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

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These reports are available in PDF and XSLX only (Draft Systematic Review [PDF, 545.2 KB]; Draft Appendixes A–D and G [PDF, 986.9 KB], Draft Appendix E [XLSX, 244.8 KB], Draft Appendix F [XSLX, 44.9 KB]). For additional assistance, please contact us.

 

Structured Abstract

Objectives. To identify and abstract data from posttraumatic stress disorder (PTSD) treatment randomized controlled trials (RCTs) to update the PTSD Trials Standardized Data Repository (PTSD-Repository).

Data sources. We searched PTSDpubs, Ovid® MEDLINE®, Cochrane CENTRAL, PsycINFO®, Embase®, CINAHL®, and Scopus® for eligible RCTs published from 1980 to September 2019, and reviewed reference lists of selected systematic reviews and clinical practice guidelines.

Review methods. In consultation with the National Center for PTSD (NCPTSD), we expanded inclusion criteria to RCTs targeting comorbid PTSD/substance used disorder (SUD) and added data elements. We dually reviewed citations and the full text of potentially includable articles for eligibility, resolving disagreements by consensus. One team member abstracted data and a second reviewer checked for accuracy. 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, completed by one investigator and checked for accuracy by a second reviewer. We undertook an exploratory assessment of additional ROB elements developed with guidance from a Technical Expert Panel and NCPTSD, which will be pilot tested on a small subset of studies.

Results. We identified 36 new RCTs of interventions for PTSD and 22 RCTs for comorbid PTSD/SUD, resulting in 379 studies included in the PTSD-Repository. We included 115 pharmacologic and 264 nonpharmacologic studies published from 1988 to 2020. Psychotherapy interventions were the most common (61%), followed by pharmacologic interventions (24%). Most studies were conducted in the United States (63%), and had sample sizes ranging from 25 to 99 participants (58%). Approximately half of studies enrolled community participants (54%) and most were conducted in the outpatient setting (70%). Studies typically enrolled participants with a mix of trauma types (51%), followed by studies of participants with combat-related trauma (18%). Most RCTs (57%) were rated as having a medium ROB. Our pilot testing of additional ROB elements explored: (1) assessment of methods for managing missing data including considering dropout from treatment versus measurement, (2) differential assessment of subjective and objective outcomes, and (3) consideration of a 5-category overall rating system.

Conclusions. The PTSD-Repository is a comprehensive database of detailed data compiled from PTSD intervention trials. The PTSD-Repository will allow clinical, research, education, and policy stakeholders to understand current research on treatment effectiveness and harms, and enable these stakeholders to make informed decisions about future research, mental health policy, and clinical care priorities. Data from 379 RCTs of treatments for PTSD are included in the PTSD-Repository. 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 risk of bias-related data elements. Future research priorities may be shaped by identification of limitations in study designs and reporting of data elements across included studies—there was wide variation in measures used to diagnose PTSD; 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, suicidality, or SUDs, and the number of trauma types.

Main Points

  • This update adds newly published studies on posttraumatic stress disorder (PTSD, 36 randomized controlled trials [RCTs]), studies targeting comorbid PTSD and substance use disorders (SUDs, 22 RCTs), and variables related to comorbidities such as SUDs and suicidality, to the PTSD-Repository, a database of RCTs of interventions to treat PTSD.
  • We abstracted data from 379 RCTs, which included psychotherapeutic interventions (61%), pharmacologic interventions (24%), and complementary and integrative or nonpharmacologic biological treatments (14%).
  • Reporting was incomplete for many data elements in published studies: less than half of studies reported on the loss of PTSD diagnosis or clinically meaningful response/remission of symptoms.
  • Risk of bias (ROB) was assessed for all included studies; most were rated as having a medium risk of bias (57%). An exploration of expanded ROB data elements, specific to PTSD studies, was undertaken.

Background and Purpose

PTSD is a disorder that results from being exposed to a traumatic event. People with PTSD have symptoms such as flashbacks, avoidance of trauma-related stimuli, negative beliefs about themselves and/or others, and hypervigilance. These symptoms reduce quality of life and functioning. The purpose of this project was to update and expand the PTSD Trials Standardized Data Repository (PTSD-Repository), a publicly accessible clinical trials database maintained by the National Center for PTSD (NCPTSD). A comprehensive data repository allows future systematic reviews to easily identify includable studies and extract data relevant to their review. The PTSD-Repository can also help identify research gaps to determine future research priorities and encourage researches to adopt standard data elements in research and reporting. It will also serve as a source for patients, clinicians, and policymakers to search for evidence on interventions' effectiveness and augment existing patient educations tools. The PTSD-Repository included data from 318 RCTs of interventions targeting treatment of PTSD. This update expands on our previous work (Agency for Healthcare Research and Quality [AHRQ] Technical Brief No. 32)1 by adding RCTs published since that work was completed, broadening some inclusion criteria (e.g., studies of comorbid PTSD/substance use disorder, SUD) and elements of data abstracted (e.g., inclusion/exclusion criteria related to suicide and psychotic disorders), and conducting ROB assessments for all studies included in the repository (both those found in this update and those included previously). We also explored expanding specific elements of ROB that may affect studies of PTSD more particularly, pilot testing on a small set of RCTs.

