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New treatment option for Insomnia
Official title Restorative Early Sleep Treatment After the Emergency Department
ClinicalTrials.gov ID: NCT07121270
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- i.e., assault with a weapon, physical assault, or sexual assault
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Detroit, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.