Beating the Blues for Your Heart

Phase 2

Completed

Conditions: Depressive Symptoms
Cardiovascular Disease (CVD)
Heart Disease
Depression
Coronary Artery Disease (CAD)

Interventions: Behavioral: Beating the Blues (BtB)
Other: Usual Care

Registration Number: NCT01605552

Lead Sponsor: Indiana University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 29

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Beating the Blues (BtB)	Beating the Blues (BtB)	An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)
Usual Care	Usual Care	Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.

Primary Outcome Measures

Name	Time	Method
Post-Treatment Brachial Flow-Mediated Dilation (FMD) Adjusted for Pre-Treatment FMD	12 weeks	Patients will undergo ultrasound assessment of brachial FMD in accordance with established guidelines. After a 10-minute supine rest, high-resolution baseline images of the brachial artery will be obtained from 3 consecutive cardiac cycles. Next, the forearm cuff will be inflated to 250 mmHg for 5 minutes and then will be rapidly deflated. At 60 and 90 seconds post-deflation, images from 3 consecutive cardiac cycles will be acquired. FMD values will be computed as the % change in brachial diameter at either 60 or 90 seconds after cuff deflation.

Secondary Outcome Measures

Name	Time	Method
Post-Treatment C-reactive Protein (CRP) Adjusted for Pre-Treatment CRP	12 weeks	A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.
Post-Treatment Interleukin-6 (IL-6) Adjusted for Pre-Treatment IL-6	12 weeks	A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.
Post-Treatment Depressive Symptoms Severity (SCL-20 Score) Adjusted for Pre-Treatment SCL-20 Score	12 Weeks	Self-reported depressive symptom severity was measured at pre- (0 weeks) and post- (12 weeks) treatment visits by the 20 depression items from the Symptom Checklist 90 (Hopkins Symptom Checklist depression scale; SCL-20). Each item on the scale ranges from 0 (not at all) to 4 (extremely). Total scores are the average across all response items and range from 0 to 4 with higher scores indicating greater levels of depressive symptoms.