跳至主要内容
临床试验/NCT02956434
NCT02956434已完成不适用

An Adjunctive Family Intervention for Individual PTSD Treatment

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Treatment Attendance/Dropout

研究概览

简要总结

This study aims to test a brief family intervention (the BFI) to enhance individually-delivered PTSD treatment for Veterans.

详细描述

The investigators will enroll pairs of Veterans and one adult family member who lives with them. Veterans will be beginning a course of PTSD-focused treatment at the Boston VA; Veterans' treatment will not be limited or changed by their participation in this study.

Family members will receive or not receive (depending on which Phase of the study they are recruited in) the BFI. The BFI consists of 2 sessions in which the family member meets one-on-one with a clinician to discuss PTSD, PTSD treatment, and how families can be most helpful to patients in treatment.

Veterans and family members will also be interviewed about their opinions and experiences regarding family-inclusive treatment for PTSD. Clinicians will be recruited and enrolled to obtain their information and feedback (via qualitative interviews), and to deliver the intervention in Phase II.

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 (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

入选标准

  • Veterans must have a diagnosis of PTSD and be beginning a course of Prolonged Exposure (PE) or Cognitive Processing Therapy (CPT) at the Boston VA.
  • Must also have an eligible family member who is willing to participate.

排除标准

  • Current diagnosis of unstable bipolar disorder, substance dependence, past or present psychosis, or organic mental disorder
  • Clear and current suicidal risk
  • Current participation in family/couples therapy

结局指标

主要结局

Treatment Attendance/Dropout

时间窗: 16 weeks

A measure of Veterans' treatment attendance or premature dropout. Data represents the Veterans who dropped out of their standard-care PTSD treatment.

Clinician-Administered PTSD Scale, 5th Edition

时间窗: 16 weeks

A measure of PTSD severity and diagnostic status. Min value = 0, max value = 80. Higher scores mean worse outcome.

次要结局

  • Significant Others' Responses to Trauma Scale (SORTS)(16 weeks)
  • Revised Dyadic Adjustment Scale(16 weeks)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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