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

2 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

110

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Susan Robles
  • Telefonnummer: 206-598-0501
  • E-post: msstudy@uw.edu

Studieorter

  • Förenta staterna
    • Washington
      • Seattle, Washington, Förenta staterna, 98133
        • University of Washington
        • Kontakt:
          • Susan R Robles, BS
          • Telefonnummer: 206-668-7754
          • E-post: msstudy@uw.edu
        • Huvudutredare:
          • Dawn M Ehde, PhD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Enhet: 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.
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Depressive Symptom Severity
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Sleep Disturbance
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Washington

Utredare

  • Huvudutredare: Dawn M Ehde, PhD, University of Washington

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 september 2027

Avslutad studie (Beräknad)

1 november 2027

Studieregistreringsdatum

Först inskickad

28 maj 2026

Först inskickad som uppfyllde QC-kriterierna

2 juni 2026

Första postat (Faktisk)

9 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • STUDY00023270
  • RFA-2411-44095 (Annat bidrag/finansieringsnummer: National Multiple Sclerosis Society)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Ja

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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