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NCT Number: NCT07792291

Behavioral Resources and Awareness for Veterans With Episodic Migraine: Impact on Neurological Disability and Quality of Life- Pilot

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).

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Episodic Migraine Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Migraine Headache Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Connecticut Healthcare System, West Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Cognitive behavioral therapy for migraine (CBTm)

Behavioral

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.

MEintervention

Behavioral

A digital intervention delivered via six 15-minute remote education sessions with a study research assistant from the VA Connecticut coordination center.

Primary outcomes

  1. Retention Rate

    Time frame: From randomization to week 12

    Percent of randomized participants who complete Week 12 primary endpoint measure.

  2. Feasibility of Intervention

    Time frame: From randomization to week 12

    Average percent of CBTm/ME sessions attended

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah McGlone, MS

CONTACT

[email protected]

203-932-5711 ext. 14724

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Behavioral Resources and Awareness for Veterans With Episodic Migraine: Impact on Neurological Disability and Quality of Life

Acronym: Brave-Mind

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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