RecruitingNot ApplicableNCT07121270

Restorative Early Sleep Treatment After the Emergency Department

Sponsor

Henry Ford Health System

Enrollment

80 participants

Start Date

Mar 17, 2025

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a sleep intervention provided in the emergency department (ED) to people who have just experienced a traumatic event involving interpersonal violence (such as assault) can prevent the development of PTSD (post-traumatic stress disorder). The study focuses on improving sleep in the critical early window after trauma, since poor sleep is linked to worse PTSD outcomes. **You may be eligible if...** - You are 18 or older, a Michigan resident, and fluent in English - You were treated at Henry Ford Hospital after exposure to interpersonal violence (physical assault, assault with a weapon, or sexual assault) - The traumatic event occurred recently and meets criteria for a Criterion A trauma (life-threatening or involving serious injury or sexual violence) - You have been experiencing significant distress **You may NOT be eligible if...** - You are currently taking medications that affect sleep - You have a prior diagnosis of PTSD or a serious sleep disorder - You have severe psychiatric conditions - You are not a Michigan resident or do not speak English fluently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCognitive 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.

BEHAVIORALCognitive 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.

BEHAVIORALSleep 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).

BEHAVIORALSleep 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.