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Ensaio clínico

Deconstrução e Reprocessamento do Pesadelo vs. Pulseira NightWare

NCT: NCT06399874 · ACTIVE_NOT_RECRUITING

ID NCTNCT06399874
EstadoACTIVE_NOT_RECRUITING
Data de início2024-06-11
SponsorUniformed Services University of the Health Sciences (FED)
First posted
Last updated

Resumo breve

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.

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