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NCT Number: NCT07121270

Restorative Early Sleep Treatment After the Emergency Department

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Participants will be patients who present to Henry Ford Hospital's Emergency Department within >72hr following a potential trauma.

Eligible patients will be randomized (1:1) to the active treatment condition (CBT-I or CBT-I&N) or to the control condition (sleep education with or without nightmare education).

Patients with insomnia and comorbid nightmares who are randomized to the active treatment condition will be triaged to CBT-I&N, whereas patients with insomnia and comorbid nightmares who are randomized to the control condition will be triaged to receive sleep education + nightmare education. All other patients with insomnia only will be triaged to receive either CBT-I (active) or sleep education (control).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia

Behavioral

Cognitive Behavioral Therapy for Insomnia (CBT-I) is delivered via 6 weekly 60-min sessions via telemedicine. CBT-I is a multisession treatment approach that focuses on sleep-specific behaviors and thoughts through various methods.

Cognitive Behavioral Therapy for Insomnia and Nightmares

Behavioral

Cognitive Behavioral Therapy for Insomnia and Nightmares (CBT-I&N) is a combination of CBT for Insomnia (CBT-I) and Exposure, Relaxation, and Rescripting Therapy used for the treatment of nightmares (ERRT). CBT-I&N is delivered via 6 weekly 60-min sessions via telemedicine and includes the modification of sleep habits, exposure, and progressive muscle relaxation.

Sleep Education

Behavioral

Sleep education is delivered via telemedicine via 6 weekly 60-min sessions. These sessions will be focused on psychoeducation on sleep after trauma, including common sleep disturbances that may emerge and sleep hygiene guidelines to minimize these disruptions (e.g., wind-down routine, avoid caffeine).

Sleep Education enhanced with Nightmare Education

Behavioral

Sleep education enhanced with nightmare education will include all the components of normal sleep education, as described above, in addition to normalizing the experience of nightmares after trauma and providing psychoeducation on nightmares. The treatment is provided over 6 weekly 60-min sessions via telemedicine.

Primary outcomes

  1. Session Attendance

    Time frame: 1-Week Post-Treatment

    Session attendance (# visits attended/# of total visits) ≥ 65% indicates feasibility

  2. Retention Rate

    Time frame: 1-Week Post-Treatment

    Retention rate (# CBT patients who completed ≥ 4 sessions/ # randomized to CBT) ≥ 65% indicates acceptability

  3. Patient Satisfaction

    Time frame: 1-Week Post-Treatment

    Patient satisfaction with the CBT treatments will be assessed using the Client Satisfaction Questionnaire. Each item is rated on a 1-4 scale, with higher scores indicating greater satisfaction. Mean scores ≥ 3 indicate satisfaction.

  4. Change in Insomnia Symptoms (Insomnia Severity Index)

    Time frame: From Pre-Treatment to 1-Week Post-Treatment, 1-Month Post-Treatment, and 3-Months Post-Treatment

    The Insomnia Severity Index (ISI) is a commonly used self-report measure of insomnia symptoms. Scores on the ISI range from 0-28, with a higher score indicating greater insomnia severity.

Secondary outcomes

  1. Change in Nightmare Symptoms (Nightmare Disorder Index)

    Time frame: From Pre-Treatment to 1-Week Post-Treatment, 1-Month Post-Treatment, and 3-Months Post-Treatment

    The Nightmare Disorder Index (NDI) is a commonly used self-report measure of nightmare severity. Scores on the NDI range from 0-20, with a higher score indicating greater nightmare disorder severity.

  2. Change in PTSD Symptoms (PTSD Checklist for DSM-5)

    Time frame: From Pre-Treatment to 1-Week Post-Treatment, 1-Month Post-Treatment, and 3-Months Post-Treatment

    The PTSD Checklist for DSM-5 (PCL-5) is a commonly used self-report measure of PTSD severity. Scores on the PCL-5 range from 0-80, with a higher score indicating greater PTSD severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Anthony Reffi, PhD

CONTACT

[email protected]

3138053080

Lily Jankowiak, BS

CONTACT

[email protected]

3139165179

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • American Academy of Sleep Medicine

Registry information

Acronym: RESTED

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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