Beating the Blues for Your Heart (BtB-Heart)

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01605552
First received: May 9, 2012
Last updated: March 23, 2016
Last verified: March 2016
Results First Received: January 27, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Depression
Depressive Symptoms
Cardiovascular Disease (CVD)
Coronary Artery Disease (CAD)
Heart Disease
Interventions: Behavioral: Beating the Blues (BtB)
Other: Usual Care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Beating the Blues (BtB)

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

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.

Usual Care

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

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.


Participant Flow:   Overall Study
    Beating the Blues (BtB)     Usual Care  
STARTED     13     16  
COMPLETED     7 [1]   14  
NOT COMPLETED     6     2  
[1] 4 dropped out before the first BtB visit; it is unlikely that the treatment was the cause of dropout



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Beating the Blues (BtB)

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

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.

Usual Care

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

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.

Total Total of all reporting groups

Baseline Measures
    Beating the Blues (BtB)     Usual Care     Total  
Number of Participants  
[units: participants]
  13     16     29  
Age  
[units: years]
Mean (Standard Deviation)
  47.6  (6.3)     50.5  (6.7)     49.2  (6.6)  
Gender  
[units: participants]
     
Female     7     8     15  
Male     6     8     14  



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

2.  Secondary:   Change in Depressive Symptoms Severity (SCL-20 Score) From Pre- to Post- Treatment   [ Time Frame: 0 and 12 Weeks ]

3.  Secondary:   Change in C-reactive Protein (CRP) From Pre- to Post- Treatment   [ Time Frame: 0 and 12 weeks ]

4.  Secondary:   Change in Interleukin-6 (IL-6) From Pre- to Post- Treatment   [ Time Frame: 0 and 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

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.



  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jesse C. Stewart, Ph.D.
Organization: Indiana University-Purdue University Indianapolis (IUPUI)
phone: (317) 274-6761
e-mail: jstew@iupui.edu



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 )
Study First Received: May 9, 2012
Results First Received: January 27, 2016
Last Updated: March 23, 2016
Health Authority: United States: Institutional Review Board