Psychological Treatment for Persistent Fatigue

Fatigue Clinical Trial

Official title:

Psychological Treatment for Persistent Fatigue: a Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06341751
• Other study ID #: 2024-00393-01
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2024
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Karolinska Institutet
• Contact: Frank Svärdman, psychologist
• Phone: 0702308870
• Email: Frank.svardman[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exhaustion; Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Syndrome

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Sweden	Gustavsberg University Primary Care Clinic	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska Institutet	Forte, Region Stockholm, The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment fidelity	Treatment fidelity will be assessed by audio recording all synchronous treatment sessions, of which a random selection will be assessed for fidelity using checklists that correspond to the central treatment components in each phase of the treatment.	Continuously throughout the 6-month treatment phase
Other	Evaluation of participants' experience of treatment	When all treatments have been completed in the study, semi-structured interviews will be conducted with up to 10 included patients and up to three therapists. These will tap deeper, qualitative information about perceptions of working with the treatment and the data-collection procedures. All interviews will be audio recorded and transcribed for thematic content analysis.	Post-treatment completion (at 6 months)
Other	Acceptability, Appropriateness, and Feasibility from the perspective of the clinic	a survey based on the "Triple P Systems Implementation Outcomes: Acceptability, Appropriateness, and Feasibility of intervention measure" will be disseminated to healthcare staff at participating primary health care clinics, to which they respond anonymously.	Assessed post-treatment completion (after 6 months)
Primary	Treatment adherence and completion	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	Post-treatment (6 months)
Primary	Treatment credibility	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.	Three weeks after treatment start
Primary	Patient satisfaction	Client Satisfaction Questionnaire (CSQ-8). Total scores range from 8 to 32, with higher scores indicating greater treatment satisfaction.	Post-treatment (6 months)
Primary	Working alliance	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.	Week 3 and 15 of treatment
Primary	Negative effects of treatment	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).	Post-treatment (6 months)
Primary	Open-ended questions regarding treatment content and presentation	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.	Post-treatment (6 months)
Secondary	Feasibility of study inclusion procedures and data-collection	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.	Data will be collected during the recruitment and inclusion phase of the study.
Secondary	Fatigue severity, primary self-rated symptom outcome	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.	Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.
Secondary	Problems concentrating	Subscale in the Checklist Individual Strengths Questionnaire (CIS), 5 items. Scale range: 5 to 35 with higher scores representing more problems concentrating.	Assessed pre- and at post treatment (6 months)
Secondary	Reduced physical activity	Subscale in the Checklist Individual Strengths Questionnaire (CIS), 3 items. Scale range: 3 to 21 with higher scores representing less physical activity.	Assessed pre- and at post treatment (6 months)
Secondary	Reduced motivation	Subscale in the Checklist Individual Strengths Questionnaire (CIS), 4 items. Scale range: 4 to 28 with higher scores representing less motivation.	Assessed pre- and at post treatment (6 months)
Secondary	Depressive symptoms	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.	Assessed pre- and at post treatment (6 months). The individual item assessing suicide risk will be administered every 3 weeks during the traetment phase.
Secondary	Somatic symptoms	Physical Health Questionnaire-15 (PHQ-15). Scale range is from 0 to 30, higher scores representing more somatic symptoms	Assessed pre- and at post treatment (6 months)
Secondary	General anxiety	The General Anxiety Questionnaire (GAD-7). Scale range is from 0 to 21, higher scores representing more anxiety.	Assessed pre- and at post treatment (6 months)
Secondary	Insomnia	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.	Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.
Secondary	Perceived Stress	The Perceived Stress Scale (PSS-10). Scale range is from 0 to 40, higher scores representing a higher level of perceived stress.	Assessed pre- and at post treatment (6 months)
Secondary	Burnout	The Shirom-Melamed Burnout Questionnaire (SMBQ-18). Scale range is from 0 to 6, higher scores representing a higher level of burnout.	Assessed pre- and at post treatment (6 months)
Secondary	Self-rated health	The Self-rated health questionnaire (SRH-5). A single item with 5 response-categories, 0 (very bad health); 4 (very good health)	Assessed pre- and at post treatment (6 months)
Secondary	Cognitive and behavioral responses to symptoms	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).	Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.
Secondary	General self-efficacy	The General self-efficacy scale (GSE), 10 items. Scale range is from 10 to 40, higher scores representing a higher level of self-efficacy.	Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.
Secondary	Functional disability	World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), 12 items. Scoring from 0 (maximum functional disability) to 100 (no functional disability)	Assessed pre- and at post treatment (6 months)
Secondary	Work and Social Adjustment	the Work and Social Adjustment Scale (WSAS), 5 items. Scale range 0 to 40 with higher scores representing better work and social adjustment.	Assessed pre- and at post treatment (6 months)