Clinical trial NCT01201967: A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients
Official title: A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients (MOSAIC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Generalized Anxiety Disorder
Panic Disorder
Keywords: Collaborative care
Cardiovascular disease
Depression
Anxiety
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2010-09-15
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 \*

Eligibility 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

Primary outcomes:
measure: Change in Mental Health-related Quality of Life From Baseline to 24 Weeks
timeFrame: Baseline, 24 weeks
Secondary outcomes:
measure: Change in Depression Symptoms From Baseline to 24 Weeks
timeFrame: Baseline, 24 weeks
measure: Change in Anxiety Symptoms From Baseline to 24 Weeks
timeFrame: Baseline, 24 weeks
measure: Rate of Adequate Treatment of Depression and/or Anxiety Symptoms 5 Days After Enrollment
timeFrame: 5 days after enrollment
measure: Change in Adherence to Health Behaviors From Baseline to 24 Weeks
timeFrame: Baseline, 24 weeks
measure: Number of Rehospitalizations From Baseline to 24 Weeks
timeFrame: 24 weeks
measure: Change in Health Status From Baseline to 24 Weeks
timeFrame: Baseline, 24 weeks
measure: Change in Physical Function From Baseline to 24 Weeks
timeFrame: Baseline, 24 weeks
measure: Change in Physical Health-related Quality of Life From Baseline to 24 Weeks
timeFrame: Baseline, 24 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jeff C Huffman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huffman JC, Mastromauro CA, Beach SR, Celano CM, DuBois CM, Healy BC, Suarez L, Rollman BL, Januzzi JL. Collaborative care for depression and anxiety disorders in patients with recent cardiac events: the Management of Sadness and Anxiety in Cardiology (MOSAIC) randomized clinical trial. JAMA Intern Med. 2014 Jun;174(6):927-35. doi: 10.1001/jamainternmed.2014.739.
citation: Celano CM, Suarez L, Mastromauro C, Januzzi JL, Huffman JC. Feasibility and utility of screening for depression and anxiety disorders in patients with cardiovascular disease. Circ Cardiovasc Qual Outcomes. 2013 Jul;6(4):498-504. doi: 10.1161/CIRCOUTCOMES.111.000049. Epub 2013 Jun 11.