MigraineBrave-MindNCT07792291
Behavioral Resources and Awareness for Veterans With Episodic Migraine: Impact on Neurological Disability and Quality of Life- Pilot
A study testing Cognitive behavioral therapy for migraine (CBTm) and MEintervention in people with Migraine and Migraine Headache, run by Yale University at 2 sites in United States.
Trial summary
The current study will evaluate effectiveness of cognitive behavioral therapy for migraine compared to migraine education (ME) to improve migraine-related quality of life in the real-world setting of the Veterans Health Administration (VHA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Migraine Headache, Episodic Migraine Headache
- What is being tested?
- Cognitive behavioral therapy for migraine (CBTm) and MEintervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician diagnosis of migraine
- Fluent in English
- Capacity to consent
- Currently meets International Classification of Headache Disorders-3 (ICHD-3) migraine criteria
- Self-report 4-14 monthly headache days in past 28 days
- Score of at least moderate disability (≥ 10) on the MIDAS
Who cannot join
- Secondary headache only
- Currently meets criteria for a Trigeminal Autonomic Cephalalgia
- Self-report < 4 or >14 headache days in past 28 days
- Utilization of behavioral treatments for migraine or pain in the past 12 months
- Score of less than 10 on the MIDAS
- Reports active suicidal ideation (endorses Ideation items 3, 4 or 5, or any Suicidal Behavior items in the past 12 months
- Has a pending disability or service connection claim related to migraine or headache disorders
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
VA South Texas Healthcare System
San Antonio, Texas, 78224
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
Official title: Behavioral Resources and Awareness for Veterans With Episodic Migraine: Impact on Neurological Disability and Quality of Life
The current study will evaluate effectiveness of cognitive behavioral therapy for migraine compared to migraine education (ME) to improve migraine-related quality of life in the real-world setting of the Veterans Health Administration (VHA).
Read the detailed description
This registration is for the Planning Phase Pilot Trial. The study team will aim to identify facilitators and barriers to effectiveness of CBTm in real-world settings and conduct a pilot study to demonstrate feasibility of study procedures and intervention delivery.
- Conditions
- Migraine, Migraine Headache, Episodic Migraine Headache
- Being tested
- Cognitive behavioral therapy for migraine (CBTm), MEintervention
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy for migraine (CBTm)Behavioural
A standardized multi-modal behavioral treatment protocol typically delivered by psychologists via six sessions to help people better manage their migraine through behavior changes, warning sign identification and acute treatment optimization, medication adherence, and restructuring unhelpful thoughts about migraine and stress.
MEinterventionBehavioural
A digital intervention delivered via six 15-minute remote education sessions with a study research assistant from the VA Connecticut coordination center.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy for migraine (CBTm) | Experimental | Participants to receive 6 sessions of CBTm Receives: Behavioral: Cognitive behavioral therapy for migraine (CBTm) |
| Migraine education intervention (MEintervention) | Experimental | Participants to receive 6 sessions of a remotely delivered interactive MEintervention Receives: Behavioral: MEintervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Rate
Percent of randomized participants who complete Week 12 primary endpoint measure.
Measured: From randomization to week 12
Feasibility of Intervention
Average percent of CBTm/ME sessions attended
Measured: From randomization 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 posted28 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Jason Sico, MD, Principal investigator, VA Connecticut Healthcare SystemMargaret Bauer, PhD, Principal investigator, VA Connecticut Healthcare SystemNicholas Rattray, PhD, Principal investigator, Richard L. Roudebush VA Medical CenterDaniel Rogers, PhD, Principal investigator, VA Connecticut Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792291
- Sponsor's protocol ID
- 2000043492
- Other IDs
- 1UG3AT013498-01
- Acronym
- Brave-Mind
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As required by studies funded by the NIH/VA/Department of Defense Pain Management Collaboratory, the database created through this project will be made available to future VA investigators for a period of 10 years through an NIH Helping to End Addiction Long-term (HEAL)-compliant repository (Vivli) which is currently being used for a VA cooperative study. Data will be disposed of 10 years following the completion of the study, as required by the National Institutes of Health. Only members of the research team at the VA will have access to the crosswalk. Banked data
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Resources and Awareness for Veterans With Episodic Migraine: Impact on Neurological Disability and Quality of Life
- ClinicalTrials.gov ID
- NCT07792291
- Acronym / sponsor ID
- Brave-Mind / 2000043492
- Conditions
- Migraine, Migraine Headache, Episodic Migraine Headache
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study will evaluate effectiveness of cognitive behavioral therapy for migraine compared to migraine education (ME) to improve migraine-related quality of life in the real-world setting of the Veterans Health Administration (VHA).
Detailed description
This registration is for the Planning Phase Pilot Trial. The study team will aim to identify facilitators and barriers to effectiveness of CBTm in real-world settings and conduct a pilot study to demonstrate feasibility of study procedures and intervention delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy for migraine (CBTm) | Experimental | Behavioral: Cognitive behavioral therapy for migraine (CBTm)Participants to receive 6 sessions of CBTm |
| Migraine education intervention (MEintervention) | Experimental | Behavioral: MEinterventionParticipants to receive 6 sessions of a remotely delivered interactive MEintervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Physician diagnosis of migraine
- Fluent in English
- Capacity to consent
- Currently meets International Classification of Headache Disorders-3 (ICHD-3) migraine criteria
- Self-report 4-14 monthly headache days in past 28 days
Key exclusion criteria (7 listed)
- Secondary headache only
- Currently meets criteria for a Trigeminal Autonomic Cephalalgia
- Self-report < 4 or >14 headache days in past 28 days
- Utilization of behavioral treatments for migraine or pain in the past 12 months
- Score of less than 10 on the MIDAS
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 |
|---|---|---|
| Cognitive behavioral therapy for migraine (CBTm)A standardized multi-modal behavioral treatment protocol typically delivered by psychologists via six sessions to help people better manage their migraine through behavior changes, warning sign identification and acute treatment optimization, medication adherence, and restructuring unhelpful thoughts about migraine and stress. | Behavioural | Cognitive behavioral therapy for migraine (CBTm) |
| MEinterventionA digital intervention delivered via six 15-minute remote education sessions with a study research assistant from the VA Connecticut coordination center. | Behavioural | Migraine education intervention (MEintervention) |
Primary outcome
Retention Rate
Time frame: From randomization to week 12
Percent of randomized participants who complete Week 12 primary endpoint measure.
Feasibility of Intervention
Time frame: From randomization to week 12
Average percent of CBTm/ME sessions attended
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Yes. As required by studies funded by the NIH/VA/Department of Defense Pain Management Collaboratory, the database created through this project will be made available to future VA investigators for a period of 10 years through an NIH Helping to End Addiction Long-term (HEAL)-compliant repository (Vivli) which is currently being used for a VA cooperative study. Data will be disposed of 10 years following the completion of the study, as required by the National Institutes of Health. Only members of the research team at the VA will have access to the crosswalk. Banked data
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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.
Jason Sico, MD principal investigator
VA Connecticut Healthcare System
Margaret Bauer, PhD principal investigator
VA Connecticut Healthcare System
Nicholas Rattray, PhD principal investigator
Richard L. Roudebush VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy for migraine (CBTm) and MEintervention in people with Migraine and Migraine Headache, run by Yale University at 2 sites 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 7 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: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah McGlone, MS (203-932-5711 ext. 14724, Sarah.Mcglone@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention Rate (time frame: From randomization to 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 31 Aug 2026.