Efficacy Study of a Computer Decision Support System to Treat Depression (CDSS-D)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00551083|
Recruitment Status : Completed
First Posted : October 30, 2007
Last Update Posted : October 30, 2007
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder||Other: Computerized Decision Support System for Depression (CDSS-D) Other: Usual Care (UC)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Efficacy Trial of a Computer Decision Support System Compared to Usual Care for Depression Treatment in Primary Care|
|Study Start Date :||March 2005|
|Actual Study Completion Date :||June 2006|
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
Other: Computerized Decision Support System for Depression (CDSS-D)
The CDSS for depression was based on an up-to-date model of the Texas Medication Algorithm Project that employs the principles of Measurement Based Care (MBC), while at the same time having a user interface for providers that is easy-to-use. MBC is the systematic use of measuring clinical outcomes at routine visits to guide treatment management. These outcomes may include symptoms, side effects, and medication adherence. Recent efforts from the large, multi-site effectiveness study, Sequenced Treatment Alternatives to Relieve Depression (STAR*D), show that a treatment plan guided by MBC is integral in implementing algorithm based care.
Active Comparator: 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
Other: Usual Care (UC)
Usual Care was up to the discretion of the study physician and the patient treated. These physicians were provided with up-to-date treatment protocols for depression, but were not instructed to strictly adhere to a treatment algorithm. Therefore, they treated depressed patients as they "usually" would.
- Mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD) Score [ Time Frame: 24 weeks ]
- Mean change from baseline on the 16-item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR-16) [ Time Frame: 24 weeks ]
- Mean change from baseline on the 30-item Inventory of Depressive Symptomatology - Clinician's version (IDS-C-30) [ Time Frame: 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00551083
|Principal Investigator:||Madhukar H. Trivedi, M.D.||University of Texas Southwestern Medical Center|