Clinical trial NCT01605552: Beating the Blues for Your Heart
Official title: Computer-Based Depression Treatment to Reduce Coronary Artery Disease Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Depressive Symptoms
Cardiovascular Disease (CVD)
Coronary Artery Disease (CAD)
Heart Disease
Keywords: Depression
Depressive Symptoms
Cardiovascular Disease (CVD)
Coronary Artery Disease (CAD)
Heart Disease
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2012-05-25
Enrollment: 29
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-Treatment Brachial Flow-Mediated Dilation (FMD) Adjusted for Pre-Treatment FMD
timeFrame: 12 weeks
Secondary outcomes:
measure: Post-Treatment Depressive Symptoms Severity (SCL-20 Score) Adjusted for Pre-Treatment SCL-20 Score
timeFrame: 12 Weeks
measure: Post-Treatment C-reactive Protein (CRP) Adjusted for Pre-Treatment CRP
timeFrame: 12 weeks
measure: Post-Treatment Interleukin-6 (IL-6) Adjusted for Pre-Treatment IL-6
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University-Purdue University Indianapolis (IUPUI)
state: Indiana
Study officials:
affiliation: Indiana University-Purdue Univerisity Indianapolis
name: Jesse C. Stewart, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: