- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03799211
Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine
July 13, 2020 updated by: NYU Langone Health
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU Langone
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Migraine diagnosis age 16+
- English speaking
Exclusion Criteria:
- Unable to read the questionnaire, no phone number
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Motivational Interviewing
|
Phone call using motivational interviewing technique
|
ACTIVE_COMPARATOR: Usual Care
|
will receive a regular study phone call after three months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Patients Who Made an Appointment for Behavioral Therapy
Time Frame: 3-6 Months
|
3-6 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Who Attended Appointments
Time Frame: 3-6 Months
|
Of those who initiated behavioral therapy, percentage who attended appointments
|
3-6 Months
|
Percentage of Participants Who Initiated Appointments
Time Frame: Month 3-4 post-recruitment
|
Month 3-4 post-recruitment
|
|
Mean Reported Importance of Managing Migraine
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)
|
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.
|
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
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)
|
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.
|
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
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)
|
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.
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mia Minen, MD, NYU Langone
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 4, 2018
Primary Completion (ACTUAL)
January 1, 2019
Study Completion (ACTUAL)
January 1, 2019
Study Registration Dates
First Submitted
December 31, 2018
First Submitted That Met QC Criteria
January 8, 2019
First Posted (ACTUAL)
January 10, 2019
Study Record Updates
Last Update Posted (ACTUAL)
July 23, 2020
Last Update Submitted That Met QC Criteria
July 13, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-00937
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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