Restorative Early Sleep Treatment After the Emergency Department for Trauma

This study is testing different types of talk therapy delivered online to help people who have experienced trauma and are having sleep problems like insomnia (trouble falling or staying asleep) and nightmares. The therapies being studied are Cognitive Behavioral Therapy for Insomnia (CBT-I), Cognitive Behavioral Therapy for Insomnia and Nightmares (CBT-I&N), and different levels of Sleep Education. The goal is to see if these therapies, given early after trauma, can improve sleep and reduce symptoms of PTSD (Post Traumatic Stress Disorder). You may be able to join if you are an adult Michigan resident treated at Henry Ford Hospital after experiencing certain types of interpersonal violence. The study will be successful if participants attend sessions, stay in the study, and are satisfied with the treatment.

Study design: This is an interventional study with 80 planned participants. You would be randomly assigned to receive one of the study treatments.
What's involved: You would participate in 6 weekly 60-minute sessions delivered online via telemedicine.
Compensation: Not stated in the trial record.
Follow-up: Your attendance, retention, and satisfaction will be measured one week after treatment ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Restorative Early Sleep Treatment After the Emergency Department

Recruiting

NAAges 18+InterventionalTreatment

Henry Ford Health System

~80 participants

Updated 2025-08-13 on ClinicalTrials.gov

What's tested:Cognitive Behavioral Therapy for InsomniaCognitive Behavioral Therapy for Insomnia and NightmaresSleep EducationSleep Education enhanced with Nightmare Education

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Session Attendance

Measured over 1-Week Post-Treatment

+3 more outcomes measured

Conditions

Insomnia

Nightmares Associated With Trauma and Stress

Nightmares

PTSD - Post Traumatic Stress Disorder

Where it's being run

1 sites across 1 states

Michigan1

Who to contact

Anthony Reffi, PhD

[email protected]

3138053080

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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)

What this trial measures

Session Attendance1-Week Post-Treatment
Session attendance (# visits attended/# of total visits) ≥ 65% indicates feasibility
Retention Rate1-Week Post-Treatment
Retention rate (# CBT patients who completed ≥ 4 sessions/ # randomized to CBT) ≥ 65% indicates acceptability
Patient Satisfaction1-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.
Change in Insomnia Symptoms (Insomnia Severity Index)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.

Trialytics