Prospective Case Series to Refine Standalone Cognitive Behavioral Therapy Components for Multiple Sclerosis Fatigue

NCT ID: NCT05848323

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-30
• Study Completion Date: 2024-09-25

Brief Summary

This prospective case series will use mixed methods to examine the feasibility, acceptability, and initial effects of three telehealth cognitive behavioral therapy components (relaxation training, behavioral activation, cognitive therapy) for fatigue in people with multiple sclerosis.

Detailed Description

Fatigue affects 80% of people with multiple sclerosis (PwMS), and nearly half report fatigue as their most disabling symptom. The cognitive behavioral model of MS fatigue theorizes that MS disease factors trigger fatigue, but fatigue is maintained or worsened by factors like daily stress and how PwMS react cognitively, behaviorally, physiologically, and emotionally to fatigue. In-person and telehealth cognitive behavioral therapy (CBT) for fatigue targets these factors and reactions and is one of the most effective treatments for MS fatigue. However, CBT is resource intensive, as it consists of multiple components (i.e., relaxation training, behavioral activation, cognitive therapy), requiring 8-16 hour-long sessions delivered by a specialized clinician. CBT has yet to be assessed via an integrated translational model that considers all stages, from intervention development to implementation. Thus, the active components of CBT for MS fatigue and their mechanisms are unclear and, despite the significant burden of MS fatigue, CBT for fatigue is not widely accessible due to various implementation barriers.

The proposed prospective case series is the first of two project aims. The overall project aims to optimize CBT for fatigue to maximize efficacy and efficiency. It will use the Multiphase Optimization Strategy to advance scientific evidence on CBT's active components and facilitate implementation, thereby improving accessibility. The proposed prospective case series (Aim 1) will:

1. examine the feasibility and acceptability of telehealth CBT components (relaxation training, behavioral activation, cognitive therapy) for fatigue in PwMS.

2. examine initial effects of telehealth CBT components (relaxation training, behavioral activation, cognitive therapy) for improving fatigue in PwMS.

3. understand participants' perceptions of the feasibility, acceptability, appropriateness, and perceived effectiveness of telehealth CBT components (relaxation training, behavioral activation, cognitive therapy) for improving fatigue in PwMS and their recommendations for improving the CBT components.

Conditions

Multiple Sclerosis; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Relaxation Training

Didactic and experiential training in one or more relaxation techniques such as diaphragmatic breathing, progressive muscle relaxation, autogenic relaxation, and guided imagery to reduce autonomic nervous system arousal.

Group Type: EXPERIMENTAL

4-week Relaxation Training

Intervention Type: BEHAVIORAL

A 4-session telehealth Relaxation Training intervention for multiple sclerosis fatigue that is derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. The intervention is based on the cognitive behavioral model of fatigue in multiple sclerosis. The intervention involves 4, 30-60-minute sessions including the following content a) education about fatigue in multiple sclerosis and the cognitive behavioral model of multiple sclerosis fatigue, b) treatment rationale, b) didactic and experiential training in relaxation techniques such as diaphragmatic breathing, progressive muscle relaxation, autogenic relaxation, and guided imagery, and c) goal setting and problem-solving barriers focused on integrating relaxation practices into daily routine.

Behavioral Activation

Didactic material and practice focused on identification and reduction of avoidance behaviors (e.g., excessive rest) and increased engagement in valued and reinforcing activities (e.g., physical activity, social engagement).

Group Type: EXPERIMENTAL

4-week Behavioral Activation

Intervention Type: BEHAVIORAL

A 4-session telehealth Behavioral Activation intervention for multiple sclerosis fatigue that is derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. The intervention is based on the cognitive behavioral model of fatigue in multiple sclerosis. The intervention involves 4, 30-60-minute sessions including the following content a) education about fatigue in multiple sclerosis, the cognitive behavioral model of multiple sclerosis fatigue, and self-monitoring activity and energy, b) treatment rationale, c) identification of values/priorities to guide activities, d) activity planning, e) goal setting and problem-solving barriers to engaging in activities.

Cognitive Therapy

Didactic material and practice focused on identifying, challenging, and modifying inaccurate and/or unhelpful patterns of thought about the self and the world (e.g., catastrophizing the meaning and consequences of fatigue) to change unwanted behavioral patterns (e.g., excessive rest).

