NCT02010554

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

1.2 years

First QC Date

December 9, 2013

Last Update Submit

November 30, 2015

Conditions

Relapsing-remitting Multiple Sclerosis

Keywords

Multiple SclerosisDisease modifying medicationRelapsing-Remitting MSMotivational InterviewingTelephone Counseling

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Adherence Treatment Survey

    10 weeks after enrollment

  • Adherence Treatment Survey

    5 weeks after enrollment

  • Adherence Treatment Survey

    5 weeks after enrollment

Other Outcomes (2)

  • Motivation/Readiness Questionnaire

    10 weeks after enrollment

  • Motivation/Readiness Questionnaire

    5 weeks after enrollment

Study Arms (2)

Brief Education

ACTIVE COMPARATOR

Patients receive a brief educational packet along with treatment as usual

Behavioral: Brief Education

MI-CBT Treatment

EXPERIMENTAL

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

Behavioral: Brief EducationBehavioral: Motivational Interviewing-Cognitive Behavioral Therapy

Interventions

Brief EducationBEHAVIORAL

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

Brief EducationMI-CBT Treatment
Motivational Interviewing-Cognitive Behavioral TherapyBEHAVIORAL

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

MI-CBT Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Missouri-Kansas City

Kansas City, Missouri, 64110, United States

Location

Kessler Rehabilitation Institute

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychology

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 12, 2013

Study Start

December 1, 2013

Primary Completion

March 1, 2015

Study Completion

September 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

US(2)