Ignite Creation Date:
2024-05-11 @ 8:28 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399874
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-04-17
Brief Title:
Pilot Trial Comparing Nightmare Deconstruction and Reprocessing vs NightWare Wristband
Sponsor:
Uniformed Services University of the Health Sciences
Organization:
Uniformed Services University of the Health Sciences
Study Overview
Official Title:
Pilot Trial Comparing Exposure and Nonexposure Treatments for Posttrauma Nightmares and Insomnia Nightmare Deconstruction and Reprocessing vs NightWare Wristband
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NDRNW
Brief 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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None