The overarching purpose of this project is to further the understanding of fatigue as a symptom in primary care patients, and to build evidence for a highly accessible treatment targeting fatigue that can be readily implemented in primary care clinics.
Data will be collected within a randomized controlled superiority trial. The primary aim is to evaluate the effectiveness of a transdiagnostic cognitive behavioral therapy (tCBT) for fatigued patients as compared to care as usual (CAU). Primary outcome will be change in fatigue severity (as measured by the Checklist Individual Strengths, fatigue subscale) pre- to post-treatment (6 months), with long-term controlled follow-up after 12 months. A register-based follow-up will be conducted up to 60 months post baseline. Moderators and mechanisms of treatment effect will be investigated with the aim to identify potential subgroups of fatigued individuals across and within diagnostic categories that may respond differently to treatment. Lastly, a health economic evaluation of long-term treatment effects will be conducted, which incorporates much needed detailed mapping of care as usual for fatigued patients.
age 18-67
enrollment at a primary care clinic in Region Stockholm
severe, functionally disabling fatigue as a central symptom for at least 3 months
The fatigue has an identifiable start and hence has not been life-long;
substance abuse disorder in the past 6 months
Current or past psychosis or bipolar disorder
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, anorexia nervosa)
elevated risk for suicide
Parallel
Cognitive behavioral therapy for persistent fatigue
BehavioralThe treatment is based on a treatment manual that has previously been evaluated in several randomized controlled trials for persistently fatigued patients with various types of chronic somatic disorders (primarily in specialized healthcare settings). In this trial we have translated the treatment manual to Swedish and adopted it for implementation in a Swedish primary care setting. The treatment format is "blended", meaning that the treatment is administered both via an online platform (where the participant can communicate with the therapist through asynchronous text-messages) and via face-to-face therapy sessions with the therapist.
Care as usual
Other interventionSince there are no standardized, structured care programs and guidelines for the patient group, CAU may include a broad variety of psychosocial support, psychological treatment, physiotherapy, occupational therapy, pharmacological treatment, follow-up within specialist healthcare, and/or follow-up by general practitioners. An important aim of the project is to carefully map the content and scope of the care offered to patients in the study within the framework of CAU.
Self-rated fatigue severity
Fatigue severity (self-rated) using the Checklist Individual Strengths - Fatigue severity subscale (CIS-F). The domain Fatigue severity contains 8 items scored on a 7-point Likert scale (range 8-56; higher scores=more severe fatigue).
Concentration
Concentration is a subscale in the Checklist Individual Strengths (CIS). The subscale contains 5 items scored on a 7-point Likert scale. Higher ratings indicate more problems with concentration.
Motivation
Motivation is a subscale in the Checklist Individual Strengths (CIS). The subscale contains 4 items scored on a 7-point Likert scale. Higher ratings indicate more difficulties with motivation.
Activity
Activity is a subscale in the Checklist Individual Strengths (CIS). The subscale contains 3 items scored on a 7-point Likert scale. Higher ratings indicate reduced activity.
Self-rated depressive symptoms
Patient Health Questionnaire-9 (PHQ-9). Scale range is from 0 to 27, higher scores representing more depressive symptoms. NOTE: The suicide-item will be administered every three weeks during the treatment phase).
Treatment credibility
Assessed using the Credibility/Expectancy Questionnaire (C-Scale). The C-Scale is a 5-item measure, scale range is 0 to 50 points with higher scores indicating higher treatment credibility.
Patient satisfaction with treatment/healthcare
Client Satisfaction Questionnaire (CSQ-8). Total scores range from 8 to 32, with higher scores indicating greater treatment satisfaction. A slightly revised version will be administered to participants in the CAU group to probe satisfaction with healthcare.
Working alliance
Assessed using the Working Alliance Questionnaire (WAI - short version). Scale range is from 6 to 42 with higher scores indicating a better percieved working alliance. Will only be administered to the exerimental treatment arm (iFAS)
Negative effects of treatment
The Negative Effects of Treatment Questionnaire (NEQ-20). The self-report measure consists of three parts. First, respondents endorse specific items in case they have occurred or not during treatment, yes/no (dummy coded as a variable: 1/0). Second, the respondents rate how negatively the negative effect was on four-point Likert-scale, ranging from "Not at all" to "Extremely", 0-4 ("0" being minimum and "4" being maximum). Third, the respondents attribute the negative effect to "The treatment I received" (1) or "Other circumstances" (0) (dummy coded as a variable: 1/0). A slightly revised version will be administered to participants in the CAU group to probe negative effects of healthcare.
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Karolinska Institutet
Lead sponsor
Region Stockholm
Collaborator
