RecruitingPhase 2NCT06399874

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

Sponsor

Uniformed Services University of the Health Sciences

Enrollment

30 participants

Start Date

Jun 11, 2024

Study Type

INTERVENTIONAL

Conditions

Nightmare

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

Min Age: 22 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments for frequent nightmares in military veterans and active-duty service members: a talk therapy approach called Nightmare Deconstruction and Reprocessing, versus a wrist-worn smartwatch device (NightWare) that detects nightmare-related disturbances during sleep and gently wakes the user. **You may be eligible if...** - You are an active-duty service member or veteran - You have at least one nightmare per week - You have an insomnia severity score of 8 or higher - If you take medications for PTSD, depression, anxiety, or insomnia, your dose has been stable for 8 weeks **You may NOT be eligible if...** - You are at serious risk of suicide - You have psychosis, bipolar disorder, or active alcohol/substance use disorder - You have untreated moderate to severe sleep apnea - You take certain medications (beta blockers, prazosin, or varenicline) - You are currently in therapy specifically targeting nightmares, insomnia, or PTSD - You have REM sleep behavior disorder or narcolepsy - You are unable or unwilling to wear a wristband or provide blood samples Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

Locations(1)

Uniformed Services University of the Health Sciences

Bethesda, Maryland, United States

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NCT06399874

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