Trial Outcomes & Findings for Comparison of Depression Interventions After Acute Coronary Syndrome (NCT NCT01032018)
NCT ID: NCT01032018
Last Updated: 2017-09-13
Results Overview
Symptoms of depression were assessed using the Beck Depression Inventory (BDI). This 21-question, multiple choice self-report instrument includes items pertaining to symptoms of depression, including hopelessness and irritability, physical symptoms such as fatigue, and thoughts such as guilt. Each item has at a set of four possible responses, ranging in intensity for least intense to most intense. The total score is calculated by adding the responses to each item. Higher scores indicate more severe depressive symptoms. The total score on the scale ranges from 0 to 63. Total scores on the scale of less 10 indicate minimal depression; total scores between 10 and 15 indicate mild depression; and total scores greater than 16 indicate a probable clinical diagnosis of depression.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
150 participants
Primary outcome timeframe
Change from depression at baseline to depression at 6-months
Results posted on
2017-09-13
Participant Flow
Participants were recruited from sites connected with 5 field centers from March 18, 2010, to January 9, 2012. To be eligible, participants had to demonstrate elevated depressive symptoms on the BDI 2 to 6 months after hospitalization for an ACS.
724 patients were medically eligible for participation in the study, of which 150 consented to randomization and were enrolled.
Participant milestones
| Measure |
Referred Care
The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
|
Stepped Care
The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
73
|
|
Overall Study
COMPLETED
|
71
|
67
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Referred Care
The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
|
Stepped Care
The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
5
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Comparison of Depression Interventions After Acute Coronary Syndrome
Baseline characteristics by cohort
| Measure |
Referred Care
n=77 Participants
The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
|
Stepped Care
n=73 Participants
The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
59.2 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
59.6 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
84 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
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Beck Depression Inventory Score, continuous
|
20.6 Scores on a scale
STANDARD_DEVIATION 7.8 • n=5 Participants
|
21.0 Scores on a scale
STANDARD_DEVIATION 7.6 • n=7 Participants
|
20.8 Scores on a scale
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Beck Depression Inventory Score, categorical
BDI score < 16
|
27 participants
n=5 Participants
|
21 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Beck Depression Inventory Score, categorical
BDI score >= 16
|
50 participants
n=5 Participants
|
52 participants
n=7 Participants
|
102 participants
n=5 Participants
|
|
Type of presenting acute coronary syndrome
Unstable angina
|
35 participants
n=5 Participants
|
35 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Type of presenting acute coronary syndrome
Non-ST segment elevated MI
|
19 participants
n=5 Participants
|
18 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Type of presenting acute coronary syndrome
ST-segment elevated MI
|
21 participants
n=5 Participants
|
19 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Type of presenting acute coronary syndrome
Bundle branch block/uncertain type of MI
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from depression at baseline to depression at 6-monthsSymptoms of depression were assessed using the Beck Depression Inventory (BDI). This 21-question, multiple choice self-report instrument includes items pertaining to symptoms of depression, including hopelessness and irritability, physical symptoms such as fatigue, and thoughts such as guilt. Each item has at a set of four possible responses, ranging in intensity for least intense to most intense. The total score is calculated by adding the responses to each item. Higher scores indicate more severe depressive symptoms. The total score on the scale ranges from 0 to 63. Total scores on the scale of less 10 indicate minimal depression; total scores between 10 and 15 indicate mild depression; and total scores greater than 16 indicate a probable clinical diagnosis of depression.
