Study of Addiction), who was part of the research team while based at UCL.

The mindfulness group drank 9.3 fewer units of alcohol (roughly equivalent to three pints of beer) in the following week compared to the week preceding the study, while there was no significant reduction in alcohol consumption among those who had learned relaxation techniques.

“Practising mindfulness can make a person more aware of their tendency to respond reflexively to urges. By being more aware of their cravings, we think the study participants were able to bring intention back into the equation, instead of automatically reaching for the drink when they feel a craving,” Dr Kamboj said.

The study itself was not very thoughtfully constructed according to a familiar recipe:

1. Appeal to neoliberal policies by setting out to claim that citizenry can learn to self-discipline themselves away from unruly behavior with cheap methods that will distract from underfunding of health and substance abuse services.

2. Take some speculations about how mindfulness applies eastern meditation techniques to change health behaviors and apply them to drinking alcohol.

3. Ignore existing conventional literature concerning skills relevant to avoiding excessive alcohol consumption.

4. Rely on effect sizes from an underpowered study of mindfulness for reducing smoking. Recruit exactly the same number of participants.

5. Assemble a battery of psychological measures that might conceivably be affected by mindfulness meditation or an imbalance of nonspecific effects between groups.

6. Assemble a set of biological measures claimed in the literature to be biomarkers for a state of contemplative mindfulness.

7. In response to criticism that past mindfulness studies have been unblinded comparisons of mindfulness to inert conditions, claim blinding of experimenters and participants and use an active treatment, relaxation.

8. Avoid measurement of whether participants actually practiced mindfulness.

9. Ignore indications from full study analyses whether within-group analyses would make for attractive results.

10. More generally, significance-chase and selectively report favorable results.

What can go wrong?

1. The authors could take advantage of lower standards of evidence required to promote results appealing to neoliberal prejudices. Yet they may have gotten carried away with claims only 11 minutes of mindfulness reduce drinking equivalent to a three pints of beer or a bottle of wine per week. And the adverse social consequences of these claims being accepted:

Weak designs with short-term subjective self-report outcomes proclaiming dramatic results can lead to continued underfunding of services and denial of more intensive services to those most in need.

2. Armchair speculations from the mindfulness literature are poor substitute for functional analysis of behavioral processes leading towards moderate versus excessive drinking. Really, let’s let some common sense in:

3. By the time that people are contemplating beer in their mouths, it may be too late for them to engage more adaptive and effective practices. Furthermore, concentrating too much on the taste of beer may be counterproductive for those who enjoy it and who would be better off focusing on distracting social cues. Namely, they could be concentrating on the conversation and the people around them drinking less, rather than getting focused on the beer in their mouth.

4. As expected, effect sizes from underpowered study in a different population and different clinical focus proved exaggerated. Moreover, given the study’s distinctive claim about elucidating the biological underpinnings of mindfulness, a much larger sample would’ve been needed to be geared to finding of facts in those outcomes if they were indeed present.


5. Many of the other psychological measures were poorly chosen and irrelevant to evaluating the intervention, but were nonetheless selectively presented. I won’t waste my readers time keeping score as I cut through this underbrush.

6. The assessment of particular biological correlates of mindfulness was a both a matter of convenience of measurement in a short session and belief in the myth that such correlates are not only biomarkers, but the mind-body indicators that participants had achieved a state of contemplative mindfulness in the process of listening only to 11 minute tape.

A biological correlates does not a biomarker make, and less specificity can be established and cross validated cut points for mindfulness verses-not mindfulness. What is also ignored is that there are no specific “biological markers” for mindfulness. Any correlates with mindfulness training are often due to nonspecific aspects of the treatment, if they are not noise.

Cardiac vagal tone is particularly dubious as a measure. It’s highly responsive to contextual factors and has large intra-and inter-individual variability. Moreover, it is susceptible to changes in breathing and so it is not surprising that changes were greater in the relaxation group. In general, it would take a much larger study under much more carefully controlled conditions to produce meaningful results.

The authors conveniently ignored that other than when conducted by promoters of transcendental meditation, reliable differences in blood pressure are typically not found. With such a grossly underpowered sample, any apparent differences are likely to be artifactual, due to outliers, or simply noise being interpreted as music..

7. The authors claim that a strength of their study is that they have a double-blinded comparison of two active treatments. Neither research assistants nor participants were told which was the mindfulness nor relaxation condition. Yet, the mindfulness tape gave much clearer instructions as to the experimenters intentions and expectations about how effects would be reported in subjective self-report measures. It’s not clear why participants would expect getting relaxed would reduce alcohol consumption.

