Pilot Trial Comparing Exposure and Nonexposure Treatments for Posttrauma Nightmares and Insomnia: Nightmare Deconstruction and Reprocessing vs. NightWare Wristband
Uniformed Services University of the Health Sciences
Summary
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.
Description
This pilot trial is testing two emerging treatments for post-traumatic nightmares: NDR, a novel exposure psychotherapy that targets post-trauma nightmares, and NW, a wristband device that provides non-exposure treatment by detecting physiologic signals of a possible nightmare and gently vibrating to rouse the sleeper without fully waking them. Nightmares and sleep disturbance are important treatment targets because they are prevalent beginning in the acute post-trauma phase and often are long lasting and treatment-resistant. The overall goal of this project is to assess the potential efficacy…
Eligibility
- Age range
- 22–64 years
- Sex
- All
- Healthy volunteers
- No
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 nightma…
Interventions
- BehavioralNightmare Deconstruction and Reprocessing
A psychotherapy that uses exposure to nightmare images for trauma activation in order to facilitate trauma memory reconsolidation
- DeviceNightWare
Wristband device that detects physiologic signals during sleep that indicate a possible nightmare and gently vibrates to rouse the sleeper without fully waking them.
Location
- Uniformed Services University of the Health SciencesBethesda, Maryland