Restorative Early Sleep Treatment After the Emergency Department

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.

Conditions

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

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia

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.

BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia and Nightmares

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.

BEHAVIORAL

Sleep Education

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).

BEHAVIORAL

Sleep Education enhanced with Nightmare Education

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.

Sponsors & Collaborators

• American Academy of Sleep Medicine

  collaborator OTHER

• Henry Ford Health System

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-17

Primary Completion

2027-08-31

Completion

2027-08-31

Countries

• United States

Study Locations