Beating the Blues for Your Heart (BtB-Heart)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Indiana University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01605552
First received: May 9, 2012
Last updated: July 12, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Depression
Depressive Symptoms
Cardiovascular Disease (CVD)
Coronary Artery Disease (CAD)
Heart Disease
Behavioral: Beating the Blues (BtB)
Other: Usual Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Computer-Based Depression Treatment to Reduce Coronary Artery Disease Risk

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 30
Study Start Date: July 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Beating the Blues (BtB) 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
Usual Care 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)

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605552

Locations
United States, Indiana
Indiana University-Purdue University Indianapolis (IUPUI)
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
American Heart Association
Investigators
Principal Investigator: Jesse C. Stewart, Ph.D. Indiana University-Purdue Univerisity Indianapolis
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01605552     History of Changes
Other Study ID Numbers: 1105005448, CRP4880000, 1703
Study First Received: May 9, 2012
Last Updated: July 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Depression
Depressive Symptoms
Cardiovascular Disease (CVD)
Coronary Artery Disease (CAD)
Heart Disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Depression
Depressive Disorder
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 14, 2014