跳至主要内容
临床试验/NCT00847132
NCT00847132已完成不适用

A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2007年7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
175
试验地点
2
主要终点
Rates of Adequate Depression Treatment at Discharge

研究概览

简要总结

Depression in cardiac patients is common, persistent, and deadly. However, the vast majority of cardiac patients with depression go unrecognized and untreated, despite the existence of treatments that clearly improve depressive symptoms and may favorably impact survival. Our research group and others have found that depression recognition and treatment appears particularly limited among patients with acute cardiac illness, though this population may be the most vulnerable to the deleterious effects of depression. We propose a project, building on successful collaborative care depression management programs in outpatient settings, to address this important issue.

The specific hypotheses behind the proposed research are that a collaborative care depression management program can be successfully adapted to inpatient cardiac units, and that such a program will lead to greater rates of adequate depression treatment and improvements in secondary outcomes.

The following specific aims capture the stepwise goals of this program:

  1. To determine whether a collaborative care depression management program ('Enhanced Care') leads to significantly increased rates of adequate depression treatment compared to usual care (screening and feedback) (Primary Aim).
  2. To assess whether this Enhanced Care program has a lasting impact on adequate depression treatment, depressive symptoms, health-related quality of life, and adherence to medical recommendations at 6 weeks, 12 weeks, and 6 months, compared to usual care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • Inpatient admission for cardiac diagnosis
  • Positive depression evaluation (PHQ-2>2, PHQ-9>9)
  • Ability to provide informed consent

排除标准

  • Active suicidal ideation
  • Bipolar disorder, psychotic disorder, active substance use disorder

结局指标

主要结局

Rates of Adequate Depression Treatment at Discharge

时间窗: 5 days after enrollment

Adequate treatment was defined a priori as either: (1) discharge prescription of an antidepressant at a clinically effective dose based on manufacturers' package labeling and treatment guidelines for the treatment of depression or (2) referral to a mental health treatment provider for psychotherapy (unless pre-planned as less than six sessions). Timeframe of "5 days after enrollment" was determined by calculating the median length of hospitalization for all subjects.

次要结局

  • Change in Depression Symptoms From Baseline to 6 Months(Baseline, 6 weeks, 12 weeks, 6 months)

研究者

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

Jeff C. Huffman, MD

Principal Investigator

Massachusetts General Hospital

研究点 (2)

Loading locations...

相似试验