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

2026년 6월 2일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

110

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Susan Robles
  • 전화번호: 206-598-0501
  • 이메일: msstudy@uw.edu

연구 장소

  • 미국
    • Washington
      • Seattle, Washington, 미국, 98133
        • University of Washington
        • 연락하다:
          • Susan R Robles, BS
          • 전화번호: 206-668-7754
          • 이메일: msstudy@uw.edu
        • 수석 연구원:
          • Dawn M Ehde, PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
장치: 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.
간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Depressive Symptom Severity
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Sleep Disturbance
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Washington

수사관

  • 수석 연구원: Dawn M Ehde, PhD, University of Washington

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 9월 1일

연구 완료 (추정된)

2027년 11월 1일

연구 등록 날짜

최초 제출

2026년 5월 28일

QC 기준을 충족하는 최초 제출

2026년 6월 2일

처음 게시됨 (실제)

2026년 6월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 2일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • STUDY00023270
  • RFA-2411-44095 (기타 보조금/기금 번호: National Multiple Sclerosis Society)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

미국에서 제조되어 미국에서 수출되는 제품

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

다발성 경화증에 대한 임상 시험

My MS Toolkit에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in El Salvador

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다