Effectiveness of Depression Treatment Following Coronary Artery Bypass Surgery

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT00091962
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 453
• Location: 1
• Arms: 3
• Duration (Months): 76
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

The purpose of this study is to treat depression in patients who have undergone coronary artery bypass graft (CABG).

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases; Coronary Disease; Heart Diseases; Depression	Behavioral: Psychoeducation; Treatment recommendations; Drug: Pharmacotherapy; Other: Usual Care	N/A

Detailed Description

BACKGROUND:

Cardiovascular disease morbidity and mortality is an important health issue. Depression has emerged as a risk factor for increased morbidity and mortality in patients with coronary heart disease. CABG is a surgical procedure that is specifically directed to improvement in quality of life for patients with severe coronary artery disease, though its impact on mortality is questionable. Patients with depression after CABG are found to not demonstrate sufficient improvement in quality of life, resulting in a significantly higher level of healthcare costs.

DESIGN NARRATIVE:

In this randomized study, 300 patients who show elevated levels of depressive symptoms at 3 to 5 days following CABG and at 2 weeks after hospital discharge will be recruited. They will be randomized to receive either 1) their physician's "usual care" for depression, or 2) a stepped collaborative care program involving a telephone-based nurse care manager. The nurse care manager will contact patients at regular intervals to assess treatment preferences for depression (e.g., counseling, self-management workbook, pharmacotherapy, or specialty referral), promote adherence with care, and monitor the therapeutic response in concert with patient's primary care physicians and under the supervision of a study clinician. One hundred and fifty nondepressed post-CABG patients will be randomly selected to serve as a control cohort to facilitate comparisons with the depressed patients on various baseline and follow-up measures, and to better understand the benefits derived from depression treatment (total N=450). Blinded telephone assessments will be conducted at 2, 4, 8, and 12 months post CABG and then every 6 months until the last patient completes his/her 8-month assessment (range: 8-44 months follow-up). Intent-to-treat analyses will be used to test the primary hypothesis that the intervention will produce at least a clinically meaningful 0.5 effect size improvement in health related quality of life (HRQoL) at 8 months post CABG, as measured by the SF-36 Mental Component Summary score, compared to patients who receive their primary care physician's "usual care" for depression. The secondary hypotheses are that compared to "usual care" patients, intervention patients will 1) experience higher levels of functional status, and lower levels of depressive symptoms, risk for future cardiovascular events, and health services costs, and 2) report similar levels of HRQoL as nondepressed post-CABG patients. Providing evidence-based, stepped, collaborative care treatment for post-CABG depression may be an ideal method for organized health care delivery systems to improve outcomes. The focus on HRQoL and health services costs will facilitate comparisons of the benefits derived from the intervention to that of other established treatments of cardiovascular risk factors and care for other chronic conditions.

Study Design

• Study Type: Interventional
• Actual Enrollment: 453 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Treatment of Depression Following Bypass Surgery
• Study Start Date: Aug 1, 2003
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Depressed Intervention 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	Behavioral: Psychoeducation; Treatment recommendations; Counseling program; Drug: Pharmacotherapy; Recommendations to patients' PCP for medication to treat depression
Active Comparator: Depressed Usual Care "Usual care" for depression; feedback of the depression finding by the study team	Other: Usual Care; Physicians' Usual care
No Intervention: Non-Depressed Control Group Non-depressed control group

Outcome Measures

Primary Outcome Measures

1. Generic Mental Health-Related Quality of Life [Measured 8 months post-CABG]

   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.

Secondary Outcome Measures

1. Hamilton Rating Scale for Depression [8 months post CABG]

   The 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

2. Generic Physical Health-Related Quality of Life [8 months post CABG]

   The 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.

3. Disease-Specific Health-Related Quality of Life [8 months post CABG]

   The 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Recently underwent CABG (combined or redo procedure) at one of 8 Pittsburgh area study hospitals

• A PHQ score greater than 10 OR if nondepressed control, a PHQ score less than 5 at both 2 days post CABG to the date of discharge following CABG and when reassessed 2 weeks after hospital discharge

• Folstein Mini-Mental State Examination (MMSE) score greater than or equal to 24

• Able to be evaluated and treated for depression as an outpatient post CABG

• Has a household telephone

Exclusion Criteria:

• Presently in treatment with a mental health specialist

• Actively suicidal

• History of psychotic illness

• History of bipolar illness according to subject self-report and past medical history

• Current alcohol dependence or other substance abuse as evidenced by chart review and the CAGE questionnaire

• Organic mood syndromes, including those secondary to medical illness or drugs

• Presence of non-cardiovascular conditions that are likely to be fatal within 1 year

• Unstable medical condition as indicated by history, physical, and/or laboratory findings

• Previous enrollment in the study cohort

• Non-English speaking, illiterate, or possessing any other communication barrier

• If nondepressed control, current or previous diagnosis or treatment of depression

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh School of Medicine	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

