Back to resultsDevelopment of a Motivational Intervention to Improve Treatment Adherence in MS (MIMS)
Primary Purpose
Relapsing-remitting Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing-Cognitive Behavioral Therapy
Brief Education
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
- Previously discontinued recommended therapy
- Provider recommendation for DMT re-initiation
- At least 18 years of age
- Access to a telephone
- English speaking
Exclusion Criteria:
- Diagnosis other than relapsing remitting MS
- Provider does not recommend DMT re-initiation
- Pregnant or breastfeeding (females)
Sites / Locations
- University of Missouri-Kansas City
- Kessler Rehabillitation 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
NCT01925690
First Posted
August 15, 2013
Last Updated
November 30, 2015
Sponsor
University of Missouri, Kansas City
Collaborators
National Multiple Sclerosis Society
1. Study Identification
Unique Protocol Identification Number
NCT01925690
Brief Title
Development of a Motivational Intervention to Improve Treatment Adherence in MS
Acronym
MIMS
Official Title
Development of a Motivational Intervention to Improve Treatment Adherence in MS
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
April 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
Collaborators
National Multiple Sclerosis Society
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
As many as 50% of MS patients prematurely discontinue their disease modifying medications. 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 resuming taking 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
80 (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)
Motivational Interviewing-Cognitive Behavioral Therapy
Intervention Description
A telephone based talk therapy discussing pros and cons of medication use in MS.
Intervention Type
Behavioral
Intervention Name(s)
Brief Education
Intervention Description
Give patients a pamphlet discussing pros and cons of disease modifying therapies
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 post-enrollment
Title
Motivation/Readiness Questionnaire
Description
Whether there is an increase in self-reported motivation to take disease modifying therapies on a 1-10 likert-type scale.
Time Frame
5 weeks post-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
Previously discontinued recommended therapy
Provider recommendation for DMT re-initiation
At least 18 years of age
Access to a telephone
English speaking
Exclusion Criteria:
Diagnosis other than relapsing remitting MS
Provider does not recommend DMT re-initiation
Pregnant or breastfeeding (females)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jared M Bruce, Ph.D.
Organizational Affiliation
University of Missouri, Kansas City
Official's Role
Principal Investigator
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 Rehabillitation Institute
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26563147
Citation
Bruce J, Bruce A, Lynch S, Strober L, O'Bryan S, Sobotka D, Thelen J, Ness A, Glusman M, Goggin K, Bradley-Ewing A, Catley D. A pilot study to improve adherence among MS patients who discontinue treatment against medical advice. J Behav Med. 2016 Apr;39(2):276-87. doi: 10.1007/s10865-015-9694-6. Epub 2015 Nov 12.
Results Reference
derived
Links:
URL
https://sites.google.com/site/clinicalneuropsychologylab/contact-us
Description
Clinical Neuropsychology Lab Research
Learn more about this trial
Development of a Motivational Intervention to Improve Treatment Adherence in MS
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