Beating the Blues for Your Heart (BtB-Heart)

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01605552
First received: May 9, 2012
Last updated: March 23, 2016
Last verified: March 2016

May 9, 2012
March 23, 2016
July 2011
December 2012   (final data collection date for primary outcome measure)
Change in Brachial Flow-Mediated Dilation (FMD) From Pre- to Post- Treatment [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]
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.
Change in Brachial Flow-Mediated Dilation (FMD) at 12 Weeks [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]
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 % increase in brachial diameter at either 60 or 90 seconds after cuff deflation.
Complete list of historical versions of study NCT01605552 on ClinicalTrials.gov Archive Site
  • Change in Depressive Symptoms Severity (SCL-20 Score) From Pre- to Post- Treatment [ Time Frame: 0 and 12 Weeks ] [ Designated as safety issue: No ]
    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.
  • Change in C-reactive Protein (CRP) From Pre- to Post- Treatment [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]
    A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.
  • Change in Interleukin-6 (IL-6) From Pre- to Post- Treatment [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]
    A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.
  • Change in Depressive Symptoms Severity at 12 Weeks [ Time Frame: 0, 6, and 12 Weeks ] [ Designated as safety issue: No ]
    Self-reported depressive symptom severity (SCL-20 score)
  • Change in Poor Health Behaviors at 12 Weeks [ Time Frame: 0, 6, and 12 weeks ] [ Designated as safety issue: No ]
    Self-reported smoking, physical inactivity, and cardiovascular medication and lifestyle adherence.
  • Change in Autonomic Nervous System Function at 12 Weeks [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]
    High-frequency heart rate variability (HRV) and pre-ejection period (PEP)
  • Change in Circulating Markers of Systemic Inflammation at 12 Weeks [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]
    Plasma C-reactive protein(CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha).
Not Provided
Not Provided
 
Beating the Blues for Your Heart
Computer-Based Depression Treatment to Reduce Coronary Artery Disease Risk
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.
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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Depression
  • Depressive Symptoms
  • Cardiovascular Disease (CVD)
  • Coronary Artery Disease (CAD)
  • Heart Disease
  • Behavioral: 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.
    Other Names:
    • Computer-Based Cognitive Behavioral Therapy (CBT)
    • Computer-Based Psychotherapy
  • Other: 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.
    Other Name: Treatment As Usual (TAU)
  • Experimental: Beating the Blues (BtB)
    An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)
    Intervention: Behavioral: Beating the Blues (BtB)
  • Usual Care
    Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.
    Intervention: Other: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01605552
1105005448, CRP4880000, 1703
Yes
Not Provided
Not Provided
Indiana University
Indiana University
American Heart Association
Principal Investigator: Jesse C. Stewart, Ph.D. Indiana University-Purdue Univerisity Indianapolis
Indiana University
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP