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

U

University of Missouri, Kansas City

Status

Completed

Conditions

Relapsing-remitting Multiple Sclerosis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02010554
0033769
HC 0138-02

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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