Outcome measures
| Measure |
Referred Care
n=77 Participants
The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
|
Stepped Care
n=73 Participants
The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
|
|---|---|---|
|
Depressive Symptom Reduction
|
-6.6 Scores on a scale
Standard Deviation 1.0 • Interval -8.5 to -4.8
|
-10.1 Scores on a scale
Standard Deviation 0.9 • Interval -12.0 to -8.1
|
PRIMARY outcome
Timeframe: 6 months after randomizationOutcome measures
| Measure |
Referred Care
n=77 Participants
The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
|
Stepped Care
n=73 Participants
The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
|
|---|---|---|
|
Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services)
|
4289.23 dollars
Standard Error 826.56
|
4358.02 dollars
Standard Error 883.76
|
Adverse Events
Referred Care
Serious events: 8 serious events
Other events: 63 other events
Deaths: 0 deaths
Stepped Care
Serious events: 7 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Referred Care
n=77 participants at risk
The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
|
Stepped Care
n=73 participants at risk
The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
|
|---|---|---|
|
General disorders
Death
|
0.00%
0/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Gastrointestinal disorders
GI bleeding
|
1.3%
1/77 • 2, 4, and 6 months after enrollment
|
2.7%
2/73 • 2, 4, and 6 months after enrollment
|
|
Infections and infestations
MRSA Infection
|
1.3%
1/77 • 2, 4, and 6 months after enrollment
|
0.00%
0/73 • 2, 4, and 6 months after enrollment
|
|
Blood and lymphatic system disorders
Internal bleeding
|
0.00%
0/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
1/77 • 2, 4, and 6 months after enrollment
|
0.00%
0/73 • 2, 4, and 6 months after enrollment
|
|
Infections and infestations
Pneumonia
|
6.5%
5/77 • 2, 4, and 6 months after enrollment
|
4.1%
3/73 • 2, 4, and 6 months after enrollment
|
|
Nervous system disorders
Stroke
|
0.00%
0/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
Other adverse events
| Measure |
Referred Care
n=77 participants at risk
The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
|
Stepped Care
n=73 participants at risk
The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Abdominal hernia
|
0.00%
0/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Psychiatric disorders
Worsened agitation
|
9.1%
7/77 • 2, 4, and 6 months after enrollment
|
5.5%
4/73 • 2, 4, and 6 months after enrollment
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Psychiatric disorders
Worsened anxiety/nervousness
|
6.5%
5/77 • 2, 4, and 6 months after enrollment
|
5.5%
4/73 • 2, 4, and 6 months after enrollment
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
2/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Gastrointestinal disorders
Blood in stool
|
2.6%
2/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
2/77 • 2, 4, and 6 months after enrollment
|
0.00%
0/73 • 2, 4, and 6 months after enrollment
|
|
Gastrointestinal disorders
Worsened decreased appetite
|
10.4%
8/77 • 2, 4, and 6 months after enrollment
|
8.2%
6/73 • 2, 4, and 6 months after enrollment
|
|
Gastrointestinal disorders
Worsened diarrhea
|
3.9%
3/77 • 2, 4, and 6 months after enrollment
|
6.8%
5/73 • 2, 4, and 6 months after enrollment
|
|
Gastrointestinal disorders
Diverticulitis
|
1.3%
1/77 • 2, 4, and 6 months after enrollment
|
0.00%
0/73 • 2, 4, and 6 months after enrollment
|
|
Nervous system disorders
Worsened dizziness
|
0.00%
0/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Nervous system disorders
Worsened drowsiness
|
9.1%
7/77 • 2, 4, and 6 months after enrollment
|
2.7%
2/73 • 2, 4, and 6 months after enrollment
|
|
Skin and subcutaneous tissue disorders
Worsened dry mouth
|
18.2%
14/77 • 2, 4, and 6 months after enrollment
|
11.0%
8/73 • 2, 4, and 6 months after enrollment
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Gastrointestinal disorders
Dysphagia
|
1.3%
1/77 • 2, 4, and 6 months after enrollment
|
0.00%
0/73 • 2, 4, and 6 months after enrollment
|
|
Ear and labyrinth disorders
Ear bleeding
|
0.00%
0/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Musculoskeletal and connective tissue disorders
Fall
|
2.6%
2/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Gastrointestinal disorders
GI problems
|
32.5%
25/77 • 2, 4, and 6 months after enrollment
|
41.1%
30/73 • 2, 4, and 6 months after enrollment
|
|
Blood and lymphatic system disorders
Gum bleeding
|
1.3%
