Methodologic feasibility of comprehensive biomarker collection in a pilot trial of a novel psychotherapy for trauma-related nightmares

This study examined the methodologic feasibility of integrating collection of multiple types of biomarkers into a pilot trial of Nightmare Deconstruction and Reprocessing (NDR), a novel treatment for trauma-related nightmares (TRNs). Biomarkers included cardiovascular activity, electrodermal activity, and actigraphic data collected via the Empatica E4 wristband, and peripheral blood samples collected between 0900 and 1200 at three study visits. Active duty military service members and veterans with TRNs and sleep disturbance completed eight NDR sessions, provided blood samples for assay within the specified time frame, and wore the Empatica E4 wristband continuously and uploaded its data daily. Outcomes included percentage of wristband data uploaded, and percentage of blood samples collected within the specified timeframe and therapist adherence to NDR model. Participants provided a mean of 84.02% of possible physiologic data, and 89% of blood samples were collected in the specified window, and therapist mean adherence to the NDR model was 4.33 on a 5-point scale. Calculations of operational stress index from E4 wristband data indicated feasibility (Author change in response to Reviewer Comment R1.2) to associate nocturnal physiologic signals with self-report of nightmare occurrence. Results indicate that therapists can learn and adhere to the NDR model of working with nightmares and suggest that collection of comprehensive biomarker data is feasible in trials of trauma-focused treatments.