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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Physician diagnosis of migraine

Fluent in English

Capacity to consent

Currently meets International Classification of Headache Disorders-3 (ICHD-3) migraine criteria

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Cognitive behavioral therapy for migraine (CBTm)Experimental treatment 1 intervention
Group B: Migraine education intervention (MEintervention)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Retention Rate

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

Time frame
From randomization to week 12
2

Feasibility of Intervention

Average percent of CBTm/ME sessions attended

Time frame
From randomization to week 12

Secondary outcomes

Other outcomes

Sponsors and contacts

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Yale University

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: