Design and methods of a randomized controlled trial evaluating the effects of the PE Coach mobile application on prolonged exposure among veterans with PTSD.

BACKGROUND:Little is known about the impact of mobile applications (apps) designed to support patients progressing through an evidence-based psychotherapy. Prolonged exposure (PE) is an efficacious treatment for posttraumatic stress disorder (PTSD) and PE Coach is a treatment companion app that may increase patient engagement with the active components of PE, thereby supporting recovery. METHODS:This paper describes a randomized clinical trial that will evaluate PE delivered with and without PE Coach at post-treatment, and 1-month and 4-months post-treatment. Veterans with PTSD (N = 124) will be randomized (1:1) to conditions and complete up to 15 treatment sessions based on a priori defined termination criteria. We hypothesize that compared to PE without PE Coach, PE with the app will result in greater improvements in PTSD-related social and occupational functioning (primary outcome is the PTSD-Related Functioning Inventory), quality of life, and greater reductions in functional impairment, neurobehavioral symptoms, depression, and suicidal ideation (Aim 1). We also hypothesize that including PE Coach will reduce assessor-masked PTSD symptom severity, relative to PE without the app, as assessed by the revised Clinician-Administered PTSD Scale for DSM-5 (Aim 2). We hypothesize that PE Coach will facilitate increased treatment adherence, as measured by completion of PE homework (Aim 3). We will explore the impact of PE Coach on treatment engagement, as measured by reduced treatment dropout. CONCLUSION:Data on the outcomes of PE Coach can inform dissemination efforts and help evaluate the return on investment to guide future mental health app development. CLINICAL TRIAL REGISTRATION NUMBER:ClinicalTrials.govNCT04959695.