Examining the characteristics of patients who continue participation in vs those who drop out of a PTSD clinical trial

BACKGROUND: Patients who drop out of clinical trials examining posttraumatic stress disorder (PTSD) may have different characteristics than patients who continue. These characteristics have never been examined in prior PTSD and attrition trials. Our goal was to examine how demographic and clinical characteristics of patients with PTSD impact attrition in a randomized controlled trial.

METHODS: A total of 18 participants were recruited. Data were collected through questionnaires to assess PTSD, depression, and mood disorders. Fisher’s exact test was used to examine the association of various categorical demographic and clinical variables with dropout. A Wilcoxon rank sum test was used to examine differences in medians.

RESULTS: The median total PTSD Checklist for DSM-5 score was 38 for patients who dropped out and 53 for those who did not. The depression scale total was also lower for the dropout group (7 vs 15). The insomnia index was lower for those who did not remain in the study (15 vs 21).

CONCLUSIONS: Posttraumatic stress disorder symptoms, depression, and insomnia were less severe in patients who dropped out compared with those who did not. Larger studies are needed to further examine these findings. This study could help guide future recruitment efforts for clinical trials examining PTSD.

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