mango
Senior Member (Voting Rights)
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
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.
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.
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?
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.
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.
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.
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.
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.
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.
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.
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).
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.
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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