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Beating the Blues for Your Heart (BtB-Heart)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01605552
First Posted: May 25, 2012
Last Update Posted: April 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Indiana University
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Computer-Based Depression Treatment to Reduce Coronary Artery Disease Risk

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Change in Brachial Flow-Mediated Dilation (FMD) From Pre- to Post- Treatment [ Time Frame: 0 and 12 weeks ]
    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.


Secondary Outcome Measures:
  • Change in Depressive Symptoms Severity (SCL-20 Score) From Pre- to Post- Treatment [ Time Frame: 0 and 12 Weeks ]
    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 ]
    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 ]
    A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.


Enrollment: 29
Study Start Date: July 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Beating the Blues (BtB)
An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)
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
Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.
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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01605552     History of Changes
Other Study ID Numbers: 1105005448
CRP4880000 ( Other Grant/Funding Number: American Heart Association )
1703 ( Other Identifier: Indiana Clinical Research Center )
First Submitted: May 9, 2012
First Posted: May 25, 2012
Results First Submitted: January 27, 2016
Results First Posted: February 24, 2016
Last Update Posted: April 21, 2016
Last Verified: March 2016

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

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