Nightmare Deconstruction and Reprocessing Pilot (NDR)

March 24, 2025 updated by: Patricia Spangler, Uniformed Services University of the Health Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disturbing Dream and Nightmare Severity Index (DDNSI)
Time Frame: Up to16 weeks, starting with screening, then weekly through the treatment period (8 weeks), and at follow-up (1 month)
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)
Time Frame: Up to16 weeks, starting with screening, then weekly through the treatment period (8 weeks), and at follow-up (1 month)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinician-Administered PSTD Scale for DSM-5 (CAPS-5)
Time Frame: Up to16 weeks, starting with screening, then at the end of the treatment period (8 weeks), and at follow-up (1 month).
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
In-Session Heart Rate (HR)
Time Frame: Approximately 10 weeks, data collected continuously (23 hours per day) during the treatment period (8 weeks) and 2 weeks into the follow-up period.
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)
Time Frame: Approximately 10 weeks, data collected continuously (23 hours per day) during the treatment period (8 weeks) and 2 weeks into the follow-up period.
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)
Time Frame: 8 weeks: blood samples taken immediately after Visit 0 and Visit 1 (week 1) and immediately after Visit 7 (week 8)
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
Time Frame: 8 weeks: blood samples taken immediately after Visit 0 and Visit 1 (week 1) and immediately after Visit 7 (week 8)
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
Time Frame: Approximately 10 weeks, data collected continuously (23 hours per day) during the treatment period (8 weeks) and 2 weeks into the follow-up period.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uniformed Services University of the Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Naval Medical Center, San Diego
Walter Reed National Military Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Patricia T Spangler, PhD, Uniformed Services University and Henry M Jackson Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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