Recovering Sleep After Trauma

Recruiting now · Not applicable

Conditions studied: Post-traumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT07196332

Run by

University of North Carolina, Chapel Hill

People needed

20

Starts

2026-04-30

Expected to finish

2026-09-01

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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