Open Sweden: Psychological treatment for severe fatigue: A feasibility study, Lindsäter et al

mango · Jul 7, 2024

A Swedish psychosocial study about CBT and gradual increase in activity (physical activity as in walking or cycling, as well as mental and social activity), is currently recruiting. It is led by Elin Lindsäter, BPS proponent and member of the Oslo Consortium.

This is not a recommendation! I find this study hugely problematic.

"International research shows that psychological treatment can have beneficial effects on fatigue and functioning in different types of fatigue conditions. Such treatment involves providing support to change lifestyle habits as well as thoughts, feelings and behaviours that may contribute to fatigue not going away on its own. In this study, we want to investigate whether such a psychological treatment can be implemented with good effects for people seeking care for long-term and severe fatigue, regardless of the triggering cause."

The study is registered at ClinicalTrials.gov here: https://clinicaltrials.gov/study/NCT06341751

The following information is copied from the ethical approval application, available to download from @MittEremltage's blog post.

Psychological treatment for severe fatigue: A feasibility study

Background said:

Background
Fatigue (a feeling of constant tiredness not alleviated by rest) is associated with increased healthcare consumption, work disability, and excess mortality (1). International studies indicate that, in primary healthcare settings, fatigue is the primary complaint of up to 10% of all patients (2) and 8.5% of patients suffer from prolonged (>6 months) episodes of medically unexplained fatigue (3). In Sweden, 15% of patients with mental health conditions in primary care are diagnosed with exhaustion disorder (ED; utmattningssyndrom) (4). ED is a fatigue-dominated diagnosis that was introduced to the Swedish version of the International Classification of Diseases, 10th edition, in 2005. The condition is classified as a “stressor-induced” disorder with the proposed etiology being exposure to long-standing sub-traumatic stressors. ED has come to account for more long-term sickness absence than any other single diagnosis in Sweden (5). Importantly, our research group recently showed that evidence for the validity of the ED diagnosis is limited and there are to date no evidence-based treatments (6). Building new knowledge regarding fatigue symptomatology to enable development of effective treatment is crucial.

Internationally, it is well established that fatigue is a common sequalae of a range of somatic and psychiatric conditions (7, 8) and the symptom has been studied extensively in specialized healthcare settings in pipelines of specific disorders (such as chronic fatigue syndrome/Myalgic encephalomyelitis [CFS/ME], post-cancer fatigue, diabetes type 1, long-covid). Research consistently indicates that the relationship between biological markers and fatigue is weak or non-existent (6, 9). Variance in fatigue severity has been found to primarily be explained by transdiagnostic factors (e.g., gender, motivational and concentration problems, sleep disturbance, and pain) rather than by disorder-specific pathophysiology (9). Further, similar cognitive and behavioral factors (e.g., fear avoidance, symptom catastrophizing, resting-behavior) have been found to moderate and mediate fatigue severity across disorders (10). This suggests that fatigue might better be conceptualized as transdiagnostic symptom dimension than as a symptom specific to different diagnostic constructs (10).

Psychological therapies based on cognitive and behavioral interventions have been found promising to reduce fatigue severity and impairment in a range of diagnosis-specific fatigued patient groups (10). However, no transdiagnostic treatment protocol targeting fatigue across medical conditions has been evaluated to date. In the primary care context, where many patients first seek help, such a treatment would enable increased accessibility to treatment, be easy to implement, and be of great assistance to healthcare staff who currently lack guidelines for treatment of fatigue.
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Objective said:

Objective
The overall purpose of the research project is to further our understanding of fatigue across and within patient groups in the primary care context and to build evidence of a highly accessible transdiagnostic treatment targeting fatigue.

The treatment is based on cognitive and behavioral interventions that have previously been found effective to reduce fatigue severity in a range of fatigued patient groups both when delivered face-to-face, via the internet, and in blended formats (a combination of face-to-face sessions and internet-delivered sessions).

The present feasibility study is part of the preparation for a full-scale randomized controlled trial (RCT) in which we will evaluate the effect of a blended format for delivering the transdiagnostic treatment. By evaluating the feasibility of the treatment, as well as the assessment and data-collection procedures, the present study will allow for potential adjustments to be made and clinical routines to be established for the main RCT.
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Research questions said:

Research questions
1. Is the blended, transdiagnostic treatment a feasible and acceptable treatment for adult primary care patients suffering from severe fatigue? (E.g., what is the treatment completion rate? Are negative effects reported? Do study participants perceive the treatment as credible and helpful?)

