Development of a Talk Therapy Protocol to Help Patients Make Treatment Decisions in MS

Study Overview
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Brief Summary
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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.

Official Title
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Development of a Talk Therapy Protocol to Help Patients Make Treatment Decisions in MS

Conditions
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Relapsing-remitting Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Brief Education
* Behavioral: Motivational Interviewing-Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brief Education<br>Patients receive a brief educational packet along with treatment as usual | Behavioral: Brief Education<br>* Give patients a pamphlet discussing pros and cons of disease modifying therapies<br>|
| Experimental: MI-CBT Treatment<br>Patients receive five 20 minute phone sessions of motivational interviewing/cognitive behavioral therapy weekly along with a brief educational packet. | Behavioral: Brief Education<br>* Give patients a pamphlet discussing pros and cons of disease modifying therapies<br>Behavioral: Motivational Interviewing-Cognitive Behavioral Therapy<br>* A telephone based talk therapy discussing pros and cons of medication use in MS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence Treatment Survey | Whether the patient indicates if he/she decided to re-initiate disease modifying therapies on a yes/no question. | 10 weeks after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence Treatment Survey | Whether the patient reports that he/she plans to discuss disease modifying therapies with a care provider on a yes/no question. | 10 weeks after enrollment | 
| Adherence Treatment Survey | Whether the patient reports that he/she plans to discuss disease modifying therapies with a care provider on a yes/no question. | 5 weeks after enrollment | 
| Adherence Treatment Survey | Whether the patient indicates if he/she decided to re-initiate disease modifying therapies on a yes/no question. | 5 weeks after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Disease modifying medication, Relapsing-Remitting MS, Motivational Interviewing, Telephone Counseling