Exclusion of Suicidal Participants From Randomized Controlled Trials for Posttraumatic Stress Disorder: A Meta-Analysis.

Abstract

There has been a lack of consensus regarding whether to include or exclude participants with suicidal ideation (SI) from posttraumatic stress disorder (PTSD) psychotherapy clinical trials and, until recently, how best to report adverse events related to suicide risk. Without consistent reporting or evaluation of SI as an outcome, clinical practice guidelines are limited in their ability to recommend interventions for this common co-occurrence. In the present meta-analysis, we compared randomized controlled trials (RCTs) of PTSD psychotherapies, based on their suicide exclusion criteria. The databases PILOTS, PsycINFO, and PubMed were searched for RCTs of psychotherapy that lasted more than 4 weeks and included adults who met the diagnostic criteria for PTSD. Included studies (N = 48) were coded by two independent reviewers. A random-effects model was used to calculate the pooled effect sizes for trials that excluded (n = 31) and did not exclude SI (n = 17). A test statistic for the significance of effect revealed that the difference between these two groups' effect sizes was not significant, z = 0.96, p = .341. This suggests that the effects observed in clinical trials are not significantly impacted by SI-related exclusion criteria.