Trial Outcomes & Findings for Depression Therapy to Improve Cardiovascular Risk in HIV (NCT NCT02309372)
NCT ID: NCT02309372
Last Updated: 2020-07-14
Results Overview
Changes in flow-mediated dilation of the brachial artery from baseline to week 12. This is calculated by the FMD value at Week 12 minus the FMD value at baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
Baseline and Week 12 of participation
Results posted on
2020-07-14
Participant Flow
Participant milestones
| Measure |
Cognitive Behavioral Therapy (CBT)
Those assigned to the CBT arm will undergo therapy with the Beating the Blues (BtB) computerized intervention.
Beating the Blues: Computerized depression treatment intervention
|
Usual Care
No specific depression care will be provided through this study for those assigned to this arm. However, the participant's caregiver may choose to provide depression treatment outside of this trial.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
|
Overall Study
COMPLETED
|
24
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Cognitive Behavioral Therapy (CBT)
Those assigned to the CBT arm will undergo therapy with the Beating the Blues (BtB) computerized intervention.
Beating the Blues: Computerized depression treatment intervention
|
Usual Care
No specific depression care will be provided through this study for those assigned to this arm. However, the participant's caregiver may choose to provide depression treatment outside of this trial.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
Baseline Characteristics
Depression Therapy to Improve Cardiovascular Risk in HIV
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral Therapy (CBT)
n=27 Participants
Those assigned to the CBT arm will undergo therapy with the Beating the Blues (BtB) computerized intervention.
Beating the Blues: Computerized depression treatment intervention
|
Usual Care
n=27 Participants
No specific depression care will be provided through this study for those assigned to this arm. However, the participant's caregiver may choose to provide depression treatment outside of this trial.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.6 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
45.6 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
45.1 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12 of participationChanges in flow-mediated dilation of the brachial artery from baseline to week 12. This is calculated by the FMD value at Week 12 minus the FMD value at baseline.
Outcome measures
| Measure |
Cognitive Behavioral Therapy (CBT)
n=24 Participants
Those assigned to the CBT arm will undergo therapy with the Beating the Blues (BtB) computerized intervention.
Beating the Blues: Computerized depression treatment intervention
|
Usual Care
n=25 Participants
No specific depression care will be provided through this study for those assigned to this arm. However, the participant's caregiver may choose to provide depression treatment outside of this trial.
|
|---|---|---|
|
Change in Brachial Artery Flow-mediated Dilation From Baseline to Week 12
|
-0.47 absolute percent change
Standard Deviation 2.65
|
0.29 absolute percent change
Standard Deviation 2.93
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Participants who had blood samples available for analysis at both baseline and Week 12
Interleukin-6 (IL-6) is a measure of systemic inflammation. This is calculated by the IL-6 value at Week 12 minus the IL-6 value at baseline.
Outcome measures
| Measure |
Cognitive Behavioral Therapy (CBT)
n=23 Participants
Those assigned to the CBT arm will undergo therapy with the Beating the Blues (BtB) computerized intervention.
Beating the Blues: Computerized depression treatment intervention
|
Usual Care
n=24 Participants
No specific depression care will be provided through this study for those assigned to this arm. However, the participant's caregiver may choose to provide depression treatment outside of this trial.
|
|---|---|---|
|
Changes in Circulating IL-6 From Baseline to Week 12
|
2.38 pg/mL
Standard Deviation 8.71
|
1.24 pg/mL
Standard Deviation 4.16
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants who had blood samples available for analysis at both baseline and Week 12
hsCRP (high sensitivity C-reactive protein) is a measure of systemic inflammation. This is calculated by the hsCRP value at Week 12 minus the hsCRP value at baseline.
Outcome measures
| Measure |
Cognitive Behavioral Therapy (CBT)
n=23 Participants
Those assigned to the CBT arm will undergo therapy with the Beating the Blues (BtB) computerized intervention.
Beating the Blues: Computerized depression treatment intervention
|
Usual Care
n=24 Participants
No specific depression care will be provided through this study for those assigned to this arm. However, the participant's caregiver may choose to provide depression treatment outside of this trial.
|
|---|---|---|
|
Change in hsCRP From Baseline to Week 12
|
1.22 mg/L
Standard Deviation 3.89
|
1.06 mg/L
Standard Deviation 4.71
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants who had blood samples available for analysis at both baseline and Week 12
D-dimer is a measure of systemic coagulation. This is calculated by the D-dimer value at Week 12 minus the D-dimer value at baseline.
Outcome measures
| Measure |
Cognitive Behavioral Therapy (CBT)
n=23 Participants
Those assigned to the CBT arm will undergo therapy with the Beating the Blues (BtB) computerized intervention.
Beating the Blues: Computerized depression treatment intervention
|
Usual Care
n=24 Participants
No specific depression care will be provided through this study for those assigned to this arm. However, the participant's caregiver may choose to provide depression treatment outside of this trial.
|
|---|---|---|
|
Change in D-dimer From Baseline to Week 12
|
3.69 ng/mL
Standard Deviation 466
|
-10.26 ng/mL
Standard Deviation 651
|
Adverse Events
Cognitive Behavioral Therapy (CBT)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cognitive Behavioral Therapy (CBT)
n=27 participants at risk
Those assigned to the CBT arm will undergo therapy with the Beating the Blues (BtB) computerized intervention.
Beating the Blues: Computerized depression treatment intervention
|
Usual Care
n=27 participants at risk
No specific depression care will be provided through this study for those assigned to this arm. However, the participant's caregiver may choose to provide depression treatment outside of this trial.
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
3.7%
1/27 • 6 months
|
0.00%
0/27 • 6 months
|
|
Nervous system disorders
Migraine
|
3.7%
1/27 • 6 months
|
0.00%
0/27 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Elevated creatine kinase
|
3.7%
1/27 • 6 months
|
0.00%
0/27 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
1/27 • 6 months
|
0.00%
0/27 • 6 months
|
|
Psychiatric disorders
Alcohol abuse
|
3.7%
1/27 • 6 months
|
0.00%
0/27 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthroplasty of toe
|
0.00%
0/27 • 6 months
|
3.7%
1/27 • 6 months
|
Additional Information
Samir K. Gupta, MD, MS
Indiana University School of Medicine
Phone: 3172747926
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place