Beating the Blues for Your Heart

NCT01605552 | Completed Phase 2 Results DMC

• 3 other identifiers: 1105005448CRP48800001703
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Post-Treatment Brachial Flow-Mediated Dilation (FMD) Adjusted for Pre-Treatment FMD

  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.

  12 weeks

Secondary Outcomes (3)

• Post-Treatment Depressive Symptoms Severity (SCL-20 Score) Adjusted for Pre-Treatment SCL-20 Score

  12 Weeks

• Post-Treatment C-reactive Protein (CRP) Adjusted for Pre-Treatment CRP

  12 weeks

• Post-Treatment Interleukin-6 (IL-6) Adjusted for Pre-Treatment IL-6

  12 weeks

Study Arms (2)

Beating the Blues (BtB)

EXPERIMENTAL

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

Behavioral: Beating the Blues (BtB)

Usual Care

OTHER

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

Other: Usual Care

Interventions

Beating the Blues (BtB) 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.

Also known as: Computer-Based Cognitive Behavioral Therapy (CBT), Computer-Based Psychotherapy

Beating the Blues (BtB)

Usual Care 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.

Also known as: Treatment As Usual (TAU)

Usual Care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary care patients
• Age ≥40 years
• Clinically significant depressive symptoms (Patient Health Questionnaire-9 ≥10)
• No history of cardiovascular disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• American Heart Association: collaborator

Study Sites (1)

Indiana University-Purdue University Indianapolis (IUPUI)

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Depression; Cardiovascular Diseases; Coronary Artery Disease; Heart Diseases

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

Missing data precluded analysis of one secondary outcome variables: Tumor Necrosis Factor-Alpha (TNF-a). Due to the very small sample of randomized patients, conclusions should not be drawn from the results of this pilot trial.

Results Point of Contact

• Title: Jesse C. Stewart, Ph.D.
• Organization: Indiana University-Purdue University Indianapolis (IUPUI)

jstew@iupui.edu

(317) 274-6761

Study Officials

• Jesse C. Stewart, Ph.D.

  Indiana University-Purdue Univerisity Indianapolis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Study Record Dates

• First Submitted: May 9, 2012
• First Posted: May 25, 2012
• Study Start: July 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 29, 2022
• Results First Posted: February 24, 2016

Record last verified: 2022-11

Locations

US (1)