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My MS Toolkit: An Internet-Based Depression Self-Management Program for Adults Living With Multiple Sclerosis

2026年6月2日 更新者：Dawn Ehde、University of Washington
We are conducting this study to test if the new Toolkit depression module is accessible and helpful for people with multiple sclerosis (MS) in decreasing depression severity.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

First, we will modify My MS Toolkit to make it more helpful and relevant to adults with MS and depressive symptoms. We plan to add:

  1. a depression-specific step with robust content about depressive symptoms, disorders, and treatments specific to MS
  2. a depression quiz to help participants understand their depression symptoms and what Toolkit skills will be most helpful to them based on the quiz
  3. more resources specific to depression self-management and care, including resources within the MS community
  4. information on how to get mental health treatment if needed.

Second, we will evaluate the ease, convenience, and effectiveness of the improved My MS Toolkit. We will compare how well the Toolkit reduces people's feelings of depression compared to those who don't have access to the Toolkit. We will use website data to assess participant engagement and treatment ease, and explore factors like age, initial feelings of depression, and other symptoms that may impact outcomes. Understanding these factors will help determine who benefits most from My MS Toolkit and who might need different depression treatments.

Participants will either have access or no access to the Toolkit for 4 months and complete 3 online surveys over that time period.

研究类型

介入性

注册 (估计的)

110

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Susan Robles
  • 电话号码：206-598-0501
  • 邮箱：msstudy@uw.edu

学习地点

  • 美国
    • Washington
      • Seattle、Washington、美国、98133
        • University of Washington
        • 接触：
          • Susan R Robles, BS
          • 电话号码：206-668-7754
          • 邮箱：msstudy@uw.edu
        • 首席研究员：
          • Dawn M Ehde, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Self-reported diagnosis of MS (with screening questions such as current disease modifying therapy)
  • At least 18 years of age
  • Can read, write, and speak in English
  • Score of >4 on the Patient Health Questionnaire, indicating at least mild depressive symptoms
  • Have access to an internet-connected device for accessing the intervention

Exclusion Criteria:

  • Previous diagnosis of bipolar disorder or schizophrenia
  • Started medication for depression or anxiety in the past 2 months
  • Currently undergoing psychotherapy for depression
  • Are of moderate or high risk for suicide on the Columbia Suicide Severity Rating Scale (C-SSRS)
  • Participating in another clinical trial

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：My MS Toolkit
Participants will be given access to the My MS Toolkit and encouraged to start their participation via a "Getting Started" page that provides guidance on how best to use the program's modules. This is accessed online via the Internet.
设备：My MS Toolkit
The My MS Toolkit is an online self-management intervention created for and in partner with people living with multiple sclerosis. With an approach based in cognitive behavioral therapy, this program guides users in building skills to help manage common symptoms of MS, such as fatigue, pain, and depression.
无干预：Usual Care
Participants will be notified of their assignment to the waitlist and told that they can continue to receive or seek care as they normally would, including care from their MS health care provider. After completion of the final 4-month assessment, usual care participants will obtain access to My MS Toolkit and will be encouraged to use it.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Depressive Symptom Severity
大体时间：Baseline (prior to treatment), 12-week and 4-month
This will be measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Depression 8a. Change from pre- to post-treatment will be measured and compared between My MS Toolkit and usual care participants. Responses from each item will be summed to form a total raw score ranging from 4-20. Higher scores indicate higher self-reported levels of depressive symptoms.
Baseline (prior to treatment), 12-week and 4-month

