Multiple SclerosisNCT07636434
My MS Toolkit: An Internet-Based Depression Self-Management Program for Adults Living With Multiple Sclerosis
A study testing My MS Toolkit in people with Multiple Sclerosis and Multiple Sclerosis (MS), run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis (MS)
- What is being tested?
- My MS Toolkit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to Nov 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Washington
Seattle, Washington, 98133
Susan R Robles, BS, 206-668-7754, msstudy@uw.edu
Dawn M Ehde, PhD
About this study
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.
Read the detailed description
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:
- a depression-specific step with robust content about depressive symptoms, disorders, and treatments specific to MS
- a depression quiz to help participants understand their depression symptoms and what Toolkit skills will be most helpful to them based on the quiz
- more resources specific to depression self-management and care, including resources within the MS community
- 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.
- Conditions
- Multiple Sclerosis, Multiple Sclerosis (MS)
- Being tested
- My MS Toolkit
- Keywords
- multiple sclerosis, depression, self-management
- Medical subject headings
- Multiple Sclerosis, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My MS ToolkitDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| My MS Toolkit | Experimental | 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. Receives: Device: My MS Toolkit |
| Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptom Severity
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.
Measured: Baseline (prior to treatment), 12-week and 4-month
Secondary outcomes (12)
Sleep Disturbance
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.
Measured: Baseline (prior to treatment), 12-week, and 4-month
Fatigue Severity
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.
Measured: Baseline (prior to treatment), 12-week, and 4-month
Fatigue Impact
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.
Measured: Baseline (prior to treatment), 12-week, and 4-month
Pain Intensity
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.
Measured: Baseline (prior to treatment), 12-week, and 4-month
Anxiety
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.
Measured: Baseline (prior to treatment), 12-week, and 4-month
Pain Interference
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.
Measured: Baseline (prior to treatment), 12-week, and 4-month
Social Participation
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.
Measured: Baseline (prior to treatment), 12-week, and 4-month
Treatment Engagement
Treatment engagement will be assessed through examination of website analytic data such as number and duration of page visits.
Measured: 12-week and 4-month
Treatment Satisfaction
Global assessment of treatment satisfaction will be measured by participant self-report on a scale of 0 (very dissatisfied) - 4 (very satisfied).
Measured: 12-week and 4-month
Treatment Recommendation
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).
Measured: 12-week and 4-month
Perception of Change
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).
Measured: 12-week and 4-month
Self-Efficacy
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.
Measured: Baseline (prior to treatment),12-week, and 4-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawn Ehde, University of Washington
- Investigators
- Dawn M Ehde, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636434
- Sponsor's protocol ID
- STUDY00023270
- Other IDs
- RFA-2411-44095
- Status last verified
- Jun 2026
- First submitted
- 28 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Study data may be shared in de-identified form with outside researchers and collaborators as requested and deemed acceptable by study investigators.