Recovering Sleep After Trauma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in PTSD Symptom Severity Over Time
研究概览
简要总结
The main objective of this pilot trial is to assess the feasibility and preliminary efficacy of telehealth-delivered behavioral therapy to reduce the development of posttraumatic stress and depressive symptoms following motor vehicle collision among individuals at high risk. This pilot trial will provide the data necessary to design and support a large-scale trial.
详细描述
Each year, more than 40 million Americans present to US emergency departments (EDs) for evaluation after traumatic stress exposure. The overwhelming majority of these individuals are discharged home after evaluation. A wealth of data demonstrates that the development of adverse posttraumatic neuropsychiatric sequelae such as posttraumatic stress disorder (PTSD) is common in this population, and that individuals with a history of traumatic stress exposure and/or posttraumatic stress symptoms-such as military veterans-are at increased risk. Unfortunately, no secondary preventive interventions are currently widely available that can prevent PTSD among those at high risk. This pilot REST trial will assess the ability of brief behavioral treatment for insomnia (BBTI) to reduce the incidence and severity of PTSD and depression after one of the most common traumatic stress exposures in industrialized countries, motor vehicle collision (MVC). BBTI is an evidence-based, low-cost intervention that has been demonstrated to be effective in treating insomnia and reducing PTSD symptoms. However, BBTI has never been tested as a secondary preventive intervention for PTSD and depression. In addition, the efficacy of BBTI when administered as a telehealth intervention has never been assessed. This REST pilot trial will randomize 20 (N=20) individuals who present to a study ED for care after MVC to four sessions of brief behavioral treatment for insomnia (BBTI) versus a progressive muscle relaxation training (PMRT) control. Both interventions will be administered via telehealth, with 10 individuals receiving BBTI and 10 receiving PMRT. Each therapist will administer both interventions. Participants will be assessed via traditional self-report surveys and sleep diaries. Results of this trial will demonstrate the feasibility and potential efficacy of BBTI to prevent the development of PTSD and depression after traumatic stress exposure and will provide the data necessary to design/support a large-scale trial. Developing preventive interventions to reduce PTSD and depression among individuals experiencing civilian trauma exposures would reduce suffering and considerable costs associated with these disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Alert and oriented at time of screening
- •Written and spoken English
- •Presents to the ED within 72 hours of MVC
- •Discharged home after ED evaluation
- •Has an email and mailing address
- •Owns a smartphone compatible with iOS or Android, has not experienced service interruption due to non-payment in the past year, and has maintained the same phone number for at least one year
- •Meets PTSD risk score criteria (score of ≥ 16 on the PTSD risk stratification tool)
- •Willing to participate in four remote therapy sessions
排除标准
- •Age <18 or >65
- •Prisoner or in police custody
- •Present to ED >72 hours after trauma
- •Admitted to the hospital after ED evaluation
- •Severely injured (e.g., severely broken bones) as a result of the MVC that, in the opinion of the investigator, may impact PTSD trajectories
- •Had a change in psychiatric medication or psychotherapy regimen within 1 month of enrollment
- •Currently receiving or planning to receive evidence-based treatments that directly target insomnia or PTSD (e.g., CBT-I, Cognitive Processing Therapy, or Prolonged Exposure Therapy)
- •MVC was self-inflicted or occupation-related
- •Report or indicate that they are experiencing ongoing domestic violence
- •Has conditions that may be associated with comorbid insomnia, including a lifetime history of any psychiatric disorder with psychotic features, manic or hypomanic episodes. We will not exclude individuals based on any other mental health condition, including depression
研究组 & 干预措施
Brief Behavioral Treatment for Insomnia (BBTI)
Four sessions of telehealth-delivered brief behavioral treatment for insomnia
干预措施: Brief Behavioral Treatment for Insomnia (BBTI) (Behavioral)
Progressive Muscle Relaxation Training (PMRT)
Four sessions of telehealth-delivered progressive muscle relaxation training
干预措施: Progressive Muscle Relaxation Training (PMRT) (Behavioral)
结局指标
主要结局
Changes in PTSD Symptom Severity Over Time
时间窗: Baseline, Week 4, Week 8, Month 3
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure designed to assess PTSD symptoms as defined by the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5). The PCL-5 will be completed in reference to the motor vehicle collision (MVC) that occurred just before enrollment into the study. Each item of the PCL-5 is scored on a five-point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed to provide a total severity score (range = 0-80), with higher scores indicating greater symptom severity. PTSD symptom severity will be compared between treatment groups over time.
Recruitment Rates
时间窗: Baseline
To assess the feasibility of the study recruitment protocol, the proportion of eligible participants who enroll in the study and are randomized will be calculated.
Retention Rates
时间窗: Month 3
To assess feasibility of the study protocol, the proportion of participants who complete the study protocol, according to study arm and in total, will be calculated.
Treatment Completion Rates
时间窗: Week 4
To assess feasibility of the treatment protocol, treatment completion rates will be calculated according to the study arm and in total. Treatment completers will be defined as participants who complete at least 3 out of 4 REST or control sessions.
次要结局
- Change in Depressive Symptom Score Over Time(Baseline, Week 4, Week 8, Month 3)
- Change in Somatic Score Symptoms Over Time(Baseline, Week 4, Week 8, Month 3)
- Change in Pain Symptom Severity and Extent Over Time(Baseline, Week 4, Week 8, Month 3)
