Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine
1 other identifier
interventional
76
1 country
1
Brief Summary
Migraine patients are oftentimes referred for evidence based behavioral therapies to prevent migraine. Yet, at follow-up visits, they report not seeing the behavioral therapist. This is a pilot feasibility acceptability study to assess whether motivational interviewing (MI) can be implemented in the headache center setting to help improve initiation and adherence to behavioral therapy for migraine. We will also assess patients' reasons for making/not making the appointment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
1 active site
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
June 4, 2018
CompletedFirst Submitted
Initial submission to the registry
December 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedFirst Posted
Study publicly available on registry
January 10, 2019
CompletedResults Posted
Study results publicly available
July 23, 2020
CompletedJuly 23, 2020
July 1, 2020
7 months
December 31, 2018
June 26, 2020
July 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Patients Who Made an Appointment for Behavioral Therapy
3-6 Months
Secondary Outcomes (5)
Percentage of Participants Who Attended Appointments
3-6 Months
Percentage of Participants Who Initiated Appointments
Month 3-4 post-recruitment
Mean Reported Importance of Managing Migraine
First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline)
Mean Reported Confidence in Managing Migraines
First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline)
Mean Reported Confidence in Behavioral Therapy
First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline)
Study Arms (2)
Motivational Interviewing
EXPERIMENTALUsual Care
ACTIVE COMPARATORInterventions
Phone call using motivational interviewing technique
Eligibility Criteria
You may qualify if:
- Migraine diagnosis age 16+
- English speaking
You may not qualify if:
- Unable to read the questionnaire, no phone number
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mia Minen, MD, MPH
- Organization
- NYU Langone Health
Study Officials
- PRINCIPAL INVESTIGATOR
Mia Minen, MD
NYU Langone
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 31, 2018
First Posted
January 10, 2019
Study Start
June 4, 2018
Primary Completion
January 1, 2019
Study Completion
January 1, 2019
Last Updated
July 23, 2020
Results First Posted
July 23, 2020
Record last verified: 2020-07