Telehealth Behavioral Migraine Management

Migraine Clinical Trial

— TeleBMM  

Official title:

Telehealth Behavioral Migraine Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03982316
• Other study ID #: 2019-10345
• Secondary ID: UL1TR002556
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: Albert Einstein College of Medicine
• Contact: Elizabeth K Seng, Ph.D.
• Phone: 646-592-4368
• Email: Elizabeth.Seng[@]einsteinmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Behavioral:
• Telehealth Behavioral Migraine Management
1) Weekly online modules; 2) Monthly 50 minute telephone calls; 3) 3 15-minute telephone check ins.

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of TeleBMM	Number of treatment components participants complete (out of 20)	Week 0 through Week 12
Secondary	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
Secondary	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)
Secondary	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