Telehealth Behavioral Migraine Management (TeleBMM)
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|ClinicalTrials.gov Identifier: NCT03982316|
Recruitment Status : Not yet recruiting
First Posted : June 11, 2019
Last Update Posted : June 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Behavioral: Telehealth Behavioral Migraine Management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Telehealth Behavioral Migraine Management|
|Estimated Study Start Date :||July 15, 2019|
|Estimated Primary Completion Date :||January 15, 2020|
|Estimated Study Completion Date :||March 15, 2020|
Experimental: Telehealth Behavioral Migraine Management
Participants will receive weekly online education sessions in the following categories: Relaxation, Early Warning Signs, Triggers, Medication Adherence, Reducing Migraine Impact, Stress Management, Biofeedback, and Relapse Prevention. Participants will receive four monthly 50-minute telehealth sessions with a doctoral psychology student in a clinical health psychology program covering these topics, and three check-ins to enhance adherence to behavior change strategies. Participants will complete a daily headache diary throughout the course of treatment.
Behavioral: Telehealth Behavioral Migraine Management
1) Weekly online modules; 2) Monthly 50 minute telephone calls; 3) 3 15-minute telephone check ins.
- Feasibility of TeleBMM [ Time Frame: Week 0 through Week 12 ]Number of treatment components participants complete (out of 20)
- Patient-rated satisfaction [ Time Frame: Post-treatment survey at Week 12 ]Patient-rated satisfaction (acceptability) with the program on a Likert-type scale ranging from 0 ("Not at all satisfied") to 4 ("Very satisfied")
- Quality of Life (Migraine Specific) [ Time Frame: Change from Pre-treatment (Week 0) to Post-treatment (Week 12) ]Score on the MSQ v 2.1, a 14-item survey assessing quality of life in people with migraine.
- Headache frequency [ Time Frame: Slope change from Week 0 to Week 12 ]Participants complete a daily headache diary, on which each 7 day week they denote whether they have had a headache attack.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982316
|Contact: Elizabeth K Seng, Ph.D.||646-592-4368||Elizabeth.Seng@einstein.yu.edu|
|Principal Investigator:||Elizabeth K Seng, Ph.D.||Yeshiva University/Albert Einstein College of Medicine|