Nightmare Deconstruction and Reprocessing vs. NightWare Wristband

Description

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.

Conditions

Nightmare

Study Overview

Study Details

Study overview

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.

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

Nightmare Deconstruction and Reprocessing vs. NightWare Wristband

Condition
Nightmare
Intervention / Treatment

-

Contacts and Locations

Bethesda

Uniformed Services University of the Health Sciences, Bethesda, Maryland, United States, 20814

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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

Ages Eligible for Study

22 Years to 64 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Uniformed Services University of the Health Sciences,

James C West, MD, PRINCIPAL_INVESTIGATOR, Uniformed Services University of the Health Sciences

Study Record Dates

2026-03