A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients (MOSAIC)

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Jeff C. Huffman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01201967
First received: September 7, 2010
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Depression
Generalized Anxiety Disorder
Panic Disorder
Other: Collaborative care
Other: Usual care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Enrollment: 183
Study Start Date: September 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
  • 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (age 18-up)admitted to inpatient cardiac unit at Massachusetts General Hospital
  • Primary diagnosis of acute coronary syndrome, congestive heart failure, or arrhythmia
  • Positive anxiety or depression screen during initial nursing intake interview that is performed as part of usual clinical care
  • Meets criteria for clinical depression, generalized anxiety disorder, or panic disorder

Exclusion Criteria:

  • Bipolar disorder
  • Substance use disorder
  • Psychosis
  • Cognitive disorder
  • Active suicidal ideation
  • Medical condition with likely survival less than 6 months
  • Non-English speaking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201967

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
American Heart Association
Investigators
Principal Investigator: Jeff C Huffman, MD Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeff C. Huffman, MD, Medical Director, Blake 11, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01201967     History of Changes
Other Study ID Numbers: 2010P-001414
Study First Received: September 7, 2010
Last Updated: July 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Collaborative care
Cardiovascular disease
Depression
Anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Panic Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on September 11, 2014