Nightmare Deconstruction and Reprocessing Pilot (NCT06904950) | Clinical Trial Compass
CompletedNot Applicable
Nightmare Deconstruction and Reprocessing Pilot
United States11 participantsStarted 2019-11-27
Plain-language 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.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Disturbing Dream and Nightmare Severity Index (DDNSI)
Timeframe: Up to16 weeks, starting with screening, then weekly through the treatment period (8 weeks), and at follow-up (1 month)
2
Pittsburgh Sleep Quality Index (PSQI)
Timeframe: Up to16 weeks, starting with screening, then weekly through the treatment period (8 weeks), and at follow-up (1 month)
Trial details
NCT IDNCT06904950
SponsorUniformed Services University of the Health Sciences