Trial Outcomes & Findings for Effectiveness of Depression Treatment Following Coronary Artery Bypass Surgery (NCT NCT00091962)
NCT ID: NCT00091962
Last Updated: 2016-04-14
Results Overview
The 36-item Medical Outcomes Study Form (v.2) Mental Component Scale (SF-36 MCS). Range 0-100; Population norm is 50 with standard deviation of 10. Higher scores are better. Ware J, Kosinski M, Keller S. SF-36 Physical and Mental Health Summary Scales: A User's Manual. 2nd ed. Boston, MA: New England Medical Center; 1994.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
453 participants
Primary outcome timeframe
Measured 8 months post-CABG
Results posted on
2016-04-14
Participant Flow
Participant milestones
| Measure |
Depressed Intervention
Collaborative care program for depression involving a telephone-based nurse care manager
Counseling: Counseling program
Pharmacotherapy: Medication to treat depression
|
Depressed Usual Care
Control group will receive usual care for depression
Usual Care: Usual care for depression
|
Non-Depressed Control Group
|
|---|---|---|---|
|
Overall Study
STARTED
|
150
|
152
|
151
|
|
Overall Study
COMPLETED
|
150
|
152
|
151
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Depression Treatment Following Coronary Artery Bypass Surgery
Baseline characteristics by cohort
| Measure |
Depressed Intervention
n=150 Participants
Collaborative care program for depression involving a telephone-based nurse care manager
Counseling: Counseling program
Pharmacotherapy: Medication to treat depression
|
Depressed Usual Care
n=152 Participants
Control group will receive usual care for depression
Usual Care: Usual care for depression
|
Non-Depressed Control
n=151 Participants
Observational only
|
Total
n=453 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
85 Participants
n=39 Participants
|
84 Participants
n=41 Participants
|
60 Participants
n=35 Participants
|
229 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
65 Participants
n=39 Participants
|
68 Participants
n=41 Participants
|
91 Participants
n=35 Participants
|
224 Participants
n=31 Participants
|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 10.8 • n=39 Participants
|
64 years
STANDARD_DEVIATION 11.2 • n=41 Participants
|
66 years
STANDARD_DEVIATION 9.6 • n=35 Participants
|
65 years
STANDARD_DEVIATION 10 • n=31 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=39 Participants
|
56 Participants
n=41 Participants
|
56 Participants
n=35 Participants
|
181 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=39 Participants
|
96 Participants
n=41 Participants
|
95 Participants
n=35 Participants
|
272 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
147 Participants
n=39 Participants
|
152 Participants
n=41 Participants
|
149 Participants
n=35 Participants
|
448 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
52 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
132 Participants
n=39 Participants
|
142 Participants
n=41 Participants
|
122 Participants
n=35 Participants
|
396 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
150 participants
n=39 Participants
|
152 participants
n=41 Participants
|
151 participants
n=35 Participants
|
453 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Measured 8 months post-CABGThe 36-item Medical Outcomes Study Form (v.2) Mental Component Scale (SF-36 MCS). Range 0-100; Population norm is 50 with standard deviation of 10. Higher scores are better. Ware J, Kosinski M, Keller S. SF-36 Physical and Mental Health Summary Scales: A User's Manual. 2nd ed. Boston, MA: New England Medical Center; 1994.
Outcome measures
| Measure |
Depressed Intervention
n=150 Participants
Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs' direction; referral to mental health specialist
Psychoeducation; Treatment recommendations: Counseling program
Pharmacotherapy: Medication to treat depression
|
Depressed Usual Care
n=152 Participants
"Usual care" for depression by patients' PCP
|
Non-Depressed Control
n=151 Participants
Non-depressed control group with no intervention
|
|---|---|---|---|
|
Generic Mental Health-Related Quality of Life
|
50.0 units on a scale
Standard Error 1.0
|
46.2 units on a scale
Standard Error 1.1
|
57.2 units on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: 8 months post CABGThe 17-item Depression Interview and Structured Hamilton (DISH) version of the Hamilton Rating Scale for Depression Standard provides an accurate DSM-IV diagnosis of a cardiac patient's mood disorder and a reliable HRS-D score. Range 0-52. Higher scores are worse. Psychosom Med. 2002;64(6):897-905
Outcome measures
| Measure |
Depressed Intervention
n=150 Participants
Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs' direction; referral to mental health specialist
Psychoeducation; Treatment recommendations: Counseling program
Pharmacotherapy: Medication to treat depression
|
Depressed Usual Care
n=152 Participants
"Usual care" for depression by patients' PCP
|
Non-Depressed Control
n=151 Participants
Non-depressed control group with no intervention
|
|---|---|---|---|
|
Hamilton Rating Scale for Depression
|
9.0 units on a scale
Standard Error 0.7
|
11.4 units on a scale
Standard Error 0.7
|
3.8 units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: 8 months post CABGThe 36-item Medical Outcomes Study Form (v.2) Physical Component Scale (SF-36 PCS). Range 0-100; Population norm is 50 with standard deviation of 10. Higher scores are better. Ware J, Kosinski M, Keller S. SF-36 Physical and Mental Health Summary Scales: A User's Manual. 2nd ed. Boston, MA: New England Medical Center; 1994.
Outcome measures
| Measure |
Depressed Intervention
n=150 Participants
Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs' direction; referral to mental health specialist
Psychoeducation; Treatment recommendations: Counseling program
Pharmacotherapy: Medication to treat depression
|
Depressed Usual Care
n=152 Participants
"Usual care" for depression by patients' PCP
|
Non-Depressed Control
n=151 Participants
Non-depressed control group with no intervention
|
|---|---|---|---|
|
Generic Physical Health-Related Quality of Life
|
44.0 participants
Standard Error 0.8
|
41.4 participants
Standard Error 0.8
|
48.7 participants
Standard Error 0.7
|
SECONDARY outcome
Timeframe: 8 months post CABGThe 12-item Duke Activity Status Index (DASI). Scores range from 0-58.2, and higher scores the better the functional capacity (Am J Cardiol. 1989;64(10):651-654).
Outcome measures
| Measure |
Depressed Intervention
n=150 Participants
Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs' direction; referral to mental health specialist
Psychoeducation; Treatment recommendations: Counseling program
Pharmacotherapy: Medication to treat depression
|
Depressed Usual Care
n=152 Participants
"Usual care" for depression by patients' PCP
|
Non-Depressed Control
n=151 Participants
Non-depressed control group with no intervention
|
|---|---|---|---|
|
Disease-Specific Health-Related Quality of Life
|
25.2 units on a scale
Standard Error 1.0
|
21.4 units on a scale
Standard Error 1.0
|
33.2 units on a scale
Standard Error 1.1
|
Adverse Events
Depressed Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Depressed Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Depressed Control
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
Dr. Bruce L Rollman, Principal Investigator
University of Pittsburgh School of Medicine
Phone: (412) 692-2659
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place