RECRUITING

Restorative Early Sleep Treatment After the Emergency Department

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Conditions

InsomniaNightmares Associated With Trauma and StressNightmaresPTSD - Post Traumatic Stress DisorderCBT-ITraumaSleep EducationPTSDCBT-I&NAcute TraumaRCTEarly interventionBehavioral sleep medicinePosttraumatic stressTrauma-induced insomniaCognitive behavioral therapyPrevention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Restorative Early Sleep Treatment After the Emergency Department

Quick Facts

Study Start:2025-03-17
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07121270

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Michigan residents treated at Henry Ford Hospital
  2. * Fluent in English
  3. * Age 18 years or older
  4. * 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
  5. * i.e., assault with a weapon, physical assault, or sexual assault
  6. * Qualifying trauma occurred within the past \~72hr
  7. * Hospital Mental Health Risk Screen score ≥ 10 (indicating at-risk for developing mental health problems)
  8. * Patient is not in any other cognitive behavioral treatment with a master's level clinician or above
  9. * Patient is appropriate for outpatient treatment and level of acuity does not require inpatient treatment
  1. * Presenting to ED for non-interpersonal trauma
  2. * Defined as any experience that does not involve being intentionally and directly harmed by another individual
  3. * i.e., falls, motor vehicle collisions, self-injury or suicide attempt
  4. * Current or past history of schizophrenia or other psychoses based on EMR data
  5. * Current or past PTSD based on EMR data
  6. * Unmanaged mania or bipolar disorder based on EMR data
  7. * Active, untreated substance use disorder based on EMR data other than alcohol use disorder, cannabis use disorder, nicotine use disorder, or tobacco use disorder
  8. * Active suicidality:
  9. * Presented to ED with self-inflicted injury or attempted suicide
  10. * Current suicidal ideation with intent (with or without a specific plan) within past month
  11. * Suicide attempts during the past three months
  12. * Current homicidal ideation
  13. * Active substance withdrawal
  14. * Pregnant
  15. * 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
  16. * No cell phone, email address, or stable home address
  17. * Evidence or risk of ongoing traumatic exposure (e.g., domestic violence)
  18. * Adults in police custody or Dept of Correction patients
  19. * Evidence of altered mental status, inability to understand study procedures/risks, or otherwise unable to give informed consent
  20. * Admission to an intensive care unit, admission or surgery, medical instability or hemodynamic compromise
  21. * Currently engaged in cognitive behavioral treatment
  22. * Currently living in a nursing home
  23. * Currently working non-standard shifts (outside the hours 7am - 6pm)

Contacts and Locations

Study Contact

Anthony Reffi, PhD
CONTACT
3138053080
areffi1@hfhs.org
Lily Jankowiak, BS
CONTACT
3139165179
ljankow2@hfhs.org

Study Locations (Sites)

Henry Ford Hospital System
Detroit, Michigan, 48202
United States

Collaborators and Investigators

Sponsor: Henry Ford Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-17
Study Completion Date2027-08

Study Record Updates

Study Start Date2025-03-17
Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

  • CBT-I
  • Nightmares
  • Insomnia
  • Trauma
  • Sleep Education
  • PTSD
  • CBT-I&N
  • Acute Trauma
  • RCT
  • Early intervention
  • Behavioral sleep medicine
  • Posttraumatic stress
  • Trauma-induced insomnia
  • Cognitive behavioral therapy
  • Prevention

Additional Relevant MeSH Terms

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