Trial Outcomes & Findings for Beating the Blues for Your Heart (NCT NCT01605552)
NCT ID: NCT01605552
Last Updated: 2022-12-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
12 weeks
Results posted on
2022-12-29
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
16
|
|
Overall Study
COMPLETED
|
7
|
14
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Beating the Blues for Your Heart
Baseline characteristics by cohort
| Measure |
Beating the Blues (BtB)
n=13 Participants
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
n=16 Participants
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
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.6 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
50.5 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
49.2 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPatients 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.
Outcome measures
| Measure |
Beating the Blues (BtB)
n=7 Participants
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
n=14 Participants
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.
|
|---|---|---|
|
Post-Treatment Brachial Flow-Mediated Dilation (FMD) Adjusted for Pre-Treatment FMD
|
4.18 % change in brachial diameter
Standard Deviation 2.86
|
2.47 % change in brachial diameter
Standard Deviation 2.72
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: 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.
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.
Outcome measures
| Measure |
Beating the Blues (BtB)
n=7 Participants
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
n=13 Participants
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.
|
|---|---|---|
|
Post-Treatment Depressive Symptoms Severity (SCL-20 Score) Adjusted for Pre-Treatment SCL-20 Score
|
0.83 SCL-20 points
Standard Deviation 0.36
|
1.44 SCL-20 points
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: 12 weeksA marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.
Outcome measures
| Measure |
Beating the Blues (BtB)
n=7 Participants
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
n=14 Participants
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.
|
|---|---|---|
|
Post-Treatment C-reactive Protein (CRP) Adjusted for Pre-Treatment CRP
|
2.70 mg/l
Standard Deviation 3.15
|
4.71 mg/l
Standard Deviation 1.82
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: One case was excluded from the usual care group due to extreme values.
A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.
Outcome measures
| Measure |
Beating the Blues (BtB)
n=7 Participants
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
n=13 Participants
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.
|
|---|---|---|
|
Post-Treatment Interleukin-6 (IL-6) Adjusted for Pre-Treatment IL-6
|
3.76 pg/ml
Standard Deviation 1.65
|
4.75 pg/ml
Standard Deviation 2.84
|
Adverse Events
Beating the Blues (BtB)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jesse C. Stewart, Ph.D.
Indiana University-Purdue University Indianapolis (IUPUI)
Phone: (317) 274-6761
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place