Development of a Talk Therapy Protocol to Help Patients Make Treatment Decisions in MS (MIMS)
Primary Purpose
Relapsing-remitting Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Education
Motivational Interviewing-Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional health services research trial for Relapsing-remitting Multiple Sclerosis focused on measuring Multiple Sclerosis, Disease modifying medication, Relapsing-Remitting MS, Motivational Interviewing, Telephone Counseling
Eligibility Criteria
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:
-
Sites / Locations
- University of Missouri-Kansas City
- Kessler Rehabilitation Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Brief Education
MI-CBT Treatment
Arm Description
Patients receive a brief educational packet along with treatment as usual
Patients receive five 20 minute phone sessions of motivational interviewing/cognitive behavioral therapy weekly along with a brief educational packet.
Outcomes
Primary Outcome Measures
Adherence Treatment Survey
Whether the patient indicates if he/she decided to re-initiate disease modifying therapies on a "yes"/"no" question.
Secondary Outcome Measures
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.
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.
Adherence Treatment Survey
Whether the patient indicates if he/she decided to re-initiate disease modifying therapies on a "yes"/"no" question.
Full Information
NCT ID
NCT02010554
First Posted
December 9, 2013
Last Updated
November 30, 2015
Sponsor
University of Missouri, Kansas City
1. Study Identification
Unique Protocol Identification Number
NCT02010554
Brief Title
Development of a Talk Therapy Protocol to Help Patients Make Treatment Decisions in MS
Acronym
MIMS
Official Title
Development of a Talk Therapy Protocol to Help Patients Make Treatment Decisions in MS
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri, Kansas City
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-remitting Multiple Sclerosis
Keywords
Multiple Sclerosis, Disease modifying medication, Relapsing-Remitting MS, Motivational Interviewing, Telephone Counseling
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brief Education
Arm Type
Active Comparator
Arm Description
Patients receive a brief educational packet along with treatment as usual
Arm Title
MI-CBT Treatment
Arm Type
Experimental
Arm Description
Patients receive five 20 minute phone sessions of motivational interviewing/cognitive behavioral therapy weekly along with a brief educational packet.
Intervention Type
Behavioral
Intervention Name(s)
Brief Education
Intervention Description
Give patients a pamphlet discussing pros and cons of disease modifying therapies
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing-Cognitive Behavioral Therapy
Intervention Description
A telephone based talk therapy discussing pros and cons of medication use in MS.
Primary Outcome Measure Information:
Title
Adherence Treatment Survey
Description
Whether the patient indicates if he/she decided to re-initiate disease modifying therapies on a "yes"/"no" question.
Time Frame
10 weeks after enrollment
Secondary Outcome Measure Information:
Title
Adherence Treatment Survey
Description
Whether the patient reports that he/she plans to discuss disease modifying therapies with a care provider on a "yes"/"no" question.
Time Frame
10 weeks after enrollment
Title
Adherence Treatment Survey
Description
Whether the patient reports that he/she plans to discuss disease modifying therapies with a care provider on a "yes"/"no" question.
Time Frame
5 weeks after enrollment
Title
Adherence Treatment Survey
Description
Whether the patient indicates if he/she decided to re-initiate disease modifying therapies on a "yes"/"no" question.
Time Frame
5 weeks after enrollment
Other Pre-specified Outcome Measures:
Title
Motivation/Readiness Questionnaire
Description
Whether there is increased self-reported motivation to take disease modifying therapies on a 1-10 likert-type scale.
Time Frame
10 weeks after enrollment
Title
Motivation/Readiness Questionnaire
Description
Whether there is increased self-reported motivation to take disease modifying therapies on a 1-10 likert-type scale.
Time Frame
5 weeks after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Facility Information:
Facility Name
University of Missouri-Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64110
Country
United States
Facility Name
Kessler Rehabilitation Institute
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Development of a Talk Therapy Protocol to Help Patients Make Treatment Decisions in MS
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