Actively Recruiting
Recovering Sleep After Trauma
Led by University of North Carolina, Chapel Hill · Updated on 2026-05-04
20
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
H
Heart and Armor Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main objective of this pilot trial is to assess the feasibility and preliminary efficacy of telehealth-delivered behavioral therapy to reduce the development of posttraumatic stress and depressive symptoms following motor vehicle collision among individuals at high risk. This pilot trial will provide the data necessary to design and support a large-scale trial.
CONDITIONS
Official Title
Recovering Sleep After Trauma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Alert and oriented at time of screening
- Able to read and speak English
- Age between 18 and 65 years
- Presented to the emergency department within 72 hours of a motor vehicle collision
- Discharged home after emergency department evaluation
- Has an email address and mailing address
- Owns a smartphone compatible with iOS or Android, with no service interruption due to non-payment in the past year, and has maintained the same phone number for at least one year
- Meets PTSD risk score criteria with a score of 16 or higher on the PTSD risk stratification tool
- Willing to participate in four remote therapy sessions
You will not qualify if you...
- Younger than 18 or older than 65 years
- Pregnant
- Prisoner or in police custody
- Presented to the emergency department more than 72 hours after the trauma
- Admitted to the hospital after emergency department evaluation
- Severely injured resulting from the motor vehicle collision, as judged by the investigator
- Changed psychiatric medication or psychotherapy regimen within 1 month prior to enrollment
- Currently receiving or planning to receive evidence-based treatments directly targeting insomnia or PTSD, such as CBT-I, Cognitive Processing Therapy, or Prolonged Exposure Therapy
- Motor vehicle collision was self-inflicted or related to occupation
- Experiencing ongoing domestic violence
- Has conditions associated with comorbid insomnia, including a lifetime history of psychiatric disorders with psychotic features or manic/hypomanic episodes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27516
Actively Recruiting
Research Team
A
Andrea A Massa, PhD
CONTACT
R
Romina Soudavari, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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