1/77 • 2, 4, and 6 months after enrollment
|
2.7%
2/73 • 2, 4, and 6 months after enrollment
|
|
Nervous system disorders
Headaches
|
0.00%
0/77 • 2, 4, and 6 months after enrollment
|
2.7%
2/73 • 2, 4, and 6 months after enrollment
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
1.3%
1/77 • 2, 4, and 6 months after enrollment
|
0.00%
0/73 • 2, 4, and 6 months after enrollment
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
0.00%
0/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Gastrointestinal disorders
Worsened increase in appetite
|
6.5%
5/77 • 2, 4, and 6 months after enrollment
|
12.3%
9/73 • 2, 4, and 6 months after enrollment
|
|
Gastrointestinal disorders
Worsened indigestion
|
19.5%
15/77 • 2, 4, and 6 months after enrollment
|
19.2%
14/73 • 2, 4, and 6 months after enrollment
|
|
Nervous system disorders
Worsened insomnia
|
3.9%
3/77 • 2, 4, and 6 months after enrollment
|
5.5%
4/73 • 2, 4, and 6 months after enrollment
|
|
Gastrointestinal disorders
Irregular menstrual period
|
1.3%
1/77 • 2, 4, and 6 months after enrollment
|
0.00%
0/73 • 2, 4, and 6 months after enrollment
|
|
Musculoskeletal and connective tissue disorders
Joint pains
|
1.3%
1/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Musculoskeletal and connective tissue disorders
Knee injury
|
0.00%
0/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Cardiac disorders
Leg edema
|
28.6%
22/77 • 2, 4, and 6 months after enrollment
|
20.5%
15/73 • 2, 4, and 6 months after enrollment
|
|
Metabolism and nutrition disorders
Low potassium
|
0.00%
0/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Psychiatric disorders
Mood disturbance
|
1.3%
1/77 • 2, 4, and 6 months after enrollment
|
0.00%
0/73 • 2, 4, and 6 months after enrollment
|
|
Gastrointestinal disorders
Worsened nausea
|
10.4%
8/77 • 2, 4, and 6 months after enrollment
|
8.2%
6/73 • 2, 4, and 6 months after enrollment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Blood and lymphatic system disorders
Nosebleed
|
2.6%
2/77 • 2, 4, and 6 months after enrollment
|
9.6%
7/73 • 2, 4, and 6 months after enrollment
|
|
Nervous system disorders
Numbness of arms and legs
|
1.3%
1/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Blood and lymphatic system disorders
Oral bleedin
|
1.3%
1/77 • 2, 4, and 6 months after enrollment
|
0.00%
0/73 • 2, 4, and 6 months after enrollment
|
|
Nervous system disorders
Pain
|
0.00%
0/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Cardiac disorders
Palpitations
|
1.3%
1/77 • 2, 4, and 6 months after enrollment
|
0.00%
0/73 • 2, 4, and 6 months after enrollment
|
|
Nervous system disorders
Pruritus
|
1.3%
1/77 • 2, 4, and 6 months after enrollment
|
0.00%
0/73 • 2, 4, and 6 months after enrollment
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
1/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Gastrointestinal disorders
Rectal bleeding
|
5.2%
4/77 • 2, 4, and 6 months after enrollment
|
6.8%
5/73 • 2, 4, and 6 months after enrollment
|
|
Reproductive system and breast disorders
Worsened sexual side effects
|
6.5%
5/77 • 2, 4, and 6 months after enrollment
|
4.1%
3/73 • 2, 4, and 6 months after enrollment
|
|
Infections and infestations
Strep throat
|
0.00%
0/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
|
Metabolism and nutrition disorders
Worsened sweating
|
5.2%
4/77 • 2, 4, and 6 months after enrollment
|
8.2%
6/73 • 2, 4, and 6 months after enrollment
|
|
Nervous system disorders
Tingling of fingers and toes
|
1.3%
1/77 • 2, 4, and 6 months after enrollment
|
0.00%
0/73 • 2, 4, and 6 months after enrollment
|
|
Nervous system disorders
Worsened tremors
|
7.8%
6/77 • 2, 4, and 6 months after enrollment
|
4.1%
3/73 • 2, 4, and 6 months after enrollment
|
|
Infections and infestations
Upper respiratory infection
|
1.3%
1/77 • 2, 4, and 6 months after enrollment
|
0.00%
0/73 • 2, 4, and 6 months after enrollment
|
|
Gastrointestinal disorders
Upset stomach
|
42.9%
33/77 • 2, 4, and 6 months after enrollment
|
47.9%
35/73 • 2, 4, and 6 months after enrollment
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/77 • 2, 4, and 6 months after enrollment
|
2.7%
2/73 • 2, 4, and 6 months after enrollment
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
1.3%
1/77 • 2, 4, and 6 months after enrollment
|
0.00%
0/73 • 2, 4, and 6 months after enrollment
|
|
Vascular disorders
Varicose veins
|
0.00%
0/77 • 2, 4, and 6 months after enrollment
|
1.4%
1/73 • 2, 4, and 6 months after enrollment
|
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