Restorative Early Sleep Treatment After the Emergency Department

Not Applicable

Recruiting

• Conditions: Insomnia; Nightmares Associated With Trauma and Stress; Nightmares; PTSD - Post Traumatic Stress Disorder

• Registration Number: NCT07121270
• Lead Sponsor: Henry Ford Health System

Brief 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.

Detailed Description

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).

Study Timeline

• Study Start: 2025-03-17
• Study First Submitted: 2025-07-21
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Primary Completion: 2027-08
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Session Attendance	1-Week Post-Treatment	Session attendance (# visits attended/# of total visits) ≥ 65% indicates feasibility
Retention Rate	1-Week Post-Treatment	Retention rate (# CBT patients who completed ≥ 4 sessions/ # randomized to CBT) ≥ 65% indicates acceptability
Patient Satisfaction	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.
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.

Secondary Outcome Measures

Name	Time	Method
Change in Nightmare Symptoms (Nightmare Disorder Index)	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.
Change in PTSD Symptoms (PTSD Checklist for DSM-5)	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.

Trial Locations

Locations (1)

Henry Ford Hospital System; 🇺🇸 Detroit, Michigan, United States