Telehealth Behavioral Migraine Management (TeleBMM)

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 New York. 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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Behavioral: Telehealth Behavioral Migraine Management; Behavioral: Education Modules

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • The Bronx, New York, United States, 10461
      • Albert Einstein College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Active Comparator: Education Modules; Participants will receive eight online weekly educational modules about migraine that will take you approximately 15 minutes to complete in the following categories: Relaxation, Early Warning Signs, Triggers, Medication Adherence, Reducing Migraine Impact, Stress Management, \Biofeedback, and Relapse Prevention. Participants will complete a daily headache diary throughout the course of treatment.	Behavioral: Education Modules; Participants will receive eight online weekly educational modules about migraine that will take you approximately 15 minutes to complete.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of TeleBMM	Feasibility of the study will be based on patient adherence to the protocol. The number of treatment components participants complete (out of 20) will be tabulated. It is hypothesized that at least half of the participants will attend all four study sessions and complete all three self-guided modules. Dropouts will be included in the analysis. Results will be summarized using basic descriptive statistics.	Week 0 through Week 12
Acceptability - Patient-Rated Satisfaction	Patient-rated satisfaction (acceptability) with the program will be based on responses to the overall satisfaction question on a satisfaction survey. Participants are asked to rate overall satisfaction with the Telehealth Behavioral Management Program on a Likert-type scale ranging from 0 ("Not at all satisfied") to 4 ("Very satisfied"). Acceptability was to have been evaluated both on completers and assuming that individuals who dropped out were not satisfied (i.e., "Not at all satisfied").	Post-treatment survey at Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life (Migraine Specific)	Change in Migraine-related disability over the prior 4 week period was assessed based on Version 2.1 of the Migraine Specific Quality of Life Questionnaire (MSQ). The MSQ is a 14-item survey assessing quality of life in people with migraine. Responses from the 14 Items (which are reverse-coded) encompassing three domains (Role Restriction - 7 items; Role Prevention - 4 items; and Emotional Function - 3 items) were rated on a 6-point scale ranging from 1 ("None of the time") to 6 ("All of the time"). Raw scores were summed and linearly converted to a 0-100 scale wherein higher scores are associated with a better quality of life. For purposes of this study, change from baseline was assessed such that higher scores reflect an increased quality of life from baseline and negative scores reflect a decreased quality of life from baseline. Scores are summarized by study arm using descriptive statistics.	Change from Pre-treatment (Week 0) to Post-treatment (Week 12)
Change in Headache Frequency	Participants were asked to complete a daily headache diary, on which each 7 day week they denoted whether they have had a headache attack. Slope change from Week 0 to Week 12 is reported as a proportion of headache days/month (ranging from 0-1) and is summarized by study arm.	Change from Week 0 to Week 12

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Elizabeth K Seng, Ph.D., Yeshiva University/Albert Einstein College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): September 15, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: June 8, 2019
• First Submitted That Met QC Criteria: June 8, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 2019-10345; UL1TR002556 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No