Restorative Early Sleep Treatment After the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Session Attendance
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Cognitive Behavioral Therapy
Cognitive Behavioral Therapy (CBT) is an evidence-based treatment modality that focuses on modifying maladaptive or unhelpful thoughts and behaviors.
干预措施: 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.
干预措施: Cognitive Behavioral Therapy for Insomnia and Nightmares (Behavioral)
Sleep Education
Sleep Education provides general information on human sleep and sleep hygiene guidelines.
干预措施: Sleep Education (Behavioral)
Sleep Education
Sleep Education provides general information on human sleep and sleep hygiene guidelines.
干预措施: Sleep Education enhanced with Nightmare Education (Behavioral)
结局指标
主要结局
Session Attendance
时间窗: 1-Week Post-Treatment
Session attendance (# visits attended/# of total visits) ≥ 65% indicates feasibility
Retention Rate
时间窗: 1-Week Post-Treatment
Retention rate (# CBT patients who completed ≥ 4 sessions/ # randomized to CBT) ≥ 65% indicates acceptability
Patient Satisfaction
时间窗: 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)
时间窗: 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.
次要结局
- 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)
研究者
Anthony Reffi
Principal Investigator
Henry Ford Health System