The prevalence and impact of psychoneuroimmunological factors in ME/CFS: Effects and mechanisms of ACT (2019) Olsson et al.

mango

mango

Senior Member (Voting Rights)
These posts have been moved from this thread: Sweden: ACT for ME/CFS - an Open Case Trial

This is from the ethical approval application document. It says, roughly translated:

"Treatment
The aim of the treament is to get the participants to return to an active life, which means to gradually increase their activity levels. This means doing activities that have been avoided because of symptoms and other kinds of [discomfort, uncomfortable feelings]. However, according to our assessment there is no risk of negative effects of the rehabilitation program (see for example Dougall et al, 2014)."

ETA: Dougall et al is: "Adverse events and deterioration reported by participants in the PACE trial of therapies for chronic fatigue syndrome." by Dougall, Johnson, Goldsmith, Sharpe, Angus, Chalder, White...
 

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This is also from the ethical approval application document. It says that one of the main goals is to introduce terminology based on the patients' problematic behaviours and avoidance behaviours in relation to pain and other kinds of [discomfort, uncomfortable feelings].

It says that during the physiology education session, the doctor will give the patient adequate info about ME/CFS according to existing research and based on the bodily systems and their functions, with the purpose of changing the context in which the symptoms are experienced (for example, pain or fatigue should not be experienced as dangerous). The doctor will also teach an "understandable" model that will help the patients understand their symptoms from a behavioural medicine perspective (aetiology, experience and behaviour in a particular context).
 

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And this one is about session 11 Recruitment, where they will identify behaviours in the patient's surroundings that "steer" towards avoidance. And then make a plan to help these other people coach the patient in a more adequate manner...
 

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This trial is still happening. One thing has recently changed: they have sent an application to the Ethical Review Authority asking permission to continue the patient data collection at a different place, Bragée ME-center.

Another recent change is that the Swedish patient organisation RME, who have strongly and openly opposed this project up until now, seem to have flipped. RME emailed all their members the other day recommending/encouraging them to take part in "all trials approved by the Ethical Review Authority", which includes this one.

In the same email RME spoke very strongly against a number of unnamed pwME (including many of their own members) who are criticising the study’s methodological and ethical problems and expressing concern about the evident risk of harm. RME made it very clear that they do not want to see any open discussion of the problematic aspects of this study, nor any criticism against it. Needless to say, I wildly disagree.
 
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Clementine said:
In 2015, a bunch of Swedish BPS-people started a study where they wanted to test Acceptance & Commitment Therapy on pwME. From the information given in the application for ethical approval, it's clear that the aim is to get the participants to increase their activity. The study is so far called "Prevalens och påverkan av psykoneuroimmunologiska faktorer vid Myalgisk encefalomyelit/Kroniskt trötthetssyndrom -behandlingseffekt av Acceptance & Commitment Therapy"

Due to changes in healthcare for pwME in Stockholm during the last couple of years, the venue for recruiting participants has changes and therefore, this study has been discussed a lot among Swedish people with ME lately. As a consequence, this study is now discussed in a series of entries on the Swedish blog Pace Inspector. Here's the first part, which describes how this study is designed to only include people with the mildes form of ME, since it demands a lot from participants. Still, the people behind the study aim at using this sample as a base of subgrouping people with ME.

https://pacegranskaren.wordpress.co...vensk-beteendestudie-av-me-sjuka-del-1-urval/
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Clementine said:
Here's part two in the series of blog posts about the Swedish BPS study mentioned above. This post describes how the the participants is subjected to fairly high risks of PEM but are told that the tests and procedures are safe.

https://pacegranskaren.wordpress.co...ensk-beteendestudie-av-me-sjuka-del-2-risker/
Click to expand...

Two independent bloggers have published a series of articles on the study on their respective blogs. Brilliant, well worth a read!

Pacegranskaren
Google Translate, English ("Methodological and ethical problems in a Swedish behavioural study of people with ME")
Part 1, part 2, part 3, part 4.

Mitt Eremitage
Google Translate, English ("Negative effect")
Part 1, part 2, part 3, part 4.
 
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Snowdrop said:
Could this flip be a result of the recent and sad passing of J Bergquist? The RME's position as stated on their website is pretty clear that they do not support anything around PACE.

I think this study needs to be watched carefully. Do we know anyone who is signed on as a participant?
Is it possible to get any of the information they might plan to give to participants?

Who is now driving this change? I noticed that the Scientific Advisory board includes a neurologist, a psychiatrist and a rehabilitation specialist. Perhaps patients should be voicing an opinion on who they would find appropriate to be on the advisory board.
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No, it doesn't have anything to do with Bergquist. It's been brewing much longer than that... This change isn't coming from the scientific advisory board, but from the top of the organisation, the board (what's the name in English? Board of directors?), and follows the recent reorganisation. Lots of new people overall, because lots of people left during the reorganisation, it was not a smooth or easy process... One of the current board members is a psychologist and there are others who are also very interested in the psychosocial side of things.

RME hasn't made any official statement (yet) about their new approach, but I know several people have been emailing them questions.

Yes, some study participants have shared some of the info they have been given earlier in the study. This new phase of the study hasn't started yet, the ethical application hasn't been processed yet (there's no reason to believe that it won't be approved).
 
From the English summary of the Research Plan/Ethical Approval Application

"Purpose and Aims
[...] The overarching aim of this project is to evaluate ACT for patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, to investigate if, how, and for whom this treatment works."

"Project description
The present resarch project constitutes a cross-sectional study based on pre-treatment data, a pilot treatment study and a randomized controlled trial with active treatment (ACT) compared to waitlist control and. The project includes analyses of tretatment effects, predictors and moderators of treatment success, and psychological as well as biological mechanisms of change."

"Scientific hypotheses and research questions
Based on current research and clinical experience, we hypothesize that ACT treatment can improve functioning and quality of life in patients with the main symptom fatigue, in line with previous research evaluating treatment for patients with other debilitating symptoms where ACT has shown evidence of efficacy, such as chronic pain and tinnitus. Furthermore, we hypothesize that ME/CFS is not one single disease entity, and a subgrouping of patients will aid the identification of different pathogeneses, as well as predictors for successful treatment outcome in ACT.

The overall aim of the research project is to increase the understanding of the relationships between psychological, neuroimmunological and endochrinological factors in ME/CFS, and to evaluate the effects of an ACT-based treatment program. More specifically, our aims are to, in a Swedish ME/CFS sample, investigate 1) the relationships between psychological, neurological, immunological and endocrinological markers as well as physical activity and sleep; 2) evaluate the efficacy of an ACT-based behavioral medicine treatment on quality of life, functional capacity and degree of fatigue, and; 3) the importance of psychological, neurological, immunological and endocrinological factors as well as physical activity and sleep for the effects of an ACT-based behavioral medicine treatment."
 
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In their recently published article Acceptance & Commitment Therapy for ME/CFS (Chronic Fatigue Syndrome) – a feasibility study (thread here) the authors concluded that "Changes in psychological flexibility are related to improvements."

Psychological flexibility is defined as "the ability to act in line with important long-term goals or values in life, even in the presence of negative experiences".

The Psychological Inflexibility in Pain Scale (PIPS)

"the avoidance subscale measures the self-reported tendency to engage in certain behaviours that lead to avoidance of pain and related distress, while the fusion subscale assesses the patients’ experienced frequency of thoughts that, if they are acted on, are likely to lead to avoidance behaviours"

Here are the PIPS questions:

1. I cancel planned activities when I am in pain. (Avoidance)

2. I say things like "I don't have any energy", "I am not well enough", "I don't have time", "I don't dare", "I have too much pain", "I feel too bad", or "I dont't feel like it". (Avoidance)

3. I need to understand what is wrong in order to move on. (Fusion)

4. Because of my pain, I no longer plan for the future. (Avoidance)

5. I avoid doing things when there is a risk it will hurt or make things worse. (Avoidance)

6. It is important to understand what causes my pain. (Fusion)

7. I don't do things that are important to me to avoid pain. (Avoidance)

8. I postpone things because of my pain. (Avoidance)

9. I would do almost anything to get rid of my pain. (Fusion)

10. It's not me that controls my life, it's my pain. (Avoidance)

11. I avoid planning activities because of my pain. (Avoidance)

12. It is important that I learn to control my pain. (Fusion)

Source: The Psychological Inflexibility in Pain Scale (PIPS). Wicksell, Olsson et al (2012)
https://onlinelibrary.wiley.com/doi/abs/10.1016/j.ejpain.2009.11.015
 
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