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Development of a Motivational Intervention to Improve Treatment Adherence in MS

NCT ID: NCT01925690

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Relapsing-remitting Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Brief Education

Patients receive a brief educational packet along with treatment as usual

Group Type ACTIVE_COMPARATOR

Brief Education

Intervention Type BEHAVIORAL

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

MI-CBT Treatment

Patients receive five 20 minute phone sessions of motivational interviewing/cognitive behavioral therapy weekly along with a brief educational packet.

Group Type EXPERIMENTAL

Motivational Interviewing-Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

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

Brief Education

Intervention Type BEHAVIORAL

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

Interventions

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Motivational Interviewing-Cognitive Behavioral Therapy

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

Intervention Type BEHAVIORAL

Brief Education

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Multiple Sclerosis Society

OTHER

Sponsor Role collaborator

University of Missouri, Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Jared Bruce

Associate Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jared M Bruce, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Missouri, Kansas City

Locations

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University of Missouri-Kansas City

Kansas City, Missouri, United States

Site Status

Kessler Rehabillitation Institute

West Orange, New Jersey, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26563147 (View on PubMed)

Related Links

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https://sites.google.com/site/clinicalneuropsychologylab/contact-us

Clinical Neuropsychology Lab Research

Other Identifiers

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National MS Society

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0033769

Identifier Type: -

Identifier Source: org_study_id