Telehealth Behavioral Migraine Management

Study Overview
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Brief Summary
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This project aims to develop the protocol and obtain feasibility and acceptability information for Telehealth Behavioral MIgraine Management in a single-arm pre-post pilot study. The investigator and study team aim to recruit 20 people with migraine from the Montefiore Headache Center in the Bronx NY. Participants will receive the 12-week protocol including a mobile app headache diary, an online patient manual with interactive vignettes, 4 50-minute telehealth sessions, and 3 15-minute check-ins.

Official Title
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Telehealth Behavioral Migraine Management

Conditions
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Migraine

Intervention / Treatment
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* Behavioral: Telehealth Behavioral Migraine Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physician diagnosis of migraine Current self-reported symptoms meeting the International Classification for Headache Disorders -- 3 criteria for migraine Self-reported between 4 and 20 headache days/month Aged 18-65 Can read English Capacity to consent Exclusion Criteria: Psychiatric illness that would interfere with study participation Meeting criteria for probable medication overuse headache

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth Behavioral Migraine Management<br>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<br>* 1) Weekly online modules; 2) Monthly 50 minute telephone calls; 3) 3 15-minute telephone check ins.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of TeleBMM | Number of treatment components participants complete (out of 20) | Week 0 through Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-rated satisfaction | Patient-rated satisfaction (acceptability) with the program on a Likert-type scale ranging from 0 (Not at all satisfied) to 4 (Very satisfied) | Post-treatment survey at Week 12 | 
| Quality of Life (Migraine Specific) | Score on the MSQ v 2.1, a 14-item survey assessing quality of life in people with migraine. | Change from Pre-treatment (Week 0) to Post-treatment (Week 12) | 
| Headache frequency | Participants complete a daily headache diary, on which each 7 day week they denote whether they have had a headache attack. | Slope change from Week 0 to Week 12 |