Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
Study NCT ID:
NCT01201967
Status:
COMPLETED
Last Update Posted:
2014-09-25
First Post:
2010-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients (MOSAIC)
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOSAIC
Brief Summary:
For this trial, the investigators propose a prospective trial of a collaborative care program to identify and treat depression, generalized anxiety disorder, and panic disorder among patients admitted to the hospital for an acute cardiac illness (acute coronary syndrome, congestive heart failure, or arrhythmia). Such assessment and treatment for depression/generalized anxiety disorder/panic disorder 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-with primary care physicians 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, generalized anxiety disorder, and panic disorder: 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, generalized anxiety disorder, and panic disorder 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 primary care physicians 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.
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-with primary care physicians 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, generalized anxiety disorder, and panic disorder: 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, generalized anxiety disorder, and panic disorder 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 primary care physicians 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.
Detailed Description:
* Primary in-hospital outcome measure:
\- Adequate treatment by discharge (percent rates)
* Primary overall study measure:
\- Change from baseline mental health-related quality of life (Short Form-12 Mental Component Score)
* Depression outcome measures:
\- Change from baseline depression (Patient Health Questionnaire-9)
* Anxiety outcome measures:
\- Change from baseline anxiety (Hospital Anxiety and Depression Scale-Anxiety Subscale)
* Medical outcome measures:
* Change from baseline physical function (Duke Activity Status Index)
* Change from baseline adherence (Medical Outcomes Study Specific Adherence Scale)
* Change from baseline physical health-related quality of life (Short Form-12 Physical Component Score)
* Change in rates of cardiac rehospitalizations at 24 weeks (exploratory aim)
* 24 weeks is primary endpoint for all post-discharge analyses \*
\- Adequate treatment by discharge (percent rates)
* Primary overall study measure:
\- Change from baseline mental health-related quality of life (Short Form-12 Mental Component Score)
* Depression outcome measures:
\- Change from baseline depression (Patient Health Questionnaire-9)
* Anxiety outcome measures:
\- Change from baseline anxiety (Hospital Anxiety and Depression Scale-Anxiety Subscale)
* Medical outcome measures:
* Change from baseline physical function (Duke Activity Status Index)
* Change from baseline adherence (Medical Outcomes Study Specific Adherence Scale)
* Change from baseline physical health-related quality of life (Short Form-12 Physical Component Score)
* Change in rates of cardiac rehospitalizations at 24 weeks (exploratory aim)
* 24 weeks is primary endpoint for all post-discharge analyses \*
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: