Beating the Blues for Your Heart

NCT ID: NCT01605552

Last Updated: 2022-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Beating the Blues (BtB)

An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)

Group Type: EXPERIMENTAL

Beating the Blues (BtB)

Intervention Type: BEHAVIORAL

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

Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.

Group Type: OTHER

Usual Care

Intervention Type: OTHER

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.

Interventions

Beating the Blues (BtB)

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.

Intervention Type: BEHAVIORAL

Usual Care

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.

Intervention Type: OTHER

Other Intervention Names

Computer-Based Cognitive Behavioral Therapy (CBT); Computer-Based Psychotherapy; Treatment As Usual (TAU)

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Jesse Stewart

Assistant Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jesse C. Stewart, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Indiana University-Purdue Univerisity Indianapolis

Locations

Indiana University-Purdue University Indianapolis (IUPUI)

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

CRP4880000

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1703

Identifier Type: OTHER

Identifier Source: secondary_id

1105005448

Identifier Type: -

Identifier Source: org_study_id