Restorative Early Sleep Treatment After the Emergency Department
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Henry Ford Health System
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Session Attendance
Study Overview
Brief 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:
- Test the acceptability, feasibility, and satisfaction of sleep-focused CBT delivered early after trauma
- Evaluate the impact of sleep-focused CBT delivered early after trauma on sleep disturbance
- 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.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
- •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)
Arms & Interventions
Cognitive Behavioral Therapy
Cognitive Behavioral Therapy (CBT) is an evidence-based treatment modality that focuses on modifying maladaptive or unhelpful thoughts and behaviors.
Intervention: Cognitive Behavioral Therapy for Insomnia (Behavioral)
Cognitive Behavioral Therapy
Cognitive Behavioral Therapy (CBT) is an evidence-based treatment modality that focuses on modifying maladaptive or unhelpful thoughts and behaviors.
Intervention: Cognitive Behavioral Therapy for Insomnia and Nightmares (Behavioral)
Sleep Education
Sleep Education provides general information on human sleep and sleep hygiene guidelines.
Intervention: Sleep Education (Behavioral)
Sleep Education
Sleep Education provides general information on human sleep and sleep hygiene guidelines.
Intervention: Sleep Education enhanced with Nightmare Education (Behavioral)
Outcomes
Primary Outcomes
Session Attendance
Time Frame: 1-Week Post-Treatment
Session attendance (# visits attended/# of total visits) ≥ 65% indicates feasibility
Retention Rate
Time Frame: 1-Week Post-Treatment
Retention rate (# CBT patients who completed ≥ 4 sessions/ # randomized to CBT) ≥ 65% indicates acceptability
Patient Satisfaction
Time Frame: 1-Week Post-Treatment
Patient satisfaction with the CBT treatments will be assessed using the Client Satisfaction Questionnaire. Each item is rated on a 1-4 scale, with higher scores indicating greater satisfaction. Mean scores ≥ 3 indicate satisfaction.
Change in Insomnia Symptoms (Insomnia Severity Index)
Time Frame: From Pre-Treatment to 1-Week Post-Treatment, 1-Month Post-Treatment, and 3-Months Post-Treatment
The Insomnia Severity Index (ISI) is a commonly used self-report measure of insomnia symptoms. Scores on the ISI range from 0-28, with a higher score indicating greater insomnia severity.
Secondary Outcomes
- Change in Nightmare Symptoms (Nightmare Disorder Index)(From Pre-Treatment to 1-Week Post-Treatment, 1-Month Post-Treatment, and 3-Months Post-Treatment)
- Change in PTSD Symptoms (PTSD Checklist for DSM-5)(From Pre-Treatment to 1-Week Post-Treatment, 1-Month Post-Treatment, and 3-Months Post-Treatment)
Investigators
Anthony Reffi
Principal Investigator
Henry Ford Health System