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

Investigators

• Study Chair: Bruce L. Rollman, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Bruce Rollman, Professor of Medicine, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT00091962
• Other Study ID Numbers: 164; R01HL070000
• First Posted: Sep 23, 2004
• Last Update Posted: Apr 14, 2016
• Last Verified: Mar 1, 2016

• Additional relevant MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Depression; Depressive Disorder

Study Results

Participant Flow

Arm/Group Title	Depressed Intervention	Depressed Usual Care	Non-Depressed Control Group
Arm/Group Description	Collaborative care program for depression involving a telephone-based nurse care manager Counseling: Counseling program Pharmacotherapy: Medication to treat depression	Control group will receive usual care for depression Usual Care: Usual care for depression
Period Title: Overall Study
STARTED	150	152	151
COMPLETED	150	152	151
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Depressed Intervention	Depressed Usual Care	Non-Depressed Control	Total
Arm/Group Description	Collaborative care program for depression involving a telephone-based nurse care manager Counseling: Counseling program Pharmacotherapy: Medication to treat depression	Control group will receive usual care for depression Usual Care: Usual care for depression	Observational only	Total of all reporting groups
Overall Participants	150	152	151	453
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	85 56.7%	84 55.3%	60 39.7%	229 50.6%
>=65 years	65 43.3%	68 44.7%	91 60.3%	224 49.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64 (10.8)	64 (11.2)	66 (9.6)	65 (10)
Sex: Female, Male (Count of Participants)
Female	69 46%	56 36.8%	56 37.1%	181 40%
Male	81 54%	96 63.2%	95 62.9%	272 60%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 2%	0 0%	2 1.3%	5 1.1%
Not Hispanic or Latino	147 98%	152 100%	149 98.7%	448 98.9%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.7%	0 0%	1 0.7%	2 0.4%
Asian	0 0%	0 0%	2 1.3%	2 0.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	1 0.7%	1 0.2%
Black or African American	17 11.3%	10 6.6%	25 16.6%	52 11.5%
White	132 88%	142 93.4%	122 80.8%	396 87.4%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	150 100%	152 100%	151 100%	453 100%

Outcome Measures

1. Primary Outcome

Title	Generic Mental Health-Related Quality of Life
Description	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.
Time Frame	Measured 8 months post-CABG

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Depressed Intervention	Depressed Usual Care	Non-Depressed Control
Arm/Group Description	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	"Usual care" for depression by patients' PCP	Non-depressed control group with no intervention
Measure Participants	150	152	151
Mean (Standard Error) [units on a scale]	50.0 (1.0)	46.2 (1.1)	57.2 (0.5)

2. Secondary Outcome

Title	Hamilton Rating Scale for Depression
Description	The 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
Time Frame	8 months post CABG

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Depressed Intervention	Depressed Usual Care	Non-Depressed Control Group
Arm/Group Description	Collaborative care program for depression involving a telephone-based nurse care manager Counseling: Counseling program Pharmacotherapy: Medication to treat depression	Control group will receive usual care for depression Usual Care: Usual care for depression	Non-depressed groups as Control to see the natural course of recovery after CABG
Measure Participants	150	152	151
Mean (Standard Error) [units on a scale]	9.0 (0.7)	11.4 (0.7)	3.8 (0.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Depressed Intervention, Depressed Usual Care
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments	repeated measures mixed-effect model with treatment, time (4 time points), and sex; all 2- and 3-factor interaction terms with subject intercepts were treated as a random effect to account for individual differences at randomization.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.001
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Generic Physical Health-Related Quality of Life
Description	The 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.
Time Frame	8 months post CABG

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Depressed Intervention	Depressed Usual Care	Non-Depressed Control
Arm/Group Description	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	"Usual care" for depression by patients' PCP	Non-depressed control group with no intervention
Measure Participants	150	152	151
Mean (Standard Error) [participants]	44.0 (0.8) 29.3%	41.4 (0.8) 27.2%	48.7 (0.7) 32.3%

4. Secondary Outcome

Title	Disease-Specific Health-Related Quality of Life
Description	The 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).
Time Frame	8 months post CABG

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Depressed Intervention	Depressed Usual Care	Non-Depressed Control
Arm/Group Description	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	"Usual care" for depression by patients' PCP	Non-depressed control group with no intervention
Measure Participants	150	152	151
Mean (Standard Error) [units on a scale]	25.2 (1.0)	21.4 (1.0)	33.2 (1.1)

Adverse Events

Arm/Group Title	Depressed Intervention		Depressed Usual Care		Non-Depressed Control
Arm/Group Description	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		"Usual care" for depression by patients' PCP		Non-depressed control group with no intervention
All Cause Mortality
	Depressed Intervention		Depressed Usual Care		Non-Depressed Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Depressed Intervention		Depressed Usual Care		Non-Depressed Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/150 (0%)		0/152 (0%)		0/151 (0%)
Other (Not Including Serious) Adverse Events
	Depressed Intervention		Depressed Usual Care		Non-Depressed Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/150 (0%)		0/152 (0%)		0/151 (0%)

Limitations/Caveats

Selection bias if patients with severe depression were less likely to participate in our screening procedure. Also, the trial recruited just from one U.S. region.

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.