MigraineTeleBMMNCT03982316
Telehealth Behavioral Migraine Management
A study testing Telehealth Behavioral Migraine Management and Education Modules in people with Migraine, run by Albert Einstein College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Telehealth Behavioral Migraine Management and Education Modules
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Psychiatric illness that would interfere with study participation
- Meeting criteria for probable medication overuse headache
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
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
- Being tested
- Telehealth Behavioral Migraine Management, Education Modules
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth Behavioral Migraine ManagementBehavioural
- Weekly online modules; 2) Monthly 50 minute telephone calls; 3) 3 15-minute telephone check ins.
Education ModulesBehavioural
Participants will receive eight online weekly educational modules about migraine that will take you approximately 15 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Education Modules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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").
Measured: Post-treatment survey at Week 12
Secondary outcomes (2)
Change in Quality of Life (Migraine Specific)
Change in Migraine-related disability over the prior 4 week period was assessed based on Version 2.1 of the Migraine Specific Quality of Life Questionnaire (MSQ). The MSQ is a 14-item survey assessing quality of life in people with migraine. Responses from the 14 Items (which are reverse-coded) encompassing three domains (Role Restriction - 7 items; Role Prevention - 4 items; and Emotional Function - 3 items) were rated on a 6-point scale ranging from 1 ("None of the time") to 6 ("All of the time"). Raw scores were summed and linearly converted to a 0-100 scale wherein higher scores are associated with a better quality of life. For purposes of this study, change from baseline was assessed such that higher scores reflect an increased quality of life from baseline and negative scores reflect a decreased quality of life from baseline. Scores are summarized by study arm using descriptive statistics.
Measured: Change from Pre-treatment (Week 0) to Post-treatment (Week 12)
Change in Headache Frequency
Participants were asked to complete a daily headache diary, on which each 7 day week they denoted whether they have had a headache attack. Slope change from Week 0 to Week 12 is reported as a proportion of headache days/month (ranging from 0-1) and is summarized by study arm.
Measured: Change from Week 0 to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start15 Sep 2020
- Primary completion15 Sep 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Elizabeth K Seng, Ph.D., Principal investigator, Yeshiva University/Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982316
- Sponsor's protocol ID
- 2019-10345
- Other IDs
- UL1TR002556, 2019
- Acronym
- TeleBMM
- Status last verified
- Feb 2026
- First submitted
- 8 Jun 2019
- Last updated
- 11 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Behavioral Migraine Management
- ClinicalTrials.gov ID
- NCT03982316
- Acronym / sponsor ID
- TeleBMM / 2019-10345
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 11 Jun 2019 (actual)
- Results
- Posted 11 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehealth Behavioral Migraine Management | Experimental | Behavioral: Telehealth Behavioral Migraine ManagementParticipants 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. |
| Education Modules | Active comparator | Behavioral: Education ModulesParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Psychiatric illness that would interfere with study participation
- Meeting criteria for probable medication overuse headache
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth Behavioral Migraine Management1) Weekly online modules; 2) Monthly 50 minute telephone calls; 3) 3 15-minute telephone check ins. | Behavioural | Telehealth Behavioral Migraine Management |
| Education ModulesParticipants will receive eight online weekly educational modules about migraine that will take you approximately 15 minutes to complete. | Behavioural | Education Modules |
Primary outcome
Feasibility of TeleBMM
Time frame: Week 0 through Week 12
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.
Acceptability - Patient-Rated Satisfaction
Time frame: Post-treatment survey at Week 12
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").
2 secondary outcomes
Change in Quality of Life (Migraine Specific)
Time frame: Change from Pre-treatment (Week 0) to Post-treatment (Week 12)
Change in Headache Frequency
Time frame: Change from Week 0 to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth K Seng, Ph.D. principal investigator
Yeshiva University/Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth Behavioral Migraine Management and Education Modules in people with Migraine, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of TeleBMM (time frame: Week 0 through Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.