The authors seem unaware of the literature concerning how easy it is to induce changes in subjective self-report of short-term alcohol consumption. In the 80s, a number of us did studies in which the active intervention was simply eliciting reports of alcohol consumption and giving participants feedback that it was more than peers rank or compared to some normative standard. I seem to recall that if you follow that literature back further, you’ll see that this active treatment had started as a control condition with significant effect on self-reported alcohol consumption in the short term. I’m very skeptical about whether such changes persist over the long-term, except in participants otherwise motivated to reduce the alcohol consumption.

8. Despite the assembly of a full range of psychological and biological measures, the authors fail to access whether participants actually went home and practice mindfulness. They don’t report any attrition, but that might be in effect a participants been able to report in remotely, rather than not showing up for reassessment as part of an otherwise noncompliance with the study.

9. The abstract of the published study clearly indicated the point at which the authors commit themselves to significance chasing and p-hacking.

Both groups showed acute reductions in craving after training, although a trend Group x Time interaction (p=0.056) suggested that this reduction was greater in the relaxation group (d = 0.722 P < .001) compared with the mindfulness group (d = 0.317, P = .004).

10. I could go on, but I think you get the picture. An overwhelming number of statistical tests within and between groups on a full range of often irrelevant variables are mustered to make the case that more of this sort of research is needed. The spin on the findings in the press campaign can only serve to encourage more of this research and strengthen the tendency towards confirmatory bias. But in the end, the authors hypothesized a group by time interaction in changes in cravings and did not obtain it, although admittedly in an underpowered study. But they made it into Time magazine and The London Times described in exactly the words they provided.

As an experiment, I did not provide my usual links to relevant literature. I’ve been disappointed in how few readers click through and actually access those links, despite my efforts to make many of them open access. However if any readers want to take issue with me, I invite them to provide links to studies at odds with what I’m saying and I will see what I can come up with in response.

Is acceptance and commitment therapy (ACT) in a post-evidence phase?

Steve Hayes encouraged me to give the evidence for the efficacy of ACT another look. I did and I wasn’t impressed.

Recent interviews with three founders of ACT make little reference to evidence, but a lot of reaching for roles as gurus, not as trainers in evidence-based therapy.

I recently tweeted about acceptance and commitment therapy (ACT).

my tweet

I got a quick reply from Steve Hayes:

edited steve hayes exchange

I checked the document, and had lots of numbers, but little indication of accumulating quality studies. I recognized some of the meta-analyses were quite bad.


The document listed 2 organizations that describe ACT, or areas of ACT, as evidence based, APA Division 12 and SAMHA. Both sourceds depend heavily on promoters of a particular approach assembling and evaluating material, with all the biases that that introduces, not independent, systematic evaluation. The APA page was written by an ACT his enthusiasts, but was nonetheless not particularly impressive. Only ACT for chronic pain received an evaluation of more than modest support.

American Psychological Association, Society of Clinical Psychology (Div. 12), Research Supported Psychological Treatments.

Chronic Pain – Strong Research Support

Depression – Modest Research Support

Mixed anxiety – Modest Research Support

Obsessive-Compulsive Disorder – Modest Research Support

Psychosis – Modest Research Support

I checked the most recent review and meta analysis of ACT for chronic pain.

Veehof MM, Trompetter HR, Bohlmeijer ET, Schreurs KM. Acceptance-and mindfulness-based interventions for the treatment of chronic pain: a meta-analytic review. Cognitive Behaviour Therapy. 2016 Jan 2;45(1):5-31.

The review combined  28 studies evaluating mindfulness or ACT. It did not provide separate evaluations for the two treatments. There were 9 studies comparing ACT to routine care or wait list. Only one had more than 35 patients in the smallest group at follow up, a study of ACT with fibromyalgia patients. There was one study comparing  ACT with CBT having such a minimal sample size, and the two treatments did not differ. There were two comparisons with multidisciplinary treatment, but neither met this minimal sample size.

A systematic review that is almost as recent further showed what bad shape the literature concerning ACT for pain is in.

Hann, K. E. J. & McCracken, L. M. (2014). A systematic review of randomized controlled trials of Acceptance and Commitment Therapy for adults with chronic pain: Outcome domains, design quality, and efficacy. Journal of Contextual Behavioral Science, 3, 217-227.

