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Completed

NCT Number: NCT02010554

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

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.

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Key information

Conditions

Relapsing-Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri-Kansas City, Kansas City, Missouri, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Brief Education

Behavioral

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

Motivational Interviewing-Cognitive Behavioral Therapy

Behavioral

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

Primary outcomes

  1. Adherence Treatment Survey

    Time frame: 10 weeks after enrollment

    Whether the patient indicates if he/she decided to re-initiate disease modifying therapies on a "yes"/"no" question.

Secondary outcomes

  1. Adherence Treatment Survey

    Time frame: 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.

  2. Adherence Treatment Survey

    Time frame: 5 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.

  3. Adherence Treatment Survey

    Time frame: 5 weeks after enrollment

    Whether the patient indicates if he/she decided to re-initiate disease modifying therapies on a "yes"/"no" question.

Other outcomes

  1. Motivation/Readiness Questionnaire

    Time frame: 10 weeks after enrollment

    Whether there is increased self-reported motivation to take disease modifying therapies on a 1-10 likert-type scale.

  2. Motivation/Readiness Questionnaire

    Time frame: 5 weeks after enrollment

    Whether there is increased self-reported motivation to take disease modifying therapies on a 1-10 likert-type scale.

Sponsors and collaborators

Lead sponsor

University of Missouri, Kansas City

Other

Registry information

Acronym: MIMS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 12, 2013
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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