Efficacy Study of a Computer Decision Support System to Treat Depression (CDSS-D)
October 29, 2007 updated by: University of Texas Southwestern Medical Center
A Pilot Efficacy Trial of a Computer Decision Support System Compared to Usual Care for Depression Treatment in Primary Care
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD) Score
Time Frame: 24 weeks
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mean change from baseline on the 16-item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR-16)
Time Frame: 24 weeks
|
24 weeks
|
|
Mean change from baseline on the 30-item Inventory of Depressive Symptomatology - Clinician's version (IDS-C-30)
Time Frame: 24 weeks
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
October 29, 2007
First Submitted That Met QC Criteria
October 29, 2007
First Posted (Estimate)
October 30, 2007
Study Record Updates
Last Update Posted (Estimate)
October 30, 2007
Last Update Submitted That Met QC Criteria
October 29, 2007
Last Verified
October 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S1143107
- R01 MH-164062-01A1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.