Back to resultsAdherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine
Primary Purpose
Migraine
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Treatment as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility Criteria
Inclusion Criteria:
- Migraine diagnosis age 16+
- English speaking
Exclusion Criteria:
- Unable to read the questionnaire, no phone number
Sites / Locations
- NYU Langone
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Motivational Interviewing
Usual Care
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Patients Who Made an Appointment for Behavioral Therapy
Secondary Outcome Measures
Percentage of Participants Who Attended Appointments
Of those who initiated behavioral therapy, percentage who attended appointments
Percentage of Participants Who Initiated Appointments
Mean Reported Importance of Managing Migraine
Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance.
Mean Reported Confidence in Managing Migraines
Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence.
Mean Reported Confidence in Behavioral Therapy
Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03799211
Brief Title
Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine
Official Title
Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
January 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Motivational Interviewing
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
Phone call using motivational interviewing technique
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
will receive a regular study phone call after three months
Primary Outcome Measure Information:
Title
Percentage of Patients Who Made an Appointment for Behavioral Therapy
Time Frame
3-6 Months
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Attended Appointments
Description
Of those who initiated behavioral therapy, percentage who attended appointments
Time Frame
3-6 Months
Title
Percentage of Participants Who Initiated Appointments
Time Frame
Month 3-4 post-recruitment
Title
Mean Reported Importance of Managing Migraine
Description
Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance.
Time Frame
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)
Title
Mean Reported Confidence in Managing Migraines
Description
Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence.
Time Frame
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)
Title
Mean Reported Confidence in Behavioral Therapy
Description
Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence.
Time Frame
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Migraine diagnosis age 16+
English speaking
Exclusion Criteria:
Unable to read the questionnaire, no phone number
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mia Minen, MD
Organizational Affiliation
NYU Langone
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine
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