Design of a clinical effectiveness trial of in-home cognitive processing therapy for combat-related PTSD

Approximately 14% of military personnel and veterans who have deployed to the combat theater are at risk for combat-related posttraumatic stress disorder (PTSD). The treatment of combat-related PTSD in active duty service members and veterans is challenging. Combat trauma may involve multiple high levels of exposure to different types of traumatic events (e.g., human carnage after explosive blasts, life threat/injuries to self/others, etc.). Many service members and veterans are unable or unwilling to receive treatment in government facilities due to avoidance, scheduling difficulties, transportation or parking problems, concerns about career advancement, or stigma associated with seeking treatment. Innovative treatment-delivery approaches are needed to help overcome these barriers. The present study is a randomized clinical trial to evaluate three versions of Cognitive Processing Therapy (CPT; [54]) for the treatment of combat-related PTSD in active duty military service members and veterans: (1) standard In-Office CPT, (2) In-Home Telebehavioral Health CPT from the provider's office to the participant's home, and (3) In-Home CPT in which the provider delivers treatment in the participant's home. Use of an equipoise-stratified randomization design allows participants to decline one of the treatment arms. This research design partly overcomes the problems active duty military and veterans face when receiving PTSD treatment by allowing them to opt out of one inappropriate or unacceptable treatment modality and still permitting randomization to the two remaining treatment modalities. This manuscript provides an overview of the research design and methods for the study.