The review discretely suggests that the weak designs and potential for p-hacking of the typical study of ACT for pain would allow even homeopathy to look better than nothing.

A systematic search identified 1034 articles and ten studies were selected as eligible for review. Overall, 15 outcome domains were assessed using 39 different measurement tools across the ten RCTs. The outcome domains assessed in the reviewed trials were, to an extent, in-line with recognized guidelines. Six of the ten studies identified primary and secondary outcomes; one included just one outcome and three did not categorize outcomes. All ten trials included a measure of some aspect of psychological flexibility; however these were not always formally identified as process variables. Pain and emotional functioning were the most frequently measured outcome domains. A review of outcome results suggests that ACT is efficacious particularly for enhancing general, mostly physical functioning, and for decreasing distress, in comparison to inactive treatment comparisons. It is recommended that future RCTs (a) formally define outcomes as primary, secondary and process variables, (b) consider including measures of physical or social functioning, rather than pain and emotional functioning, as primary outcomes, (c) address existing risks of bias, such as reporting bias, and (d) include more components of psychological flexibility, such as cognitive defusion and self-related variables.

Are the leaders of the ACT movement giving up on accumulating evidence and reaching for guru status? Maybe, if some recent interviews are any indication.

3 Founders of ACT in BPS Psychologist

Aseries of interviews by Kal Kseib with three founders of ACT can be found in the BPS Psychologist– Kelly Wilson, Kirk Strosahl and Steve Hayes.

Kelly Wilson

The title of the interview with Kelly Wilson suggests he is going to pluck some flowers stuck between his toes in his Gucchi sandals 

Kelly you find some connection

Kelly doesn’t disappoint.  He does mention evidence three times. Twice here:

There’s interesting evidence out there about how even just small doses of such things can make a difference. In research looking at sedentary behaviour, just a couple of minutes each hour of getting up and moving around is shown to disrupt some of those destructive metabolic processes. Reducing exposure to toxins including social toxins, moving your body, getting enough sleep, eating nutritious food, engaging in some small mindfulness practice – every bit of evidence seems to suggest that really small amounts matter. And if you look at behavioural activation, which is one of the tier 1 treatments for depression, it’s about ‘get them started’. The smallest thing – even if just your feet move! Go down to the corner, go out for coffee, go out to a movie with a friend. That work was really built on the idea that these patterns of small activities give a chance for the stream of life to kind of pull you back in.

And then

For instance, there’s evidence to show that people with high levels of self-stigma about their obesity massively increase their risk of all-cause mortality and cardiac mortality.

I wouldn’t interpret modest effect sizes in observational studies in this way. But whatever….

Then there is the too-much-information, grab-your-guru-status disclosure.

What’s something people might not know about you that, if they knew, would surprise them?

I came to psychology late. I was 30-years-old when I started college. I dropped out of school when I was 16. And between the ages of 16 and the age of 30, I was a drug addict and an alcoholic. Chronically unemployed and unemployable – a serial felon. Terribly, terribly depressed – suicidally depressed pretty much all the time, except for little glorious windows in time when I’d get just the right combination of drugs and I’d be able to feel like I could stay in my own skin for a minute. But mostly it was just hard and destructive to me and to a lot of other people. In 1985, at the age of 30, after many years of overdoses and car accidents and violence, illness, and just wanting to die, I was admitted into a locked psychiatric ward. I joke with people sometimes – although it’s true – that I got my start in psychology in a psychiatric hospital

I have written about aspiring TED talk gurus like Amy Cuddy and Kelly having to find their redemptive selves, linking the product they sell to overcoming the adversity in their lives. I think there may be some literary license in play here, but if it is meant to inform, rather than just entertain, what is the takeaway message?

What is the greatest lesson life has taught you recently?

That the things you love the most are also the things that are the sources of the most extraordinary pain possible. And there is no greater joy or pain life can deliver than that you get from your children. Sweet and sad, poured from the same vessel in equal measure.

What motivates you to inspire self-care in others?

I lost my eldest brother Randy in 1987 to suicide. Since then, I lost my brother David in 2011 to a cerebral haemorrhage, and my baby brother Michael in 2013, to a heart attack. In 1998 I was given a head and neck cancer diagnosis. My interest in self-care, kindness and wellbeing is not a casual interest, it has to do with me, it has to do with the people who I love, both the ones who I know, the ones I’ve lost, and the ones who I don’t know yet.

