Recruiting

iFASTransdiagnostic Fatigue Treatment for Primary Care Patients

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What is being tested

Cognitive behavioral therapy for persistent fatigue

+ Care as usual

BehavioralOther
Who is being recruted

Burnout, Psychological+4

+ Behavior

+ Behavioral Symptoms

From 18 to 67 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2025
See protocol details

Summary

Principal SponsorKarolinska Institutet
Study ContactFrank Svärdman, PhD-studentMore contacts
Last updated: March 12, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 6, 2025

Actual date on which the first participant was enrolled.

This clinical trial focuses on understanding and treating fatigue, a condition characterized by extreme and persistent tiredness or exhaustion. Fatigue is a common complaint among 20-30% of patients in primary care, with up to 10% presenting it as their main issue. Despite its high prevalence, the causes of fatigue remain largely unknown. Recent research suggests that factors not attributable to a specific medical condition, such as demographic and psychosocial variables, may better explain fatigue severity. This study aims to evaluate a transdiagnostic cognitive behavioral therapy (tCBT) adapted for primary care patients suffering from persistent fatigue, independent of their primary diagnosis. Participants in this study will be recruited from primary healthcare clinics in Region Stockholm and randomly assigned to either the tCBT group or the care as usual (CAU) group. The tCBT treatment is delivered in a blended format, combining face-to-face therapy with internet-delivered texts and exercises, over a period of 4 - 6 months. The study will measure fatigue severity as the primary outcome, using the Checklist Individual Strengths - Fatigue severity subscale (CIS-F). Secondary outcomes include self-rated symptoms, cognitive functioning, and net days on sick leave. Data collection includes clinician-rated data, self-rated symptom measures, and register-based data. Cognitive functioning will be assessed using a digital cognitive test-battery at baseline and at the 12-month follow up. Additionally, changes in physiological variables will be explored in a subset of participants from baseline to the 12-month follow-up using continuous data collected from biometric rings.

Official TitleCharacterization, Treatment, and Long-term Follow-up of Fatigued Patients in Primary Care
NCT06786832
Principal SponsorKarolinska Institutet
Study ContactFrank Svärdman, PhD-studentMore contacts
Last updated: March 12, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

190 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 67 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Burnout, PsychologicalBehaviorBehavioral SymptomsFatigueSigns and SymptomsStress, PsychologicalPathological Conditions, Signs and Symptoms

Criteria

8 inclusion criteria required to participate
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 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

Show More Criteria

13 exclusion criteria prevent from participating
ongoing psychological treatment and/or multimodal rehabilitation

BMI > 40

deliberate self harm in the past 6-months (e.g., cutting, burning, poisoning)

substance abuse disorder in the past 6 months

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Gustavsberg University Primary Care Clinic

Stockholm, SwedenOpen Gustavsberg University Primary Care Clinic in Google Maps
Recruiting
One Study Center