Study design for a randomized clinical trial of cognitive-behavioral therapy for posttraumatic headache

Donald D McGeary, Donald B Penzien, Patricia A Resick, Cindy A McGeary, Carlos A Jaramillo, Blessen C Eapen, Stacey Young-McCaughan, Paul S Nabity, John C Moring, Timothy T Houle, Terence M Keane, Alan L Peterson, Donald D McGeary, Donald B Penzien, Patricia A Resick, Cindy A McGeary, Carlos A Jaramillo, Blessen C Eapen, Stacey Young-McCaughan, Paul S Nabity, John C Moring, Timothy T Houle, Terence M Keane, Alan L Peterson

Abstract

Posttraumatic headache (PTH) is a common debilitating condition arising from head injury and is highly prevalent among military service members and veterans with traumatic brain injury (TBI). Diagnosis and treatment for PTH is still evolving, and surprisingly little is known about the putative mechanisms that drive these headaches. This manuscript describes the design of a randomized clinical trial of two nonpharmacological (i.e., behavioral) interventions for posttraumatic headache. Design of this trial required careful consideration of PTH diagnosis and inclusion criteria, which was challenging due to the lack of standard clinical characteristics in PTH unique from other types of headaches. The treatments under study differed in clinical focus and dose (i.e., number of treatment sessions), but the trial was designed to balance the treatments as well as possible. Finally, while the primary endpoints for pain research can vary from assessments of pain intensity to objective and subjective functional measures, this trial of PTH interventions chose carefully to establish clinically relevant endpoints and to maximize the opportunity to detect significant differences between groups with two primary outcomes. All these issues are discussed in this manuscript.

Keywords: AUDIT, Alcohol Use Disorders Identification Test-Self Report; B-IPF, Brief Inventory of Psychosocial Functioning; CAP, Consortium to Alleviate PTSD; CAPS-5, Clinician-Administered PTSD Scale for DSM-5; CBT, cognitive-behavioral therapy; CCBT, clinic-based cognitive-behavioral therapy intervention for headache; CEQ, Credibility and Expectancy Questionnaire; CGRP, calcitonin gene-related peptide; CPRS, Computerized Patient Record System; CPT, Cognitive Processing Therapy; CRIS, Community Reintegration of Injured Service Members; DRRI-2-D, Deployment Risk and Resilience Inventory-2-Deployment Environment; DRRI-2-P, Deployment Risk and Resilience Inventory-Postbattle Experiences; DSI-SS, Depressive Symptom Index-Suicide Subscale; DoD, U.S. Department of Defense; GAD-7, Generalized Anxiety Disorder Screener; GLM, general linear mixed; HIPAA, Health Insurance Portability and Accountability Act; HIT-6, Headache Impact Test; HMSE, Headache Management Self-Efficacy Scale; HSLC, Headache-Specific Locus of Control Scale; Headache; ICHD-2, International Classification of Headache Disorders, 2nd Edition; ICHD-3, International Classification of Headache Disorders, 3rd Edition; IRB, institutional review board; ISI, Insomnia Severity Index; ITT, intent to treat; LEC-5, Life Events Checklist for DSM-5; NIH, National Institutes of Health; NSI, Neurobehavioral Symptom Inventory; OSU TBI-ID-SF, Ohio State University TBI Identification Method-Interview Form; PCL-5, PTSD Checklist for DSM-5; PHQ-15, Patient Health Questionnaire-15; PHQ-9, Patient Health Questionnaire-9 Item; PP, per protocol; PRC, Polytrauma Rehabilitation Center; PROMIS, Patient-Reported Outcomes Measurement Information System; PTCI, Posttraumatic Cognitions Inventory; PTH, posttraumatic headache; PTHA Study, posttraumatic headache and PTSD study; PTSD; PTSD, posttraumatic stress disorder; Polymorbidity; QDS, Quick Drinking Screen; RSES, Response to Stressful Experiences Scale; SDIH-R, Structured Diagnostic Interview for Headache-Revised, Brief Version; SITBI, Self-Injurious Thoughts and Behaviors Interview – Short Form; STOP, Snoring, Tired, Observed, Blood Pressure; TAU, treatment as usual; TBI, traumatic brain injury; Traumatic brain injury; VA, U.S. Department of Veterans Affairs; VHCS, Veterans Health Care System; VR-12, Veterans RAND 12-Item Health Survey; Veterans.

Conflict of interest statement

None to report.

© 2021 The Authors.

Figures

Fig. 1
Fig. 1
Timeline of PTHA study participation. PTHA = posttraumatic headache and posttraumatic stress disorder.
Fig. 2
Fig. 2
PTHA study recruitment mechanisms. PTHA = posttraumatic headache and posttraumatic stress disorder; VHCS = Veterans Health Care System; PRC = Polytrauma Rehabilitation Center; STRONG STAR = South Texas Research Organizational Network Guiding Studies on Trauma and Resilience.

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