This pilot trial is testing two emerging treatments for post-traumatic nightmares: NDR, a
novel exposure psychotherapy that targets post-trauma nightmares, and NW, a wristband
device that provides non-exposure treatment by detecting physiologic signals of a
possible nightmare and gently vibrating to rouse the sleeper without fully waking them.
Nightmares and sleep disturbance are important treatment targets because they are
prevalent beginning in the acute post-trauma phase and often are long lasting and
treatment-resistant. The overall goal of this project is to assess the potential efficacy
of these contrasting treatments, which have the potential to treat acute post-trauma
nightmares and sleep disturbance in low-resource or far-forward military environments and
provide long-term solutions for individuals with treatment-resistant nightmares. The
investigators will also test the feasibility collecting biomarker samples at specific
time points during treatment, which will provide more information about the potential
utility of molecular, neuroendocrine, and physiologic signals of psychological distress
related to exposure or non-exposure methods of treating nightmares.
Study Design:
Following up on preliminary studies of NDR and NW, the proposed study will be a Phase
IIa, single-blind randomized controlled pilot trial. Up to 30 servicemembers and veterans
will be consented. Study duration for each participant is 18 weeks: 6 weeks of
observation, 6 weeks of active treatment, and 6 weeks of follow up. Participants have
weekly assessments during the observation period, which serves as a within-subjects
control. At the end of observation, Participants are randomized to 6 weeks of active
treatment in either the NDR or the NW treatment arm. After completing the active
treatment period, follow-up assessments are at 2 weeks, 4 weeks, and 6 weeks
post-treatment.
Participants in the NW group will receive psychoeducation, equipment instruction, and
troubleshooting at each treatment visit. Participants in the NDR group will receive
psychoeducation, and NDR treatment at each treatment visit. The investigators will
collect blood samples from both treatment groups immediately before and after the first
treatment visit (first exposure to nightmares for the NDR arm), and and immediately
before and after the final treatment visit (last exposure to nightmares for the NDR arm).
All participants will be issued an Empatica EmbracePlus wristband to be worn 23 hours per
day. The investigators anticipate that participants in both treatment groups will have a
clinically significant decrease in nightmares and nightmare-related sleep disturbance and
that molecular, neuroendocrine, and physiologic markers of stress will relate to
treatment arm (trauma activation through exposure in NDR or no trauma activation in NW).
The investigators also anticipate that biosample collection, processing, and storage
methods will be feasible.
Primary and Secondary Outcomes:
The primary outcomes of the proposed trial are nightmare severity and insomnia severity.
Nightmare severity will be measured by the Disturbing Dreams and Nightmares Severity
Index (DDNSI). Insomnia severity will be assessed using the Insomnia Severity Index
(ISI). Nightmare and insomnia severity and variability will be assessed with the DDNSI,
the ISI, and EmpaticaPlus wristband data at 14 time points, including screening, once a
week during the observation and treatment periods, and follow-up visits.
Secondary outcomes are molecular and neuroendocrine biomarkers (BDNF, cortisol, and ACTH)
as well as physiologic parameters (HRV, EDA, and accelerometry data). Change in BDNF,
cortisol, and ACTH will be determined through assay of blood samples taken in all
treatment groups before and after the first and last treatment sessions. Physiologic data
collected via the Empatica EmbracePlus wristband will include HRV and EDA during
treatment sessions and accelerometry to track sleep patterns.