Prospective Case Series to Refine Standalone Cognitive Behavioral Therapy Components for Multiple Sclerosis Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Intervention Acceptability
研究概览
简要总结
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.
详细描述
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:
- examine the feasibility and acceptability of telehealth CBT components (relaxation training, behavioral activation, cognitive therapy) for fatigue in PwMS.
- examine initial effects of telehealth CBT components (relaxation training, behavioral activation, cognitive therapy) for improving fatigue in PwMS.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MS diagnosis of any subtype per chart review
- •Score 4 or higher on the Fatigue Severity Scale
- •Presence of chronic, problematic fatigue that, in the opinion of the patient, has interfered with their daily activities for 3 or more months
- •Are able to comply with study procedures and complete measures independently assessed via self-report
- •All genders
- •18 years of age or older
- •Able to read and speak English
- •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)
排除标准
- •Score greater than 7 on the Patient Determined Disease Steps Scale
- •Has significant cognitive impairment as indicated by 1 or more errors on the 6-item Cognitive Screener
- •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)
- •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)
- •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)
- •Currently engaged in psychotherapy for fatigue assessed via self-report
- •Current pregnancy (although participants will be considered eligible when they are no longer pregnant)
- •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).
结局指标
主要结局
Intervention Acceptability
时间窗: Collected via online survey at post-treatment (approximately 4-8 weeks after the pre-treatment survey).
Intervention Acceptability will be measured with the Acceptability of Intervention Measure (AIM). When assessed via online survey, responses from the Intervention Acceptability items are averaged to create a mean score \[1-5\]. A higher score indicates more agreement with intervention acceptability while a lower score indicates less agreement with intervention acceptability.
Intervention Appropriateness
时间窗: Collected via online survey at post-treatment (approximately 4-8 weeks after the pre-treatment survey).
Intervention Appropriateness will be measured with the Intervention Appropriateness Measure (IAM). When assessed via online survey, responses from the Intervention Appropriateness items are averaged to create a mean score \[1-5\]. A higher score indicates more agreement with intervention appropriateness while a lower score indicates less agreement with intervention appropriateness.
Intervention Feasibility
时间窗: Collected via online survey at post-treatment (approximately 4-8 weeks after the pre-treatment survey).
Intervention Feasibility will be measured with the Feasibility of Intervention Measure (FIM). When assessed via online survey, responses from the Intervention Feasibility items are averaged to create a mean score \[1-5\]. A higher score indicates more agreement with intervention feasibility while a lower score indicates less agreement with intervention feasibility.
次要结局
- Fatigue(Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey).)
- Participation in Social Roles and Activities(Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey).)
- Relaxation/Serenity(Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey).)
- Fatigue Catastrophizing(Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey).)
- Behavioral Activation(Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey).)
- Cognitive Behavioural Responses Questionnaire - Short Form(Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey).)
- Global Impression of Change(Collected via online survey at post-treatment (approximately 4-8 weeks after the pre-treatment survey).)
研究者
Lindsey Knowles
Acting Assistant Professor: School of Medicine
University of Washington