Nightmare Deconstruction and Reprocessing vs. NightWare Wristband

ConditionNightmare
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age22-64
SponsorUniformed Services University of the Health Sciences

About this trial

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 criteria

Qualifiers

Active duty service members and veterans

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Nightmare Deconstruction and Reprocessing
  • NightWare

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators