Nightmare Deconstruction and Reprocessing vs. NightWare Wristband
Pilot Trial Comparing Exposure and Nonexposure Treatments for Posttrauma Nightmares and Insomnia: Nightmare Deconstruction and Reprocessing vs. NightWare Wristband
Who can join
Ages 22 to 64 · All sexes
Full eligibility criteria
Inclusion Criteria: * Active duty service members and veterans * Minimum symptom severity: * Has had at least 1 nightmare per week for the past month * Has a minimum ISI score of 8 * If taking medications for PTSD, depression, anxiety, or insomnia, must be on stable dose for 8 weeks. Exclusion Criteria: * Serious risk of suicide * Psychosis, bipolar disorder, or alcohol or substance use disorder * Untreated moderate to severe sleep apnea * Use of synthetic glucocorticoid beta blockers, prazosin, or varenicline * Current evidence-based or experimental psychotherapy directly targeting nightmares, insomnia, or PTSD * Inability to recall nightmare content * Inability to wear wristband or sync wristband data * Inability to comply with blood draws * Refusal to consent to DNA analysis of blood samples * Refusal to consent to audio recording of study visits * REM sleep behavior disorder or narcolepsy as determined by investigator
About the study
The overall goal of this Phase IIa randomized controlled pilot trial is to assess the potential efficacy of two emerging treatments for post-trauma nightmares and to test the feasibility of study design and methods. Symptom change will be assessed in two treatment arms: (1) Nightmare Deconstruction and Reprocessing (NDR), an exposure-based psychotherapy; and (2) NightWare (NW), a non-exposure approach using a wristband device. The investigators will also assess the feasibility of circadian-dependent blood sampling and use of another wristband to collect physiologic data. Specific aims are: (1) Compare evidence of how well participants tolerate and comply with the two treatments and test feasibility of methods and procedures; (2) Collect additional evidence of the potential efficacy of two contrasting non-pharmacologic approaches to treating posttraumatic nightmares; (3) Explore the operational stress index (OSI) as a reliable, objective measure of sleep disturbance and nightmare events.
What is being tested
- Nightmare Deconstruction and Reprocessing (behavioral)
- NightWare (device)
Sponsor: Uniformed Services University of the Health Sciences · Participants: 30 · Started: Jun 11, 2024
Contact the study team
- Patricia Spangler, PhD · Phone: 240-620-4076
Official record on ClinicalTrials.gov — NCT06399874
Locations in the U.S.
| Maryland | Uniformed Services University of the Health Sciences, Bethesda |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.