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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis; Multiple Sclerosis (MS)
• Intervention / Treatment: Device: My MS Toolkit

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:

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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan Robles; Phone Number: 206-598-0501; Email: msstudy@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98133
      • University of Washington
      • Contact: Susan R Robles, BS; Phone Number: 206-668-7754; Email: msstudy@uw.edu
      • Principal Investigator: Dawn M Ehde, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (prior to treatment), 12-week and 4-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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).	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).	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).	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.	Baseline (prior to treatment),12-week, and 4-month

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Dawn M Ehde, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: depression; self-management; multiple sclerosis
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Behavior; Multiple Sclerosis; Depression
• Other Study ID Numbers: STUDY00023270; RFA-2411-44095 (Other Grant/Funding Number: National Multiple Sclerosis Society)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study data may be shared in de-identified form with outside researchers and collaborators as requested and deemed acceptable by study investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes