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CompletedNCT01925690MIMSUpdated Dec 2, 2015

Development of a Motivational Intervention to Improve Treatment Adherence in MS

An interventional study of Motivational Interviewing-Cognitive Behavioral Therapy and Brief Education in Relapsing-remitting Multiple Sclerosis, sponsored by University of Missouri, Kansas City. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-02.

Sponsored by University of Missouri, Kansas City · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Relapsing-remitting Multiple Sclerosis

Keywords

  • Multiple Sclerosis
  • Disease modifying medication
  • Relapsing-Remitting MS
  • Motivational Interviewing
  • Telephone Counseling
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 80 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

University of Missouri, Kansas City is the lead sponsor of 47 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Diagnosis other than relapsing remitting MS
  • Provider does not recommend DMT re-initiation
  • Pregnant or breastfeeding (females)
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    Brief Education

    Patients receive a brief educational packet along with treatment as usual

    Behavioral: Brief Education

  • 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: Motivational Interviewing-Cognitive Behavioral Therapy · Behavioral: Brief Education

Interventions

  • BehavioralMotivational Interviewing-Cognitive Behavioral Therapy

    A telephone based talk therapy discussing pros and cons of medication use in MS.

  • BehavioralBrief Education

    Give patients a pamphlet discussing pros and cons of disease modifying therapies

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What researchers measure

Primary outcomes

  1. Adherence Treatment Survey

    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 outcomes

  1. 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.

    Time frame: 10 weeks after enrollment

  2. 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.

    Time frame: 5 weeks after enrollment

  3. Adherence Treatment Survey

    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 outcomes

  1. Motivation/Readiness Questionnaire

    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

  2. Motivation/Readiness Questionnaire

    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

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Study locations

2 sites
  • University of Missouri-Kansas City
    Kansas City, Missouri 64110, United States
  • Kessler Rehabillitation Institute
    West Orange, New Jersey 07052, United States
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References and documents

Publications

  • 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. PubMed 26563147 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01925690
Lead sponsor
University of Missouri, Kansas City
Collaborators
National Multiple Sclerosis Society
Responsible party
Jared Bruce (Associate Professor of Psychology, University of Missouri, Kansas City) — Principal investigator
First posted
Aug 20, 2013
Start date
Feb 2013
Primary completion
Apr 2015
Completion
Sep 2015
Last update
Dec 2, 2015

Study contacts

Jared M Bruce, Ph.D.
principal investigator · University of Missouri, Kansas City

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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