次要结果测量

结果测量
措施说明
大体时间
Sleep Disturbance
大体时间：Baseline (prior to treatment), 12-week, and 4-month
Change in sleep quality will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 4a, version 1.0. Responses from each item will be summed to form a total raw score ranging from 4-20. Higher scores indicate higher self-reported levels of sleep disturbance.
Baseline (prior to treatment), 12-week, and 4-month
Fatigue Severity
大体时间：Baseline (prior to treatment), 12-week, and 4-month
Change in fatigue severity will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue-MS Short Form 8a, version 1.0. Responses from each item will be summed to form a total raw score ranging from 8-40. Higher scores indicate higher self-reported levels of fatigue.
Baseline (prior to treatment), 12-week, and 4-month
Fatigue Impact
大体时间：Baseline (prior to treatment), 12-week, and 4-month
Change in fatigue impact will be measured using the Modified Fatigue Impact Scale (MFIS). In the 21-item MFIS, participants rate their agreement with each statement on a 5-point Likert scale, from 0 = 'Never' to 4 = 'Almost always'.. Responses can add up to a total score (0-84) and subscales for physical (0-36), cognitive (0-40) and psychosocial functioning (0-8). Higher numbers indicate greater impact of fatigue on a person's activities.
Baseline (prior to treatment), 12-week, and 4-month
Pain Intensity
大体时间：Baseline (prior to treatment), 12-week, and 4-month
Participant-rated pain intensity assessed via the 3-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity scale. Raw scores range from 3-15. Higher scores indicate higher self-reported levels of pain intensity.
Baseline (prior to treatment), 12-week, and 4-month
Anxiety
大体时间：Baseline (prior to treatment), 12-week, and 4-month
Change in symptoms of anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 7a, version 1.0. Responses from each item will be summed to form a total raw score ranging from 7-35. Higher scores indicate higher self-reported levels of anxiety symptoms.
Baseline (prior to treatment), 12-week, and 4-month
Pain Interference
大体时间：Baseline (prior to treatment), 12-week, and 4-month
Change in pain interference will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6a, version 1.1. Responses from each item will be summed to form a total raw score ranging from 6-30. Higher scores indicate higher self-reported levels of pain interference.
Baseline (prior to treatment), 12-week, and 4-month
Social Participation
大体时间：Baseline (prior to treatment), 12-week, and 4-month
Change in pain interference will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6a, version 1.1. Responses from each item will be summed to form a total raw score ranging from 8-40. Higher scores indicate greater self-reported satisfaction and a higher quality of life regarding ability to engage with family, friends, and daily responsibilities.
Baseline (prior to treatment), 12-week, and 4-month
Treatment Engagement
大体时间：12-week and 4-month
Treatment engagement will be assessed through examination of website analytic data such as number and duration of page visits.
12-week and 4-month
Treatment Satisfaction
大体时间：12-week and 4-month
Global assessment of treatment satisfaction will be measured by participant self-report on a scale of 0 (very dissatisfied) - 4 (very satisfied).
12-week and 4-month
Treatment Recommendation
大体时间：12-week and 4-month
Treatment recommendation will be measured using an adapted version of the NET Promoter Score. Participations will be asked how likely they are to recommend the treatment to a friend or colleague with MS and depression on a scale of 0 (Not at all likely) to 10 (Extremely likely).
12-week and 4-month
Perception of Change
大体时间：12-week and 4-month
Global impression of change will be measured by participant self-report. Participants will report, since the start of the study, how much they think their overall depression or depressive symptom severity has changed on a scale of 1 (no change) - 7 (A great deal better and a considerable improvement that has made all the difference).
12-week and 4-month
Self-Efficacy
大体时间：Baseline (prior to treatment),12-week, and 4-month
Self-efficacy will be measured using the University of Washington Self-Efficacy Scale(UW-SES) 6a Short Form v1.0. Raw scores range from 6-30. Higher scores indicate greater belief in ability to manage challenges and achieve desired outcomes.
Baseline (prior to treatment),12-week, and 4-month

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Washington

调查人员

  • 首席研究员：Dawn M Ehde, PhD、University of Washington

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年9月1日

研究完成 (估计的)

2027年11月1日

研究注册日期

首次提交

2026年5月28日

首先提交符合 QC 标准的

2026年6月2日

首次发布 (实际的)

2026年6月9日

研究记录更新

最后更新发布 (实际的)

2026年6月9日

上次提交的符合 QC 标准的更新

2026年6月2日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • STUDY00023270
  • RFA-2411-44095 (其他赠款/资助编号：National Multiple Sclerosis Society)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Study data may be shared in de-identified form with outside researchers and collaborators as requested and deemed acceptable by study investigators.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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