Episodic Migraine Headache, Migraine, Migraine Headache
Conditions
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).
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.
Interventions
BEHAVIORALCognitive 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.
BEHAVIORALMEintervention
A digital intervention delivered via six 15-minute remote education sessions with a study research assistant from the VA Connecticut coordination center.
Sponsors
Yale University
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention Rate | From randomization to week 12 | Percent of randomized participants who complete Week 12 primary endpoint measure. |
| Feasibility of Intervention | From randomization to week 12 | Average percent of CBTm/ME sessions attended |
Countries
United States
Contacts
CONTACTSarah McGlone, MS
PRINCIPAL_INVESTIGATORJason Sico, MD
VA Connecticut Healthcare System
PRINCIPAL_INVESTIGATORMargaret Bauer, PhD
VA Connecticut Healthcare System
PRINCIPAL_INVESTIGATORNicholas Rattray, PhD
Richard L. Roudebush VA Medical Center
PRINCIPAL_INVESTIGATORDaniel Rogers, PhD
VA Connecticut Healthcare System
Outcome results
None listed