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

NCT07636434 | Not Yet Recruiting FDA Device

• 2 other identifiers: STUDY00023270RFA-2411-44095
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis; Multiple Sclerosis (MS)

Keywords

multiple sclerosis; depression; self-management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Sleep Disturbance

  Baseline (prior to treatment), 12-week, and 4-month

• Fatigue Severity

  Baseline (prior to treatment), 12-week, and 4-month

• Fatigue Impact

  Baseline (prior to treatment), 12-week, and 4-month

• Pain Intensity

  Baseline (prior to treatment), 12-week, and 4-month

• Anxiety

  Baseline (prior to treatment), 12-week, and 4-month

Study Arms (2)

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.

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.

Interventions

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.

My MS Toolkit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98133, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Depression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Dawn M Ehde, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Robles

CONTACT

206-598-0501; msstudy@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: School of Medicine, Rehabilitation Medicine: Psychology

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)