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临床试验/NCT01685528
NCT01685528已完成不适用

VA Home-Based Emotional Learning With Practical Skills (VA-HELPS): Treatment for Depressed and/or Anxious Rural Veterans in Home-Based Primary Care

Baylor College of Medicine2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
Generalized Anxiety Disorder-7

研究概览

简要总结

The purpose of this study is to determine the feasibility and acceptability of providing evidence-based, person-centered, culturally tailored treatment for anxiety and/or depression via telephone to rural Veterans receiving home-based primary care.

详细描述

VA-HELPS will include flexibility in both content and delivery to meet the needs of Home Based Primary Care (HBPC) Veterans. Content will be modular to meet the needs of both anxious and depressed participants. Modular skills-based treatment has been used successfully with a range of clinical problems (Chorpita et al., 2004; Henin et al., 2001; Wetherell et al., 2009, 2011), including our own group's work treating generalized anxiety disorder (GAD) in primary care (Calleo et al., in press) and anxiety-depression in patients with chronic illness (Cully et al., 2010). To further support a patient-centered treatment approach, patients will have the opportunity to include R/S. Research points to the importance of R/S in coping with illness, with 50-90% of patients reporting using their belief systems to enhance coping skills (Koenig & Adams, 2008). Along with content modifications, delivery of treatment should complement the needs of HBPC Veterans. Providing one initial in-home session, followed by telephone contact for subsequent sessions, allows cost effectiveness to be taken into consideration; and greater numbers of rural HBPC patients will have access to the intervention.

Treatment will involve approximately 6 to 8 weekly sessions lasting approximately 30-40 minutes each. After the first in-person session, all sessions will be delivered via telephone. At least one booster call (15-20 minutes) will occur during the month following completion of active treatment. All participants will complete assessments at baseline, 8 weeks, and 12 weeks.

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

  • Age 18 or older
  • Part of Home-Based Primary Care
  • Reside in a rural community, as defined by the US Census Bureau
  • Symptoms of anxiety and/or depression

排除标准

  • Significant cognitive impairment
  • Active suicidal intent
  • Current uncontrolled psychosis, bipolar, or substance-abuse disorders within the past month

结局指标

主要结局

Generalized Anxiety Disorder-7

时间窗: 12 weeks

Geriatric Anxiety Inventory

时间窗: 12 weeks

Penn State Worry Questionnaire (PSWQ-A)

时间窗: 12 weeks

次要结局

  • Brief RCOPE(12 weeks)
  • Working Alliance Inventory(12 weeks)
  • Patient Health Questionnaire-9(12 weeks)
  • Insomnia Severity Index(12 weeks)
  • SF-12 Health Survey(12 weeks)
  • Client Satisfaction Questionnaire(12 weeks)
  • Brief Multidimensional Measure of Religiousness and Spirituality(12 weeks)
  • Geriatric Depression Scale(12 weeks)

研究者

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

Melinda Stanley

Professor

Baylor College of Medicine

研究点 (2)

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