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NCT Number: NCT07636434

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Behavioral Symptoms Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Depression Immune System Diseases Multiple Sclerosis (MS) Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98133, United States

Location contact

Dawn M Ehde, PhD

PRINCIPAL_INVESTIGATOR

Susan R Robles, BS

CONTACT

[email protected]

206-668-7754

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

My MS Toolkit

Device

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.

Primary outcomes

  1. Depressive Symptom Severity

    Time frame: 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.

Secondary outcomes

  1. Sleep Disturbance

    Time frame: 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.

  2. Fatigue Severity

    Time frame: 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.

  3. Fatigue Impact

    Time frame: 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.

  4. Pain Intensity

    Time frame: 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.

  5. Anxiety

    Time frame: 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.

  6. Pain Interference

    Time frame: 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.

  7. Social Participation

    Time frame: 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.

  8. Treatment Engagement

    Time frame: 12-week and 4-month

    Treatment engagement will be assessed through examination of website analytic data such as number and duration of page visits.

  9. Treatment Satisfaction

    Time frame: 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).

  10. Treatment Recommendation

    Time frame: 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).

  11. Perception of Change

    Time frame: 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. Self-Efficacy

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Susan Robles

CONTACT

[email protected]

206-598-0501

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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