NCT01925690

Brief Summary

As many as 50% of MS patients prematurely discontinue their disease modifying medications. 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 resuming taking 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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

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

February 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 20, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
5 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

2.2 years

First QC Date

August 15, 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 post-enrollment

  • Motivation/Readiness Questionnaire

    5 weeks post-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: Motivational Interviewing-Cognitive Behavioral TherapyBehavioral: Brief Education

Interventions

Motivational Interviewing-Cognitive Behavioral TherapyBEHAVIORAL

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

MI-CBT Treatment
Brief EducationBEHAVIORAL

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

Brief EducationMI-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
  • Previously discontinued recommended therapy
  • Provider recommendation for DMT re-initiation
  • At least 18 years of age
  • Access to a telephone
  • English speaking

You may not qualify if:

  • Diagnosis other than relapsing remitting MS
  • Provider does not recommend DMT re-initiation
  • Pregnant or breastfeeding (females)

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 Rehabillitation Institute

West Orange, New Jersey, 07052, United States

Location

Related Publications (1)

  • Bruce J, Bruce A, Lynch S, Strober L, O'Bryan S, Sobotka D, Thelen J, Ness A, Glusman M, Goggin K, Bradley-Ewing A, Catley D. A pilot study to improve adherence among MS patients who discontinue treatment against medical advice. J Behav Med. 2016 Apr;39(2):276-87. doi: 10.1007/s10865-015-9694-6. Epub 2015 Nov 12.

    PMID: 26563147DERIVED

Related Links

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 Officials

  • Jared M Bruce, Ph.D.

    University of Missouri, Kansas City

    PRINCIPAL INVESTIGATOR

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

August 15, 2013

First Posted

August 20, 2013

Study Start

February 1, 2013

Primary Completion

April 1, 2015

Study Completion

September 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

US(2)