NightmareNDRNCT06904950
Nightmare Deconstruction and Reprocessing Pilot
A study testing Nightmare Deconstruction and Reprocessing in people with Nightmare, run by Uniformed Services University of the Health Sciences at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Nightmare
- What is being tested?
- Nightmare Deconstruction and Reprocessing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Nov 2019to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Active duty servicemembers and DEERS-eligible veterans
- DDNSI score ≥ 10
- PSQI score > 5
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Naval Medical Center San Diego
San Diego, California, 92134
About this study
Official title: 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.
Read the 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.
- Conditions
- Nightmare
- Being tested
- Nightmare Deconstruction and Reprocessing
- Keywords
- Nightmares, Sleep disturbance, Posttraumatic
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nightmare Deconstruction and ReprocessingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nightmare Deconstruction and Reprocessing (NDR) | Experimental | Eight-session exposure-based treatment for posttraumatic nightmares and insomnia. Receives: Behavioral: Nightmare Deconstruction and Reprocessing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: Up to16 weeks, starting with screening, then at the end of the treatment period (8 weeks), and at follow-up (1 month).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start27 Nov 2019
- Primary completion31 Jul 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NightmareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Single-arm pilot trial
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Collaborators
- Walter Reed National Military Medical Center, United States Naval Medical Center, San Diego
- Responsible party
- Principal investigator, Patricia Spangler, Uniformed Services University of the Health Sciences
- Investigators
- Patricia T Spangler, PhD, Principal investigator, Uniformed Services University and Henry M Jackson Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904950
- Sponsor's protocol ID
- PSY-88-9157
- Acronym
- NDR
- Status last verified
- Mar 2025
- First submitted
- 28 Sep 2021
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Nightmare Deconstruction and Reprocessing, a Novel Treatment for PTSD-Related Nightmares and Insomnia
- ClinicalTrials.gov ID
- NCT06904950
- Acronym / sponsor ID
- NDR / PSY-88-9157
- Conditions
- Nightmare
- Keywords
- Nightmares, Sleep disturbance, Posttraumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Collaborators
- Walter Reed National Military Medical Center, United States Naval Medical Center, San Diego
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm pilot trial
| Arm | Type | Receives |
|---|---|---|
| Nightmare Deconstruction and Reprocessing (NDR) | Experimental | Behavioral: Nightmare Deconstruction and ReprocessingEight-session exposure-based treatment for posttraumatic nightmares and insomnia. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Active duty servicemembers and DEERS-eligible veterans
- DDNSI score ≥ 10
- PSQI score > 5
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nightmare Deconstruction and ReprocessingEight-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. | Behavioural | Nightmare Deconstruction and Reprocessing (NDR) |
Primary outcome
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.
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.
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Description of studyLink provided by the sponsor.
- Study recruitment surveyLink provided by the sponsor.
- Study Facebook pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Nightmare
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Validation of an Algorithm for Predicting Awakenings Associated With Trauma-related Nightmares, Based on the Analysis of Physiological Patterns in Military and Former Military Patients Suffering From Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, Trauma-related Nightmares
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Nightmare Deconstruction and Reprocessing vs. NightWare Wristband
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Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
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Predicting Responses to PTSD Treatment With Iris and Cardiovascular Tests
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia T Spangler, PhD principal investigator
Uniformed Services University and Henry M Jackson Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nightmare Deconstruction and Reprocessing in people with Nightmare, run by Uniformed Services University of the Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.