Clinical trial · Interventional
Characterization, Treatment, and Long-term Follow-up of Fatigued Patients in Primary Care
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Exhaustion Disorder | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Fatigue Post Viral | — | UNRESOLVED | — |
| Fatigue Related to Cancer Treatment | — | UNRESOLVED | — |
| Fatigue Symptom | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Care as usual | Other | — | UNRESOLVED |
| Cognitive behavioral therapy for persistent fatigue | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cognitive behavioral therapy for persistent fatigue
- description
- The treatment consists of three main phases: 1) goal-setting; stabilizing sleep-wake patterns and even distribution of activities over the day (pacing). Attention-shifting and cognitive reappraisal 2. Gradual increase in physical activity followed by gradual increase in mental and social activity 3. Gradual steps to reach individual goals.
- interventionNames
- Behavioral: Cognitive behavioral therapy for persistent fatigue
- type
- OTHER
- label
- Care as usual (CAU)
- description
- 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.
- interventionNames
- Other: Care as usual
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 67 Years
Show eligibility criteria text
Inclusion Criteria: 1. age 18-67 2. enrollment at a primary care clinic in Region Stockholm 3. severe, functionally disabling fatigue as a central symptom for at least 3 months 4. The fatigue has an identifiable start and hence has not been life-long; 5. 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 6. regular access to a computer and to the Internet 7. ability to read and write in Swedish. 8. 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 Criteria: 1. substance abuse disorder in the past 6 months 2. Current or past psychosis or bipolar disorder 3. 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) 4. elevated risk for suicide 5. deliberate self harm in the past 6-months (e.g., cutting, burning, poisoning); 6. BMI\>40 7. Initiated or changed psychopharmacological medication (e.g., for depression or anxiety disorders) in the past month 8. ongoing chemotherapy 9. intellectual disability (e.g., severe autism) that affects ability to work with the treatment 10. pregnancy 11. 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) 12. ongoing psychological treatment and/or multimodal rehabilitation. 13. working night shifts
References
Publications (0)
Data not yet available