Recovering sleep after a car crash

Recovering Sleep After Trauma

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

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of North Carolina, Chapel Hill (other)
• Locations: 1 site (Chapel Hill, North Carolina)
• Trial ID: NCT07196332 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Chapel Hill, North Carolina

• 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

Conditions: Post-traumatic Stress Disorder, Trauma and Stressor Related Disorders, Mental Disorders, Stress Disorders, Traumatic, Stress Disorders, Post-Traumatic, Motor Vehicle Collision