COPES Phase I Randomized Controlled Trial of Treatment For Distress in Heart Disease Patients

• Sponsor: Columbia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00158054
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 157
• Locations: 3
• Arms: 2
• Duration (Months): 122.9
• Patients Per Site: 52.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The specific aim of the "Coronary Patients Evaluation Study" (COPES) Project 2 is, within a Phase-I RCT, to examine patient satisfaction, treatment safety, and symptom reduction associated with treatment for symptoms of distress and/or depressed mood among post acute coronary syndrome (ACS) patients, as compared to usual cardiology care. For the purposes of this study, "symptoms of distress and/or depressed mood" is defined by a score on the Beck Depression Inventory (BDI) >10. The specific treatment approach utilized follows the, "Improving Mood-Promoting Access to Collaborative Treatment" (IMPACT) Clinical Trial, and involves up to 6-months of a patient preference, stepped-care protocol. Within this protocol, patients choose between brief, problem focused psychotherapy and anti-depressant medication. Treatment progress is reviewed at 2-month intervals, providing opportunities to 'step-up' treatment if patients are not demonstrating sufficient symptom reduction.

Condition or Disease	Intervention/Treatment	Phase
Heart Diseases; Depression	Behavioral: Enhanced depression care; Behavioral: Referred depression care	N/A

Detailed Description

Objectives: To examine patient satisfaction, treatment safety, and symptom reduction associated with treatment for symptoms of distress and/or depressed mood among post acute coronary syndrome (ACS) patients, as compared to usual cardiology care.

Research Design: The Study utilizes a Phase-I RCT design to achieve this Aim.

Methodology: Patients with confirmed ACS are screened for symptoms of distress and/or depressed mood within 7 days of the index ACS event, using the Beck Depression Inventory (BDI). Those meeting inclusion criterion on the BDI (score>10) and consenting to study are followed for 3-months, at which time they are re-assessed. Those continuing to show BDI score

10 and consenting, are randomized to the intervention condition (INT) or to usual cardiologic care (UCC). INT is defined by up to 6-months of a patient preference, stepped care treatment whereby patients chose between brief, problem-focused psychotherapy (PST) and antidepressant medication (MED). Patients are re-evaluated at 2- and 4-months after randomization. Those not showing sufficient improvement in symptoms receive augmented therapy. Those who initially choose PST can receive more frequent sessions and/or the addition of MED; those who initially choose MED can receive a change of agent, an increase in dosage, an additional medication, and/or PST.

Hypotheses to be tested are:

1. Patient satisfaction within intervention treatment (INT) will be higher than in the usual cardiologic care (UCC) condition, as evidenced by self-report and levels of participation

2. The INT group will experience a greater reduction in symptoms of distress and/or depression over the treatment period than the UCC group (secondary hypothesis).

3. Improvement in symptoms of distress and/or depression will be associated with reduction in levels of inflammatory markers and improvement in adherence with physician prescribed aspirin therapy (secondary hypothesis).

This is a multi-site study involving Mt. Sinai, and Yale and Columbia University Schools of Medicine. A total of 500 people will be screened into the initial 'observational period', which occurs at the time of new ACS diagnosis. From among these, it is anticipated that 200 people will evidence persistent BDI > 10 at 3-month follow-up and agree to be enrolled in the Phase 1 RCT.

The clinical relevance of the Study concerns demonstration of the acceptability and satisfaction with the treatment approach by post-ACS patients, as preliminary to a Phase-III RCT that would test the effect of such an intervention on event-free survival after ACS.

Study Design

• Study Type: Interventional
• Actual Enrollment: 157 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Consortium for Translation of Psychosocial Depression Theories to Interventions and Dissemination - Project 2: Phase I Randomized Controlled Trial of Patient Preference, Stepped-Care Treatment For Distress in Heart Disease Patients
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Condition (INT) Enhanced depression care: Participants assigned to INT condition will be given an information brochure describing the intervention. This description will include an overview of the two elements of treatment (Problem Solving Therapy (PST), pharmacotherapy), the choice that the participant has for which element of treatment they will receive, and the stepped care aspect of treatment.	Behavioral: Enhanced depression care; Initial patient preference for problem-solving therapy and/or pharmacotherapy, then a stepped-care approach.; Other Names: Patience-preference stepped care distress treatment intervention condition (INT)
Other: Usual Cardiologic Care Condition (UCC) Referred depression care: Participants assigned to the usual cardiologic care condition (UCC) condition will be scheduled for their next follow-up visit and thanked for their time.	Behavioral: Referred depression care; Physician notified of depression symptoms, usual care followed.; Other Names: Usual Cardiologic Care (UCC)

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms. [6 months]

   Number of participants who rated their depression care as excellent or very good as a percentage.

