Pharmacologic and Nonpharmacologic Treatments for Posttraumatic Stress Disorder: An Update of the PTSD-Repository Evidence Base

Objectives Identify and abstract data from posttraumatic stress disorder (PTSD) treatment randomized controlled trials (RCTs) to update the PTSD Trials Standardized Data Repository (PTSD-Repository) with data on PTSD and mental health, including suicide-related outcomes and substance use. Data sources We searched PTSDpubs, Ovid® MEDLINE®, Cochrane CENTRAL, PsycINFO®, Embase®, CINAHL®, and Scopus® for eligible RCTs published from 1980 to May 22, 2020. Review methods In consultation with the National Center for PTSD (NCPTSD), we updated the PTSD-Repository by expanding inclusion criteria to RCTs targeting comorbid PTSD/substance use disorder (SUD) and adding data elements. The primary publication for each RCT was abstracted; data and citations from secondary publications (i.e., companion papers) appear in the same record. We assessed risk of bias (ROB) for all studies in the PTSD-Repository. We undertook an exploratory assessment of an expanded ROB system developed with guidance from a Technical Expert Panel and NCPTSD, which was pilot tested on a small subset of studies. Results We identified 47 new RCTs of interventions for PTSD and 21 RCTs for comorbid PTSD/SUD, resulting in 389 included studies published from 1988 to 2020. Psychotherapy interventions were the most common (63%), followed by pharmacologic interventions (25%). Most studies were conducted in the United States (62%) and had sample sizes ranging from 25 to 99 participants (60%). Approximately half of studies enrolled community participants (55%), and most were conducted in the outpatient setting (72%). Studies typically enrolled participants with a mix of trauma types (53%). Most RCTs (60%) were rated as having a medium ROB, and only 6 percent were rated as having a low ROB. Our pilot testing of an expanded ROB assessment tool emphasized more detailed assessment of elements, including: (1) methods for managing missing data, including both dropout from treatment and missing measurements (i.e., loss to followup); (2) differential assessment of subjective and objective outcomes; and (3) consideration of a five-category overall rating system. Conclusions The PTSD-Repository is a comprehensive database of data from PTSD trials. The PTSD-Repository allows clinical, research, education, and policy stakeholders to understand current research on treatment effectiveness and harms, and enable informed decisions about future research, mental health policy, and clinical care priorities. This report updates the studies and variables included in the PTSD-Repository to include recently published trials, interventions targeting comorbid PTSD/SUD, variables related to comorbidities such as suicide and SUDs, and ROB assessment.