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Telehealth Behavioral Migraine Management (TeleBMM)

Primary Purpose

Migraine

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth Behavioral Migraine Management
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Albert Einstein College of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Telehealth Behavioral Migraine Management

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility of TeleBMM
Number of treatment components participants complete (out of 20)

Secondary Outcome Measures

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")
Quality of Life (Migraine Specific)
Score on the MSQ v 2.1, a 14-item survey assessing quality of life in people with migraine.
Headache frequency
Participants complete a daily headache diary, on which each 7 day week they denote whether they have had a headache attack.

Full Information

First Posted
June 8, 2019
Last Updated
November 14, 2022
Sponsor
Albert Einstein College of Medicine
Collaborators
National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT03982316
Brief Title
Telehealth Behavioral Migraine Management
Acronym
TeleBMM
Official Title
Telehealth Behavioral Migraine Management
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telehealth Behavioral Migraine Management
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telehealth Behavioral Migraine Management
Intervention Description
1) Weekly online modules; 2) Monthly 50 minute telephone calls; 3) 3 15-minute telephone check ins.
Primary Outcome Measure Information:
Title
Feasibility of TeleBMM
Description
Number of treatment components participants complete (out of 20)
Time Frame
Week 0 through Week 12
Secondary Outcome Measure Information:
Title
Patient-rated satisfaction
Description
Patient-rated satisfaction (acceptability) with the program on a Likert-type scale ranging from 0 ("Not at all satisfied") to 4 ("Very satisfied")
Time Frame
Post-treatment survey at Week 12
Title
Quality of Life (Migraine Specific)
Description
Score on the MSQ v 2.1, a 14-item survey assessing quality of life in people with migraine.
Time Frame
Change from Pre-treatment (Week 0) to Post-treatment (Week 12)
Title
Headache frequency
Description
Participants complete a daily headache diary, on which each 7 day week they denote whether they have had a headache attack.
Time Frame
Slope change from Week 0 to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth K Seng, Ph.D.
Phone
646-592-4368
Email
Elizabeth.Seng@einstein.yu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth K Seng, Ph.D.
Organizational Affiliation
Yeshiva University/Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth K Seng, Ph.D.
Phone
646-592-4368
Email
Elizabeth.Seng@einsteinmed.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Telehealth Behavioral Migraine Management

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