Psychological Treatment for Persistent Fatigue

Not Applicable

Active, not recruiting

• Conditions: Exhaustion; Syndrome; Fatigue; Fatigue Syndrome, Chronic
• Interventions: Behavioral: Psychological treatment for persistent fatigue

• Registration Number: NCT06341751
• Lead Sponsor: Karolinska Institutet

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.

Study Timeline

• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-25
• Study First Posted: 2024-04-02
• Study Start: 2024-04-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-05
• Last Update Posted: 2024-07-08
• Primary Completion: 2024-12
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Psychological treatment	Psychological treatment for persistent fatigue	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).

Primary Outcome Measures

Name	Time	Method
Working alliance	Week 3 and 15 of treatment	Assessed using the Working Alliance Questionnaire (WAI - short version). Scale range is from 6 to 42 with higher scores indicating a better percieved working alliance.
Treatment adherence and completion	Post-treatment (6 months)	Treatment adherence will be assessed by evaluating how many sessions (face-to-face and video-based) the patient received, how many modules of the internet-delivered material the patient accessed, and the amount of time the patient spent in the online treatment platform (data extracted from the platform).; Further, number of drop-outs (i.e., patients who discontinued treatment before treatment completion) will be analyzed
Patient satisfaction	Post-treatment (6 months)	Client Satisfaction Questionnaire (CSQ-8). Total scores range from 8 to 32, with higher scores indicating greater treatment satisfaction.
Treatment credibility	Three weeks after treatment start	Assessed using the Credibility/Expectancy Questionnaire (C-Scale). The C-Scale is a 5-item measure, scale range is 0 to 50 points with higher scores indicating higher treatment credibility.
Negative effects of treatment	Post-treatment (6 months)	The Negative Effects of Treatment Questionnaire (NEQ-20). The self-report measure consists of three parts. First, respondents endorse specific items in case they have occurred or not during treatment, yes/no (dummy coded as a variable: 1/0). Second, the respondents rate how negatively the negative effect was on four-point Likert-scale, ranging from "Not at all" to "Extremely", 0-4 ("0" being minimum and "4" being maximum). Third, the respondents attribute the negative effect to "The treatment I received" (1) or "Other circumstances" (0) (dummy coded as a variable: 1/0).
Open-ended questions regarding treatment content and presentation	Post-treatment (6 months)	Post-treatment, patients will be asked open-ended questions regarding their perception of the different components of the treatment, how much time they spent working with the treatment, and their thoughts about the usability of the digital platform.

Secondary Outcome Measures

Name	Time	Method
Somatic symptoms	Assessed pre- and at post treatment (6 months)	Physical Health Questionnaire-15 (PHQ-15). Scale range is from 0 to 30, higher scores representing more somatic symptoms
Perceived Stress	Assessed pre- and at post treatment (6 months)	The Perceived Stress Scale (PSS-10). Scale range is from 0 to 40, higher scores representing a higher level of perceived stress.
Feasibility of study inclusion procedures and data-collection	Data will be collected during the recruitment and inclusion phase of the study.	The recruitment procedure will be evaluated by accessing data from ALMA (a fully automated clinical desicion-support in the medical journal). ALMA aggregates anonymous data regarding number of times the algorithm has been activated and the number of times it has resulted in a referral to the study platform where screening for study inclusion is completed. Of those who complete screening, we will assess the proportion of patients who are included or excluded in the study.; Data-collection procedures will be assessed by evaluating data-attrition at the various measurement points.
Depressive symptoms	Assessed pre- and at post treatment (6 months). The individual item assessing suicide risk will be administered every 3 weeks during the traetment phase.	Patient Health Questionnaire-9 (PHQ-9). Scale range is from 0 to 27, higher scores representing more depressive symptoms Note: the suicide-item will be administered every three weeks during the treatment phase.
Fatigue severity, primary self-rated symptom outcome	Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.	Fatigue severity (self-rated) using the Checklist Individual Strenghts- Fatigue severity subscale. The domain Fatigue severity contains 8 items scored on a 7-point Likert scale (range 8-56; higher scores=more severe fatigue). A score above 35 points on the CIS-F indicates severe fatigue.
Reduced physical activity	Assessed pre- and at post treatment (6 months)	Subscale in the Checklist Individual Strengths Questionnaire (CIS), 3 items. Scale range: 3 to 21 with higher scores representing less physical activity.
Self-rated health	Assessed pre- and at post treatment (6 months)	The Self-rated health questionnaire (SRH-5). A single item with 5 response-categories, 0 (very bad health); 4 (very good health)
Problems concentrating	Assessed pre- and at post treatment (6 months)	Subscale in the Checklist Individual Strengths Questionnaire (CIS), 5 items. Scale range: 5 to 35 with higher scores representing more problems concentrating.
Reduced motivation	Assessed pre- and at post treatment (6 months)	Subscale in the Checklist Individual Strengths Questionnaire (CIS), 4 items. Scale range: 4 to 28 with higher scores representing less motivation.
Burnout	Assessed pre- and at post treatment (6 months)	The Shirom-Melamed Burnout Questionnaire (SMBQ-18). Scale range is from 0 to 6, higher scores representing a higher level of burnout.
Insomnia	Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.	The Insomnia Severity Inventory (ISI) 7 items. Scale range is from 0 to 28, higher scores representing higher insomnia severity.; NOTE: an additional item will be added to assess hypersomnia.
Cognitive and behavioral responses to symptoms	Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.	Cognitive and Behavioral Responses to Symptoms Questionnaire (CBRQ), 18-items. The scale assesses six domains: Fear avoidance (3 items, scale range 0-12); Damage beliefs (3 items, scale range 0-12); Embarrassment avoidance (3 items, scale range 0-12); Symptom focusing (3 items, scale range 0-12); All-or-nothing behaviour (3 items, scale range 0-12); Resting behaviour (3 items, scale range 0-12).
General anxiety	Assessed pre- and at post treatment (6 months)	The General Anxiety Questionnaire (GAD-7). Scale range is from 0 to 21, higher scores representing more anxiety.
General self-efficacy	Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.	The General self-efficacy scale (GSE), 10 items. Scale range is from 10 to 40, higher scores representing a higher level of self-efficacy.
Functional disability	Assessed pre- and at post treatment (6 months)	World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), 12 items. Scoring from 0 (maximum functional disability) to 100 (no functional disability)
Work and Social Adjustment	Assessed pre- and at post treatment (6 months)	the Work and Social Adjustment Scale (WSAS), 5 items. Scale range 0 to 40 with higher scores representing better work and social adjustment.

Trial Locations

Locations (1)

Gustavsberg University Primary Care Clinic; 🇸🇪 Stockholm, Sweden