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

NCT06786832 | Recruiting

• 4 other identifiers: 2024-05857-01STY-2023/00082023-0592020240093
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Psychological treatment; Primary care; cognitive behavioral therapy; blended treatment; randomized controlled trial; Fatigue; burnout; chronic stress; register data; cognitive testing

Outcome Measures

Primary Outcomes (1)

• Self-rated fatigue severity

  Fatigue severity (self-rated) using the Checklist Individual Strengths - Fatigue severity subscale (CIS-F). The domain Fatigue severity contains 8 items scored on a 7-point Likert scale (range 8-56; higher scores=more severe fatigue).

  Baseline (Pre intervention), during treatment phase (every three weeks), post (6 months after baseline) and long term follow up (12 months after baseline))

Secondary Outcomes (16)

• Concentration

  Baseline (Pre intervention), during treatment phase (every three weeks), post (6 months after baseline) and long term follow up (12 months after baseline)

• Motivation

  Baseline (Pre intervention), during treatment phase (every three weeks), post (6 months after baseline) and long term follow up (12 months after baseline)

• Activity

  Baseline (Pre intervention), during treatment phase (every three weeks), post (6 months after baseline) and long term follow up (12 months after baseline)

• Self-rated depressive symptoms

  Baseline (Pre treatment), Post treatment (6 months), long-term follow-up (12 months). Suicide-item will be administered every three weeks during the treatment phase.

• Somatic symptoms

  Baseline (Pre treatment), Post treatment (6 months), long-term follow-up (12 months).

Other Outcomes (19)

• Treatment credibility

  Three weeks after treatment start

• Patient satisfaction with treatment/healthcare

  Post-treatment (6 months)

• Working alliance

  Week 3 and 15 of treatment

Study Arms (2)

Cognitive behavioral therapy for persistent fatigue

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.

Behavioral: Cognitive behavioral therapy for persistent fatigue

Care as usual (CAU)

OTHER

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.

Other: Care as usual

Interventions

Cognitive behavioral therapy for persistent fatigue BEHAVIORAL

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.

Also known as: tCBT

Cognitive behavioral therapy for persistent fatigue

Care as usual OTHER

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.

Also known as: CAU

Care as usual (CAU)

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Academic Primary Health Care Centre, Region Stockholm: collaborator

Study Sites (1)

Gustavsberg University Primary Care Clinic

Stockholm, Gustavsberg, 134 40, Sweden

RECRUITING

MeSH Terms

Conditions

Fatigue; Burnout, Psychological

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Elin Lindsäter, PhD, Ass. Prof

  Region Stockholm and Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank Svärdman, PhD-student

CONTACT

+46 702308870; frank.svardman@ki.se

Conrad Samuelsson, PhD-student

CONTACT

+46 706437077; conrad.samuelsson@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical psychologist, PhD, Associate professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 22, 2025
• Study Start: February 6, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): January 1, 2033
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)