Development of a Talk Therapy Protocol to Help Patients Make Treatment Decisions in MS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Adherence Treatment Survey
Study Overview
Brief Summary
Between 15-20% of MS patients decide not to initiate disease modifying therapies after being diagnosed with MS. For this study, we will develop a telephone-based talk therapy intervention and then conduct a randomized controlled trial. Patients will be assigned to either 5 weekly 20 minute telephone sessions of psychotherapy or a brief education control condition. We hypothesize that patients undergoing phone therapy will be more likely to indicate they are interested in initiating disease modifying medications than patients given brief education and treatment as usual.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of relapsing remitting MS based on established guidelines
- •Not taking recommended therapy
- •Provider recommendation for DMT use
- •At least 18 years of age
- •Access to a telephone
- •English speaking
Exclusion Criteria
- Not provided
Arms & Interventions
Brief Education
Patients receive a brief educational packet along with treatment as usual
Intervention: Brief Education (Behavioral)
MI-CBT Treatment
Patients receive five 20 minute phone sessions of motivational interviewing/cognitive behavioral therapy weekly along with a brief educational packet.
Intervention: Brief Education (Behavioral)
MI-CBT Treatment
Patients receive five 20 minute phone sessions of motivational interviewing/cognitive behavioral therapy weekly along with a brief educational packet.
Intervention: Motivational Interviewing-Cognitive Behavioral Therapy (Behavioral)
Outcomes
Primary Outcomes
Adherence Treatment Survey
Time Frame: 10 weeks after enrollment
Whether the patient indicates if he/she decided to re-initiate disease modifying therapies on a "yes"/"no" question.
Secondary Outcomes
- Adherence Treatment Survey(5 weeks after enrollment)
- Adherence Treatment Survey(10 weeks after enrollment)
Investigators
Jared Bruce
Associate Professor of Psychology
University of Missouri, Kansas City