Status:
NOT_YET_RECRUITING
Recovering Sleep After Trauma
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Heart and Armor Foundation
Conditions:
Post-traumatic Stress Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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...
Detailed Description
Each year, more than 40 million Americans present to US emergency departments (EDs) for evaluation after traumatic stress exposure. The overwhelming majority of these individuals are discharged home a...
Eligibility Criteria
Inclusion
- Alert and oriented at time of screening
- Written and spoken English
- Age 18-65
- Presents to the ED within 72 hours of MVC
- Discharged home after ED evaluation
- Has an email and mailing address
- Owns a smartphone compatible with iOS or Android, has not experienced 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 (score of ≥ 16 on the PTSD risk stratification tool)
- Willing to participate in four remote therapy sessions
Exclusion
- Age \<18 or \>65
- Pregnant
- Prisoner or in police custody
- Present to ED \>72 hours after trauma
- Admitted to the hospital after ED evaluation
- Severely injured (e.g., severely broken bones) as a result of the MVC that, in the opinion of the investigator, may impact PTSD trajectories
- Had a change in psychiatric medication or psychotherapy regimen within 1 month of enrollment
- Currently receiving or planning to receive evidence-based treatments that directly target insomnia or PTSD (e.g., CBT-I, Cognitive Processing Therapy, or Prolonged Exposure Therapy)
- MVC was self-inflicted or occupation-related
- Report or indicate that they are experiencing ongoing domestic violence
- Has conditions that may be associated with comorbid insomnia, including a lifetime history of any psychiatric disorder with psychotic features, manic or hypomanic episodes. We will not exclude individuals based on any other mental health condition, including depression
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07196332
Start Date
January 1 2026
End Date
September 1 2026
Last Update
December 12 2025
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27516