NCT07792291

Brief 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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Oct 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 24, 2026

Last Update Submit

August 24, 2026

Conditions

MigraineMigraine HeadacheEpisodic Migraine Headache

Outcome Measures

Primary Outcomes (2)

  • Retention Rate

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

    From randomization to week 12

  • Feasibility of Intervention

    Average % of CBTm/ME sessions attended

    From randomization to week 12

Study Arms (2)

Cognitive behavioral therapy for migraine (CBTm)

EXPERIMENTAL

Participants to receive 6 sessions of CBTm

Behavioral: Cognitive behavioral therapy for migraine (CBTm)

Migraine education intervention (MEintervention)

EXPERIMENTAL

Participants to receive 6 sessions of a remotely delivered interactive MEintervention

Behavioral: MEintervention

Interventions

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.

Cognitive behavioral therapy for migraine (CBTm)
MEinterventionBEHAVIORAL

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

Migraine education intervention (MEintervention)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physician diagnosis of migraine
  • Fluent in English
  • Capacity to consent
  • Currently meets 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

VA South Texas Healthcare System

San Antonio, Texas, 78224, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah McGlone, MS

CONTACT

203-932-5711Sarah.Mcglone@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2026

First Posted

August 28, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

August 28, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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 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

Locations

US(2)