2. Is the planned procedure for inclusion, assessment, and data-collection feasible? (E.g., what is the rate of recruitment and inclusion? To what extent do participants complete self-assessments? What is treatment drop-out rate?)

3. Is the treatment associated with a reduction in the primary outcome fatigue severity and in secondary symptom domains pre- to post-treatment? What are the within-group effect sizes on primary and secondary symptom outcomes?

4. How do patients, therapists and other healthcare personnel perceive the study procedures and the treatment?
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Method: Design said:

Method
Design
This is a prospective, non-randomized pilot study that is conducted in preparation for a planned RCT. The study has a mixed methods approach in that it will include both quantitative and qualitative data to assess the feasibility of study procedures and treatment. Measurements will be carried out prior to treatment start, during the treatment phase, and at treatment completion (after 6 months). Interviews with patients and therapists will be carried out after completion of the quantitative data-collection. The study will be pre-registered on ClinicalTrials.gov and follow CONSORT-guidelines.

Power calculation
Thirty consecutively recruited primary care patients will be included in this study, which is sufficient to answer the research questions pertaining to the feasibility of inclusion procedures and treatment. The purpose of this study is not primarily to evaluate treatment effect. However, a power analysis indicates that 30 participants yield a power of 80% to identify a moderate within-group effect size of d=0.6 (alpha .05) on the main outcome measure with a 10% attrition rate.
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Recruitment procedure said:

Recruitment procedure
This study will recruit patients directly from primary care clinics in Region Stockholm. Hence, no advertisement in newspapers or in social media will be conducted. An algorithm will be developed in ALMA (Automated Learnable Medical Assistant) to assist physicians in identifying potential candidates for the study. ALMA is a CE-certified support system for decision-making in healthcare and is available in the TakeCare journal system. Consecutive working-age primary care patients will be referred by healthcare personnel to the study webpage for online screening if they (a) report at least three months of severe fatigue as a central symptom and (b) a physician has assessed that the fatigue is not a direct effect of an active disease process motivating another treatment (e.g., hypo-/hyperthyroidism, anemia, cancer, dementia) or the effect of medication.

On the study webpage, referred patients can read about the aim of the study, the treatment, and the assessment procedures. Before completing an initial online screening, they will be asked to give digital informed consent. After having completed the screening, eligible patients will be contacted to book an in-depth assessment (approximately 120 minutes) with a specially trained physician and a licensed psychologist. The assessment will include full medical examination and psychiatric assessment. Patients who meet all inclusion criteria and no exclusion criteria (see below) will be included in thev study and will be booked for treatment start with a therapist working in the project. Excluded patients will receive other treatment recommendations if needed and will have full access to care as usual.
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Inclusion and exclusion criteria said:

Inclusion and exclusion criteria
Inclusion criteria are (a) age 18-67; (b) severe, functionally disabling fatigue as a central symptom for at least 3 months; (c) The fatigue is not a direct effect of an active disease process motivating another treatment (e.g., hypo-/hyperthyroidism, anemia, cancer, dementia) or the effect of medication; (d) regular access to a computer and to the Internet; (e) ability to read and write in Swedish.

Exclusion criteria are (a) substance abuse disorder in the past 6 months; (b) Current or past psychosis or bipolar disorder; (c) Primary psychiatric disorder of such severity that it merits evidence-based treatment (e.g., obsessive compulsive disorder, moderate to severe depression, post-traumatic stress disorder); (d) elevated risk for suicide; (e) anorexia nervosa; (f) BMI>40; (g) Initiated or changed psychopharmacological medication (e.g., for depression or anxiety disorders) in the past month; (h) ongoing chemotherapy; (i) intellectual disability (e.g., severe autism) that affects ability to work with the treatment; (j) self-harm; (k) pregnancy; (l) life circumstances that complicate or make treatment impossible (e.g., domestic violence or ongoing legal disputes); (m) ongoing psychological treatment and/or multimodal rehabilitation.
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Variables and measures said:

Variables and measures
Online screening
A digital survey will collect sociodemographic (e.g., age, sex, level of education) and clinical (e.g., prior diagnoses, sick leave, medications) variables. The patient will also complete self-rating scales to support the following in-depth assessment: Checklist Individual Strengths (CIS) (11); depressive symptoms (PHQ-9)(12); somatic symptoms (PHQ-15)(13); Childhood trauma questionnaire (14); childhood symptoms of ADHD and/or autism (WURS-25 and RAADS-14 respectively), alcohol use (AUDIT), and The Work and Social Adjustment Scale (WSAS)(15).

