NCT06809192

Brief Summary

This randomized controlled factorial trial will examine whether and how relaxation training, behavioral activation, and cognitive therapy improve fatigue and functioning in fatigued adults living with multiple sclerosis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
10mo left

Started Jan 2025

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Jan 2025Mar 2027

Study Start

First participant enrolled

January 10, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

January 22, 2025

Last Update Submit

March 12, 2026

Conditions

Multiple Sclerosis

Keywords

FatigueMultiphase Optimization StrategyCognitive Behavioral TherapyRelaxationBehavioral ActivationCognitive TherapyOptimizationFactorial Trial

Outcome Measures

Primary Outcomes (2)

  • Modified Fatigue Impact Scale

    This is a 21-item self-report questionnaire assessing fatigue-related symptoms in the previous four weeks via 5-point Likert-type scale. A higher score indicates greater fatigue.

    Collected via online survey at baseline/pre-treatment, post-treatment (3 days after last treatment session or 2 months post-randomization for participants in the No Treatment condition), and 3-month follow-up.

  • PROMIS Short Form - Ability to Participate in Social Roles and Activities

    This 8-item short form is a self-report questionnaire that assesses the perceived ability to perform one's usual social roles and activities via 5-point Likert-type scale. A lower score indicates lower ability to participate in social roles and activities.

    Collected via online survey at baseline/pre-treatment, post-treatment (3 days after last treatment session or 2 months post-randomization for participants in the No Treatment condition), and 3-month follow-up.

Secondary Outcomes (15)

  • Perceived Stress Questionnaire - Tension scale

    Collected via online survey at baseline/pre-treatment, post-treatment (3 days after last treatment session or 2 months post-randomization for participants in the No Treatment condition), and 3-month follow-up.

  • Behavioral Activation for Depression Scale Short Form

    Collected via online survey at baseline/pre-treatment, post-treatment (3 days after last treatment session or 2 months post-randomization for participants in the No Treatment condition), and 3-month follow-up.

  • Fatigue Catastrophizing Scale

    Collected via online survey at baseline/pre-treatment, post-treatment (3 days after last treatment session or 2 months post-randomization for participants in the No Treatment condition), and 3-month follow-up.

  • The Multiple Sclerosis-Fatigue Self Efficacy Scale

    Collected via online survey at baseline/pre-treatment, post-treatment (3 days after last treatment session or 2 months post-randomization for participants in the No Treatment condition), and 3-month follow-up.

  • Perceived Stress Scale

    Collected via online survey at baseline/pre-treatment, post-treatment (3 days after last treatment session or 2 months post-randomization for participants in the No Treatment condition), and 3-month follow-up.

  • +10 more secondary outcomes

Study Arms (8)

No Treatment

NO INTERVENTION

Participants in the "No Treatment" condition will not complete any component sessions and will complete assessments at baseline (within 1 month of randomization), at approximately 2 months after randomization (the weighted average of weeks of treatment in the other conditions), and 3-month follow-up (dated from randomization). Upon study completion, these participants will be offered the opportunity to complete a component of their choice (Relaxation Training, Behavioral Activation, or Cognitive Therapy).

Relaxation Training only

EXPERIMENTAL

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, c) didactic and experiential training in relaxation techniques such as diaphragmatic breathing, progressive muscle relaxation, and autogenic relaxation, and d) goal setting and problem-solving barriers to integrate relaxation practices into daily routine.

Behavioral: 4-session Relaxation Training

Behavioral Activation only

EXPERIMENTAL

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.

Behavioral: 4-session Behavioral Activation

Cognitive Therapy only

EXPERIMENTAL

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, c) labeling thoughts as helpful, unhelpful, or neutral, d) using distraction to cope with unhelpful thoughts, e) challenging and changing unhelpful thoughts, f) problem-solving barriers to coping with or changing unhelpful thoughts.

Behavioral: 4-session Cognitive Therapy

Relaxation Training and Behavioral Activation

EXPERIMENTAL

4 sessions of telehealth Relaxation Training and 4 sessions of telehealth Behavioral Activation for multiple sclerosis fatigue that are derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. Each intervention involves 4, 30-60-minute sessions delivered via phone or videoconference.

Behavioral: 4-session Relaxation TrainingBehavioral: 4-session Behavioral Activation

Relaxation Training and Cognitive Therapy

EXPERIMENTAL

4 sessions of telehealth Relaxation Training and 4 sessions of telehealth Cognitive Therapy for multiple sclerosis fatigue that are derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. Each intervention involves 4, 30-60-minute sessions delivered via phone or videoconference.

