Actively Recruiting

Phase Not Applicable
Age: 18Years - 67Years
All Genders
NCT06786832

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

412 weeks

Total Duration

On this page

Sponsors

K

Karolinska Institutet

Lead Sponsor

R

Region Stockholm

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 67Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 67 years
  • Registered at a primary care clinic in Region Stockholm
  • Severe, disabling fatigue present for at least 3 months
  • Fatigue has a clear start and is not lifelong
  • Fatigue not caused by active diseases requiring other treatments (e.g., thyroid issues, anemia, cancer, dementia) or medication side effects
  • Regular access to a computer and internet
  • Ability to read and write Swedish
  • Ability to attend study visits up to 60 minutes and use internet materials
Not Eligible

You will not qualify if you...

  • Substance abuse disorder within the past 6 months
  • Current or past psychosis or bipolar disorder
  • Severe psychiatric disorders needing evidence-based treatment (e.g., OCD, moderate/severe depression, PTSD, anorexia nervosa)
  • Elevated suicide risk
  • Self-harm in past 6 months (e.g., cutting, burning, poisoning)
  • Body mass index over 40
  • Started or changed psychiatric medications in past month
  • Ongoing chemotherapy
  • Intellectual disability affecting treatment participation
  • Pregnancy
  • Life situations that prevent treatment (e.g., domestic violence, legal disputes, planned surgery, ongoing disability assessments)
  • Receiving psychological treatment or multimodal rehabilitation currently
  • Working night shifts

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Gustavsberg University Primary Care Clinic

Stockholm, Gustavsberg, Sweden, 134 40

Actively Recruiting

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Research Team

F

Frank Svärdman, PhD-student

CONTACT

C

Conrad Samuelsson, PhD-student

CONTACT

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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