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

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

Inclusion Criteria9

  • 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

Exclusion Criteria23

  • Presenting to ED for non-interpersonal trauma
  • Defined as any experience that does not involve being intentionally and directly harmed by another individual
  • i.e., falls, motor vehicle collisions, self-injury or suicide attempt
  • Current or past history of schizophrenia or other psychoses based on EMR data
  • Current or past PTSD based on EMR data
  • Unmanaged mania or bipolar disorder based on EMR data
  • Active, untreated substance use disorder based on EMR data other than alcohol use disorder, cannabis use disorder, nicotine use disorder, or tobacco use disorder
  • Active suicidality:
  • Presented to ED with self-inflicted injury or attempted suicide
  • Current suicidal ideation with intent (with or without a specific plan) within past month
  • Suicide attempts during the past three months
  • Current homicidal ideation
  • Active substance withdrawal
  • Pregnant
  • Evidence of a current or past traumatic brain injury or loss of consciousness due to head injury at the time of trauma based on EMR data
  • No cell phone, email address, or stable home address
  • Evidence or risk of ongoing traumatic exposure (e.g., domestic violence)
  • Adults in police custody or Dept of Correction patients
  • Evidence of altered mental status, inability to understand study procedures/risks, or otherwise unable to give informed consent
  • Admission to an intensive care unit, admission or surgery, medical instability or hemodynamic compromise
  • Currently engaged in cognitive behavioral treatment
  • Currently living in a nursing home
  • Currently working non-standard shifts (outside the hours 7am - 6pm)

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.


Locations(1)

Henry Ford Hospital System

Detroit, Michigan, United States

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NCT07121270


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