This trial is active, not recruiting.

Conditions depression, depressive symptoms, cardiovascular disease (cvd), coronary artery disease (cad), heart disease
Treatments beating the blues (btb), usual care
Phase phase 2
Sponsor Indiana University
Collaborator American Heart Association
Start date July 2011
End date December 2012
Trial size 30 participants
Trial identifier NCT01605552, 1105005448, 1703, CRP4880000


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
beating the blues (btb) Computer-Based Cognitive Behavioral Therapy (CBT)
BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session.
usual care Treatment As Usual (TAU)
Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive.

Primary Outcomes

Change in Brachial Flow-Mediated Dilation (FMD) at 12 Weeks
time frame: 0 and 12 weeks

Secondary Outcomes

Change in Depressive Symptoms Severity at 12 Weeks
time frame: 0, 6, and 12 Weeks
Change in Poor Health Behaviors at 12 Weeks
time frame: 0, 6, and 12 weeks
Change in Autonomic Nervous System Function at 12 Weeks
time frame: 0 and 12 weeks
Change in Circulating Markers of Systemic Inflammation at 12 Weeks
time frame: 0 and 12 weeks

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

Official title Computer-Based Depression Treatment to Reduce Coronary Artery Disease Risk
Principal investigator Jesse C. Stewart, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by Indiana University.