- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00847132
A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients
Depression in cardiac patients is common, persistent, and deadly. However, the vast majority of cardiac patients with depression go unrecognized and untreated, despite the existence of treatments that clearly improve depressive symptoms and may favorably impact survival. Our research group and others have found that depression recognition and treatment appears particularly limited among patients with acute cardiac illness, though this population may be the most vulnerable to the deleterious effects of depression. We propose a project, building on successful collaborative care depression management programs in outpatient settings, to address this important issue.
The specific hypotheses behind the proposed research are that a collaborative care depression management program can be successfully adapted to inpatient cardiac units, and that such a program will lead to greater rates of adequate depression treatment and improvements in secondary outcomes.
The following specific aims capture the stepwise goals of this program:
- To determine whether a collaborative care depression management program ('Enhanced Care') leads to significantly increased rates of adequate depression treatment compared to usual care (screening and feedback) (Primary Aim).
- To assess whether this Enhanced Care program has a lasting impact on adequate depression treatment, depressive symptoms, health-related quality of life, and adherence to medical recommendations at 6 weeks, 12 weeks, and 6 months, compared to usual care.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Inpatient admission for cardiac diagnosis
- Positive depression evaluation (PHQ-2>2, PHQ-9>9)
- Ability to provide informed consent
Exclusion Criteria:
- Active suicidal ideation
- Bipolar disorder, psychotic disorder, active substance use disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Collaborative Care
Collaborative Care Treatment: A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations
|
Depression education, treatment recommendations, coordination of care
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ACTIVE_COMPARATOR: Usual Care
Usual Care Treatment: Primary medical providers are informed that the patient has depression and that treatment is recommended.
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Treatment as usual, providers are notified of diagnoses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rates of Adequate Depression Treatment at Discharge
Time Frame: 5 days after enrollment
|
Adequate treatment was defined a priori as either: (1) discharge prescription of an antidepressant at a clinically effective dose based on manufacturers' package labeling and treatment guidelines for the treatment of depression or (2) referral to a mental health treatment provider for psychotherapy (unless pre-planned as less than six sessions). Timeframe of "5 days after enrollment" was determined by calculating the median length of hospitalization for all subjects. |
5 days after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Depression Symptoms From Baseline to 6 Months
Time Frame: Baseline, 6 weeks, 12 weeks, 6 months
|
Depression symptoms measured by the Patient Health Questionnaire-9 (PHQ-9).
The PHQ-9 is a 9-item scale that measures depression severity.
Each question asks how often the subject experiences symptoms of depression and offers four answers: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day.
Scores are totaled and range from 0-27.
To be considered depressed, subjects had to (a) have a total score of 10 or more, (b) answer five questions with a score of 2 or 3, and (c) one of the five questions had to be question 1 or question 2 (or both).
Anyone who did not meet these criteria were not considered depressed.
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Baseline, 6 weeks, 12 weeks, 6 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Sowden GL, Mastromauro CA, Seabrook RC, Celano CM, Rollman BL, Huffman JC. Baseline physical health-related quality of life and subsequent depression outcomes in cardiac patients. Psychiatry Res. 2013 Aug 15;208(3):288-90. doi: 10.1016/j.psychres.2013.05.019. Epub 2013 Jun 5.
- Bauer LK, Caro MA, Beach SR, Mastromauro CA, Lenihan E, Januzzi JL, Huffman JC. Effects of depression and anxiety improvement on adherence to medication and health behaviors in recently hospitalized cardiac patients. Am J Cardiol. 2012 May 1;109(9):1266-71. doi: 10.1016/j.amjcard.2011.12.017. Epub 2012 Feb 9.
- Celano CM, Mastromauro CA, Lenihan EC, Januzzi JL, Rollman BL, Huffman JC. Association of baseline anxiety with depression persistence at 6 months in patients with acute cardiac illness. Psychosom Med. 2012 Jan;74(1):93-9. doi: 10.1097/PSY.0b013e31823d38bc. Epub 2011 Dec 30.
- Huffman JC, Mastromauro CA, Sowden G, Fricchione GL, Healy BC, Januzzi JL. Impact of a depression care management program for hospitalized cardiac patients. Circ Cardiovasc Qual Outcomes. 2011 Mar;4(2):198-205. doi: 10.1161/CIRCOUTCOMES.110.959379. Epub 2011 Mar 8.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007P-001152
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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