Development of a Motivational Intervention to Improve Treatment Adherence in MS (MIMS)

November 30, 2015 updated by: Jared Bruce, University of Missouri, Kansas City
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64110
        • University of Missouri-Kansas City
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Kessler Rehabillitation Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 weeks after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence Treatment Survey
Time Frame: 10 weeks after enrollment
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
Time Frame: 5 weeks after enrollment
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
Time Frame: 5 weeks after enrollment
Whether the patient indicates if he/she decided to re-initiate disease modifying therapies on a "yes"/"no" question.
5 weeks after enrollment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motivation/Readiness Questionnaire
Time Frame: 10 weeks post-enrollment
Whether there is increased self-reported motivation to take disease modifying therapies on a 1-10 likert-type scale.
10 weeks post-enrollment
Motivation/Readiness Questionnaire
Time Frame: 5 weeks post-enrollment
Whether there is an increase in self-reported motivation to take disease modifying therapies on a 1-10 likert-type scale.
5 weeks post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri, Kansas City

Collaborators

National Multiple Sclerosis Society

Investigators

  • Principal Investigator: Jared M Bruce, Ph.D., University of Missouri, Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

August 15, 2013

First Submitted That Met QC Criteria

August 19, 2013

First Posted (Estimate)

August 20, 2013

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0033769 (National MS Society)
  • National MS Society (Other Grant/Funding Number: National MS Society)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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