RecruitingNot ApplicableNCT06786832

Characterization, Treatment, and Long-term Follow-up of Fatigued Patients in Primary Care

Sponsor

Karolinska Institutet

Enrollment

190 participants

Start Date

Feb 6, 2025

Study Type

INTERVENTIONAL

Conditions

Fatigue Fatigue Symptom Fatigue Related to Cancer Treatment Fatigue Post Viral Exhaustion Disorder

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 67 Years

Inclusion Criteria8

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;
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
regular access to a computer and to the Internet
ability to read and write in Swedish.
ability to visit a study center for participation in potential assessments and treatment sessions (maximum 60 minutes) and to take part of written material via the internet.

Exclusion Criteria13

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
deliberate self harm in the past 6-months (e.g., cutting, burning, poisoning);
BMI\>40
Initiated or changed psychopharmacological medication (e.g., for depression or anxiety disorders) in the past month
ongoing chemotherapy
intellectual disability (e.g., severe autism) that affects ability to work with the treatment
pregnancy
life circumstances that complicate or make treatment impossible (e.g., domestic violence, ongoing legal disputes, disputes with social insurance agency, planed or on-going work capacity assesment regarding permanent work disability pension or planed surgery)
ongoing psychological treatment and/or multimodal rehabilitation.
working night shifts

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Interventions

BEHAVIORALCognitive behavioral therapy for persistent fatigue

The 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.

OTHERCare as usual

Since 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.