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Early Intervention to Prevent Development of PTSD in Burn Survivors and Their Caregivers

2026年6月14日 更新者:University of Southern California
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.

研究概览

研究类型

介入性

注册 (估计的)

44

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • California
      • Los Angeles、California、美国、90033
        • University of Southern California, Keck School of Medicine & Los Angeles General Medical Center
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Promotion of Emotional Disclosure for Burns (PoED-B)
Participants randomized into this arm will receive Promotion of Emotional Disclosure for Burns (PoED-B), a cognitive behavioral therapy intervention designed for burn survivors and a loved one of their choosing to complete together. The standard treatment length will be 4 sessions, however participants and providers may agree to additional sessions as warranted.
PoED-B is a dyadic treatment where both patient and identified informal caregiver participate. PoED-B targets reducing disclosure-constraining behaviors (e.g., invalidating, negative statements) using psychoeducation, motivational interviewing, and skills training. The goal is to encourage the patient-caregiver dyad to engage in natural disclosures, supportive responses, and approach coping after the burn trauma to facilitate emotional processing. It is four sessions long. Delivery format takes into account stakeholder feedback, considering overall burden during acute hospitalization and the transition to outpatient care. Sessions one and two are 30 minutes and one week apart. Sessions three and four are 50 minutes long and two weeks apart. Session one must occur during hospitalization. Sessions 2-4 can be completed via video/telehealth if the patient is discharged during the treatment course.
有源比较器:minimally Enhanced Usual Care control (mEUC)
Participants randomized into this arm will receive a minimally enhanced version of usual burn care. This will include one, 30-minute supportive therapy session focused on psychoeducation about the potential psychological impact of burn injury and hospitalization and referral to outpatient resources, if wanted.
mEUC is an individually-administered psychoeducation control for burn patients modeled after minimally enhanced care in acute care surgery units. In one 30-minute session, the therapist reviews with the participant a standardized psychoeducation handout on common psychological reactions after burn injury, giving them time to ask questions or express concerns within a supportive therapy framework. Then, the participant is given the handout, which also includes self-help skills. After study completion, participants will be given referrals for outpatient mental health services.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Social Constraints Scale
大体时间:Before treatment, immediately after ending treatment, 6-week follow-up
The Social Constraints Scale is a self-report scale administered to both the patient and caregiver. It is designed to assess perceptions of negative reactions to trauma-disclosures. The scale contains 15 items, and each item is scored on a four-point scale ranging from 1 (never) to 4 (often) with total scores ranging from 15 to 60. A higher score indicates a higher frequency of experiencing social constraints.
Before treatment, immediately after ending treatment, 6-week follow-up
Feasibility of Recruitment
大体时间:baseline
Proportion of participants who agree to participate from the total number of those that are eligible and approached.
baseline
Feasibility of Data Collection
大体时间:From enrollment to the end of study assessments at 6-weeks posttreament
Proportion of participants who completed each and all assessment timepoints
From enrollment to the end of study assessments at 6-weeks posttreament
Acceptability: Satisfaction with Treatment
大体时间:Immediately after ending treatment
Client Satisfaction Questionnaire (CSQ) - Self-Report - The CSQ has 8 items assessing client satisfaction with the treatment they have received. Total scores range from 8-32; higher scores indicate greater client satisfaction/treatment acceptability. This measure will be completed by both patients and their loved ones.
Immediately after ending treatment
Acceptabilitly: Retention
大体时间:Immediately after ending treatment
Proportion of enrolled dyads who completed at least 3 out of 4 PoED sessions.
Immediately after ending treatment
Acceptability: Global Improvement Rating
大体时间:Immediately after ending treatment
Proportion of participants who report overall improvement on the Global Rating of Change Scale
Immediately after ending treatment

次要结果测量

结果测量
措施说明
大体时间
PTSD Checklist for DSM-5 (PCL-5)
大体时间:Pretreatment, Immediately after ending treatment, 6-week follow-up
The PTSD Checklist for DSM-5 is a 20 item self-report measure assessing PTSD symptom severity. Total scores range from 0-80 with higher scores indicating more severe PTSD symptoms.
Pretreatment, Immediately after ending treatment, 6-week follow-up
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
大体时间:Immediately after ending treatment, 6-week follow-up
The Clinician-Administered PTSD Scale for DSM-5 is a structured interview measure of PTSD symptom severity (frequency and intensity) in the past month. Scores can range from 0-80, with higher scores indicating worse symptom severity. Only burn patients will complete this measure, not caregivers.
Immediately after ending treatment, 6-week follow-up
Hospital Anxiety and Depression Scale (HADS)
大体时间:Pretreatment, immediately after ending treatment, 6-week follow-up
The Hospital Anxiety and Depression Scale is a 14-item self-report measure of anxiety and depression symptoms that was designed for the hospital environment. Each subscale has 7-items answered on a 4-point scale ranging from 0 to 3, yielding a maximum possible score of 21 for each subscale. Higher scores indicate worse symptoms.
Pretreatment, immediately after ending treatment, 6-week follow-up
MINI Montreal International Neuropsychiatric Interview v. 7.0.2 (MINI)
大体时间:Pretreatment, immediately after ending treatment, 6-week follow-up
The MINI is a brief (~15 minutes) structured psychodiagnostic interview for assessing DSM-5 disorders.
Pretreatment, immediately after ending treatment, 6-week follow-up
Dyadic Relationship Scale (DRS)
大体时间:Pretreatment, immediately after ending treatment, 6-week follow-up
The Dyadic Relationship Scale is a self-report survey measuring dyadic strain and positive dyadic interaction specific to patient's health. There is a 10-item patient-version and 11-item caregiver version. Dyadic strain subscale scores range from 0-12 (patient version) and 0-15 (caregiver version). Positive dyadic interaction subscale scores range from 0-18. Higher scores on each of these scales indicate higher levels of strain and positive interaction, respectively.
Pretreatment, immediately after ending treatment, 6-week follow-up
Significant Other's Responses to Trauma Scale (SORTS)
大体时间:Pretreatment, immediately after ending treatment, 6-week follow-up
The Significant Other's Responses to Trauma Scale is a 14-item self-report measure assessing frequency & intensity of caregiver PTSD accommodation behaviors. Total scores can range from 0-112 with higher scores indicating greater accommodation.
Pretreatment, immediately after ending treatment, 6-week follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Sarah Stoycos, PhD、University of Southern California, Keck School of Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2028年12月31日

研究完成 (估计的)

2029年2月28日

研究注册日期

首次提交

2026年6月3日

首先提交符合 QC 标准的

2026年6月14日

首次发布 (实际的)

2026年6月18日

研究记录更新

最后更新发布 (实际的)

2026年6月18日

上次提交的符合 QC 标准的更新

2026年6月14日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • HS-25-00383
  • 1K23MH141296-01 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

De-identified demographic and raw quantitative data will be deposited into the NIMH Data Archive (NDA). All data will be de-identified prior to receipt by the repository. Data will be de-identified pursuant to the HIPAA Privacy Rule, 45 CFR § 164.514(b). A brief study protocol will also be submitted to NDA and will be made freely available.

IPD 共享时间框架

Data will be deposited starting 18 months after the award begins and will be deposited every six months thereafter following the usual NDA data submission dates. Data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data is controlled by the NDA; NDA currently has no process for deleting or retiring datasets, and thus far no data has been removed to our knowledge.

IPD 共享访问标准

To request access to the data, researchers can use the standard processes at NDA; the NDA Data Access Committee will review requests and decide which requests to grant. The standard NDA access process allows access for one year and is renewable thereafter.

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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