Telehealth Behavioral Migraine Management

NCT ID: NCT03982316

Last Updated: 2025-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2024-10-30

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.

Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Telehealth Behavioral Migraine Management

Intervention Type BEHAVIORAL

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

Interventions

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Telehealth Behavioral Migraine Management

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth K Seng, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yeshiva University/Albert Einstein College of Medicine

Locations

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Albert Einstein College of Medicine

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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UL1TR002556

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2019-10345

Identifier Type: -

Identifier Source: org_study_id

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