Secondary Outcome Measures

1. Level of Depressive Symptoms [6 months]

   Depressive 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).

2. Number of Participants Experiencing Major Adverse Cardiovascular Events [6 months]

   The table represents the number of participants experiencing major adverse cardiovascular events

3. All-cause Mortality [18 months]

   All- cause mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Hospitalization with a verified diagnosis of unstable angina (UA) or acute myocardial infarction (AMI). UA is defined as new-onset angina within 2 months, exacerbation of previous angina with pain at rest or with minimal exercise, prolonged chest pain (lasting > 20 minutes), or angina within 2 weeks following discharge for myocardial infarction in patients with documented coronary artery disease (defined as ischemic ECG ST-T segment changes, previously documented MI, positive nuclear treadmill test result, or coronary angiographic evidence of blockage of 50% stenosis in >1 major coronary artery). AMI is defined as at least 2 of the following: ischemic chest pain lasting >20 minutes, acute rise in serum troponin-I >1.0 ng/L, and new pathologic ST segments in >2 contiguous ECG leads.

2. Score on the Beck Depression Inventory (BDI) > 10 within 7 days of index ACS event and 3-months later.

Exclusion Criteria:

1. active suicidal or homicidal ideation, as these patients require immediate referral for assessment and treatment (see below for procedures for these patients);

2. current alcohol or other substance abuse disorders (as depressive symptoms may be a result of these disorders),

3. any current psychotic disorder,

4. history of psychotic disorder, bipolar disorder, or serious personality disorders,

5. diagnosis of a terminal non-cardiac illness,

6. ACS diagnosis secondary to diagnosis of a severe medical disease,

7. inability to communicate in English,

8. levels of cognitive impairment indicative of dementia,

9. unavailability for the period of the study,

10. overt hypothyroid, and

11. currently taking triptans.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University	New Haven	Connecticut	United States	06520
2	Mount Sinai School of Medicine	New York	New York	United States	10029
3	Columbia University	New York	New York	United States	10032

Sponsors and Collaborators

• Columbia University
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Karina Davidson, Ph.D., Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Karina Davidson, Professor of Behavioral Medicine, Columbia University
• ClinicalTrials.gov Identifier: NCT00158054
• Other Study ID Numbers: AAAB5166; GCO 02-0247; N01HC25197-0-0-0
• First Posted: Sep 12, 2005
• Last Update Posted: Aug 23, 2017
• Last Verified: Aug 1, 2017

• Keywords provided by Karina Davidson, Professor of Behavioral Medicine, Columbia University: depression; acute coronary syndrome; clinical trials
• Additional relevant MeSH terms: Heart Diseases; Depression; Depressive Disorder

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Enhanced Depression Care	Referred Depression Care
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	80	77
COMPLETED	70	74
NOT COMPLETED	10	3

Baseline Characteristics

Arm/Group Title	Enhanced Depression Care	Referred Depression Care	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	80	77	157
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.3 (10.6)	61.1 (10.6)	60.1 (10.6)
Sex: Female, Male (Count of Participants)
Female	41 51.3%	43 55.8%	84 53.5%
Male	39 48.8%	34 44.2%	73 46.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	36 45%	32 41.6%	68 43.3%
Not Hispanic or Latino	44 55%	45 58.4%	89 56.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (participants) [Number]
White	47 58.8%	40 51.9%	87 55.4%
Black/African American	12 15%	17 22.1%	29 18.5%
Asian/Indian	8 10%	7 9.1%	15 9.6%
Asian/Pacific Islander	0 0%	1 1.3%	1 0.6%
Native American	1 1.3%	0 0%	1 0.6%
Other	10 12.5%	10 13%	20 12.7%
Unknown/Decline to state	2 2.5%	2 2.6%	4 2.5%
Type of presenting acute coronary syndrome (participants) [Number]
Unstable angina	58 72.5%	60 77.9%	118 75.2%
Non-ST-segment elevation MI	13 16.3%	9 11.7%	22 14%
ST-segment elevation MI	8 10%	8 10.4%	16 10.2%
Other	1 1.3%	0 0%	1 0.6%
Beck Depression Inventory Score, categorical (participants) [Number]
BDI score >=16	52 65%	52 67.5%	104 66.2%
BDI score < 16	28 35%	25 32.5%	53 33.8%
Diagnosis of major depressive episode (participants) [Number]
Yes	23 28.8%	21 27.3%	44 28%
No	57 71.3%	56 72.7%	113 72%
GRACE ACS Risk and Mortality Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	91 (24)	94 (23)	93 (23)

