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.
Brief Title
Telehealth Behavioral Migraine Management
Categories
Completion Date
Completion Date Type
Actual
Conditions
Migraine
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
65 Years
Minimum Age
18 Years
NCT Id
NCT03982316
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2019-10345
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Telehealth Behavioral Migraine Management
Primary Outcomes
Outcome Description
Number of treatment components participants complete (out of 20)
Outcome Measure
Feasibility of TeleBMM
Outcome Time Frame
Week 0 through Week 12
Secondary Ids
Secondary Id
UL1TR002556
Secondary Outcomes
Outcome Description
Patient-rated satisfaction (acceptability) with the program on a Likert-type scale ranging from 0 ("Not at all satisfied") to 4 ("Very satisfied")
Outcome Time Frame
Post-treatment survey at Week 12
Outcome Measure
Patient-rated satisfaction
Outcome Description
Score on the MSQ v 2.1, a 14-item survey assessing quality of life in people with migraine.
Outcome Time Frame
Change from Pre-treatment (Week 0) to Post-treatment (Week 12)
Outcome Measure
Quality of Life (Migraine Specific)
Outcome Description
Participants complete a daily headache diary, on which each 7 day week they denote whether they have had a headache attack.
Outcome Time Frame
Slope change from Week 0 to Week 12
Outcome Measure
Headache frequency
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
65
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Elizabeth Seng
Investigator Email
elizabeth.seng@einsteinmed.org
Investigator Phone