Trial By Error: CBT and Irritable Bowel Syndrome

Cheshire

Cheshire

Senior Member (Voting Rights)
Had things gone as planned, the PACE trial should have been able to serve as proof that so-called medically unexplained symptoms (MUS)—in this case what the investigators referred to as chronic fatigue syndrome–could be successfully treated with psychological and behavioral therapies. The Lancet published the first PACE results, which reported benefits from cognitive behavioural therapy and graded exercise therapy, in early 2011. The timing dovetailed with the National Health Service’s expansion of a program called Improving Access to Psychological Therapies (IAPT).

Launched in England in 2008 to increase links between medical care and mental health services for those identified as suffering from depression and anxiety disorders, IAPT’s mandate next expanded to include other groups of patients, specifically those suffering from either long-term conditions, such as cancer, and from conditions identified as part of the MUS category. Many academic promoters of IAPT are colleagues of key PACE investigators. They are also fellow proponents of the CBT/GET paradigm for the illness, or cluster of illnesses, variously referred to as CFS, myalgic encephomyelitis, ME/CFS and CFS/ME.
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http://www.virology.ws/2020/01/24/trial-by-error-cbt-and-irritable-bowel-syndrome/
 
Trial By Error: A Commercial Deal for King’s College London’s IBS-CBT Digital Program
On January 10th, the following information was announced in a press release:

Mahana Therapeutics, a digital therapeutics company reimagining the treatment of chronic diseases, today announced that the Company has entered into a licensing and collaboration agreement with King’s College London, a leading research university and one of the oldest and most prestigious universities in England. Mahana has acquired a worldwide exclusive license to an innovative digital therapeutic for the treatment of irritable bowel syndrome (IBS).

This exciting development in Mahana’s efforts to reimagine the treatment of chronic diseases is related to the IBS study I wrote about last week. In the study, two versions of CBT performed somewhat better than treatment-as-usual (TAU) at 12 and, to a lesser extent, at 24 weeks. One group received a course of telephone CBT from a therapist. The second received a web-based course of CBT called “Regul8: A Self-Management Programme for IBS,” supplemented by a minimal amount of therapist contact. After the study ended, those in the TAU arm were offered online access to the Regul8 program [American spelling], but without therapist support.
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http://www.virology.ws/2020/01/27/t...ings-college-londons-ibs-cbt-digital-program/
 
COI from the PRINCE trial (Persistent physical symptoms reduction intervention: a system change and evaluation (PRINCE)—integrated GP care for persistent physical symptoms: protocol for a feasibility and cluster randomised waiting list, controlled trial)

https://bmjopen.bmj.com/content/9/7/e025513

Competing interests MHotopf reported grants from Innovative Medicines Initiative and European Federation of Pharmaceutical Industries and Associations, outside the submitted work.

In addition, TC and RM-M declared the following; organisational financial interests:
TC received ad hoc payments for conducting workshops on evidence-based treatments for persistent physical symptoms.
TC has received grants from NIHR programme grants, HTA, RfPB, Guy’s and St Thomas Charity, King’s Challenge Fund, Muscular Dystrophy, Multiple Sclerosis Society.

King’s College London received payment from Taylor and Francis for editorial role.

RM-M currently receives grant funding from NIHR programme grants, Breast Cancer Now, Crohn’s and Colitis UK, and National MS Society.

In the previous 36 months, RM-M received funding from MS society UK and NIHR HTA.

In 2019, payments from Taylor and Francis to King’s College London for RMM’s role as Editor of Health Psychology Review. Payments for adhoc lectures and workshops on long-term conditions.

Personal financial interests:
TC is the author of several self-help books on chronic fatigue and received royalties in the past.
TC received expenses and ad hoc payment for role as external examiner NUI Galway and Waterford Institute of Technology.
TC received expenses for keynote speeches at UK Society for Behavioural Medicine, BABCP Conferences (travel and accommodation).
TC received ad hoc payments for conducting workshops on evidence-based treatments for persistent physical symptoms.
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RM-M received payments for her role as National Advisor to NHS England for Increasing Access to Psychological Therapies (IAPT) for people with long-term conditions from 2011 to 2016.
RM-M received ad hoc payments for workshop training in IBS in 2017 and 2018 and this will continue in 2019.
RM-M receives ad hoc consultancy payments from Mahana therapeutics and this is likely to continue in 2019.
RM-M has stock options in Mahana therapeutics.
RM-M received travel expenses for keynote speech to Internal Society of Behavioural Medicine.

In 2019, RM-M will be a keynote speaker for Association for Researchers in Psychology and Health (the Netherlands), European Health Psychology Society Annual Conference (Croatia) and the 9th World Congress of Behavioural and Cognitive Therapies (Germany). Travel and accommodation expenses will be reimbursed.
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Looking on the Mahana Therapeutics website, it seems that originally the web version of Prof Moss-Morris's self management manual for CBT for IBS was called Regul8 but is now renamed Parallel on the Mahana Therapeutics website:


https://www.kcl.ac.uk/ioppn/depts/p...earchGroupings/healthpsych/research-group/IBS

"Irritable Bowel Syndrome Overview

Irritable Bowel Syndrome (IBS) affects 10–22% of the UK population. Current treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many suffer on-going symptoms. Professor Moss-Morris has developed a CBT based self-management manual for treating IBS in primary care with minimal therapist contact. In collaboration with colleagues in Southampton, and funded through NIHR RfPB, a web version of this treatment approach was developed called Regul8. Publications from modelling work for the intervention and trials of the approaches are listed below "


Now called Parallel on the Mahana Therapeutics website :

https://www.mahanatx.com/treatments/parallel

"Parallel, formerly known as Regul8, originally was developed by Rona Moss-Morris Ph.D, Head of Psychology Department, King’s College London (KCL) in collaboration with Trudie Chalder, Ph.D, Professor of Cognitive Behavioural Psychotherapy and Alice Sibelli, Ph.D. at KCL and Dr. Hazel Everitt, Professor of Primary Care Research, University of Southampton. Initial clinical funding support was provided by the UK National Institute for Health Research (NIHR)"

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And on that same link:

"The Parallel Approach

For years, CBT has been used successfully to treat health issues like chronic pain (4) heart disease (5) and multiple sclerosis (6). Parallel takes CBT online to help reduce the severity of IBS.


Parallel Clinical Trial

The Parallel program was tested in the world’s largest (n=558) randomized, controlled trial of Cognitive Behavioral Therapy for IBS (the “ACTIB” Trial) 3. The outcomes were dramatic and potentially game-changing for patients. Starting at just 3 months, patients experienced significant and clinically meaningful reduction in the severity of their IBS.

At 12 months 66% of patients reported significant and clinically meaningful reduction in the severity of their IBS .

On average, reduction in IBS severity was twice that of patients receiving medical care as usual.

3. Everett et al. Gut. 2019 Sep;68(9):1613-1623."

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They are in the process of developing CBT treatments for IBD:

https://www.mahanatx.com/treatments/ibd-research

"A New Way to Treat IBD

Mahana is currently developing a personalized digital treatment for adolescents and adults with Inflammatory Bowel Disease. This product will be tested in a series of research studies and randomized, controlled trials. This treatment will tap into the power of Cognitive Behavioral Therapy (CBT) to help patients living with IBD."

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https://www.mahanatx.com/publications

"Publications

A Decade of Peer-reviewed Research

Mahana is committed to developing safe and effective products. Below are links to peer-reviewed publications for Parallel1, our IBS treatment. Studies for our IBD treatment are in progress."
 
For years, CBT has been used successfully to treat health issues like chronic pain (4) heart disease (5) and multiple sclerosis (6). Parallel takes CBT online to help reduce the severity of IBS.
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So now they're claiming CBT is effective as a primary treatment rather than an adjunct therapy. At least this is how that reads to me. Deliberately misleading.
 
dave30th said:
I wasn't sure if it was deliberately misleading or just written badly by an intern. And then not carefully vetted.
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Either way, it's misleading and the company who published it are responsible.

In my old job any document being written for, or shared with other departments or clients had to be proof read by two people. At least one of those had to be technically competent enough to catch tech errors and the other focusing on misleading wording. Otherwise you could be leaving yourself open to disputes and damaged client relationships or even financial penalties.

Very, very sloppy. Funny how the sloppiness with language always works to try to make their therapy look more effective than it actually is. :rolleyes:
 
RM-M receives ad hoc consultancy payments from Mahana therapeutics and this is likely to continue in 2019.
RM-M has stock options in Mahana therapeutics.
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AYFKM?

Was commercializing this always the intent? I would bet it was and that it is possible to establish the timeline for this. This is very similar to the intent with commercializing the PACE trial with OneHealth, again with Chalder on the board of directors.

e: derped acronym
 
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I don't know if it's worth pointing them out, there are so many, but there was this in the CoI declaration that, yet again, says the quiet part loud. It's really weird that FND folks still pretend they don't mean psychogenic when they admit to it all the time.
TC reports grants from Guy’s and St Thomas’ Charity. She was a faculty member, Third International Conference on Functional (Psychogenic) Neurological Disorders
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Sly Saint said:
I didn't realise before that Peter White was also involved in the IBS cbt research



https://gut.bmj.com/content/68/9/1613
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He was also involved in a commercial venture to promote the BPS model with Chalder while they were doing PACE.

I'm sure that's a happy coincidence that did not have any impact whatsoever on the research and that assurances were given to the editors who saw no reason to be concerned.
 
Daisymay said:
They are in the process of developing CBT treatments for IBD:

https://www.mahanatx.com/treatments/ibd-research

"A New Way to Treat IBD

Mahana is currently developing a personalized digital treatment for adolescents and adults with Inflammatory Bowel Disease. This product will be tested in a series of research studies and randomized, controlled trials. This treatment will tap into the power of Cognitive Behavioral Therapy (CBT) to help patients living with IBD."
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Good grief. IBD is on a whole other level. Are they deliberately trying to get people killed for profit?
 
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