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

NCT01201967 | Completed Phase 4 Results

• 1 other identifier: 2010P-001414
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Generalized Anxiety Disorder; Panic Disorder

Keywords

Collaborative care; Cardiovascular disease; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in Mental Health-related Quality of Life From Baseline to 24 Weeks

  Mental health-related quality of life is measured by the Short Form-12 Mental Component Score (SF-12 MCS). The SF-12 MCS is a 6-item scale that assesses mental health-related quality of life. Each question provides the option of 2-6 answers. Some questions are Yes/No (2 options), while others ask how often something occurs (6 options, etc.). Scores are calculated using a formula and can range from 0 to 100. A score of 50 indicates average mental health-related quality of life. Higher scores represent higher than average mental health-related quality of life, and lower scores represent lower mental health-related quality of life.

  Baseline, 24 weeks

Secondary Outcomes (8)

• Change in Depression Symptoms From Baseline to 24 Weeks

  Baseline, 24 weeks

• Change in Anxiety Symptoms From Baseline to 24 Weeks

  Baseline, 24 weeks

• Rate of Adequate Treatment of Depression and/or Anxiety Symptoms 5 Days After Enrollment

  5 days after enrollment

• Change in Adherence to Health Behaviors From Baseline to 24 Weeks

  Baseline, 24 weeks

• Number of Rehospitalizations From Baseline to 24 Weeks

  24 weeks

Study Arms (2)

Collaborative care

EXPERIMENTAL

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

Usual care

PLACEBO COMPARATOR

Patient's physicians are informed of diagnosis of depression/anxiety disorder

Other: Usual care

Interventions

Collaborative care OTHER

Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians.

Collaborative care

Usual care OTHER

Patient's primary medical physician informed of mental health symptoms/diagnosis

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Bipolar disorder
• Substance use disorder
• Psychosis
• Cognitive disorder
• Active suicidal ideation
• Medical condition with likely survival less than 6 months
• Non-English speaking

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Heart Association: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• 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.

  PMID: 24733277 DERIVED

• 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.

  PMID: 23759474 DERIVED

MeSH Terms

Conditions

Depression; Generalized Anxiety Disorder; Panic Disorder; Cardiovascular Diseases; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Results Point of Contact

• Title: Jeff C. Huffman, MD
• Organization: Massachusetts General Hospital

jhuffman@partners.org

6177242910

Study Officials

• Jeff C Huffman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Blake 11

Study Record Dates

• First Submitted: September 7, 2010
• First Posted: September 15, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 25, 2014
• Results First Posted: September 25, 2014

Record last verified: 2014-09

Locations

US (1)