NCT07121270 Restorative Early Sleep Treatment After the Emergency Department
| NCT ID | NCT07121270 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Henry Ford Health System |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-03-17 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-03-17 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this randomized controlled trial is to pilot the virtual delivery of cognitive behavioral therapy for insomnia (CBT-I) and nightmares (CBT-I\&N) via telehealth as an early intervention for treating posttraumatic sleep disturbance in acute trauma patients exposed to interpersonal violence. The main aims are to: 1. Test the acceptability, feasibility, and satisfaction of sleep-focused CBT delivered early after trauma 2. Evaluate the impact of sleep-focused CBT delivered early after trauma on sleep disturbance 3. Evaluate the impact of sleep-focused CBT delivered early after trauma on PTSD symptoms The investigators will compare CBT-I and CBT-I\&N to sleep education control. Participants will meet with a provider for 6 weekly sessions via telehealth and complete surveys on the participants' symptoms.
Eligibility Criteria
Inclusion criteria: * Michigan residents treated at Henry Ford Hospital * Fluent in English * Age 18 years or older * Presenting to ED following exposure to Criterion A trauma (exposure to actual or threatened death, serious injury, or sexual violence) characterized by interpersonal violence (defined as any victimization experience that involved being intentionally and directly harmed by another individual * i.e., assault with a weapon, physical assault, or sexual assault * Qualifying trauma occurred within the past \~72hr * Hospital Mental Health Risk Screen score ≥ 10 (indicating at-risk for developing mental health problems) * Patient is not in any other cognitive behavioral treatment with a master's level clinician or above * Patient is appropriate for outpatient treatment and level of acuity does not require inpatient treatment Exclusion criteria: * Presenting to ED for non-interpersonal trauma * Defined as any experience that does not involve being intentionally and directly harmed by another individual * i.e., falls, motor vehicle collisions, self-injury or suicide attempt * Current or past history of schizophrenia or other psychoses based on EMR data * Current or past PTSD based on EMR data * Unmanaged mania or bipolar disorder based on EMR data * Active, untreated substance use disorder based on EMR data other than alcohol use disorder, cannabis use disorder, nicotine use disorder, or tobacco use disorder * Active suicidality: * Presented to ED with self-inflicted injury or attempted suicide * Current suicidal ideation with intent (with or without a specific plan) within past month * Suicide attempts during the past three months * Current homicidal ideation * Active substance withdrawal * Pregnant * Evidence of a current or past traumatic brain injury or loss of consciousness due to head injury at the time of trauma based on EMR data * No cell phone, email address, or stable home address * Evidence or risk of ongoing traumatic exposure (e.g., domestic violence) * Adults in police custody or Dept of Correction patients * Evidence of altered mental status, inability to understand study procedures/risks, or otherwise unable to give informed consent * Admission to an intensive care unit, admission or surgery, medical instability or hemodynamic compromise * Currently engaged in cognitive behavioral treatment * Currently living in a nursing home * Currently working non-standard shifts (outside the hours 7am - 6pm)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07121270 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07121270 currently recruiting?
Yes, NCT07121270 is actively recruiting participants. Contact the research team at areffi1@hfhs.org for enrollment information.
Where is the NCT07121270 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT07121270 clinical trial?
NCT07121270 is sponsored by Henry Ford Health System. The trial plans to enroll 80 participants.
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