Beating the Blues for Your Heart (BtB-Heart)
|ClinicalTrials.gov Identifier: NCT01605552|
Recruitment Status : Completed
First Posted : May 25, 2012
Results First Posted : February 24, 2016
Last Update Posted : April 21, 2016
|Condition or disease||Intervention/treatment||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 (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Computer-Based Depression Treatment to Reduce Coronary Artery Disease Risk|
|Study Start Date :||July 2011|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2012|
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.
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)
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01605552
|United States, Indiana|
|Indiana University-Purdue University Indianapolis (IUPUI)|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Jesse C. Stewart, Ph.D.||Indiana University-Purdue Univerisity Indianapolis|