Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07196332

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27516

Actively Recruiting

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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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