A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients (MOSAIC)
For this trial, the investigators propose a prospective trial of a collaborative care program to identify and treat depression, generalized anxiety disorder (GAD), and panic disorder (PD) among patients admitted to the hospital for an acute cardiac illness (acute coronary syndrome [ACS], congestive heart failure [CHF], or arrhythmia). Such assessment and treatment for depression/GAD/PD will begin in the hospital, and ongoing management will continue for six months following discharge.
The investigators hypothesize that this model will lead to increased treatment rates, improved mood, reduced anxiety, and improved medical outcomes in this vulnerable population. If this model is effective, it could be implemented clinically to provide better and more complete care to patients hospitalized with acute cardiac illness, for whom depression and anxiety may be a risk factor for complications and death.
This will be a two-arm, single-blind randomized controlled trial, with one-half of patients randomized to collaborative care and one-half randomized to the control condition (usual care). Psychiatric treatment in the intervention arm will be provided in concert with patients' primary care physicians (PCPs)—with PCPs prescribing all medications—within a framework supervised by a psychiatrist.
The investigators will enroll patients who have any (or all) of the three included psychiatric diagnoses to improve the utility of the intervention. The investigators have chosen to enroll patients with several different cardiac diagnoses. This will allow the researchers to include patients with heterogeneous diagnoses and illness severity to determine if our intervention is effective in a broad population of patients with heart disease. The investigators will study an intervention targeting depression, GAD, and PD: all three disorders are disabling and associated with adverse cardiovascular outcomes, treatments for the conditions are highly similar, the investigators can treat patients who have more than one disorder, and a prior outpatient program successfully simultaneously addressed more than one mental health condition.
The project will involve: (1) screening patients for depression, GAD, and PD as part of usual clinical care, (2) evaluation of positive-screen patients by a study social work care manager, (3) a multicomponent in-hospital intervention (for collaborative care patients) that involves patient education, specialist-provided treatment recommendations, and a goal of in-hospital treatment initiation, and (4), after discharge, continued phone-based evaluation and care coordination with PCPs to provide stepwise treatment in the collaborative care arm. The intervention has been designed to be low-cost, low-burden, and easily generalizable to other settings.
Generalized Anxiety Disorder
Other: Collaborative care
Other: Usual care
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
- Mental-health related quality of life [ Time Frame: 6, 12, 18, and 24 weeks (24 weeks primary) ] [ Designated as safety issue: No ]SF-12 Mental Component Score
- Depression Symptoms [ Time Frame: at 6, 12, 18, and 24 weeks (24 weeks primary) ] [ Designated as safety issue: No ]PHQ-9 score (Change from baseline PHQ-9 score at 24 weeks is the primary depression outcome)
- Anxiety [ Time Frame: 6, 12, 18, and 24 weeks ] [ Designated as safety issue: No ]Hospital Anxiety and Depression Scale--Anxiety subscale (change from baseline at 24 weeks is the primary anxiety outcome)
- Cardiac symptoms [ Time Frame: 6, 12, 18, and 24 weeks ] [ Designated as safety issue: No ]Cardiac symptom scale scores
- Rates of adequate treatment of depression/anxiety at discharge [ Time Frame: 5 days post-enrollment (average, based on median length of hospitalization) ] [ Designated as safety issue: No ]Antidepressant or psychotherapy
- Adherence to health-related behaviors [ Time Frame: 6, 12, 18, and 24 weeks (24 weeks primary) ] [ Designated as safety issue: No ]Medical Outcome Study Specific Adherence Scale (MOS-SAS)
- Rehospitalizations [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Readmissions to the hospital between discharge and 24 weeks (exploratory)
- Optimism and Pessimism [ Time Frame: 6, 12, 18, and 24 weeks ] [ Designated as safety issue: No ]Life Orientation Test-Revised
- Generalized Anxiety Disorder symptom severity [ Time Frame: 6, 12, 18, and 24 weeks ] [ Designated as safety issue: No ]Generalized Anxiety Disorder Severity Scale
- Panic Disorder symptom severity [ Time Frame: 6, 12, 18, and 24 weeks ] [ Designated as safety issue: No ]Panic Disorder Severity Scale
- Standardised measure of health status [ Time Frame: 6, 12, 18, and 24 weeks ] [ Designated as safety issue: No ]EuroQol-5D
- Functional capacity [ Time Frame: 6, 12, 18, and 24 weeks ] [ Designated as safety issue: No ]Duke Activity Status Index (Change in DASI score at 24 weeks is primary medical outcome variable)
|Study Start Date:||September 2010|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Collaborative care
Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.
Other: Collaborative care
Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians.
Placebo Comparator: Usual care
Patient's physicians are informed of diagnosis of depression/anxiety disorder
Other: Usual care
Patient's primary medical physician informed of mental health symptoms/diagnosis
Primary in-hospital outcome measure:
- Adequate treatment by discharge (% rates)
Primary overall study measure:
- Change from baseline mental HRQoL (measured via SF-12 MCS)
Depression outcome measures:
- Change from baseline PHQ-9 score (primary depression measure)
Anxiety outcome measures***:
- Change from baseline HADS score (primary anxiety measure)
- Change from baseline GADSS and PDSS scores (as indicated)
Medical outcome measures:
- Change from baseline DASI score (primary medical outcome measure)
- Change from baseline MOS specific adherence score
- Change from baseline physical HRQoL (SF-12 PCS)
- Change from baseline cardiac symptoms (WISE scale)
Change in rates of cardiac readmissions at 24 weeks (exploratory)
- 24 weeks is primary endpoint for all postdischarge analyses
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201967
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Jeff C Huffman, MD||Massachusetts General Hospital|