Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT07196332
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07196332
Study Brief:
Protocol Section:
NCT07196332