About this trial
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.
Eligibility criteria
Qualifiers
Active duty service members and veterans
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Nightmare Deconstruction and Reprocessing
- NightWare
Treatment groups
Sponsors and collaborators
Uniformed Services University of the Health Sciences
Lead sponsor
NightWare
Collaborator