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
Uniformed Services University of the Health Sciences
30 participants
Jun 11, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria11
- 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
Interventions
A psychotherapy that uses exposure to nightmare images for trauma activation in order to facilitate trauma memory reconsolidation
Wristband device that detects physiologic signals during sleep that indicate a possible nightmare and gently vibrates to rouse the sleeper without fully waking them.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06399874