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临床试验/NCT00551083
NCT00551083已完成不适用

A Pilot Efficacy Trial of a Computer Decision Support System Compared to Usual Care for Depression Treatment in Primary Care

University of Texas Southwestern Medical Center0 个研究点目标入组 60 人开始时间: 2005年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
主要终点
Mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD) Score

研究概览

简要总结

The purpose of this study was designed to test the feasibility and effectiveness of implementing a Computerized Decision Support System for depression (CDSS-D) during acute care in a primary care setting.

详细描述

The research project was designed to test the feasibility and effectiveness of implementing a Computerized Decision Support System for depression (CDSS-D) during acute care in a primary care setting. The basic experimental design was a two-group, two-site study design. Three different clinics with a total of 4 primary care physicians agreed and provided informed consent and participated in the study. Half of the physicians used the CDSS-D to treat patients with MDD and the other half provided Usual Care (UC) treatment.

The intervention, CDSS-D, incorporated a pre-existing depression treatment algorithm (Texas Medication Algorithm Project for Depression, Trivedi et al) with computer decision support programming, providing the treatment group physicians with a computerized algorithm.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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
否

入选标准

  • •Outpatients aged 18 and over
  • •Met Criteria for Non-Psychotic Major Depressive Disorder
  • •Had a baseline HRSD-17 score of at least 14

排除标准

  • •Patients with a current Axis I diagnosis of somatization disorder, anorexia nervosa, bulimia, or obsessive-compulsive disorder
  • •Patients with current alcohol or substance dependence
  • •Women with a positive pregnancy test or who are lactating
  • •Women of child-bearing potential who are not practicing a clinically accepted method of contraception
  • •Patients with general medical conditions that contraindicate antidepressant medications
  • •Patient whose clinical status requires inpatient or day hospital treatment

研究组 & 干预措施

CDSS-D

Experimental

Computer Decision Support System for Depression (CDSS-D) - This arm provided physicians with a computerized treatment algorithm and a decision support system to treat their patients suffering Major Depressive Disorder

干预措施: Computerized Decision Support System for Depression (CDSS-D) (Other)

UC

Active Comparator

Usual Care (UC) - This group of physicians treated their patients suffering from Major Depressive Disorder with their standard treatment as usual, and received no algorithm support with regard to treatment decisions

干预措施: Usual Care (UC) (Other)

结局指标

主要结局

Mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD) Score

时间窗: 24 weeks

次要结局

  • Mean change from baseline on the 16-item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR-16)(24 weeks)
  • Mean change from baseline on the 30-item Inventory of Depressive Symptomatology - Clinician's version (IDS-C-30)(24 weeks)

研究者

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