Kirk Strosahl

Maybe he is just being flippant, but I was uncomfortable with the strong, but implicit suggestion of Kirk’s title that people chose to suffer.

Kirk pain is inevitable

How would you describe ACT in a nutshell?

I think ACT tries to promote people who are open to their own experience and can separate themselves from the literal meaning of their experience – so that they’re not governed by thoughts or feelings or emotional reactions to things. They are in touch with their personal values so that they are geared toward living life to its fullest.

What are your most inspired actions?

I think the time I truly felt the most inspired simply in terms of output was writing my most recent book, Inside This Moment. I was in a zone for the entire time that I was writing it, it was coming from the heart. It was actually quite an amazing experience. The book zeroes in on how to use the present moment in therapy to inspire people to live their lives to the fullest, and not to run from their own demons, but rather cradle them. So that was enjoyable. Then I’ve also always been inspired to work with Patti [Dr Patricia Robinson]. We have a lot of fun and there’s intellectual growth when we write and get our arms around stuff together. So I’ve been very lucky that way.

Where are ACT and the other so-called ‘third-wave therapies’ heading now?
I think people are going to have to get their arms around what we mean by ‘mindfulness’ in a much more scientifically sound sense. Not the term, not the popular concept, but understanding exactly what goes into it. We’re still very overly general about it in our conversations, and because of that we’re losing leverage in therapy that we would otherwise gain by being more discriminating. That’s one area I think is going to see a lot of further growth. And I think we’re going to be looking at how we get our treatments briefer without losing effectiveness, because resource systems out there simply can’t afford the longer-term version of CBT or ACT for the masses – that’s another big area. How are we going to populate these concepts into public health models and work with lay people, primary care providers and teachers, for example? We’re still very therapist-centric in our profession, and because of that our population health effectiveness has been extremely limited.

I think the other area that is going to become bigger and more important is values-based behaviour change. It’s not like people haven’t been exploring it, but I think the amount of development will increase. There are measurement issues that are going to have to be dealt with, as well as creating more efficient ways of talking to people about motivating factors in their lives.

Kirk is modest in his aspirations for ACT, but I don’t see the relevance of evidence.

What is the greatest opportunity ACT has in today’s world?

I actually think that, if we don’t fall on our own sword, it’s going to be about bringing mindfulness concepts into the general public and Western civilisation. That’s not going to mean getting everybody in the West to put in hours of practice a day, sitting on a pillow ‘umm-ing’. Rather it’s this idea that these are actually pretty portable interventions based on neuroscience. They have a very rapid effect on brain neural pathway development and brain efficiency, and they don’t have to be these onerous, lifelong practices. There’s going to be a huge opportunity there if we can get the right message to people – that these are things you can teach yourself and your brain in small bits, and that it’s more about persistence than the amount of time you take. It’s about doing things intentionally and practising intention, as well as practising paying attention. These two things go hand in hand in mindfulness – this ability to pay attention in a particular way and then to act with intention inside of your own space. To me those things are so intricately linked to psychological health that if we could get those out into the public domain in ways which didn’t seem overwhelming to people, that would be a huge accomplishment for ACT, or for any of the mindfulness-based therapies that could get this figured out. So it isn’t just in the hands of a few peopl

Are ACT and CBT actually little more than saying to people ‘live with it, or change it’?
There are hidden properties of treatments, and then there are the observable properties of treatments. In ACT the observable properties are quite different, with an emphasis on values. It’s saying to people ‘don’t just tolerate your life, build your life from within’. ACT uses values as a foundation for addressing that.

Then there’s the ability to create space between you and what starts to show up in your life when you start doing things that matter. It’s an optimistic treatment that assumes people can do amazing things if they get lined up behind the right psychological processes. And it might well be that in CBT, even though ostensibly focusing on helping people change thoughts and behaviours, the act of talking about thoughts and behaviours is in a way itself a kind of a ‘defusion’ intervention. That’s what I mean by ‘hidden’ properties. You think that the mechanism is about the client becoming more logical and less irrational, but it may in fact be that by talking about thoughts you’re actually doing ‘defusion’ without even realising it.

I am also uncomfortable with the message that effective therapy can be delivered in 15 minutes. I am sure it sells well in behavioral health settings or in neoliberal societies where the goal is to underfund mental health services, but claim to offer them broadly. But strong claims with such potentially socially pernicious implications need very strong evidence. I have searched and can find none.

