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

Relapsing-remitting Multiple Sclerosis Clinical Trial

— MIMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02010554
• Other study ID #: HC 0138-02
• Secondary ID: 0033769
• Status: Completed
• Phase: N/A
• First received: December 9, 2013
• Last updated: November 30, 2015
• Start date: December 2013
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: University of Missouri, Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-remitting Multiple Sclerosis

Intervention

Behavioral:
• Brief Education
Give patients a pamphlet discussing pros and cons of disease modifying therapies
• Motivational Interviewing-Cognitive Behavioral Therapy
A telephone based talk therapy discussing pros and cons of medication use in MS.

Locations

Country	Name	City	State
United States	University of Missouri-Kansas City	Kansas City	Missouri
United States	Kessler Rehabilitation Institute	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri, Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Motivation/Readiness Questionnaire	Whether there is increased self-reported motivation to take disease modifying therapies on a 1-10 likert-type scale.	10 weeks after enrollment	No
Other	Motivation/Readiness Questionnaire	Whether there is increased self-reported motivation to take disease modifying therapies on a 1-10 likert-type scale.	5 weeks after enrollment	No
Primary	Adherence Treatment Survey	Whether the patient indicates if he/she decided to re-initiate disease modifying therapies on a "yes"/"no" question.	10 weeks after enrollment	No
Secondary	Adherence Treatment Survey	Whether the patient reports that he/she plans to discuss disease modifying therapies with a care provider on a "yes"/"no" question.	10 weeks after enrollment	No
Secondary	Adherence Treatment Survey	Whether the patient reports that he/she plans to discuss disease modifying therapies with a care provider on a "yes"/"no" question.	5 weeks after enrollment	No
Secondary	Adherence Treatment Survey	Whether the patient indicates if he/she decided to re-initiate disease modifying therapies on a "yes"/"no" question.	5 weeks after enrollment	No