Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine

Migraine Clinical Trial

Official title:

Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03799211
• Other study ID #: 16-00937
• Status: Completed
• Phase: N/A
• Start date: June 4, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: July 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Migraine diagnosis age 16+

• English speaking

Exclusion Criteria:

• Unable to read the questionnaire, no phone number

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Behavioral:
• Motivational Interviewing
Phone call using motivational interviewing technique
• Treatment as Usual
will receive a regular study phone call after three months

Locations

Country	Name	City	State
United States	NYU Langone	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Who Made an Appointment for Behavioral Therapy		3-6 Months
Secondary	Percentage of Participants Who Attended Appointments	Of those who initiated behavioral therapy, percentage who attended appointments	3-6 Months
Secondary	Percentage of Participants Who Initiated Appointments		Month 3-4 post-recruitment
Secondary	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.	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)
Secondary	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.	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)
Secondary	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.	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)