Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06399874 |
Other study ID # |
PSY-88-13264 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
May 2024 |
Est. completion date |
March 2026 |
Study information
Verified date |
July 2023 |
Source |
Uniformed Services University of the Health Sciences |
Contact |
Patricia Spangler, PhD |
Phone |
240-620-4076 |
Email |
patricia.spangler.ctr[@]usuhs.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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. We will also assess
the feasibility of circadian-dependent blood sampling and use of another wristband to collect
physiologic data. Toward this goal, we will pursue the following specific aims: (1) Compare
evidence of how well participants tolerate and comply with the different treatments and to
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.
Description:
This pilot trial will test 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. We will also test methodologic feasibility of biomarker
sample collection, which will enable us to determine 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. Thirty service members and veterans will be
randomized to one of two treatment groups: (1) NDR, an exposure-based psychotherapy and (2)
NW, a wristband device (non-exposure treatment). As an attention control, participants in
both groups will have the same number of in-person and virtual study visits. Four visits will
be in-person to allow for equipment assignment and return and blood sampling; 12 visits will
be conducted by video teleconference. Participants in the NW group will receive
psychoeducation, equipment instruction and troubleshooting, and psychometric assessment at
each treatment visit. Participants in the NDR group will receive psychoeducation, NDR
treatment, and psychometric assessment at each treatment visit. We will collect blood samples
from both treatment groups during Visit 1, and before and after their treatment sessions in
Visit 7 (first exposure to nightmares for the NDR group) and Visit 12 (final exposure for
NDR). All participants will be issued an Empatica EmbracePlus wristband to be worn 23 hours
per day. We anticipate results that participants in both treatment groups will have a
clinically significant decrease in nightmares and nightmare-related sleep disturbance. We
expect that molecular, neuroendocrine, and physiologic markers of stress will relate to
treatment group (trauma activation through exposure or no trauma activation in non-exposure
treatment.) We 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 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 treatment sessions in Visit 7 (initial NDR exposure component), and Visit 12
(NDR final exposure). Physiologic data collected via the Empatica EmbracePlus wristband will
include HRV and EDA during treatment sessions and accelerometry to track sleep patterns.