Beating the Blues for Your Heart
Condition: Depression; Depressive Symptoms; Cardiovascular Disease (CVD); Coronary Artery Disease (CAD); Heart Disease
MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Depression; Depressive Disorder
Intervention: Beating the Blues (BtB); Usual Care
Intervention description: 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.; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 29.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Depression; Depressive Symptoms; Cardiovascular Disease (CVD); Coronary Artery Disease (CAD); Heart Disease

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.
    

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