Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07121270

Restorative Early Sleep Treatment After the Emergency Department

Led by Henry Ford Health System · Updated on 2025-08-13

80

Participants Needed

1

Research Sites

123 weeks

Total Duration

On this page

Sponsors

H

Henry Ford Health System

Lead Sponsor

A

American Academy of Sleep Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Restorative Early Sleep Treatment After the Emergency Department

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Michigan residents treated at Henry Ford Hospital
  • Fluent in English
  • Age 18 years or older
  • Presenting to Emergency Department following exposure to Criterion A trauma involving interpersonal violence (such as assault with a weapon, physical assault, or sexual assault)
  • Trauma occurred within approximately the past 72 hours
  • Hospital Mental Health Risk Screen score of 10 or higher indicating risk for mental health problems
  • Not currently in cognitive behavioral treatment with a master's level clinician or above
  • Appropriate for outpatient treatment and do not require inpatient care
Not Eligible

You will not qualify if you...

  • Presenting to Emergency Department for non-interpersonal trauma (e.g., falls, motor vehicle collisions, self-injury, suicide attempt)
  • Current or past history of schizophrenia or other psychoses
  • Current or past PTSD
  • Unmanaged mania or bipolar disorder
  • Active untreated substance use disorder except alcohol, cannabis, nicotine, or tobacco use disorders
  • Active suicidality including recent suicide attempts or current suicidal intent
  • Current homicidal ideation
  • Active substance withdrawal
  • Pregnant
  • Evidence of traumatic brain injury or loss of consciousness from head injury at time of trauma
  • No cell phone, email address, or stable home address
  • Evidence or risk of ongoing traumatic exposure such as domestic violence
  • Adults in police custody or Department of Correction patients
  • Altered mental status or inability to understand study procedures or give informed consent
  • Admission to intensive care unit, surgery, medical instability, or hemodynamic compromise
  • Currently engaged in cognitive behavioral treatment
  • Currently living in a nursing home
  • Currently working non-standard shifts (outside 7am to 6pm)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Henry Ford Hospital System

Detroit, Michigan, United States, 48202

Actively Recruiting

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Research Team

A

Anthony Reffi, PhD

CONTACT

L

Lily Jankowiak, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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