Clinical trial NCT05848323: Prospective Case Series to Refine Standalone Cognitive Behavioral Therapy Components for Multiple Sclerosis Fatigue
Official title: Prospective Case Series to Refine Standalone Cognitive Behavioral Therapy Components for Multiple Sclerosis Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Fatigue
Keywords: Multiple sclerosis
Fatigue
Cognitive behavioral therapy
Relaxation training
Behavioral activation
Cognitive therapy
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Intervention Acceptability
timeFrame: Collected via online survey at post-treatment (up to 1 month after treatment session 4)
measure: Intervention Appropriateness
timeFrame: Collected via online survey at post-treatment (up to 1 month after treatment session 4)
measure: Intervention Feasibility
timeFrame: Collected via online survey at post-treatment (up to 1 month after treatment session 4)
Secondary outcomes:
measure: Fatigue
timeFrame: Collected via online survey at pre-treatment (up to 1 month before treatment session 1) and post-treatment (up to 1 month after treatment session 4)
measure: Participation in Social Roles and Activities
timeFrame: Collected via online survey at pre-treatment (up to 1 month before treatment session 1) and post-treatment (up to 1 month after treatment session 4)
measure: Relaxation/Serenity
timeFrame: Collected via online survey at pre-treatment (up to 1 month before treatment session 1) and post-treatment (up to 1 month after treatment session 4)
measure: Fatigue Catastrophizing
timeFrame: Collected via online survey at pre-treatment (up to 1 month before treatment session 1) and post-treatment (up to 1 month after treatment session 4)
measure: Behavioral Activation
timeFrame: Collected via online survey at pre-treatment (up to 1 month before treatment session 1) and post-treatment (up to 1 month after treatment session 4)
measure: Cognitive Behavioural Responses Questionnaire - Short Form
timeFrame: Collected via online survey at pre-treatment (up to 1 month before treatment session 1) and post-treatment (up to 1 month after treatment session 4)
measure: Global Impression of Change
timeFrame: Collected via online survey at post-treatment (up to 1 month after treatment session 4)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Multiple Sclerosis Center at UW Medical Center - Northwest
state: Washington
Study officials:
affiliation: University of Washington
name: Lindsey Knowles, PhD
role: PRINCIPAL_INVESTIGATOR
References: