Trial Outcomes & Findings for Understanding Trauma Nightmares Using In-Home Measurement (NCT NCT03974503)

Understanding Trauma Nightmares Using In-Home Measurement

Sleep efficiency will be calculated per night from a mattress actigraphy system and averaged for two time-periods (the week between mattress installation and the first treatment session; the week between the last treatment session to the 1-week post-5-week treatment assessment). Sleep efficiency is defined as the ratio of the aggregate duration of quiescent sleep periods divided by the duration of the total in bed period multiplied by 100 to convert sleep efficiency to percentage points. Lower sleep efficiency indicates more disrupted sleep.

Respiratory sinus arrhythmia (RSA) was computed in the 0.15-0.40 Hz band, using median values from high-quality inter-beat-intervals segments, each night. These data were averaged for two time-periods (the week between mattress installation and the first treatment session; the week between the last treatment session to the 1-week post-5-week treatment assessment). Lower RSA indicates more cardiac vagal withdrawal.

This fill-in-the-blank variable assesses the number of nightmares experienced in the past week (range = 0 - X nightmares) at each assessment (baseline, one week following 5-week treatment, and three months following treatment).

Change in PTSD Symptoms will be assessed using the Clinician-Administered PTSD Scale DSM 5 (CAPS-5). The items on the CAPS-5 are on a 5-point scale (0 - 4), (possible range: 0-80, with higher scores indicating more severe symptoms). A symptom is considered present if the severity is rated 2 or higher. Total scores are comprised of four symptom clusters (reexperiencing/intrusions, avoidance, cognitive/emotional and hyperarousal)

The variable from the Trauma-Related Nightmare Survey assesses the severity of the nightmares experienced in the past week (range = 0 - 4) at each assessment (baseline, one week following 5-week treatment, and three months following treatment). Higher scores indicate greater nightmare-related severity.

Nox A1 portable polysomnography system (Nox Medical, Reykjavik, Iceland) used to record sleep stage measures and patterns of arousals, to calibrate sleep efficiency derived from the mattress system, and to detect sleep apnea.

Change in sleep Quality will be assessed using the Pittsburgh Sleep Quality Index, a 19-item self-report measure assessing qualities and problems associated with sleep in the past month. A global sleep quality score is obtained by summing seven component scores. Higher scores reflect poorer sleep quality. The global score ranges from 0 to 21, with a cut-off score of 5 as distinguishing "good" sleepers from "poor" sleepers.

The patient health questionnaire (PHQ-9), is a 9-item self-report instrument used to assess depression severity. Items are scored 0 to 3, with the total score being the sum of the 9 items (Total scores range from 0 to 27). Higher scores indicate greater depression severity, with a score of 10 or greater considered major depression, and scores of 20 or more is severe major depression.

Change in the impact of nightmares will be assessed using the change in Nightmare Effects Survey, an 11 item Likert-type questionnaire designed to assess the impact of nightmares on 11 areas of life including work, social, and leisure activities. Total scores range from 0 to 44, with higher scores indicating greater level of nightmare-related impairment.

Change in fear of sleep will be assessed using the Fear of Sleep Inventory- Short Form, a 13-item self-report measure that assesses trauma-related thoughts and activities associated with sleep and the occurrence of traumas associated with the bedroom or sleep. Total scores range from 0 to 52, with higher scores indicating greater fear of sleep.

Change in suicidal ideation will be assessed using the Depressive Symptom Index: Suicidality Subscale (DSI-SS). The four items of the DSI-SS are scored on a 0-3 scale, with total possible sum scores ranging from 0-12; higher scores indicate greater severity of suicidal ideation.