Pharmacologic and Nonpharmacologic Treatments for Posttraumatic Stress Disorder: Groundwork for a Publicly Available Repository of Randomized Controlled Trial Data

Background Posttraumatic stress disorder (PTSD) reduces quality of life and functioning. People with PTSD have symptoms such as intrusive thoughts, nightmares, flashbacks, avoidance of trauma-related stimuli, negative beliefs about themselves and/or others, and hypervigilance. The symptoms may be due to direct or indirect exposure to trauma, such as witnessing actual or threatened death, injury, or violence, including sexual violence and threats of harm. Although recent clinical practice guidelines and reviews exist, providing a single, updatable source of PTSD treatment trials would be useful for clinicians, researchers, and policymakers. Purpose To provide detailed information on PTSD treatment research, we systematically abstracted data from randomized controlled trials (RCTs) of PTSD interventions. The National Center for Posttraumatic Stress Disorder (NCPTSD) intends to use the data to develop a publicly available data repository. The NCPTSD is part of the U.S. Department of Veterans Affairs. Data sources We searched PTSDpubs (formerly PILOTS), Ovid® MEDLINE®, Cochrane CENTRAL, PsycINFO®, Embase®, CINAHL®, and Scopus® for eligible RCTs and reviewed reference lists of selected systematic reviews and clinical practice guidelines. Methods In consultation with NCPTSD, we established inclusion criteria for RCTs and specific data elements to be abstracted. We dually reviewed citations from the literature search, and then the full text of potentially includable articles for eligibility, resolving any disagreements using consensus. One team member abstracted data from included RCTs into evidence tables, and a second reviewer checked abstracted data for accuracy and completeness. The primary publication for each RCT was abstracted; data and citations from any secondary publications (i.e., companion papers) appear in the same record. Findings We identified 318 RCTs of PTSD interventions for abstraction (106 pharmacologic studies and 212 nonpharmacologic studies) published from 1988 to 2018, with a peak number of publications (31) in 2015. Psychotherapeutic interventions were the most commonly studied (55%), whereas 30 percent evaluated pharmacologic interventions. Most studies were conducted in the United States (61%), and most had sample sizes in the range of 25 to 100 participants (60% of studies), with a relatively small number of studies enrolling fewer than 25 participants (18%). More studies enrolled participants from a community population (57%) than from a military, veteran, or other population, and the majority of studies were conducted in the outpatient setting (67%). Studies most often enrolled participants with a mix of trauma types (51%), followed by studies of participants with combat-related trauma (20%). Although there was wide variation, the most commonly used PTSD assessment methods were the Clinician-Administered PTSD Scale (CAPS) and the Structured Clinical Interview for DSM (SCID). Less than half of the studies reported loss of PTSD diagnosis or clinically meaningful response/remission of symptoms. Several other data elements were infrequently reported, including the number of participants with a history of traumatic brain injuries and the number of trauma types. Conclusions The data abstracted from 318 RCTs of treatments for PTSD can be used to create a publicly available data repository. By identifying important gaps in the research, such a data repository can inform future study design and conduct.