Recruiting

CBT-I & CBT-I&NRestorative Early Sleep Treatment After the Emergency Department

Sponsor:

Henry Ford Health System

Code:

NCT07121270

Conditions

Insomnia

Nightmares Associated With Trauma and Stress

Nightmares

PTSD - Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Therapy for Insomnia

Cognitive Behavioral Therapy for Insomnia and Nightmares

Sleep Education

Sleep Education enhanced with Nightmare Education

Study Details

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:

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.

Conditions

Insomnia

Nightmares Associated With Trauma and Stress

Nightmares

PTSD - Post Traumatic Stress Disorder

Study ID

NCT07121270

Start date

Mar 17, 2025

Status verified date

Aug, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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
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)

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cognitive Behavioral Therapy

Cognitive Behavioral Therapy (CBT) is an evidence-based treatment modality that focuses on modifying maladaptive or unhelpful thoughts and behaviors.

active comparator: Sleep Education

Sleep Education provides general information on human sleep and sleep hygiene guidelines.

Interventions

Cognitive 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.

Cognitive 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.

Sleep 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).

Sleep 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.

Primary outcome measure

Session Attendance [ Time Frame: 1-Week Post-Treatment ]
Retention Rate [ Time Frame: 1-Week Post-Treatment ]
Patient Satisfaction [ Time Frame: 1-Week Post-Treatment ]
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 ]

Central Contacts and Locations

Central contacts

Anthony Reffi, PhD

3138053080 areffi1@hfhs.org

Lily Jankowiak, BS

3139165179 ljankow2@hfhs.org

Locations

Henry Ford Hospital System

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Anthony Reffi, PhD

313-805-3080 areffi1@hfhs.org

Lily Jankowiak, BS

3139165179 ljankow2@hfhs.org

Principal Investigator:

Anthony Reffi, PhD

More Information

Sponsor

Henry Ford Health System

Last update posted

Aug 13, 2025

Last verified

Aug, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2025-08-13.