In-depth clinical assessment
Consent for the physician and the licensed psychologist to access the patient’s medical journal will be obtained in the screening procedure. This is to ensure that the clinical assessment can be carried out as safely as possible. The assessment includes a physical examination and lab workup (as needed to complement previously conducted physical examinations); lifetime anamnestic interview; Mini International Neuropsychiatric Interview (16) for psychiatric morbidity and assessment of criteria for common fatigue-dominated diagnoses such as ED and CFS/ME.
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Outcome measures said:

Outcome measures
All self-assessed outcome measures will be completed on the online study platform (BASS) pre- and post-intervention (6-months after treatment start).

Primary outcome: Fatigue severity (self-rated) using the CIS-F (11). The domain Fatigue severity contains 8 items scored on a 7-point Likert scale (range 8-56; higher scores=more severe fatigue). A score above 35 points on the CIS-F indicates severe fatigue (17).

Secondary outcomes: Problems with concentrating, reduction in motivation, and reduced physical activity level (as assessed by other subscales in the CIS); PHQ-15 (13); PHQ-9 (12); Anxiety (GAD-7)(18); Insomnia severity (ISI)(19) and an additional item to assess hypersomnia; Perceived Stress (PSS-10)(20); Burnout (SMBQ-18)(21); Self-rated health (SRH-5)(22); Cognitive and Behavioral Responses to Symptoms Questionnaire (CBRQ)(23), and general self-efficacy (GSE)(24). Functional ability will be assessed using the WSAS (15) and the WHODAS 2.0 (25). The CIS-F, the ISI, the CBRQ and the GSE will be administered regularly throughout the treatment phase, together with the suicide-item in the PHQ-9.
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Feasibility measures said:

Feasibility measures
Treatment credibility will be assessed in week 3 of treatment, using the Credibility/Expectancy Questionnaire (26). Patient satisfaction with the treatment will be assessed after treatment completion (6 months) using the Client satisfaction questionnaire (27). Participants will rate working alliance with the therapist using the Working Alliance Inventory (WAI-Short version) in week 3 and 16 of the treatment phase. The Negative Effects of Treatment Questionnaire (NEQ)(28) will be administered post-treatment, and at this time patients will also be asked to respond to open-ended questions regarding their perception of the different components of the treatment and how they worked with the treatment.

The recruitment procedure will be evaluated by accessing data from ALMA. ALMA aggregates anonymous data regarding number of times the algorithm has been activated and the number of times it has resulted in a referral to the study platform. Of those who complete screening, we will assess the proportion of patients who are included or excluded in the study. Treatment adherence will be assessed by evaluating how many sessions (face-to-face and video-based) the patient received, how many modules of the internet-delivered material the patient accessed, and the amount of time the patient spent in the online treatment platform.

Treatment fidelity will be assessed by audio recording synchronous treatment sessions, of which a random selection will be assessed for fidelity using checklists that correspond to the central treatment components in each phase of the treatment. Drop-out and treatment completion rate will be monitored, as will data-completion rate.

Evaluation of participants’ experience of treatment and possible implementation
When all treatments have been completed in the study, semi-structured interviews will be conducted with up to 10 included patients and up to three therapists. These will tap deeper, qualitative information about perceptions of working with the treatment and the data-collection procedures. All interviews will be audio recorded and transcribed for thematic content analysis. Further, a survey based on the ”Triple P Systems Implementation Outcomes: Acceptability, Appropriateness, and Feasibility of intervention measure” will be disseminated to healthcare staff at participating primary health care clinics, to which they respond anonymously.
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Treatment said:

Treatment
The treatment that will be evaluated is based on principles and treatment
components that form the basis of several treatment manuals for persistent fatigue across long-term medical conditions. These manuals have been indicated to reduce fatigue severity in various fatigued populations when evaluated in randomized controlled trials (29-33).

The treatment period is up to six months and consists of three central phases:

(1) Psychoeducation about fatigue and identification of cognitive and behavioral factors that may contribute to perpetuating fatigue. This phase includes individual goal setting, stabilizing the sleep-wake cycle, and work to evenly distribute activities across the day.

(2) Gradual increase in activity. This is done in small steps in close collaboration with the patient. The patient follows an individually tailored schedule that initially focuses on increased physical activity (walking or cycling) but later also incorporates work to slowly increase capacity for mental and social activity.

