Psychological Treatment for Persistent Fatigue

NCT ID: NCT06341751

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-11
• Study Completion Date: 2025-01-15

Brief Summary

This is a non-randomized pilot study to investigate the feasibility and acceptability of a transdiagnostic psychological intervention for primary care patients in Region Stockholm, Sweden, who suffer from persistent and disabling fatigue.

Detailed Description

Previous research indicates that fatigue is a transdiagnostic symptom dimension rather than a disorder-specific pathofysiology. Similar psychosocial mechanisms can contribute to the development and perpetuation of fatigue across medical conditions. Cognitive and behavioral interventions targeting these perpetuating mechanisms have been found effective in reducing fatigue severity and functional impairment in a range of different fatigue-dominated diagnostic groups. Based on these findings, the investigators have developed a transdiagnostic intervention for primary care patients who suffer from persistent fatigue, independent of primary diagnosis. The treatment is a psychological intervention based on cognitive and behavioral principles that is administered over a period of 4-6 months. Treatment material will be delivered via an online treatment platform and therapist support will be given both face-to-face and via written asynchronous text-messages in the online treatment platform.

This initial feasibility study is non-randomized, meaning that all included patients will recieve treatment.

The project could provide feasibility of a transdiagnostic treatment for primary care patients with severe and persistent fatigue across medical conditions. If the inclusion procedure, the data-collection procedure, and the treatment are feasible, a larger randomized clinical trial (RCT) studying treatment effect is called for. An adequately powered RCT could provide firm scientific support for a novel, scalable, and cost-effective way to deliver an evidence-based treatment for this large and currently under-treated patient group. This would have a desirable impact on patients, families, healthcare units, and society at large, given that fatigue is associated with substantial suffering and work-disability and that treatment guidelines are currently lacking.

Conditions

Fatigue; Fatigue Syndrome, Chronic; Exhaustion; Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Psychological treatment

Blended treatment, i.e., both physical face-to-face sessions and internet-based asynchronous support. Treatment period is 4-6 months (6 months primary endpoint).

Group Type: EXPERIMENTAL

Psychological treatment for persistent fatigue

Intervention Type: BEHAVIORAL

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. Individual work to reach treatment goals.

Interventions

Psychological treatment for persistent fatigue

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. Individual work to reach treatment goals.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. age 18-67

2. severe, functionally disabling fatigue as a central symptom for at least 3 months

3. 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

4. regular access to a computer and to the Internet

5. ability to read and write in Swedish.

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)

4. elevated risk for suicide

5. anorexia nervosa

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. self-harm

11. pregnancy

12. life circumstances that complicate or make treatment impossible (e.g., domestic violence or ongoing legal disputes)

13. ongoing psychological treatment and/or multimodal rehabilitation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forte

INDUSTRY

Sponsor Role: collaborator

The Swedish Research Council

OTHER_GOV

Sponsor Role: collaborator

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Elin Lindsäter

clinical psychologist, PhD, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elin Lindsäter, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Stockholm and Karolinska Institutet

Locations

Gustavsberg University Primary Care Clinic

Stockholm, Stockholm County, Sweden

Countries

Sweden

Other Identifiers

2024-00393-01

Identifier Type: -

Identifier Source: org_study_id