Behavioral: 4-session Relaxation TrainingBehavioral: 4-session Cognitive Therapy

Behavioral Activation and Cognitive Therapy

EXPERIMENTAL

4 sessions of telehealth Behavioral Activation and 4 sessions of telehealth Cognitive Therapy for multiple sclerosis fatigue that are derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. Each intervention involves 4, 30-60-minute sessions delivered via phone or videoconference.

Behavioral: 4-session Behavioral ActivationBehavioral: 4-session Cognitive Therapy

Relaxation Training, Behavioral Activation, and Cognitive Therapy

EXPERIMENTAL

4 sessions of telehealth Relaxation Training, 4 sessions of telehealth Behavioral Activation, and 4 sessions of telehealth Cognitive Therapy for multiple sclerosis fatigue that are derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. Each intervention involves 4, 30-60-minute sessions delivered via phone or videoconference.

Behavioral: 4-session Relaxation TrainingBehavioral: 4-session Behavioral ActivationBehavioral: 4-session Cognitive Therapy

Interventions

4-session Relaxation TrainingBEHAVIORAL

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, c) didactic and experiential training in relaxation techniques such as diaphragmatic breathing, progressive muscle relaxation, and autogenic relaxation, and d) goal setting and problem-solving barriers to integrate relaxation practices into daily routine.

Relaxation Training and Behavioral ActivationRelaxation Training and Cognitive TherapyRelaxation Training onlyRelaxation Training, Behavioral Activation, and Cognitive Therapy
4-session Behavioral ActivationBEHAVIORAL

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.

Behavioral Activation and Cognitive TherapyBehavioral Activation onlyRelaxation Training and Behavioral ActivationRelaxation Training, Behavioral Activation, and Cognitive Therapy
4-session Cognitive TherapyBEHAVIORAL

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, c) labeling thoughts as helpful, unhelpful, or neutral, d) using distraction to cope with unhelpful thoughts, e) challenging and changing unhelpful thoughts, f) problem-solving barriers to coping with or changing unhelpful thoughts.

Behavioral Activation and Cognitive TherapyCognitive Therapy onlyRelaxation Training and Cognitive TherapyRelaxation Training, Behavioral Activation, and Cognitive Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed MS diagnosis of any subtype
  • Score of 4 or higher on the Fatigue Severity Scale
  • Able to fluently converse and read in English
  • years of age or older
  • Able to comply with study procedures and complete self-report measures
  • Willing to have intervention sessions audiotaped for fidelity coding
  • Has experienced fatigue for 3 or more months

You may not qualify if:

  • MS relapse within last 30 days (although participants will be considered eligible after the 30-day window)
  • Change in disease modifying medications (DMTs) in the prior three months (although participants will be considered eligible after the 3-month window)
  • Current suicidal ideation with intent or plan as indicated by a score of ≥1 on the Patient Health Questionnaire-9 suicide item and further assessment via the Columbia Suicide Severity Rating Scale (although individuals with suicidal ideation but no intent or plan will be considered eligible)
  • Currently engaged in psychotherapy for fatigue
  • 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 again once they have completed the other research study)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple Sclerosis Center at UW Medical Center - Northwest

Seattle, Washington, 98133, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Multiple SclerosisFatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lindsey Knowles, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsey Knowles, PhD

CONTACT

206-744-9640lmknow@uw.edu

Dawn Ehde, PhD

CONTACT

206-744-2811ehde@uw.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Rehabilitation Medicine

Study Record Dates

First Submitted

January 22, 2025

First Posted

February 5, 2025

Study Start

January 10, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

The investigators will make available to interested researchers a data file containing de-identified data used for each published article at the time the article is accepted for publication. The data will be de-identified to remove any variables from which it would be possible to identify any individual participants. Specifically, the investigators will create a data file that includes all variables used in the published article and a list of the variables in the data file (along with variable labels) and send to investigators who request the data a copy of: (1) the published article (which will describe the source of the data); (2) the variable list/variable labels; and (3) the dataset (as an SPSS.sav file). Note, though, even though any data files that the investigators share will be stripped of identifiers prior to release for sharing, it remains possible those who access the data could potentially use deduction to identify participants with unusual characteristics or combinations o

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The data used for the analyses for any papers published will become available to interested researchers by request after that article is published. Those data will continue to be available for at least five years following the publication of the article.
Access Criteria
The investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Locations

US(1)