Restorative Early Sleep Treatment After the Emergency Department

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Michigan
Henry Ford Hospital System
RECRUITING
Detroit
Contact Information
Primary
Anthony Reffi, PhD
areffi1@hfhs.org
3138053080
Backup
Lily Jankowiak, BS
ljankow2@hfhs.org
3139165179
Time Frame
Start Date: 2025-03-17
Estimated Completion Date: 2027-08
Participants
Target number of participants: 80
Treatments
Experimental: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy (CBT) is an evidence-based treatment modality that focuses on modifying maladaptive or unhelpful thoughts and behaviors.
Active_comparator: Sleep Education
Sleep Education provides general information on human sleep and sleep hygiene guidelines.
Related Therapeutic Areas
Sponsors
Leads: Henry Ford Health System
Collaborators: American Academy of Sleep Medicine

This content was sourced from clinicaltrials.gov