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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.
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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Henry Ford Hospital System
Detroit, Michigan, United States
Start Date
March 17, 2025
Primary Completion Date
August 1, 2027
Completion Date
August 1, 2027
Last Updated
August 13, 2025
80
ESTIMATED participants
Cognitive Behavioral Therapy for Insomnia
BEHAVIORAL
Cognitive Behavioral Therapy for Insomnia and Nightmares
BEHAVIORAL
Sleep Education
BEHAVIORAL
Sleep Education enhanced with Nightmare Education
BEHAVIORAL
Lead Sponsor
Henry Ford Health System
Collaborators
NCT06032377
NCT06807086
NCT06181643
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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