Actively Recruiting
Characterization, Treatment, and Long-term Follow-up of Fatigued Patients in Primary Care
Led by Karolinska Institutet · Updated on 2026-03-11
190
Participants Needed
1
Research Sites
291 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
R
Region Stockholm
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating fatigue as a common and persistent symptom affecting many primary care patients. This study aims to improve understanding of fatigue and test a new, accessible treatment called transdiagnostic cognitive behavioral therapy (tCBT), designed to be used in primary care settings. The study compares tCBT to usual care to see if it can reduce fatigue severity and improve other symptoms over time. It also explores which patient characteristics affect treatment response and includes a long-term follow-up of up to five years. The study involves two groups: one receiving tCBT and the other receiving care as usual (CAU). The tCBT treatment is delivered in a blended format combining face-to-face therapy sessions with online materials and exercises over 4 to 6 months. CAU includes a variety of treatments typically provided in primary care, such as psychological therapy, physiotherapy, medication, or specialist follow-up. The trial uses random assignment to place participants into one of the two groups. Participants will complete self-rated questionnaires on fatigue and related symptoms, cognitive tests, and physiological monitoring with biometric rings in some cases. Assessments occur regularly during treatment, at 6 months, 12 months, and up to 60 months after starting. Researchers will track fatigue severity changes, cognitive function, mental health symptoms, physical activity, and work ability. The study includes safety monitoring and detailed data collection from healthcare registers to evaluate treatment effects and costs over time.
CONDITIONS
Brief Title
Characterization, Treatment, and Long-term Follow-up of Fatigued Patients in Primary Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 67 years
- Enrollment at a primary care clinic in Region Stockholm
- Severe, disabling fatigue as a main symptom lasting at least 3 months
- Fatigue has a clear starting point and is not lifelong
- Fatigue is not caused by an active disease needing other treatment (e.g., thyroid problems, anemia, cancer, dementia)
- Regular access to a computer and the Internet
- Ability to read and write in Swedish
- Ability to attend study visits up to 60 minutes and use online materials
You will not qualify if you...
- Substance abuse disorder in the past 6 months
- Current or past psychosis or bipolar disorder
- Severe primary psychiatric disorder needing treatment (e.g., moderate to severe depression, PTSD, OCD, anorexia)
- Elevated risk of suicide
- Deliberate self-harm in the past 6 months
- Body mass index over 40
- Started or changed psychiatric medication in the last month
- Ongoing chemotherapy
- Intellectual disability affecting treatment ability
- Pregnancy
- Life circumstances that prevent treatment (e.g., domestic violence, legal disputes, planned surgery)
- Current psychological treatment or multimodal rehabilitation
- Working night shifts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 to 6 months
Participants receive a transdiagnostic cognitive behavioral therapy (tCBT) for persistent fatigue delivered in a blended format combining face-to-face sessions and online materials over several months.
Visits every three weeks during treatment phase
Duration - Up to 12 months after baseline
Participants complete follow-up assessments to evaluate fatigue severity, cognitive function, symptom changes, and treatment effects.
Assessments at 6 months and 12 months post baseline
Trial Site Locations
Total: 1 location
1
Gustavsberg University Primary Care Clinic
Stockholm, Gustavsberg, Sweden, 134 40
Actively Recruiting
Research Team
F
Frank Svärdman, PhD-student
C
Conrad Samuelsson, PhD-student
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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