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms.
Description	Number of participants who rated their depression care as excellent or very good as a percentage.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enhanced Depression Care	Referred Depression Care
Arm/Group Description	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.	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.
Measure Participants	80	77
Number [percentage of participants]	54.2 67.8%	18.8 24.4%

2. Secondary Outcome

Title	Level of Depressive Symptoms
Description	Depressive 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).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enhanced Depression Care	Referred Depression Care
Arm/Group Description	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.	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.
Measure Participants	80	70
Mean (95% Confidence Interval) [units on a scale]	13.2	17.7

3. Secondary Outcome

Title	Number of Participants Experiencing Major Adverse Cardiovascular Events
Description	The table represents the number of participants experiencing major adverse cardiovascular events
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enhanced Depression Care	Referred Depression Care
Arm/Group Description	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.	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.
Measure Participants	80	77
Number [participants]	3 3.8%	10 13%

4. Secondary Outcome

Title	All-cause Mortality
Description	All- cause mortality
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enhanced Depression Care	Referred Depression Care
Arm/Group Description	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.	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.
Measure Participants	80	77
Number [participants]	9 11.3%	7 9.1%

Adverse Events

Arm/Group Title	Enhanced Depression Care		Referred Depression Care
Arm/Group Description	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.		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
	Enhanced Depression Care		Referred Depression Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Enhanced Depression Care		Referred Depression Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/80 (27.5%)		22/77 (28.6%)
Cardiac disorders
ACS (intervention)	5/80 (6.3%)		7/77 (9.1%)
ACS (non-intervention)	2/80 (2.5%)		1/77 (1.3%)
Cath (diagnostic/non-intervention)	1/80 (1.3%)		4/77 (5.2%)
Chest pain	7/80 (8.8%)		6/77 (7.8%)
Hypertension	1/80 (1.3%)		0/77 (0%)
Hypotension/Postural Hypotension	0/80 (0%)		1/77 (1.3%)
Intervention (scheduled/non-urgent)	2/80 (2.5%)		6/77 (7.8%)
Life-threatening arrythmia	1/80 (1.3%)		1/77 (1.3%)
Other (cardiac)	2/80 (2.5%)		1/77 (1.3%)
General disorders
Chest pain (non-cardiac)	1/80 (1.3%)		1/77 (1.3%)
Non-CV	2/80 (2.5%)		0/77 (0%)
Other (non-cardiac)	5/80 (6.3%)		9/77 (11.7%)
Self-report only; no additional info	1/80 (1.3%)		1/77 (1.3%)
Shortness of breath, fatigue, CHF	2/80 (2.5%)		4/77 (5.2%)
Death	0/80 (0%)		1/77 (1.3%)
Psychiatric disorders
Other (psych)	1/80 (1.3%)		0/77 (0%)
Suicidal Ideation	2/80 (2.5%)		1/77 (1.3%)
Vascular disorders
Stroke	1/80 (1.3%)		0/77 (0%)
Other (Not Including Serious) Adverse Events
	Enhanced Depression Care		Referred Depression Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	60/80 (75%)		74/77 (96.1%)
Cardiac disorders
Chest pain	14/80 (17.5%)		21/77 (27.3%)
Hypotension/Postural Hypotension	1/80 (1.3%)		1/77 (1.3%)
Intervention (scheduled/non-urgent)	0/80 (0%)		1/77 (1.3%)
Other (cardiac)	1/80 (1.3%)		1/77 (1.3%)
General disorders
Chest pain (non-cardiac)	4/80 (5%)		8/77 (10.4%)
Non-CV	1/80 (1.3%)		7/77 (9.1%)
Other (non-cardiac)	58/80 (72.5%)		71/77 (92.2%)
Self-report only; no additional info	1/80 (1.3%)		5/77 (6.5%)
Shortness of breath, fatigue, CHF	23/80 (28.8%)		34/77 (44.2%)
Psychiatric disorders
Other (psych)	47/80 (58.8%)		62/77 (80.5%)
Suicidal Ideation	7/80 (8.8%)		11/77 (14.3%)
Worsening Depressioin	4/80 (5%)		7/77 (9.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.