Multiple Sclerosis, Multiple Sclerosis (MS)
Conditions
Keywords
multiple sclerosis, depression, self-management
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.
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
DEVICEMy 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.
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptom Severity | 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
| Measure | Time frame | Description |
|---|---|---|
| Sleep Disturbance | 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. |
| Fatigue Severity | 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. |
| Fatigue Impact | 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. |
| Pain Intensity | 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. |
| Anxiety | 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. |
| Pain Interference | 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. |
| Social Participation | 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. |
| Treatment Engagement | 12-week and 4-month | Treatment engagement will be assessed through examination of website analytic data such as number and duration of page visits. |
| Treatment Satisfaction | 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). |
| Treatment Recommendation | 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). |
| Perception of Change | 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). |
| Self-Efficacy | 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. |
Countries
United States
Contacts
CONTACTSusan Robles
PRINCIPAL_INVESTIGATORDawn M Ehde, PhD
University of Washington
Outcome results
None listed