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Development of a Talk Therapy Protocol to Help Patients Make Treatment Decisions in MS

NCT ID: NCT02010554

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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

Brief Education

Intervention Type BEHAVIORAL

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

Motivational Interviewing-Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

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

Interventions

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Brief Education

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

Intervention Type BEHAVIORAL

Motivational Interviewing-Cognitive Behavioral Therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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

Locations

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University of Missouri-Kansas City

Kansas City, Missouri, United States

Site Status

Kessler Rehabilitation Institute

West Orange, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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0033769

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HC 0138-02

Identifier Type: -

Identifier Source: org_study_id