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

University of Missouri, Kansas City

Status: Completed

Conditions: Relapsing-remitting Multiple Sclerosis

Treatments: Behavioral: Brief Education; Behavioral: Motivational Interviewing-Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01925690

0033769

National MS Society (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Brief Education

Active Comparator group

Description:

Patients receive a brief educational packet along with treatment as usual

Treatment:

Behavioral: Brief Education

MI-CBT Treatment

Experimental group

Description:

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

Treatment:

Behavioral: Brief Education

Behavioral: Motivational Interviewing-Cognitive Behavioral Therapy