Building Resilience In Caregivers of Trauma Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- The Hamilton Depression Rating Scale (HAM-D)
研究概览
简要总结
The purpose of the study is to examine the role of demographics, pre-existing anxiety, depression, and substance use on caregiver depression anxiety, and substance use following a critical injury to a loved one, evaluate the factors that mediate the effectiveness of traditional psychotherapy using problem solving therapy to reduce depression, anxiety, and substance use and to evaluate the factors that mediate the effectiveness of providing an ICU diary and instruction on that diary to reduce depression, anxiety, and substance use.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must anticipate serving in a Caregiver role after the patient is discharged (A. Must be either a family member or close friend of a patient who has been admitted to the trauma/critical care service ICU B. Must anticipate spending time with the patient in a caregiver or other supportive role (e.g., emotional, social, financial) after the patient is discharged
- •Caregiver and patient must report English as a primary language
- •Patient and Caregiver must be able to provide informed consent
- •Caregiver must be able to provide at least two forms of contact information
- •Trauma Patient directly admitted to the ICU (Primary cause of admission is trauma, Injury must include trauma to the head/brain or polytrauma, Admitted directly to the hospital, Patient admission of at least 48 hours, Patient is currently admitted to the ICU, Patient is expected to survive more than 96 hours at 48 hours after admission, Patient has an abbreviated injury score greater than 3 (severe, critical, maximum), Fluent in English)
- •Trauma patient must be able to communicate verbally
- •Does not anticipate serving in a Caregiver role after the patient is discharged
- •Caregiver is not a close friend or family member of the patient who has been admitted to the ICU
- •Caregiver does not expect to serve in a supportive role to the patient
- •Caregiver does not meet inclusion criteria as stated above
- •Patient is not currently admitted to the ICU and or is not expected to remain in the ICU for 48 hours
- •Patient is not expected to survive more than 96 hours
- •Patient is not expected to require assistance prior to discharge
- •Patient is not between 17 and 65 years of age
排除标准
- 未提供
结局指标
主要结局
The Hamilton Depression Rating Scale (HAM-D)
时间窗: 6 months post injury
Symptoms of depression in caregivers as assessed by the The Hamilton Depression Rating Scale (HAM-D).Although the HAM-D form lists 21 items, the scoring is based on the first 17. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0(Absent)-2(frequent)
Short form survey (SF-12)
时间窗: 6 months post injury
Quality of life of caregiver as assessed by the short form survey (SF-12).The SF-12 is a 12 item questionnaire with a range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Posttraumatic Stress Disorder Checklist (PCL-5)
时间窗: 6 months post injury
The extent to which caregivers have been bothered by PTSD symptoms as assessed by the PTSD Checklist (PCL-5) assessment.The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past month (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely).
次要结局
- The center for epidemiologic studies of depression (CESD-R )(3 months post injury)
- PTSD Checklist for (PCL-5) assessment.(3 months post injury)
- Number of days of hospitalization(6 months post injury)
- The Alcohol Use Disorders identification Test (AUDIT):(3 months post injury)
- Number of infections post discharge(6 months post injury)
研究者
Deborah M Little
Professor
The University of Texas Health Science Center, Houston