Early Intervention to Prevent Development of PTSD in Burn Survivors and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
研究概览
简要总结
The purpose of this clinical trial is to adapt and test a brief patient-caregiver early intervention designed to reduce posttraumatic stress symptoms in hospitalized burn patients and their caregivers. This intervention is a brief, 4-session cognitive-behavioral intervention designed for burn patients and their loved one to complete together, during and after hospitalization. The intervention targets relational communication and functioning through reduction of invalidating, negative statements and avoidant coping by teaching patients and their loved ones to engage in adaptive natural disclosures, supportive responses, and approach coping after the burn trauma. The intervention uses evidence-based psychotherapy techniques, including psychoeducation, motivational interviewing, and skills coaching. The clinical trial will occur in two sequential phases. In the first phase of the study (case series), the intervention will be provided to two burn patient-caregiver dyads (four adults) to pilot test the intervention, seek patient and provider feedback, and refine the intervention. All four adults will receive the intervention. In the second phase of the study, the randomized controlled trial (RCT) phase, investigators will enroll 20 more burn patient-caregiver dyads (40 more adults) who will be randomly assigned (like the flip of a coin) at the dyad level to receive the intervention or a burn survivor-only minimally enhanced usual care psychoeducation control condition (mEUC). The goals of the RCT phase are to study whether the intervention is acceptable to patients, feasible to conduct, and whether the intervention improves burn survivor-caregiver healthy relationship communication about difficult events and treatment outcomes compared to mEUC.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Alert, oriented, & not withdrawing from substance at time of screening
- •Can read and write in English
- •Hospitalized within 10 days of burn injury
- •Anticipated discharge <=4 weeks
- •Have an email, mailing address, and at least 1 smart device for telehealth sessions
- •PTSD risk score of 2 or greater (patient-only)
- •Willing to attend therapy sessions with a loved one
排除标准
- •Currently incarcerated or in police custody
- •> 10 days post-burn
- •Lifetime diagnosis of primary psychosis or intellectual disability
- •Ongoing reported domestic violence in the dyad
- •Unstable bipolar disorder, severe substance use disorder, or acute suicidality with imminent intent that does not remit within 10 days of burn-injury
- •Inflammation Confounds (patient-only) of BMI > 40, metabolic syndrome, admission A1C of >= 6.5%
- •Currently receiving couples therapy
