Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

Recovering sleep after a car crash

Official title: Recovering Sleep After Trauma

Run by University of North Carolina, Chapel Hill · NCT07196332 · Data updated 2026-11-12

This pilot will test whether four remote sessions of brief behavioral treatment for insomnia (BBTI) help people recently seen in the ER for a motor vehicle crash who are at high risk for PTSD and depression.

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment20 (estimated)
SponsorUniversity of North Carolina, Chapel Hill
Academic / other
Locations1 site (Chapel Hill, North Carolina)
StatusRecruiting
StartedApril 30, 2026
Main results expectedSeptember 2027
Study endsSeptember 2027
Registry record updatedOctober 29, 2026
Trial IDNCT07196332 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–65 who speak English, present to the UNC Chapel Hill ED within 72 hours of a motor vehicle collision, are discharged home, meet the PTSD risk score threshold (≥16), own a compatible smartphone, and are willing to complete four remote sessions are ideal candidates.

Probably not a fit

People who are hospitalized, severely injured, pregnant, incarcerated, beyond 72 hours after the crash, without a compatible smartphone or stable contact information, or with recent changes to psychiatric treatment are unlikely to benefit or are excluded.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a small randomized pilot comparing telehealth-delivered BBTI to progressive muscle relaxation training in adults discharged from a single emergency department after a motor vehicle collision. Twenty participants who present within 72 hours of the crash and meet a high PTSD risk score will be randomized to four remote therapy sessions. The trial will measure feasibility, sleep outcomes, and preliminary effects on PTSD and depressive symptoms. Results will be used to design and larger-scale trial of secondary prevention after traumatic exposure.

Why it matters

Potential benefit: If successful, the intervention could reduce the development or severity of PTSD and depression after motor vehicle crashes by improving sleep through an accessible telehealth approach.

How similar studies have gone: BBTI is an evidence-based treatment for insomnia and has reduced PTSD symptoms in other settings, but using BBTI as a telehealth secondary preventive intervention after motor vehicle collision is novel and untested in randomized trials.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Alert and oriented at time of screening
2. Written and spoken English
3. Age 18-65
4. Presents to the ED within 72 hours of MVC
5. Discharged home after ED evaluation
6. Has an email and mailing address
7. 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
8. Meets PTSD risk score criteria (score of ≥ 16 on the PTSD risk stratification tool)
9. Willing to participate in four remote therapy sessions

Exclusion Criteria:

1. Age \<18 or \>65
2. Pregnant
3. Prisoner or in police custody
4. Present to ED \>72 hours after trauma
5. Admitted to the hospital after ED evaluation
6. Severely injured (e.g., severely broken bones) as a result of the MVC that, in the opinion of the investigator, may impact PTSD trajectories
7. Had a change in psychiatric medication or psychotherapy regimen within 1 month of enrollment
8. 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)
9. MVC was self-inflicted or occupation-related
10. Report or indicate that they are experiencing ongoing domestic violence
11. 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's running

  • University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina, United States
    Recruiting

Study contacts

  • Principal investigator: Samuel McLean, MD, MPH — University of North Carolina, Chapel Hill
  • Study coordinator: Andrea A Massa, PhD
  • Email: REST@unc.edu
  • Phone: (919) 966-1644

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.