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临床试验/NCT00012974
NCT00012974已完成1 期

Innovative Strategies for Implementing New CHF Guideline Recommendations

US Department of Veterans Affairs4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2005年11月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
60
试验地点
4
主要终点
Reduction in severity of depression; scores on depression rating scales at baseline, 12 weeks and 24 weeks

研究概览

简要总结

The purpose of this study is to examine the efficacy of telephone-administered cognitive-behavioral therapy (T-CBT) in treating major depression among veterans served by community-based outpatient clinics (CBOCs) in the Veteran�s Integrated Service Network (VISN) 21, which serves rural areas in Northern California

详细描述

More that 20% of patients in primary care have depressive disorders. While primary care is the principal venue for treatment for depression, fewer than 25% of depressed patients receive adequate treatment for their depression. These outcomes can be worse when there are barriers to treatment such as living in a rural area. Several studies have found that given a choice, about two-thirds of depressed primary care patients prefer psychotherapy or counseling over antidepressant medication.

This is a controlled, randomized trial in which subjects meeting criteria for major depressive disorder (MDD) from primary care settings in VISN 21 including CBOCs will be randomly assigned to one of two conditions: 1) a 16-session manualized telephone administered cognitive behavioral therapy (T-CBT) delivered over 24 weeks or 2) a treatment-as-usual (TAU) condition. Telephone-administered cognitive behavioral therapy (T-CBT) is an intervention aimed at improving coping skills and social functioning. It is divided into two phases: 1) an initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and 2) a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains. T-CBT, administered by doctoral level psychologists, will be compared to a treatment-as-usual (TAU) condition that controls for the natural course of depression during the course of treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
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

  • Patients must have chronic heart failure, systolic left ventricular dysfunction (ejection fraction less than or equal to 45%), not be receiving beta-blockers, and not have contraindications to beta-blockers.

排除标准

  • 未提供

结局指标

主要结局

Reduction in severity of depression; scores on depression rating scales at baseline, 12 weeks and 24 weeks

次要结局

  • Maintenance of treatment gains at 6 month follow-up (week 48).

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (4)

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