NCT07121270 · Henry Ford Health System
Restorative Early Sleep Treatment After the Emergency Department
(RESTED)
What this study is about
The goal of this randomly assigned 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Detroit, Michigan
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 13, 2025 · Source of record for eligibility and locations