Nightmare Deconstruction and Reprocessing Pilot

NCT06904950 | Completed

• 1 other identifier: PSY-88-9157
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Nightmare

Keywords

Nightmares; Sleep disturbance; Posttraumatic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Clinician-Administered PSTD Scale for DSM-5 (CAPS-5)

  Up to16 weeks, starting with screening, then at the end of the treatment period (8 weeks), and at follow-up (1 month).

Other Outcomes (5)

• In-Session Heart Rate (HR)

  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)

  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)

  8 weeks: blood samples taken immediately after Visit 0 and Visit 1 (week 1) and immediately after Visit 7 (week 8)

Study Arms (1)

Nightmare Deconstruction and Reprocessing (NDR)

EXPERIMENTAL

Eight-session exposure-based treatment for posttraumatic nightmares and insomnia.

Behavioral: Nightmare Deconstruction and Reprocessing

Interventions

Nightmare Deconstruction and Reprocessing BEHAVIORAL

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.

Nightmare Deconstruction and Reprocessing (NDR)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead
• Walter Reed National Military Medical Center: collaborator
• United States Naval Medical Center, San Diego: collaborator

Study Sites (2)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Links

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

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Patricia T Spangler, PhD

  Uniformed Services University and Henry M Jackson Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: Single-arm pilot trial

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: April 1, 2025
• Study Start: November 27, 2019
• Primary Completion: July 31, 2022
• Study Completion: November 30, 2022
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)