Group Type: EXPERIMENTAL

4-week Cognitive Therapy

Intervention Type: BEHAVIORAL

A 4-session telehealth Cognitive Therapy intervention for multiple sclerosis fatigue that is derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. The intervention is based on the cognitive behavioral model of fatigue in multiple sclerosis. The intervention involves 4, 30-60-minute sessions including the following content a) education about fatigue in multiple sclerosis, the cognitive behavioral model of multiple sclerosis fatigue, self-monitoring thoughts, and core beliefs, b) treatment rationale, b) labeling thoughts as helpful, unhelpful, or neutral, c) using distraction to cope with unhelpful thoughts, d) challenging and changing unhelpful thoughts, e) problem solving barriers to coping with or changing unhelpful thoughts.

Interventions

4-week Relaxation Training

A 4-session telehealth Relaxation Training intervention for multiple sclerosis fatigue that is derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. The intervention is based on the cognitive behavioral model of fatigue in multiple sclerosis. The intervention involves 4, 30-60-minute sessions including the following content a) education about fatigue in multiple sclerosis and the cognitive behavioral model of multiple sclerosis fatigue, b) treatment rationale, b) didactic and experiential training in relaxation techniques such as diaphragmatic breathing, progressive muscle relaxation, autogenic relaxation, and guided imagery, and c) goal setting and problem-solving barriers focused on integrating relaxation practices into daily routine.

Intervention Type: BEHAVIORAL

4-week Behavioral Activation

A 4-session telehealth Behavioral Activation intervention for multiple sclerosis fatigue that is derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. The intervention is based on the cognitive behavioral model of fatigue in multiple sclerosis. The intervention involves 4, 30-60-minute sessions including the following content a) education about fatigue in multiple sclerosis, the cognitive behavioral model of multiple sclerosis fatigue, and self-monitoring activity and energy, b) treatment rationale, c) identification of values/priorities to guide activities, d) activity planning, e) goal setting and problem-solving barriers to engaging in activities.

Intervention Type: BEHAVIORAL

4-week Cognitive Therapy

A 4-session telehealth Cognitive Therapy intervention for multiple sclerosis fatigue that is derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. The intervention is based on the cognitive behavioral model of fatigue in multiple sclerosis. The intervention involves 4, 30-60-minute sessions including the following content a) education about fatigue in multiple sclerosis, the cognitive behavioral model of multiple sclerosis fatigue, self-monitoring thoughts, and core beliefs, b) treatment rationale, b) labeling thoughts as helpful, unhelpful, or neutral, c) using distraction to cope with unhelpful thoughts, d) challenging and changing unhelpful thoughts, e) problem solving barriers to coping with or changing unhelpful thoughts.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. MS diagnosis of any subtype per chart review

2. Score 4 or higher on the Fatigue Severity Scale

3. Presence of chronic, problematic fatigue that, in the opinion of the patient, has interfered with their daily activities for 3 or more months

4. Are able to comply with study procedures and complete measures independently assessed via self-report

5. All genders

6. 18 years of age or older

7. Able to read and speak English

8. Are willing to maintain current fatigue treatment regimen for duration of study (although individuals who want to make a change to their fatigue treatment regimen will be considered eligible 3 months after making that change)

Exclusion Criteria

1. Score greater than 7 on the Patient Determined Disease Steps Scale

2. Has significant cognitive impairment as indicated by 1 or more errors on the 6-item Cognitive Screener

3. Change in disease modifying medications in the prior three months assessed via self-report (although participants will be considered eligible after the 3-month window)

4. History of MS relapse within the last 30 days prior to screening assessed via self-report (although participants will be considered eligible after the 30-day window)

5. Current suicidal ideation with intent or plan as indicated by a score of 1 or higher on the Patient Health Questionnaire-9 suicide item and further assessment with the Columbia-Suicide Severity Rating Scale (although individuals with suicidal ideation but no intent or plan will be considered eligible)

6. Currently engaged in psychotherapy for fatigue assessed via self-report

7. Current pregnancy (although participants will be considered eligible when they are no longer pregnant)

8. Currently participating in another research study that could impact fatigue such as intervention studies targeting mood, energy management, exercise/physical activity, and diet (although participants can be screened for eligibility once they have completed the other research study).

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

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Lindsey Knowles

Acting Assistant Professor: School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lindsey Knowles, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Multiple Sclerosis Center at UW Medical Center - Northwest

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

STUDY00017623

Identifier Type: -

Identifier Source: org_study_id