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

August 27, 2026 updated by: Yale University

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Healthcare System
    • Texas
      • San Antonio, Texas, United States, 78224
        • VA South Texas Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive behavioral therapy for migraine (CBTm)
Participants to receive 6 sessions of CBTm
Behavioral: 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.
Experimental: Migraine education intervention (MEintervention)
Participants to receive 6 sessions of a remotely delivered interactive MEintervention
Behavioral: MEintervention
A digital intervention delivered via six 15-minute remote education sessions with a study research assistant from the VA Connecticut coordination center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention Rate
Time Frame: From randomization to week 12
Percent of randomized participants who complete Week 12 primary endpoint measure.
From randomization to week 12
Feasibility of Intervention
Time Frame: From randomization to week 12
Average percent of CBTm/ME sessions attended
From randomization to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Jason Sico, MD, VA Connecticut Healthcare System
  • Principal Investigator: Margaret Bauer, PhD, VA Connecticut Healthcare System
  • Principal Investigator: Nicholas Rattray, PhD, Richard L. Roudebush VA Medical Center
  • Principal Investigator: Daniel Rogers, PhD, VA Connecticut Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

August 24, 2026

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 28, 2026

Study Record Updates

Last Update Posted (Actual)

August 31, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000043492
  • 1UG3AT013498-01 (U.S. NIH Grant/Contract: National Center for Complementary and Integrative Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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