Nightmare Deconstruction and Reprocessing Pilot (NDR)

Uniformed Services University (USU)

Status

Completed

Conditions

Nightmare

Treatments

Behavioral: Nightmare Deconstruction and Reprocessing

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT06904950

PSY-88-9157

Details and patient eligibility

About

This is a single-arm, multisite (2 sites) pilot trial that is evaluating Nightmare Deconstruction and Reprocessing (NDR) for treating posttraumatic nightmares and insomnia in up to 30 military service members and veterans. Study aims are to test NDR's plausibility and tolerability and to test methodologic feasibility of collecting heart rate variability (HRV), electrodermal activity (EDA), and actigraphy data via a wristband device and peripheral blood samples within a pre-specified circadian window. Treatment consists of 8 sessions over 8 weeks. Participants are assessed at study visits 0, 1, and 7 and 1-month follow-up. Psychometric assessments include the Disturbing Dreams and Nightmare Severity Index, Pittsburgh Sleep Quality Index, and Clinician-Administered PTSD Scale for DSM-5.

Full description

The current study is testing NDR, a three-stage treatment that integrates exposure, reprocessing, and rescripting of nightmare images to alleviate nightmare and insomnia severity. Study aims are to test NDR's plausibility and tolerability and to test the methodologic feasibility of collecting daily HRV, EDA, and actigraphy data via the E4 wristband as well as peripheral blood samples for assay at three time points. Participants are active duty military or veterans (N = 30) ages 18 to 64 with posttraumatic nightmares and insomnia. Participants undergo 8 NDR treatment visits over 8 weeks and complete a 1-month follow-up. Psychometric measures of nightmare (Disturbing Dreams and Nightmare Severity Index) and insomnia (Pittsburgh Sleep Quality Index) are administered at each visit. Objective measurement of sleep disturbance is done via the Empatica E4 wristband. In-session distress is measured using the 1-item Subjective Units of Distress Scale (SUDS), and E4 HRV and EDA data during exposure to nightmare images. BDNF, IL-2, IL-6, and TNF alpha are being assayed from blood samples taken immediately after Visit 0 (baseline), Visit 1 (first in-session exposure to nightmare images), and Visit 7 (final in-session exposure to nightmares). To control for circadian factors regulating the expression of BDNF and inflammatory cytokines, all blood samples are collected between 0900 and 1200.

Enrollment

11 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Active duty servicemembers and DEERS-eligible veterans
DDNSI score ≥ 10
PSQI score > 5

Exclusion criteria

Current imminent risk of suicide
Psychotic or bipolar disorders
Untreated moderate to severe sleep apnea/hypopnea, circadian rhythm disorders, or narcolepsy
Current use of prazosin for nightmares
Self-reported alcohol use > 4x/ week and > 3 drinks per occasion
Concurrent evidence-based or experimental treatment directly targeting nightmares, insomnia, or PTSD
Initiation of or change in psychotropic medications for PTSD, nightmares, insomnia, depression, or anxiety in the past 8 weeks
Inability to recall nightmare content
Inability to comply with requirement to wear E4 wristband and upload daily