My MS Toolkit: An Internet-Based Depression Self-Management Program for Adults Living With Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: My MS Toolkit.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, Multiple Sclerosis (MS). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- Depressive Symptom Severity [Time frame: Baseline (prior to treatment), 12-week and 4-month]
Secondary outcome measures (12)
- Sleep Disturbance [Time frame: Baseline (prior to treatment), 12-week, and 4-month]
- Fatigue Severity [Time frame: Baseline (prior to treatment), 12-week, and 4-month]
- Fatigue Impact [Time frame: Baseline (prior to treatment), 12-week, and 4-month]
- Pain Intensity [Time frame: Baseline (prior to treatment), 12-week, and 4-month]
- Anxiety [Time frame: Baseline (prior to treatment), 12-week, and 4-month]
- Pain Interference [Time frame: Baseline (prior to treatment), 12-week, and 4-month]
- Social Participation [Time frame: Baseline (prior to treatment), 12-week, and 4-month]
- Treatment Engagement [Time frame: 12-week and 4-month]
- Treatment Satisfaction [Time frame: 12-week and 4-month]
- Treatment Recommendation [Time frame: 12-week and 4-month]
- Perception of Change [Time frame: 12-week and 4-month]
- Self-Efficacy [Time frame: Baseline (prior to treatment),12-week, and 4-month]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Washington — Seattle
Identifiers
NCT: NCT07636434 · STUDY00023270 · RFA-2411-44095