(3) Goal attainment. In the last phase, the patient takes steps towards reaching individual goals. The over-arching goal of the treatment is that the patient will no longer be inhibited by severe fatigue in such that he or she is able to engage in all daily activities.

The treatment will be disseminated in a blended format which means that it will consist of both synchronous sessions (face-to-face or video-based) and asynchronous communication via a digital treatment platform. All treatment material (e.g., psychoeducation and exercises) will be available in the treatment platform to enable for patients to access all necessary information at any time. This can support memory functions and enable a transparent overview of the various steps in the treatment.
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Analyses said:

Analyses
Descriptive statistics will be used to analyze research questions 1-2. For research question 3, linear mixed models will be used to analyze changes in primary and secondary self-rated outcomes from pretreatment to posttreatment assessments. Mixed model analyses use all available data and account for correlations between measurements within the same subject. Within-group effect-sizes will be reported as Cohen’s d.

Interviews will be audiotaped and transcribed verbatim for thematic content analysis. Descriptive statistics will be used to summarize results from the survey that will be disseminated to health-care staff post-treatment (research question 4).
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Time plan said:

Time plan
Recruitment and treatment will start in Q2 of 2024. All treatments will be completed in Q3 2024. The project will be completed Q2 in 2025.
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Significance said:

Significance
The project could provide feasibility of a transdiagnostic treatment for primary care patients with severe and persistent fatigue across medical conditions. If the inclusion procedure, the data-collection procedure, and the treatment are feasible, a larger RCT studying treatment effect is called for. An adequately powered RCT could provide firm scientific support for a
novel, scalable, and cost-effective way to deliver an evidence-based treatment for this large and currently under-treated patient group. This would have a desirable impact on patients, families, healthcare units, and society at large, given that fatigue is associated with substantial suffering and work-disability and that treatment guidelines are currently lacking.
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mango · Jul 7, 2024

Continued:

"References
1. Basu N, Yang X, Luben RN, Whibley D, Macfarlane GJ, Wareham NJ, et al. Fatigue is associated with excess mortality in the general population: results from the EPIC-Norfolk study. BMC medicine. 2016;14:1-8.

2. Nijrolder I, Van der Windt D, De Vries H, Van der Horst H. Diagnoses during follow-up of patients presenting with fatigue in primary care. CMAJ. 2009;181(10):683-7.

3. Bates DW, Schmitt W, Buchwald D, Ware NC, Lee J, Thoyer E, et al. Prevalence of fatigue and chronic fatigue syndrome in a primary care practice. Archives of internal medicine. 1993;153(24):2759-65.

4. Cullen AE, Lindsäter E, Rahman S, Taipale H, Tanskanen A, Mittendorfer-Rutz E, et al. Patient factors associated with receipt of psychological and pharmacological treatments among individuals with common mental disorders in a Swedish primary care setting. BJPsych Open. 2023;9(2):e40.

5. The Swedish Social Insurance Agency. Sickness-absence in psychiatric disorders [Sjukfrånvaro i psykiatriska diagnoser]. 2020.

6. Lindsäter E, Svärdman F, Wallert J, Ivanova E, Söderholm A, Fondberg R, et al. Exhaustion disorder: scoping review of research on a recently introduced stress-related diagnosis. BJPsych Open. 2022;8(5):e159.

7. Mozuraityte K, Stanyte A, Fineberg NA, Serretti A, Gecaite-Stonciene J, Burkauskas J. Mental fatigue in individuals with psychiatric disorders: a scoping review. Int J Psychiatry Clin Pract. 2023;27(2):186-95.

8. Goërtz YM, Braamse AM, Spruit MA, Janssen DJ, Ebadi Z, Van Herck M, et al. Fatigue in patients with chronic disease: results from the population-based Lifelines Cohort Study. Scientific reports. 2021;11(1):1-12.

9. Menting J, Tack CJ, Bleijenberg G, Donders R, Droogleever Fortuyn HA, Fransen J, et al. Is fatigue a disease-specific or generic symptom in chronic medical conditions? Health Psychol. 2018;37(6):530-43. 10. de Gier M, Picariello F, Slot M, Janse A, Keijmel S, Menting J, et al. The relation between cognitive-behavioural responses to symptoms in patients with long term medical conditions and the outcome of cognitive behavioural therapy for fatigue - A secondary analysis of four RCTs. Behav Res Ther. 2023;161:104243.

