Depression Clinical Trial
— BtB-HeartOfficial title:
Computer-Based Depression Treatment to Reduce Coronary Artery Disease Risk
Verified date | November 2022 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University-Purdue University Indianapolis (IUPUI) | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University | American Heart Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Post-Treatment Depressive Symptoms Severity (SCL-20 Score) Adjusted for Pre-Treatment SCL-20 Score | 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. | 12 Weeks | |
Secondary | Post-Treatment C-reactive Protein (CRP) Adjusted for Pre-Treatment CRP | A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment. | 12 weeks | |
Secondary | Post-Treatment Interleukin-6 (IL-6) Adjusted for Pre-Treatment IL-6 | A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment. | 12 weeks |
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