Telehealth Behavioral Migraine Management

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Behavioral: Telehealth Behavioral Migraine Management

• Registration Number: NCT03982316
• Lead Sponsor: Albert Einstein College of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-08
• Study First Submitted QC: 2019-06-08
• Study First Posted: 2019-06-11
• Study Start: 2020-09-15
• Primary Completion: 2024-09-15
• Study Completion: 2024-10-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telehealth Behavioral Migraine Management	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of TeleBMM	Week 0 through Week 12	Number of treatment components participants complete (out of 20)

Secondary Outcome Measures

Name	Time	Method
Headache frequency	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.
Patient-rated satisfaction	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)	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.

Trial Locations

Locations (1)

Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States