11. Vercoulen JH, Swanink CM, Fennis JF, Galama JM, van der Meer JW, Bleijenberg G. Dimensional assessment of chronic fatigue syndrome. Journal of psychosomatic research. 1994;38(5):383-92.

12. Kroenke K, Spitzer RL, Williams JB. The PHQ‐9: validity of a brief depression severity measure. Journal of general internal medicine. 2001;16(9):606-13. 13. Interian A, Allen LA, Gara MA, Escobar JI, Diaz-Martinez AM. Somatic complaints in primary care: further examining the validity of the Patient Health Questionnaire (PHQ-15). Psychosomatics. 2006;47(5):392-8.

14. Bernstein DP, Fink L, Handelsman L, Foote J. Childhood trauma questionnaire. Assessment of family violence: A handbook for researchers and practitioners. 1998.

15. Mundt JC, Marks IM, Shear MK, Greist JM. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. The British Journal of Psychiatry. 2002;180(5):461-4.

16. Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998;59 suppl 20:22-33.

17. Worm-Smeitink M, Gielissen M, Bloot L, van Laarhoven HWM, van Engelen BGM, van Riel P, et al. The assessment of fatigue: Psychometric qualities and norms for the Checklist individual
strength. J Psychosom Res. 2017;98:40-6. 18. Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092-7.

19. Morin CM. Insomnia: Psychological Assessment and Management. New York: The Guilford Press; 1993. 20. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983;24(4):385-96.

21. Melamed S, Shirom A, Toker S, Berliner S, Shapira I. Burnout and risk of cardiovascular disease: evidence, possible casual paths, and promising research directions. Psychol Bull. 2006;132.

22. Eriksson I, Unden AL, Elofsson S. Self-rated health. Comparisons between three different measures. Results from a population study. Int J Epidemiol. 2001;30(2):326-33.

23. Ryan EG, Vitoratou S, Goldsmith KA, Chalder T. Psychometric properties and factor structure of a long and shortened version of the cognitive and behavioural responses questionnaire. Psychosomatic medicine. 2018;80(2):230-7.

24. Chen G, Gully SM, Eden D. Validation of a new general self-efficacy scale. Organizational research methods. 2001;4(1):62-83.

25. Üstün TB. Measuring health and disability : manual for WHO Disability Assessment Schedule WHODAS 2.0. Geneva: World Health Organization; 2010. 26. Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. Journal of behavior therapy and experimental psychiatry. 2000;31(2):73-86.

27. Attkisson CC, Zwick R. The Client Satisfaction Questionnaire: Psychometric properties and correlations with service utilization and psychotherapy outcome. Evaluation and program planning. 1982;5(3):233-7.

28. Rozental A, Kottorp A, Forsström D, Månsson K, Boettcher J, Andersson G, et al. The Negative Effects Questionnaire: psychometric properties of an instrument for assessing negative effects in psychological treatments. Behavioural and cognitive psychotherapy. 2019;47(5):559-72.

29. Janse A, Worm-Smeitink M, Bleijenberg G, Donders R, Knoop H. Efficacy of web-based cognitive–behavioural therapy for chronic fatigue syndrome: randomised controlled trial. The British Journal of Psychiatry. 2018;212(2):112-8.

30. Wiborg JF, van Bussel J, van Dijk A, Bleijenberg G, Knoop H. Randomised controlled trial of cognitive behaviour therapy delivered in groups of patients with chronic fatigue syndrome. Psychotherapy and psychosomatics. 2015;84(6):368-76.

31. Kuut TA, Müller F, Csorba I, Braamse A, Aldenkamp A, Appelman B, et al. Efficacy of cognitive behavioral therapy targeting severe fatigue following COVID-19: results of a randomized controlled trial. Clin Infect Dis. 2023.

32. Abrahams HJ, Gielissen MF, Donders RR, Goedendorp MM, van der Wouw AJ, Verhagen CA, et al. The efficacy of internet‐based cognitive behavioral therapy for severely fatigued survivors of breast cancer compared with care as usual: a randomized controlled trial. Cancer. 2017;123(19):3825-34.

33. Menting J, Tack CJ, van Bon AC, Jansen HJ, van den Bergh JP, Mol MJ, et al. Web-based cognitive behavioural therapy blended with face-to-face sessions for chronic fatigue in type 1 diabetes: a multicentre randomised controlled trial. The Lancet Diabetes & Endocrinology.
2017;5(6):448-56."
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mango · Jul 7, 2024

This study is potentially very significant in relation to the political decision that led to major changes in the healthcare for pwME in Stockholm, Sweden, including updated guidelines in viss.nu for ME in primary care.

