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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Nightmare Deconstruction and Reprocessing
BehavioralA psychotherapy that uses exposure to nightmare images for trauma activation in order to facilitate trauma memory reconsolidation
NightWare
DeviceWristband device that detects physiologic signals during sleep that indicate a possible nightmare and gently vibrates to rouse the sleeper without fully waking them.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Nightmare Deconstruction and ReprocessingExperimental treatment 1 intervention
Group B: NightWareExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Disturbing Dreams and Nightmare Severity Index
The DDNSI is a 5-item self-report instrument used to assess nightmare severity and distress both as an inclusion criterion (score ≥10) and as a primary study variable. Possible score range is 0-37, with a recommended cutoff of 10.
Time frame
It will be completed at screening, weekly through the observation and treatment periods (12 weeks), and at the 3 follow-up visits (up to 18 weeks post-baseline). It will also be completed at early termination visits, if applicable.2
Insomnia Severity Index
The ISI is a 7-item self-report measure that assesses not only perceived severity of insomnia with regards to difficulty falling and staying asleep, but also daytime dysfunction. Possible score range is 0-28, with a recommended cutoff of 8 for sub-threshold insomnia.
Time frame
It will be completed at screening, weekly through the observation and treatment periods (12 weeks), and at the 3 follow-up visits (up to 18 weeks post-baseline). It will also be completed at early termination visits, if applicable.Secondary outcomes
1
Operational Stress Index (OSI)
The OSI uses physiological data (heart rate, heart rate variability, skin temperature, movement) to identify stress responses, which may allow researchers to reliably recognize sleep disturbance and nightmare events.
Time frame
Collected from baseline through study completion (up to 18 weeks).2
Brain-derived neurotrophic factor (BDNF) levels before and after exposure
Time frame
Collected at initial NDR exposure component (6 weeks after baseline) and NDR final exposure (12 weeks after baseline).3
Cortisol levels before and after exposure
Time frame
Collected at initial NDR exposure component (6 weeks after baseline) and NDR final exposure (12 weeks after baseline).4
Adrenocorticotropic hormone (ACTH) levels before and after exposure
Time frame
Collected at initial NDR exposure component (6 weeks after baseline) and NDR final exposure (12 weeks after baseline).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Uniformed Services University of the Health Sciences
Lead sponsor
NightWare
Collaborator
Source ClinicalTrials.gov