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临床试验/NCT01201967
NCT01201967已完成4 期

A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients (MOSAIC)

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 183 人开始时间: 2010年9月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
183
试验地点
2
主要终点
Change in Mental Health-related Quality of Life From Baseline to 24 Weeks

研究概览

简要总结

For this trial, the investigators propose a prospective trial of a collaborative care program to identify and treat depression, generalized anxiety disorder, and panic disorder among patients admitted to the hospital for an acute cardiac illness (acute coronary syndrome, congestive heart failure, or arrhythmia). Such assessment and treatment for depression/generalized anxiety disorder/panic disorder will begin in the hospital, and ongoing management will continue for six months following discharge.

The investigators hypothesize that this model will lead to increased treatment rates, improved mood, reduced anxiety, and improved medical outcomes in this vulnerable population. If this model is effective, it could be implemented clinically to provide better and more complete care to patients hospitalized with acute cardiac illness, for whom depression and anxiety may be a risk factor for complications and death.

This will be a two-arm, single-blind randomized controlled trial, with one-half of patients randomized to collaborative care and one-half randomized to the control condition (usual care). Psychiatric treatment in the intervention arm will be provided in concert with patients' primary care physicians-with primary care physicians prescribing all medications-within a framework supervised by a psychiatrist.

The investigators will enroll patients who have any (or all) of the three included psychiatric diagnoses to improve the utility of the intervention. The investigators have chosen to enroll patients with several different cardiac diagnoses. This will allow the researchers to include patients with heterogeneous diagnoses and illness severity to determine if our intervention is effective in a broad population of patients with heart disease. The investigators will study an intervention targeting depression, generalized anxiety disorder, and panic disorder: all three disorders are disabling and associated with adverse cardiovascular outcomes, treatments for the conditions are highly similar, the investigators can treat patients who have more than one disorder, and a prior outpatient program successfully simultaneously addressed more than one mental health condition.

The project will involve: (1) screening patients for depression, generalized anxiety disorder, and panic disorder as part of usual clinical care, (2) evaluation of positive-screen patients by a study social work care manager, (3) a multicomponent in-hospital intervention (for collaborative care patients) that involves patient education, specialist-provided treatment recommendations, and a goal of in-hospital treatment initiation, and (4), after discharge, continued phone-based evaluation and care coordination with primary care physicians to provide stepwise treatment in the collaborative care arm. The intervention has been designed to be low-cost, low-burden, and easily generalizable to other settings.

详细描述

  • Primary in-hospital outcome measure:
  • Adequate treatment by discharge (percent rates)
  • Primary overall study measure:
  • Change from baseline mental health-related quality of life (Short Form-12 Mental Component Score)
  • Depression outcome measures:
  • Change from baseline depression (Patient Health Questionnaire-9)
  • Anxiety outcome measures:
  • Change from baseline anxiety (Hospital Anxiety and Depression Scale-Anxiety Subscale)
  • Medical outcome measures:

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

  • Adult (age 18-up)admitted to inpatient cardiac unit at Massachusetts General Hospital
  • Primary diagnosis of acute coronary syndrome, congestive heart failure, or arrhythmia
  • Positive anxiety or depression screen during initial nursing intake interview that is performed as part of usual clinical care
  • Meets criteria for clinical depression, generalized anxiety disorder, or panic disorder

排除标准

  • Bipolar disorder
  • Substance use disorder
  • Psychosis
  • Cognitive disorder
  • Active suicidal ideation
  • Medical condition with likely survival less than 6 months
  • Non-English speaking

研究组 & 干预措施

Collaborative care

Experimental

Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.

干预措施: Collaborative care (Other)

Usual care

Placebo Comparator

Patient's physicians are informed of diagnosis of depression/anxiety disorder

干预措施: Usual care (Other)

结局指标

主要结局

Change in Mental Health-related Quality of Life From Baseline to 24 Weeks

时间窗: Baseline, 24 weeks

Mental health-related quality of life is measured by the Short Form-12 Mental Component Score (SF-12 MCS). The SF-12 MCS is a 6-item scale that assesses mental health-related quality of life. Each question provides the option of 2-6 answers. Some questions are Yes/No (2 options), while others ask how often something occurs (6 options, etc.). Scores are calculated using a formula and can range from 0 to 100. A score of 50 indicates average mental health-related quality of life. Higher scores represent higher than average mental health-related quality of life, and lower scores represent lower mental health-related quality of life.

次要结局

  • Change in Depression Symptoms From Baseline to 24 Weeks(Baseline, 24 weeks)
  • Change in Health Status From Baseline to 24 Weeks(Baseline, 24 weeks)
  • Change in Physical Function From Baseline to 24 Weeks(Baseline, 24 weeks)
  • Change in Anxiety Symptoms From Baseline to 24 Weeks(Baseline, 24 weeks)
  • Rate of Adequate Treatment of Depression and/or Anxiety Symptoms 5 Days After Enrollment(5 days after enrollment)
  • Change in Adherence to Health Behaviors From Baseline to 24 Weeks(Baseline, 24 weeks)
  • Number of Rehospitalizations From Baseline to 24 Weeks(24 weeks)
  • Change in Physical Health-related Quality of Life From Baseline to 24 Weeks(Baseline, 24 weeks)

研究者

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

Jeff C. Huffman, MD

Medical Director, Blake 11

Massachusetts General Hospital

研究点 (2)

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