Early restorative sleep treatment after an emergency department visit
Official title: Restorative Early Sleep Treatment After the Emergency Department
Run by Henry Ford Health System · NCT07121270 · Data updated 2026-11-12
This trial will try virtual cognitive behavioral therapy for insomnia and nightmares soon after an assault-related emergency visit to see if it improves sleep and reduces PTSD symptoms.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Henry Ford Health System Academic / other |
| Locations | 1 site (Detroit, Michigan) |
| Status | Recruiting |
| Started | March 17, 2025 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07121270 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) who are Michigan residents, fluent in English, present to Henry Ford Hospital ED within roughly 72 hours after interpersonal trauma (e.g., assault or sexual assault), screen at-risk on the hospital mental health risk screen, and are appropriate for outpatient treatment are ideal candidates.
✕Probably not a fit
Patients presenting after non-interpersonal trauma, those requiring inpatient care, people already receiving CBT from a master's-level clinician or higher, non-English speakers, or individuals who cannot participate in telehealth are unlikely to benefit from this protocol.
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 randomized controlled pilot comparing telehealth-delivered cognitive behavioral therapy for insomnia (CBT-I) and CBT-I with nightmare-focused techniques (CBT-I&N) versus sleep education (with or without nightmare education) in patients exposed to recent interpersonal trauma. Eligible Michigan residents who present to Henry Ford Hospital Emergency Department within about 72 hours of an interpersonal trauma and screen at risk for mental health problems are randomized 1:1 to active treatment or control. Active interventions involve six weekly telehealth sessions, with patients who report nightmares routed to the combined CBT-I&N protocol and others receiving standard CBT-I; controls receive sleep education matched for contact. Outcomes include acceptability, feasibility, patient satisfaction, changes in sleep disturbance, and PTSD symptom trajectories measured by participant surveys over follow-up.
Why it matters
Potential benefit: If successful, this approach could reduce early posttraumatic insomnia and nightmares and lower the risk of persistent PTSD by delivering brief telehealth CBT soon after trauma.
How similar studies have gone: CBT-I and nightmare-focused CBT approaches have shown benefit for chronic insomnia and PTSD-related nightmares, but early delivery by telehealth immediately after interpersonal trauma is novel and has limited prior evidence.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
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Henry Ford Hospital System
Detroit, Michigan, United States Recruiting
Study contacts
- Study coordinator: Anthony Reffi, PhD
- Email: areffi1@hfhs.org
- Phone: 3138053080
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.