Telemedicine-based cognitive behavioral therapy (TENACITY) for Veterans with chronic migraine: A pilot randomized controlled trial protocol

Abstract

Background Behavioral interventions for people with headache (HA) diseases have demonstrated clinical efficacy. Despite strong empirical support and endorsement by professional practice organizations, behavioral interventions are not widely accessible to HA patients. Clinic-based behavioral treatments remain inaccessible to many. The objectives of this study are to conduct a pilot randomized controlled trial and to determine the feasibility of the implementation of a cognitive behavioral therapy protocol for HA (CBT-HA) delivered via telehealth (TENACITY) compared to enhanced HA usual treatment (EHUT). Methods/design TENACITY is a single-blinded, randomized, controlled, pilot trial with a single intervention arm and an EHUT control arm analyzed as intention-to-treat. This multi-site study had a 31-day run-in/screening period to confirm chronic migraine and an approximately 12-week CBT-HA treatment period. Follow-up assessments were conducted at 3- and 6-month post-treatment initiation. Analysis plan The primary outcome will be analyzed as the change in self-reported number of HA days from the 30-day baseline run-in period before treatment to the number of self-reported days at 3 months post-treatment using a generalized mixed effects model. Secondary outcomes at 3- and 6-month post-treatment will be analyzed in addition. Trial Registration IRP 20-002, TENACITY: Telemedicine-based cognitive therapy for migraine NCT04613362