Trial Outcomes & Findings for COPES Phase I Randomized Controlled Trial of Treatment For Distress in Heart Disease Patients (NCT NCT00158054)
NCT ID: NCT00158054
Last Updated: 2017-08-23
Results Overview
Number of participants who rated their depression care as excellent or very good as a percentage.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
157 participants
Primary outcome timeframe
6 months
Results posted on
2017-08-23
Participant Flow
Participants were recruited at 5 hospital sites (Mount Sinai Hospital and New York Presbyterian Hospital, New York, New York; and New Haven Hospital, Hospital of St Raphael, and Veterans Affairs Connecticut Healthcare System-West Haven, New Haven, Connecticut) from January 1, 2005, through February 29, 2008.
Participant milestones
| Measure |
Enhanced Depression Care
The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
|
Referred Depression Care
The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
77
|
|
Overall Study
COMPLETED
|
70
|
74
|
|
Overall Study
NOT COMPLETED
|
10
|
3
|
Reasons for withdrawal
| Measure |
Enhanced Depression Care
The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
|
Referred Depression Care
The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
|
|---|---|---|
|
Overall Study
Refused to continue
|
3
|
0
|
|
Overall Study
Unavailable for follow up
|
7
|
3
|
Baseline Characteristics
COPES Phase I Randomized Controlled Trial of Treatment For Distress in Heart Disease Patients
Baseline characteristics by cohort
| Measure |
Enhanced Depression Care
n=80 Participants
The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
|
Referred Depression Care
n=77 Participants
The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
61.1 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
60.1 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
36 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
47 participants
n=5 Participants
|
40 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
12 participants
n=5 Participants
|
17 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Indian
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown/Decline to state
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Type of presenting acute coronary syndrome
Unstable angina
|
58 participants
n=5 Participants
|
60 participants
n=7 Participants
|
118 participants
n=5 Participants
|
|
Type of presenting acute coronary syndrome
Non-ST-segment elevation MI
|
13 participants
n=5 Participants
|
9 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Type of presenting acute coronary syndrome
ST-segment elevation MI
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Type of presenting acute coronary syndrome
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Beck Depression Inventory Score, categorical
BDI score >=16
|
52 participants
n=5 Participants
|
52 participants
n=7 Participants
|
104 participants
n=5 Participants
|
|
Beck Depression Inventory Score, categorical
BDI score < 16
|
28 participants
n=5 Participants
|
25 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Diagnosis of major depressive episode
Yes
|
23 participants
n=5 Participants
|
21 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Diagnosis of major depressive episode
No
|
57 participants
n=5 Participants
|
56 participants
n=7 Participants
|
113 participants
n=5 Participants
|
|
GRACE ACS Risk and Mortality Score
|
91 units on a scale
STANDARD_DEVIATION 24 • n=5 Participants
|
94 units on a scale
STANDARD_DEVIATION 23 • n=7 Participants
|
93 units on a scale
STANDARD_DEVIATION 23 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsNumber of participants who rated their depression care as excellent or very good as a percentage.
Outcome measures
| Measure |
Enhanced Depression Care
n=80 Participants
The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
|
Referred Depression Care
n=77 Participants
The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
|
|---|---|---|
|
Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms.
|
54.2 percentage of participants
|
18.8 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsDepressive symptoms were measured using the Beck Depression Inventory (BDI), which is a 21-item multiple choice, self-report instrument that is used to assess the severity of symptoms of depression. The score ranges from 0 (no symptoms) to 63 (worst symptoms).
Outcome measures
| Measure |
Enhanced Depression Care
n=80 Participants
The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
|
Referred Depression Care
n=70 Participants
The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
|
|---|---|---|
|
Level of Depressive Symptoms
|
13.2 units on a scale
Interval 11.1 to 15.3
|
17.7 units on a scale
Interval 15.6 to 19.7
|
SECONDARY outcome
Timeframe: 6 monthsThe table represents the number of participants experiencing major adverse cardiovascular events
Outcome measures
| Measure |
Enhanced Depression Care
n=80 Participants
The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
|
Referred Depression Care
n=77 Participants
The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
|
|---|---|---|
|
Number of Participants Experiencing Major Adverse Cardiovascular Events
|
3 participants
|
10 participants
|
SECONDARY outcome
Timeframe: 18 monthsAll- cause mortality
Outcome measures
| Measure |
Enhanced Depression Care
n=80 Participants
The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
|
Referred Depression Care
n=77 Participants
The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
|
|---|---|---|
|
All-cause Mortality
|
9 participants
|
7 participants
|
Adverse Events
Enhanced Depression Care
Serious events: 22 serious events
Other events: 60 other events
Deaths: 0 deaths
Referred Depression Care
Serious events: 22 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enhanced Depression Care
n=80 participants at risk
The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
|
Referred Depression Care
n=77 participants at risk
The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
|
|---|---|---|
|
General disorders
Chest pain (non-cardiac)
|
1.2%
1/80
|
1.3%
1/77
|
|
Cardiac disorders
Hypertension
|
1.2%
1/80
|
0.00%
0/77
|
|
Cardiac disorders
Hypotension/Postural Hypotension
|
0.00%
0/80
|
1.3%
1/77
|
|
Cardiac disorders
ACS (intervention)
|
6.2%
5/80
|
9.1%
7/77
|
|
Cardiac disorders
ACS (non-intervention)
|
2.5%
2/80
|
1.3%
1/77
|
|
Cardiac disorders
Cath (diagnostic/non-intervention)
|
1.2%
1/80
|
5.2%
4/77
|
|
Cardiac disorders
Chest pain
|
8.8%
7/80
|
7.8%
6/77
|
|
Cardiac disorders
Intervention (scheduled/non-urgent)
|
2.5%
2/80
|
7.8%
6/77
|
|
Cardiac disorders
Life-threatening arrythmia
|
1.2%
1/80
|
1.3%
1/77
|
|
General disorders
Non-CV
|
2.5%
2/80
|
0.00%
0/77
|
|
Cardiac disorders
Other (cardiac)
|
2.5%
2/80
|
1.3%
1/77
|
|
General disorders
Other (non-cardiac)
|
6.2%
5/80
|
11.7%
9/77
|
|
Psychiatric disorders
Other (psych)
|
1.2%
1/80
|
0.00%
0/77
|
|
General disorders
Self-report only; no additional info
|
1.2%
1/80
|
1.3%
1/77
|
|
General disorders
Shortness of breath, fatigue, CHF
|
2.5%
2/80
|
5.2%
4/77
|
|
Vascular disorders
Stroke
|
1.2%
1/80
|
0.00%
0/77
|
|
Psychiatric disorders
Suicidal Ideation
|
2.5%
2/80
|
1.3%
1/77
|
|
General disorders
Death
|
0.00%
0/80
|
1.3%
1/77
|
Other adverse events
| Measure |
Enhanced Depression Care
n=80 participants at risk
The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
|
Referred Depression Care
n=77 participants at risk
The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
|
|---|---|---|
|
Cardiac disorders
Chest pain
|
17.5%
14/80
|
27.3%
21/77
|
|
General disorders
Chest pain (non-cardiac)
|
5.0%
4/80
|
10.4%
8/77
|
|
Cardiac disorders
Hypotension/Postural Hypotension
|
1.2%
1/80
|
1.3%
1/77
|
|
Cardiac disorders
Intervention (scheduled/non-urgent)
|
0.00%
0/80
|
1.3%
1/77
|
|
General disorders
Non-CV
|
1.2%
1/80
|
9.1%
7/77
|
|
Cardiac disorders
Other (cardiac)
|
1.2%
1/80
|
1.3%
1/77
|
|
General disorders
Other (non-cardiac)
|
72.5%
58/80
|
92.2%
71/77
|
|
Psychiatric disorders
Other (psych)
|
58.8%
47/80
|
80.5%
62/77
|
|
General disorders
Self-report only; no additional info
|
1.2%
1/80
|
6.5%
5/77
|
|
General disorders
Shortness of breath, fatigue, CHF
|
28.7%
23/80
|
44.2%
34/77
|
|
Psychiatric disorders
Suicidal Ideation
|
8.8%
7/80
|
14.3%
11/77
|
|
Psychiatric disorders
Worsening Depressioin
|
5.0%
4/80
|
9.1%
7/77
|
Additional Information
Karina W Davidson, PhD
Columbia University Medical Center
Phone: 212-342-4493
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place