Clinical trial NCT06341751: Psychological Treatment for Persistent Fatigue
Official title: Psychological Treatment for Persistent Fatigue: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Fatigue Syndrome, Chronic
Exhaustion; Syndrome
Keywords: Psychological treatment
Primary care
cognitive behavioral therapy
internet intervention
feasibility
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Forte
name: The Swedish Research Council
name: Region Stockholm
First posted: 2024-04-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Treatment adherence and completion
timeFrame: Post-treatment (6 months)
measure: Treatment credibility
timeFrame: Three weeks after treatment start
measure: Patient satisfaction
timeFrame: Post-treatment (6 months)
measure: Working alliance
timeFrame: Week 3 and 15 of treatment
measure: Negative effects of treatment
timeFrame: Post-treatment (6 months)
measure: Open-ended questions regarding treatment content and presentation
timeFrame: Post-treatment (6 months)
Secondary outcomes:
measure: Feasibility of study inclusion procedures and data-collection
timeFrame: Data will be collected during the recruitment and inclusion phase of the study.
measure: Fatigue severity, primary self-rated symptom outcome
timeFrame: Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.
measure: Problems concentrating
timeFrame: Assessed pre- and at post treatment (6 months)
measure: Reduced physical activity
timeFrame: Assessed pre- and at post treatment (6 months)
measure: Reduced motivation
timeFrame: Assessed pre- and at post treatment (6 months)
measure: Depressive symptoms
timeFrame: Assessed pre- and at post treatment (6 months). The individual item assessing suicide risk will be administered every 3 weeks during the traetment phase.
measure: Somatic symptoms
timeFrame: Assessed pre- and at post treatment (6 months)
measure: General anxiety
timeFrame: Assessed pre- and at post treatment (6 months)
measure: Insomnia
timeFrame: Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.
measure: Perceived Stress
timeFrame: Assessed pre- and at post treatment (6 months)
measure: Burnout
timeFrame: Assessed pre- and at post treatment (6 months)
measure: Self-rated health
timeFrame: Assessed pre- and at post treatment (6 months)
measure: Cognitive and behavioral responses to symptoms
timeFrame: Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.
measure: General self-efficacy
timeFrame: Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.
measure: Functional disability
timeFrame: Assessed pre- and at post treatment (6 months)
measure: Work and Social Adjustment
timeFrame: Assessed pre- and at post treatment (6 months)
Other outcomes:
measure: Treatment fidelity
timeFrame: Continuously throughout the 6-month treatment phase
measure: Evaluation of participants' experience of treatment
timeFrame: Post-treatment completion (at 6 months)
measure: Acceptability, Appropriateness, and Feasibility from the perspective of the clinic
timeFrame: Assessed post-treatment completion (after 6 months)
Locations:
city: Stockholm
country: Sweden
facility: Gustavsberg University Primary Care Clinic
Study officials:
affiliation: Region Stockholm and Karolinska Institutet
name: Elin Lindsäter, PhD
role: PRINCIPAL_INVESTIGATOR
References: