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Effectiveness of Cognitive Behavioral Therapy for Migraine in the Veterans Health Administration

Award Number: UG3AT013498
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/25/2026
PERIOD OF PERFORMANCE END DATE: 07/31/2027

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Effectiveness of Cognitive Behavioral Therapy for Migraine in the Veterans Health Administration - Project Summary Migraine is common, disabling and frequently undertreated. People with migraine often try to change their behavior or lifestyle to manage migraine, but infrequently utilize evidence-based behavioral migraine treatments. Cognitive behavioral therapy for migraine (CBTm) is a standardized multi-modal behavioral treatment protocol typically delivered by psychologists 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. CBTm, particularly when combined with preventive medication, has demonstrated efficacy to improve migraine-related quality of life. However, efficacy trials for migraine often select very specific patients under very specific sets of circumstances that do not represent real-world practice very well. The current study will evaluate effectiveness of cognitive behavioral therapy for migraine compared to migraine education to improve migraine-related quality of life in the real-world setting of the Veterans Health Administration (VHA). During Phase 1 of the project, we plan to hold stakeholder groups including veterans with migraine, providers, health systems leaders and advocates, to identify barriers and facilitators of CBTm in the VHA. We will also pilot the procedures for the trial in 24 veterans with migraine to ensure the procedures and both interventions (CBTm and migraine education) are feasible in the VHA. During Phase 2 of the project, we will randomize 640 veterans with episodic migraine who are eligible for preventive treatment (e.g., experienced between 4-14 headache days in the past month and report at least a moderate level of migraine-related disability) to receive either 6 sessions of CBTm or a remotely-delivered interactive migraine education intervention. Recruitment will occur in multiple VHA health care systems across the United States that include a Headache Center of Excellence psychology team that can provide the CBTm intervention via routine care delivery mechanisms. Participants will complete surveys asking about quality of life as the primary outcome, as well as migraine symptoms, migraine-related interference, and psychiatric symptoms 4 weeks, 12 weeks, and 24 weeks after starting the intervention. Our primary question is whether changes migraine-specific quality of life from Week 0 to Week 12 are different among veterans who received CBTm and migraine education. Stakeholder engagement will remain a critical component of the study and will continue to provide feedback on study implementation and interpretation throughout Phase 2.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $789,890 )
2026	2026	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	The National Institute of Neurological Disorders and Stroke (NINDS) Helping to End Addiction Long-term® (HEAL) Initiative	000	1	8/26/2026	NEW	$789,890
														Subtotal = $789,890

Grand Total All Awards = $789,890

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Effectiveness of Cognitive Behavioral Therapy for Migraine in the Veterans Health Administration

Award Number: UG3AT013498

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/25/2026

PERIOD OF PERFORMANCE END DATE: 07/31/2027

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