Computer-Based Depression Treatment to Reduce Coronary Artery Disease Risk
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| City: |
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Indianapolis |
| State: |
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Indiana |
| Zip Code: |
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46202 |
| Conditions: |
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Depression - Depressive Symptoms - Cardiovascular Disease (CVD) - Coronary Artery Disease (CAD) - Heart Disease |
| Purpose: |
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The objective of this clinical trial is to evaluate whether a computerized depression
treatment, delivered before the onset of heart disease, reduces the risk of heart disease in
the future. Participants in this trial will be primary care patients who are depressed but
do not have a history of heart disease. Half of these patients will receive a standard
treatment (usual care), and the other half will receive eight weeks of an evidence-based
psychological treatment called Beating the Blues®, which is a computerized, cognitive
behavioral treatment program for depression. To evaluate change in heart disease risk, the
investigators will measure the functioning of the arteries using ultrasound before and after
the treatment. It is hypothesized that patients who receive Beating the Blues® will show
greater improvements in both depression and artery function than patients who receive
standard treatment.
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| Study Summary: |
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Depression is an independent risk factor for coronary artery disease (CAD); unfortunately,
past trials have not detected a cardiovascular benefit. A promising and unexplored
explanation for these results is that the interventions were delivered too late in the
natural history of CAD. Because no study has evaluated this possibility, there is a critical
need to determine whether evidence-based depression treatment, delivered before the onset of
clinical CAD, reduces cardiovascular risk. Accordingly, the objective of the proposed
clinical and translational research is to perform a preliminary evaluation of the efficacy
of a highly disseminable depression intervention in decreasing CAD risk. To achieve this
goal, a clinical trial of depressed primary care patients free of cardiovascular disease is
being conducted. Patients will be randomized to usual care or a computer-based, cognitive
behavioral intervention called Beating the Blues®, the most widely used and empirically
supported computerized treatment program for depression. The primary outcome is brachial
artery flow-mediated dilation, a noninvasive measure of endothelial function. The specific
aim of the proposed trial is to evaluate whether Beating the Blues®, delivered prior to the
onset of clinical CAD, improves endothelial dysfunction. Demonstrating that earlier
treatment of depression with Beating the Blues lowers CAD risk, the long-term expected
outcome, would place computed-based depression treatment in the armamentarium of CAD
prevention strategies of the primary care provider. This change to clinical practice should
result in improved cardiovascular risk management, which in turn would translate into
reduced CAD morbidity and mortality.
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| Criteria: |
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Inclusion Criteria:
- Primary care patients
- Age ≥40 years
- Clinically significant depressive symptoms (Patient Health Questionnaire-9 ≥10)
- No history of cardiovascular disease
Exclusion Criteria:
- Pregnant women
- A history of chronic disorders (HIV/AIDS, chronic kidney disease, systemic
inflammatory disease, or past-year cancer)
- Current use of anticoagulants or vasodilators (antihypertensive and lipid-lowering
medications are allowed)
- Current drinking problem
- History of bipolar disorder or psychosis
- Ongoing treatment for depression with a psychiatrist or psychologist/ counselor
(antidepressants alone are allowed)
- Severe cognitive impairment
- Acute risk of suicide
- Significant vision or hearing problems
- Individuals who do not read or speak English
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| NCT ID: |
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NCT01605552 |
| Primary Contact: |
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Principal Investigator
Jesse C. Stewart, Ph.D.
Indiana University-Purdue Univerisity Indianapolis
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| Backup Contact: |
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N/A |
| Location Contact: |
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Indianapolis, Indiana 46202
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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