You’re a specialist in delivering brief, or ‘focused’ ACT interventions to patients – sometimes as brief as 15 minutes. Could you give a picture of what you might focus on in a session, say for diabetes or depression?
The goal of focused ACT is to get patients to make direct contact with the unworkable results of their current life strategies. Usually, these strategies involve avoiding dealing with important life issues – such as maintaining social health, managing diet or other health risk behaviours in the case of diabetes. The counter-weight in focused ACT is to get the patient to make direct contact with what matters to them in their life, and whether their avoidance behaviours are helping them move in that direction. This discrepancy creates a ‘healthy anxiety’, which we encourage patients to accept as a ‘signal’ that some type of change in personal strategy is needed. You don’t get people to change behaviours by giving them a label, or scaring them with adverse consequences if they don’t change, or lecturing them about the necessity of change. Change comes from within, not from without. Most patients know implicitly that they are avoiding things, but they don’t want to be condescended to, criticised or cajoled about it. So focused ACT is a very humanising approach in which we readily agree that making important changes in life might likely trigger painful emotional consequences or distressing memories of past failures, et cetera. Pain is inevitable, but suffering is optional.

The therapist and patient are on the same journey in this, and they’ve just happened to run into each other. There is no difference really between us.

Steve Hayes

Last, but certainly not least, Steve’s interview is titled with a rhetorical question that he does not get around to answering.

steve why can't we

How do your ideas connect with your values?

I’ve tried in my career to be less concerned about brand names and personal applause, and more concerned about building community and connecting to this larger value of ‘how can we best serve people using science?’. I get more excited in my personal work about supporting the work of others. I mean I’m productive, I do research, I write books. But to this day I’ve never not responded to an email. If a patient contacts me and says, ‘I’m in misery, what do I do?’: yeah, it might be two or three sentences, but I’m going to try and do something. So my value is being of use and building a community that can profoundly be of use – trying to bring science into alignment with what society needs and wants from us. And I don’t think we’ve always served that.

Surely, you jest, Steve.

You’re one of the founders of acceptance and commitment therapy, or ACT. What is the greatest opportunity ACT has in today’s world?

Reaching the culture. My son’s favourite cartoon show is Steven Universe – it’s very sweet. Garrett is a kind of a meditation or mindfulness person, a wise adult. She sings a song called ‘Here comes a thought’, and the show notes say she got it from ACT. The first stanza is ‘flexibility, love and trust’, and it walks through what to do with difficult thoughts. It talks about seeing and feeling, and watching the thought. And they actually lie on the ground like they’re watching clouds. I started crying seeing it because I’m thinking, ‘how many children have shame that they’re carrying?’ It’s got to be a large percentage of children, right? And they can’t talk to their parents, and they can’t talk to their peers, because what is it they’re going to say? ‘Just don’t think about it.’ And it’s like pouring gasoline on a fire, it’s just a horrible thing to do to shame… it’s saying there’s something wrong with you for feeling and thinking that, and you just need to think differently and it’ll go away. We can do something a lot wiser than that.

When I teach brand new students, say, research methods, the very first thing I get across is this: the modal number of citations for a publication in psychology is zero, which means nobody has been influenced by it enough to actually put in writing that it mattered. So I only want something that you really have heart for, something that deep down you think might really matter. And then I tell them, ‘and by the way, your research idea almost certainly is a bad idea’, because that’s how it [the modal number of citations] gets to zero. From there we can figure out a way that maintains the heart, and that won’t have zero citations. There’s like this dialectic of ‘how do we come into our field as social human beings with this core of caring, and nurture and sustain that, but also learn how to channel our interest and questions in a way that will have a long term impact on the world – on our clients and on our colleagues?’.

What’s something people don’t know about you, that if they knew, they would be surprised?
I think people are sometimes surprised that if I wasn’t going to be a psychologist, my other big thought about what I would be is a carpenter. I’m a veteran re-modeller, I’m tearing down my house all of the time. People sometimes think I’m a geek, but I can put in plumbing and I’ve built an entire house from nothing, from the foundation to the roof – done everything myself. So I’m a builder and I try to bring that sensitivity into what I do research-wise and clinically also. I want to build something that lasts and that matters, and I think we’ve been able to do it in some of the work we’ve been doing in CBT and ACT, and Mindfulness and ACBS etc.

I can’t add to this. I will just let Steve speak for himself.