Telehealth Behavioral Migraine Management

NCT03982316 | Completed Results

• 2 other identifiers: 2019-10345UL1TR002556
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Quality of Life (Migraine Specific)

  Change from Pre-treatment (Week 0) to Post-treatment (Week 12)

• Change in Headache Frequency

  Change from Week 0 to Week 12

Study Arms (2)

Telehealth Behavioral Migraine Management

EXPERIMENTAL

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

Education Modules

ACTIVE COMPARATOR

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

Interventions

Education Modules BEHAVIORAL

Participants will receive eight online weekly educational modules about migraine that will take you approximately 15 minutes to complete.

Education Modules

Telehealth Behavioral Migraine Management BEHAVIORAL

1\) Weekly online modules; 2) Monthly 50 minute telephone calls; 3) 3 15-minute telephone check ins.

Telehealth Behavioral Migraine Management

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Psychiatric illness that would interfere with study participation
• Meeting criteria for probable medication overuse headache

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

The study did not achieve targeted sample per arm and therefore results are not generalizable and should be considered hypothesis-generating.

Results Point of Contact

• Title: Elizabeth Seng
• Organization: Albert Einstein College of Medicine

Elizabeth.Seng@yu.edu

646-592-4368

Study Officials

• Elizabeth K Seng, Ph.D.

  Yeshiva University/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2019
• First Posted: June 11, 2019
• Study Start: September 15, 2020
• Primary Completion: September 15, 2024
• Study Completion: October 30, 2024
• Last Updated: March 11, 2026
• Results First Posted: March 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)