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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05848323
• Other study ID #: STUDY00017623
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: March 2024
• Source: University of Washington
• Contact: Laurie Kavanagh, MPH
• Phone: 206-598-0501
• Email: msstudy[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Multiple Sclerosis Center at UW Medical Center - Northwest	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention Acceptability	Intervention Acceptability will be measured with the Acceptability of Intervention Measure (AIM). When assessed via online survey, responses from the Intervention Acceptability items will be averaged to create an average score [1-5]. A higher score indicates more agreement with intervention acceptability while a lower score indicates less agreement with intervention acceptability.	Collected via online survey at post-treatment (up to 1 month after treatment session 4)
Primary	Intervention Appropriateness	Intervention Appropriateness will be measured with the Intervention Appropriateness Measure (IAM). When assessed via online survey, responses from the Intervention Appropriateness items will be averaged to create an average score [1-5]. A higher score indicates more agreement with intervention appropriateness while a lower score indicates less agreement with intervention appropriateness.	Collected via online survey at post-treatment (up to 1 month after treatment session 4)
Primary	Intervention Feasibility	Intervention Feasibility will be measured with the Feasibility of Intervention Measure (FIM). When assessed via online survey, responses from the Intervention Feasibility items will be averaged to create an average score [1-5]. A higher score indicates more agreement with intervention feasibility while a lower score indicates less agreement with intervention feasibility.	Collected via online survey at post-treatment (up to 1 month after treatment session 4)
Secondary	Fatigue	Fatigue will be measured by the 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 pre-treatment (up to 1 month before treatment session 1) and post-treatment (up to 1 month after treatment session 4)
Secondary	Participation in Social Roles and Activities	Ability to Participate in Social Roles and Activities will be measured by the 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 pre-treatment (up to 1 month before treatment session 1) and post-treatment (up to 1 month after treatment session 4)
Secondary	Relaxation/Serenity	Relaxation/Serenity will be measured by the Positive and Negative Affect Schedule Serenity Subscale. This is a 3-item self-report subscale of the Positive and Negative Affect Schedule assessing perceptions of feeling of calm, relaxed, and at ease over the previous week via a 5-point Likert-type scale. A higher score indicates greater feelings of relaxation/serenity.	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)
Secondary	Fatigue Catastrophizing	Fatigue catastrophizing will be measured by the Fatigue Catastrophizing Scale. This is a 13-item self-report questionnaire assessing negative beliefs or expectations connected to one's perceptions of fatigue via a 5-point Likert-type scale. A higher score indicates greater fatigue catastrophizing.	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)
Secondary	Behavioral Activation	Behavioral activation will be measured by the Behavioral Activation for Depression Scale Short Form. This is a 9-item self-report measure. It assess the extent to which the respondent thinks they have engaged in pleasant and/or goal-directed activity over the past week via a 7-point Likert-type scale. A higher score indicates greater behavioral activation.	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)
Secondary	Cognitive Behavioural Responses Questionnaire - Short Form	This is a 18-item self-report questionnaire consisting of five subscales assessing cognitive responses (fear avoidance beliefs, embarrassment avoidance beliefs, symptom focusing) and behavioral responses (resting or avoidance of activity, all-or-nothing behavior) to fatigue one's connected to one's perceptions of fatigue via a 5-point Likert-type scale. A higher subscale scores indicate more negative responses to fatigue.	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)
Secondary	Global Impression of Change	This is a single-item self-report scale that assess the perceived intervention-related change in one's activity limitations, symptoms, emotions, and overall quality of life via 7-point Likert-type scale. A higher score indicates greater perceived change.	Collected via online survey at post-treatment (up to 1 month after treatment session 4)