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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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

110

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Susan Robles
  • 電話番号：206-598-0501
  • メール：msstudy@uw.edu

研究場所

  • アメリカ
    • Washington
      • Seattle、Washington、アメリカ、98133
        • University of Washington
        • コンタクト：
          • Susan R Robles, BS
          • 電話番号：206-668-7754
          • メール：msstudy@uw.edu
        • 主任研究者：
          • Dawn M Ehde, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
デバイス：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.
介入なし：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Depressive Symptom Severity
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Sleep Disturbance
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Washington

捜査官

  • 主任研究者：Dawn M Ehde, PhD、University of Washington

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2027年9月1日

研究の完了 (推定)

2027年11月1日

試験登録日

最初に提出

2026年5月28日

QC基準を満たした最初の提出物

2026年6月2日

最初の投稿 (実際)

2026年6月9日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月9日

QC基準を満たした最後の更新が送信されました

2026年6月2日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • STUDY00023270
  • RFA-2411-44095 (その他の助成金/資金番号：National Multiple Sclerosis Society)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

米国で製造され、米国から輸出された製品。

はい

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