My MS Toolkit: An Internet-Based Depression Self-Management Program for Adults Living With Multiple Sclerosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
My MS Toolkit
DeviceThe 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.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: My MS ToolkitExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline (prior to treatment), 12-week and 4-monthSecondary outcomes
1
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.
Time frame
Baseline (prior to treatment), 12-week, and 4-month2
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.
Time frame
Baseline (prior to treatment), 12-week, and 4-month3
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.
Time frame
Baseline (prior to treatment), 12-week, and 4-month4
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.
Time frame
Baseline (prior to treatment), 12-week, and 4-monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: