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临床试验/NCT03191760
NCT03191760已完成不适用

Open Trial of Behavioral Activation and Social Engagement (BASE) for Posttraumatic Stress Disorder (PTSD)

VA Puget Sound Health Care System2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2017年6月8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
27
试验地点
2
主要终点
Patient Health Questionnaire-9

研究概览

简要总结

The purpose of the study is to see if "Behavioral Activation and Social Engagement for PTSD" (BASE for PTSD), an individual therapy for PTSD, will help Veterans with PTSD 1) through improved understanding of how PTSD affects them, 2) by reducing ways in which they avoid meaningful activity due to PTSD, 3) by enabling them to do more of the things they really care about, and 4) by improving, strengthening, and building up their social supports.

详细描述

Posttraumatic stress disorder (PTSD) is a mental health condition that some people develop following exposure to a traumatic event. PTSD often results in a reduction in feelings of connection to other people and changes in views about others, as well as reduced participation in valued activities. Many veterans with PTSD do not seek treatment offered in specialty mental health settings and may forgo treatment of any kind.

This study is an open-trial format (no comparison condition) of U.S. military veterans who will participate in a brief psychotherapy treatment for PTSD offered in a Primary Care setting. This is a pilot trial to see if the treatment is effective at reducing symptoms of PTSD and increasing feelings of social support, and an exploratory aim is to see if veterans engage in additional treatment after completing this treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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 who:
  • are currently enrolled in either of the Primary Care Clinics (including Women's Clinic) or Primary Care Mental Health Integration clinic at VA Puget Sound Health Care System - Seattle Division
  • meet criteria for clinical or subclinical PTSD
  • are willing to have therapy sessions audiotaped for the purposes of supervision
  • plan to live in the Seattle area for 6 months following entry into the study

排除标准

  • Veterans who:
  • exhibit the presence of severe mental illness diagnosis (e.g., active psychosis and/or uncontrolled bipolar disorder)
  • have been a psychiatric in-patient admission in the past 30 days
  • have had a suicide attempt in the last 60 days
  • have had a plan or intent to harm self or others in the last 30 days
  • have a behavioral flag in their medical record
  • have had a psychiatric medication dosing or receipt that has changed in the last 30 days
  • are unwilling to provide at least 1 collateral contact
  • have impaired decision making capacity (as measured by evidence in the Computerized Patient Record System record of moderate-severe Traumatic Brain Injury, uncontrolled psychosis, dementia, communication flag, or by clinical judgment in speaking with the participant
  • are prisoners
  • are illiterate or have limited or no English proficiency
  • are terminally ill
  • are currently participating in Cognitive Processing Therapy (CPT) or Prolonged Exposure Therapy (PE)

结局指标

主要结局

Patient Health Questionnaire-9

时间窗: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks

Change in Depression symptoms

PTSD Checklist-Military Version

时间窗: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks

Change in PTSD symptoms

Network Orientation Scale

时间窗: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks

Change in social network orientation

Medical Outcomes Study Social Support Survey Form and Social Connectedness Scale - Revised

时间窗: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks

Change in social support

Behavioral Activation for Depression Scale

时间窗: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks

Change in activity level

次要结局

  • Brief COPE(baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks)
  • Qualitative assessment(12 weeks)
  • Additional treatment engagement(16 weeks)
  • Social Connectedness Scale - Revised (SCS-R)(baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks)

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Tracy Simpson

Clinician Investigator

VA Puget Sound Health Care System

研究点 (2)

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