McLean 2017.

Study name	Design of a randomized controlled trial examining the efficacy and biological mechanisms of web‐prolonged exposure and present‐centered therapy for PTSD among active‐duty military personnel and veterans.
Methods	Randomised controlled trial
Participants	120 Participants are active duty military personnel stationed at Fort Hood, TX, and veterans in the surrounding area who have deployed since 11 September 2001, who are seeking treatment for PTSD, aged 18–65 years. Up to 170 people will be consented and screened to obtain data for analysis from 120 participants (60 participants in each treatment condition). Inclusion criteria PTSD diagnosis, determined by CAPS‐5 clinical interview and CAPS‐5 score ≥ 25, as well as exposure to a combat‐related Criterion A event that was experienced during deployment. The diagnosis of PTSD may be indexed to the combat‐related Criterion A event, or to another Criterion A event Remain in the local area for the next 3 months following the first assessment Exclusion criteria Recent manic episode or psychotic disorder (determined by the bipolar and psychosis sections of the MINI) Current alcohol dependence (determined by the AUDIT) Evidence of moderate or severe TBI (determined by an inability to comprehend baseline screening questionnaires) Current suicidal ideation severe enough to warrant immediate intervention (determined by DSI‐SS and corroborated by a clinical risk assessment by a credentialed provider) Other psychiatric disorders severe enough to warrant designation as the primary disorder Current engagement in evidence‐based treatment for PTSD Concomitant medications are not exclusionary; all medication changes are monitored for the duration of the trial.
Interventions	Web PE versus PCT
Outcomes	Time point for assessment: baseline, post‐treatment, 3‐month follow‐up, and 6‐month follow‐up. Primary outcome: PTSD severity, as measured by CAPS‐5, a structured diagnostic interview that assesses DSM‐5 criteria for PTSD and yields information about PTSD symptom severity and PTSD diagnostic status. Secondary measures include: AUDIT; CEQ; CTQ; DSI‐SS; GAD‐7; ISI; LEC; MINI‐7.0; PCL‐5, 1‐month and 2‐week versions; PHQ‐9; PHQ‐15; PTCI; PWPQ (based on the Perceptions of Computerized Therapy Questionnaire); STAXI‐2; VR‐12
Starting date	Unknown
Contact information	Carmen P McLean Stanford University School of Medicine mcleanca@pennmedicine.upenn.edu
Notes