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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02010554

Acronym

MIMS

Enrollment

Registered

2013-12-12

Start date

2013-12-31

Completion date

2015-09-30

Last updated

2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing-remitting Multiple Sclerosis

Keywords

Multiple Sclerosis, Disease modifying medication, Relapsing-Remitting MS, Motivational Interviewing, Telephone Counseling

Brief summary

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.

Interventions

BEHAVIORALBrief Education

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

BEHAVIORALMotivational Interviewing-Cognitive Behavioral Therapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Adherence Treatment Survey	10 weeks after enrollment	Whether the patient indicates if he/she decided to re-initiate disease modifying therapies on a yes/no question.

Secondary

Measure	Time frame	Description
Adherence Treatment Survey	10 weeks after enrollment	Whether the patient reports that he/she plans to discuss disease modifying therapies with a care provider on a yes/no question.

Other

Measure	Time frame	Description
Motivation/Readiness Questionnaire	10 weeks after enrollment	Whether there is increased self-reported motivation to take disease modifying therapies on a 1-10 likert-type scale.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026