Psychological Treatment for Persistent Fatigue

NCT06341751 | Completed

• 1 other identifier: 2024-00393-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue; Fatigue Syndrome, Chronic; Exhaustion; Syndrome

Keywords

Psychological treatment; Primary care; cognitive behavioral therapy; internet intervention; feasibility

Outcome Measures

Primary Outcomes (6)

• 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)

• 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

• 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)

• 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

• 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)

• 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 Outcomes (16)

• Feasibility of study inclusion procedures and data-collection

  Data will be collected during the recruitment and inclusion phase of the study.

• Fatigue severity, primary self-rated symptom outcome

  Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.

• Problems concentrating

  Assessed pre- and at post treatment (6 months)

• Reduced physical activity

  Assessed pre- and at post treatment (6 months)

• Reduced motivation

  Assessed pre- and at post treatment (6 months)

Other Outcomes (3)

• Treatment fidelity

  Continuously throughout the 6-month treatment phase

• Evaluation of participants' experience of treatment

  Post-treatment completion (at 6 months)

• Acceptability, Appropriateness, and Feasibility from the perspective of the clinic

  Assessed post-treatment completion (after 6 months)

Study Arms (1)

Psychological treatment

EXPERIMENTAL

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).

Behavioral: Psychological treatment for persistent fatigue

Interventions

Psychological treatment for persistent fatigue 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.

Psychological treatment

Eligibility Criteria

• Age: 18 Years - 67 Years
• Gender Eligibility Details: In the initial screening, patients are asked to respond to the following question: "What is your gender? (with gender, we mean gender-identity, that is - your self-representation of gender)" Response-alternatives: Male Female Non-binary Other alternative Not sure Prefer not to answer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-67
• severe, functionally disabling fatigue as a central symptom for at least 3 months
• 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.

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)
• elevated risk for suicide
• anorexia nervosa
• 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
• self-harm
• pregnancy
• life circumstances that complicate or make treatment impossible (e.g., domestic violence or ongoing legal disputes)
• ongoing psychological treatment and/or multimodal rehabilitation.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Forte: collaborator
• The Swedish Research Council: collaborator
• Region Stockholm: collaborator

Study Sites (1)

Gustavsberg University Primary Care Clinic

Stockholm, Stockholm County, 134 40, Sweden

Location

MeSH Terms

Conditions

Fatigue; Fatigue Syndrome, Chronic; Syndrome

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Disease

Study Officials

• Elin Lindsäter, PhD

  Region Stockholm and Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical psychologist, PhD, Principal Investigator

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: April 2, 2024
• Study Start: April 11, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: June 3, 2025

Record last verified: 2024-07

Locations

SE (1)