BtB-Heart: Beating the Blues for Your Heart

• Sponsor: Indiana University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01605552
• Collaborator: American Heart Association (Other)
• Enrollment: 29
• Location: 1
• Arms: 2
• Duration (Months): 17.1
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

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

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• 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
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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
Other: 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 Names: Treatment As Usual (TAU)

Outcome Measures

Primary Outcome Measures

1. Change in Brachial Flow-Mediated Dilation (FMD) From Pre- to Post- Treatment [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

1. Change in Depressive Symptoms Severity (SCL-20 Score) From Pre- to Post- Treatment [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.

2. Change in C-reactive Protein (CRP) From Pre- to Post- Treatment [0 and 12 weeks]

   A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.

3. Change in Interleukin-6 (IL-6) From Pre- to Post- Treatment [0 and 12 weeks]

   A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Indiana University
• ClinicalTrials.gov Identifier: NCT01605552
• Other Study ID Numbers: 1105005448; CRP4880000; 1703
• First Posted: May 25, 2012
• Last Update Posted: Apr 21, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by Indiana University: Depression; Depressive Symptoms; Cardiovascular Disease (CVD); Coronary Artery Disease (CAD); Heart Disease
• Additional relevant MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Depression; Depressive Disorder

Study Results

Participant Flow

Arm/Group Title	Beating the Blues (BtB)	Usual Care
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	13	16
COMPLETED	7	14
NOT COMPLETED	6	2

Baseline Characteristics

Arm/Group Title	Beating the Blues (BtB)	Usual Care	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	13	16	29
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.6 (6.3)	50.5 (6.7)	49.2 (6.6)
Sex: Female, Male (Count of Participants)
Female	7 53.8%	8 50%	15 51.7%
Male	6 46.2%	8 50%	14 48.3%

Outcome Measures

1. Primary Outcome

Title	Change in Brachial Flow-Mediated Dilation (FMD) From Pre- to Post- Treatment
Description	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.
Time Frame	0 and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Beating the Blues (BtB)	Usual Care
Arm/Group Description	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.	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.
Measure Participants	7	14
Mean (Standard Deviation) [% increase in brachial diameter]	1.59 (4.53)	-0.04 (3.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Beating the Blues (BtB), Usual Care
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.21
	Comments
	Method	ANCOVA
	Comments

2. Secondary Outcome

Title	Change in Depressive Symptoms Severity (SCL-20 Score) From Pre- to Post- Treatment
Description	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.
Time Frame	0 and 12 Weeks

Outcome Measure Data

Analysis Population Description

One participant in the usual care group did not complete the SCL-20 at the pre-treatment visit. Therefore a change score could not be computed for this participant. The remaining number of participants in usual care for this analysis was 13.

Arm/Group Title	Beating the Blues (BtB)	Usual Care
Arm/Group Description	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.	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.
Measure Participants	7	13
Mean (Standard Deviation) [Change in scores on a scale]	-0.82 (0.61)	-0.16 (0.81)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Beating the Blues (BtB), Usual Care
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.019
	Comments
	Method	ANCOVA
	Comments

3. Secondary Outcome

Title	Change in C-reactive Protein (CRP) From Pre- to Post- Treatment
Description	A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.
Time Frame	0 and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Beating the Blues (BtB)	Usual Care
Arm/Group Description	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.	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.
Measure Participants	7	14
Mean (Standard Deviation) [change in mg/L]	-1.84 (3.61)	0.42 (2.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Beating the Blues (BtB), Usual Care
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.38
	Comments
	Method	ANCOVA
	Comments

4. Secondary Outcome

Title	Change in Interleukin-6 (IL-6) From Pre- to Post- Treatment
Description	A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.
Time Frame	0 and 12 weeks

Outcome Measure Data

Analysis Population Description

One case was excluded from the usual care group due to extreme values.

Arm/Group Title	Beating the Blues (BtB)	Usual Care
Arm/Group Description	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.	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.
Measure Participants	7	13
Mean (Standard Deviation) [change in pg/ml]	-0.41 (2.58)	-0.15 (5.91)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Beating the Blues (BtB), Usual Care
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.43
	Comments
	Method	ANCOVA
	Comments

Adverse Events

Time Frame	Adverse event data were collected from recruitment initiation in June 2011 until study completion in July 2013. For each participant, adverse event data were collected between the pre- and post-treatment visits, for up to 12 weeks.
Arm/Group Title	Beating the Blues (BtB)		Usual Care
Arm/Group Description	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.		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.
All Cause Mortality
	Beating the Blues (BtB)		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Beating the Blues (BtB)		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Beating the Blues (BtB)		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/16 (0%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.