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Trial record 3 of 1110 for:    migraine

Telehealth Behavioral Migraine Management (TeleBMM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03982316
Recruitment Status : Not yet recruiting
First Posted : June 11, 2019
Last Update Posted : June 11, 2019
National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA)
Information provided by (Responsible Party):
Elizabeth Seng, 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. I aim 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.

Condition or disease Intervention/treatment Phase
Migraine Behavioral: Telehealth Behavioral Migraine Management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telehealth Behavioral Migraine Management
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : January 15, 2020
Estimated Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

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.

Primary Outcome Measures :
  1. Feasibility of TeleBMM [ Time Frame: Week 0 through Week 12 ]
    Number of treatment components participants complete (out of 20)

Secondary Outcome Measures :
  1. Patient-rated satisfaction [ Time Frame: 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")

  2. Quality of Life (Migraine Specific) [ Time Frame: 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.

  3. Headache frequency [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03982316

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Contact: Elizabeth K Seng, Ph.D. 646-592-4368

Sponsors and Collaborators
Albert Einstein College of Medicine
National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA)
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Principal Investigator: Elizabeth K Seng, Ph.D. Yeshiva University/Albert Einstein College of Medicine

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Responsible Party: Elizabeth Seng, Principal Investigator, Albert Einstein College of Medicine Identifier: NCT03982316     History of Changes
Other Study ID Numbers: 2019-10345
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases