Efficacy Study of a Computer Decision Support System to Treat Depression

Not Applicable

Completed

• Conditions: Depressive Disorder
• Interventions: Other: Computerized Decision Support System for Depression (CDSS-D); Other: Usual Care (UC)

• Registration Number: NCT00551083
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2005-03
• Study Completion: 2006-06
• Status Verified: 2007-10
• Study First Submitted: 2007-10-29
• Study First Submitted QC: 2007-10-29
• Last Update Submitted: 2007-10-29
• Study First Posted: 2007-10-30
• Last Update Posted: 2007-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CDSS-D	Computerized Decision Support System for Depression (CDSS-D)	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
UC	Usual Care (UC)	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

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD) Score	24 weeks

Secondary Outcome Measures

Name	Time	Method
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