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RECRUITING
NCT06399874
PHASE2

Nightmare Deconstruction and Reprocessing vs. NightWare Wristband

Sponsor: Uniformed Services University of the Health Sciences

View on ClinicalTrials.gov

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.

Official title: Pilot Trial Comparing Exposure and Nonexposure Treatments for Posttrauma Nightmares and Insomnia: Nightmare Deconstruction and Reprocessing vs. NightWare Wristband

Key Details

Gender

All

Age Range

22 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-06-11

Completion Date

2026-03

Last Updated

2025-03-30

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Nightmare Deconstruction and Reprocessing

A psychotherapy that uses exposure to nightmare images for trauma activation in order to facilitate trauma memory reconsolidation

DEVICE

NightWare

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