Read more about this here and here in the News from Scandinavia thread.

mango · Jul 7, 2024

Do click through and read @MittEremltage's blog post on this study, where you'll also be able to download a copy of the ethical approval application with all the facts.

Ändra dina tankemönster och lev ditt liv som du vill!
https://mitteremitage.wordpress.com/2024/07/07/andra-dina-tankemonster-och-lev-ditt-liv-som-du-vill/

Auto-translate said:

Change your thinking patterns and live your life the way you want!

The psychologist Elin Lindsäter, who is the responsible reviewer for the new version of the guidelines [for ME/CFS] in viss.nu, has a research study underway that is good to know about.

I have read the ethical review application, including the project description, and thought I would share an overview of what is described about the treatment itself. At the end of this post you will find the ethics review application as a file as well as previous posts about Lindsäter and viss.nu. [...]

The target group for the study is people with fatigue for at least three months. It is a pilot study with 30 patients and the aim is to investigate both the treatment effect and the study design ahead of a larger study planned in the future. The therapy is carried out both digitally and with physical visits and the researchers believe that it makes it easier for the most severely ill. [...]

It is not a pure study on ME, but the application states that people with ME are part of the intended target group [...].

The theory behind the treatment is that fatigue is not linked to diagnosis-specific disease processes, but to other factors such as sleep, lifestyle and self-belief [...]

The treatment consists of education about fatigue, gradually increasing activity on an individualised schedule and moving towards set goals [...]

The effect of the treatment is evaluated through a variety of self-assessment questionnaires. As far as I can see, no objective outcome measures are given. [...]

MEpedia has its own page on the tool for the primary outcome measure CIS-F and states that one problem with the tool is that it is designed in a way that risks not capturing deterioration in ME sufferers and can therefore give a distorted results [...]

Using this tool as the primary outcome measure in a study where ME sufferers are included thus means that any negative effects risk being hidden and that the result will then be incorrect.

It is stated in the ethical review application that the researchers do not see any risks of negative effects with the treatment but that they will still monitor the development of symptoms and any suicide risk every week as they believe that there is always a risk of acute problems [...].

However, the questionnaire they will use to measure negative effects Negative Effects Questionnaire (NEQ) only contains questions related to mental well-being and will absolutely not be able to capture symptom increase related to PEM. Possibly if patients write about PEM in the only open question available.

The question is also who judges what is a "negative effect" - the patient or the therapist? Part of the treatment is about learning to manage negative thoughts about their symptoms. Will patients be taught that negative effects are in fact negative thoughts, and will patients' attempts to avoid increased symptoms be seen as something that needs to be challenged in therapy? [...]

In the risk assessment for the upcoming study, the researchers conveniently 'forget' to account for the amount of ME sufferers harmed by similar treatment over the years. Nor do they tell us that major international institutions such as the CDC and NICE actually strongly discourage the use of both CBT and gradual increase in activity in the UK.

If we compare the information from the ethical review application with the changes in viss.nu, I think it becomes clear that it may be advantageous for Lindsäter's study if the information to the healthcare system lacks more detailed information about PEM, if the needs of the most severely ill are not so clear and if the diagnosis is described more vaguely, etc. The now removed information about CBT and gradually increased activity is also explained, and the clarification that there is no curative psychological treatment has disappeared with Lindsäter's review.

It seems that Lindsäter has changed the guidelines in a way that makes it easier for healthcare professionals and patients to accept the treatment she and her fellow researchers will offer in the project.

So once again we have a study underway with researchers who believe that it is not illness but errors in thinking that prevent us from living the lives we want. The aim of the study is for participants to learn that their symptoms are not dangerous and then change their behaviour based on this new knowledge. Participants who do not get a positive result are likely to be told that it is their own fault for not changing their thinking patterns enough. And pushed even harder. The outcome is to be measured by the participant reporting on how the treatment has changed their symptoms, but the questionnaire used has known problems with screening out negative effects.

So it's all set up for a positive study result, even though people with diseases that cause PEM will be harmed.
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mango · Jul 7, 2024

For those of you who would like some extra help to better understand the problems with this study, do read MEdagboken's posts on Instagram, and the blog PACE-granskaren (both are in Swedish).

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Open Sweden: Psychological treatment for severe fatigue: A feasibility study, Lindsäter et al

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