Nightmare Deconstruction and Reprocessing Pilot (NDR)

Pilot Trial of Nightmare Deconstruction and Reprocessing, a Novel Treatment for PTSD-Related Nightmares and Insomnia

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.

Study Overview

• Status: Completed
• Conditions: Nightmare
• Intervention / Treatment: Behavioral: Nightmare Deconstruction and Reprocessing

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92134
      • Naval Medical Center San Diego
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nightmare Deconstruction and Reprocessing (NDR); Eight-session exposure-based treatment for posttraumatic nightmares and insomnia.	Behavioral: Nightmare Deconstruction and Reprocessing; Eight-sessions that include 1 session of psychoeducation and treatment orientation and 7 sessions of NDR. NDR consists of three stages: (1) nightmare image deconstruction, (2) meaning making and reprocessing of cognition and emotions related to images, (3) rescripting new dream images and rehearsal of new images.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disturbing Dream and Nightmare Severity Index (DDNSI)	5-item instrument used to assess nightmare severity and distress, scored by adding nights/per week (0 to 7) + nightmares/week +Q3 (0 to 4 scale) +Q4 (0 to 6 scale) + Q5 (0 to 6 scale). Higher scores indicate greater symptom severity. >10 indicates nightmare disorder and was used as the inclusion cutoff for the study.	Up to16 weeks, starting with screening, then weekly through the treatment period (8 weeks), and at follow-up (1 month)
Pittsburgh Sleep Quality Index (PSQI)	19-item instrument with 7 components that are scored on a 0-3 Likert-type scale, with higher scores indicating poorer sleep quality. >5 indicates significant sleep disturbance and was used an inclusion cutoff for the study.	Up to16 weeks, starting with screening, then weekly through the treatment period (8 weeks), and at follow-up (1 month)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician-Administered PSTD Scale for DSM-5 (CAPS-5)	30-item structured clinical interview assessing DSM-5 diagnostic criteria for PTSD. Symptoms assessed on a 5-point scale (0-4), with higher scores indicating greater symptom severity.	Up to16 weeks, starting with screening, then at the end of the treatment period (8 weeks), and at follow-up (1 month).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-Session Heart Rate (HR)	HR was collected with the E4 wristband to assess pre- to post-treatment change in response to in-session exposure to nightmare images.	Approximately 10 weeks, data collected continuously (23 hours per day) during the treatment period (8 weeks) and 2 weeks into the follow-up period.
In-session Electrodermal Activity (EDA)	EDA was collected with the E4 wristband to assess pre- to post-treatment change in response to in-session exposure to nightmare images.	Approximately 10 weeks, data collected continuously (23 hours per day) during the treatment period (8 weeks) and 2 weeks into the follow-up period.
Brain-derived neurotropic factor (BDNF)	BDNF was assayed from blood samples to evaluate pre- to post-treatment change in expression in response to exposure to nightmare images.	8 weeks: blood samples taken immediately after Visit 0 and Visit 1 (week 1) and immediately after Visit 7 (week 8)
Inflammatory cytokines	Inflammatory cytokines were assayed from blood samples to evaluate pre- to post-treatment change in expression in response to exposure to nightmare images. All blood samples taken between 0900 and 1200 to control for circadian variability in expression.	8 weeks: blood samples taken immediately after Visit 0 and Visit 1 (week 1) and immediately after Visit 7 (week 8)
Sleep Actigraphy Data	Actigraphy data was collected with the E4 wristband to assess change in sleep disturbance.	Approximately 10 weeks, data collected continuously (23 hours per day) during the treatment period (8 weeks) and 2 weeks into the follow-up period.

Collaborators and Investigators

• Sponsor: Uniformed Services University of the Health Sciences
• Collaborators: United States Naval Medical Center, San Diego; Walter Reed National Military Medical Center
• Investigators: Principal Investigator: Patricia T Spangler, PhD, Uniformed Services University and Henry M Jackson Foundation

Publications and helpful links

Helpful Links

• Description of study
• Study recruitment survey
• Study Facebook page

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2019
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Sleep disturbance; Nightmares; Posttraumatic
• Other Study ID Numbers: PSY-88-9157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No