Interactive CBT for headache and relaxation training (iCHART): Study protocol of a single-arm trial of interactive voice response technology delivery of cognitive-behavioral therapy for Veterans with post-traumatic headache

Abstract

Post-traumatic headache (PTH) is persistent and highly disabling. Cognitive-behavioral therapy for headache (CBT-HA) reduces headache frequency and severity and improves people’s quality of life, yet it is underutilized and inaccessible to many. Leveraging technology to deliver evidence-based psychological treatments for headache may address barriers to treatment engagement. This single-arm, single-site pilot trial aims to test the feasibility, acceptability, clinical signal, and cost of a five-session CBT-HA intervention delivered via interactive voice response technology (IVR). Participants will include 35 Veterans with PTH receiving care within VA Connecticut Healthcare System. Participants will complete an intake interview and a 9-item, 30-day electronic headache diary during a baseline run-in period. The same diary will be done again by participants immediately after treatment completion. Following the baseline assessment period, eligible participants will receive CBT-HA via IVR for 10 weeks, including an automated daily assessment of patient-reported outcomes and retrieval of biweekly tailored feedback from a study therapist. In addition, participants will access an electronic patient workbook, and study therapists will visualize patient-reported data through a secure provider dashboard. Participants will complete validated and reliable assessment measures at baseline, immediately post-treatment completion (week 10), and 1-month post-treatment completion (week 14). The primary clinical signal outcome is the change in self-reported headache days from the 30-day baseline run-in period before treatment (weeks −4 to 0) to the 30-day post-treatment completion (weeks 10–14). Paired-samples t-tests will explore changes in outcomes from baseline. All cost analyses will be exploratory and will use micro-costing techniques. Clinical Trials.gov: NCT05093556. Registered October 26, 2021.