Methods

We followed methods outlined in the AHRQ Evidence-based Practice Center (EPC) Program Methods Guidance where applicable.2 For this update, we searched PTSDpubs (formerly PILOTS), Ovid® MEDLINE®, Cochrane CENTRAL, PsycINFO®, Embase®, CINAHL®, and Scopus® for eligible RCTs published from June 2018 to September 2019. We also reviewed studies excluded in Technical Brief No. 321 for interventions targeting comorbid PTSD and SUD that would meet the expanded inclusion criterion. We dually reviewed citations from the literature search and potentially includable full-text articles for eligibility, resolving disagreement by consensus. One team member abstracted data from included RCTs into evidence tables developed for Technical Brief No.32,1 and a second reviewer checked for accuracy and completeness. An investigator assessed ROB for previously included studies and newly added studies following Comparative Effectiveness Review No. 2073 methods, and a second reviewer checked for accuracy. At the request of the sponsor, NCPTSD, and with guidance from NCPTSD and a Technical Expert Panel (TEP) with expertise in ROB assessment methods, we undertook exploration and development of additional ROB elements relevant to the PTSD-Repository that will be pilot tested on a small subset of studies.

Results

In this update, we added 36 RCTs targeting PTSD and 22 targeting comorbid PTSD/SUD for a total of 379 RCTs included in the PTSD-Repository. The updated report now includes 115 pharmacologic studies (trials with at least one medication arm) and 264 nonpharmacologic studies (trials with no medication arms—all other types of studies including psychotherapy, nonpharmacologic biologic, and complementary and integrative health interventions were classified as nonpharmacologic). The trials were published from 1988 to 2020, with the majority published within the last 10 years. Psychotherapeutic interventions were the most commonly studied (61%), followed by pharmacologic interventions (24%). The majority of studies were conducted in the United States (63%), and most had sample sizes in the range of 25 to 99 participants (58%), with a relatively small number of studies enrolling more than 200 participants (8%). More studies enrolled participants from a community population (54%) than from a military, veteran, or other population, and the majority of studies were conducted in the outpatient setting (70%). Studies typically enrolled participants with a mix of trauma types (51%), followed by studies of participants with combat-related trauma (18%). Fifty-seven percent of all studies included in the PTSD-Repository were rated as having a medium ROB. Our exploration and development of expanded ROB elements specific to PTSD studies included: (1) assessment of methods for managing missing data including considering dropout from treatment versus measurement, (2) differential assessment of subjective and objective outcomes, and (3) consideration of a 5-category overall rating system.

Limitations

Many data elements were not reported or were reported in an inconsistent manner across the available body of literature. For example, less than half of the included studies reported loss of PTSD diagnosis or clinically meaningful response/remission of symptoms. Several other data elements that were infrequently reported include the number of participants with a history of traumatic brain injuries, SUD, or suicidality, and mean number of trauma types per participant. As part of this PTSD-Repository update, we abstracted additional details about many of these important variables (e.g., suicide-related inclusion/exclusion criteria as well as outcomes), and also documented when these data were not reported in primary studies so that users of the PTSD-Repository are aware of the source of missing data.

Implications and Conclusions

The PTSD-Repository is a comprehensive database of detailed data compiled from trials of PTSD interventions in adults. The PTSD-Repository will allow clinical, research, education, and policy stakeholders to understand current research on treatment effectiveness and harms, and enable these stakeholders to make 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 of interventions for PTSD (36 RCTs), interventions targeting comorbid PTSD/SUD (22 RCTs), variables related to comorbidities such as suicidality and SUDs, and risk of bias assessment. Data abstraction and ROB assessment for all 379 included RCTs are being used by NCPTSD to update the PTSD-Repository, a publicly available trials database.

The PTSD-Repository may be expanded in the future by including new studies or additional outcomes and abstracting new ROB data elements. Conversion of the abstracted data into an interactive and searchable web-based dissemination of the PTSD-Repository is being completed by the NCPTSD.

References

  1. O'Neil M, McDonagh M, Hsu F, et al. Pharmacologic and Nonpharmacologic Treatments for Posttraumatic Stress Disorder: Groundwork for a Publicly Available Repository of Randomized Controlled Trial Data. Technical Brief No. 32. (Prepared by the Pacific Northwest Evidencebased Practice Center under Contract No. 290-2015-00009-I.) AHRQ Publication No. 19-EHC018-EF. Rockville, MD: Quality AfHRa; May 2019.  PMID: 31145565.
  2. Methods Guide for Effectiveness and Comparative Effectiveness Reviews. AHRQ Publication No. 10(14)-EHC063-EF. Rockville, MD: Agency for Healthcare Research and Quality; January 2014.
  3. Hoffman V, Middleton JC, Feltner C, et al. Psychological and Pharmacological Treatments for Adults With Posttraumatic Stress Disorder: A Systematic Review Update. Comparative Effectiveness Review No. 207. (Prepared by the RTI International–University of North Carolina at Chapel Hill Evidence-based Practice Center under Contract No. 290-2015-00011-I for AHRQ and PCORI.) AHRQ Publication No. 18-EHC011-EF. PCORI Publication No. 2018-SR-01. Rockville, MD: Agency for Healthcare Research and Quality; May 2018. doi: 10.23970/AHRQEPCCER207.