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Phase 4 N=183 Randomized Single-blind Treatment

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

Depression · Generalized Anxiety Disorder · Panic Disorder

Enrolled (actual)
183
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Change in Mental Health-related Quality of Life From Baseline to 24 Weeks — 8.87; 8.39 units on a scale — p=0.002

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Collaborative care (Other); Usual care (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Massachusetts General Hospital
Primary completion
Jun 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Mental Health-related Quality of Life From Baseline to 24 Weeks
8.87; 8.39 0.002 sig
SECONDARY
Change in Depression Symptoms From Baseline to 24 Weeks
-6.99; -7.67 0.045 sig
SECONDARY
Change in Anxiety Symptoms From Baseline to 24 Weeks
-3.43; -4.85 0.55
SECONDARY
Rate of Adequate Treatment of Depression and/or Anxiety Symptoms 5 Days After Enrollment
69; 6 <0.001 sig
SECONDARY
Change in Adherence to Health Behaviors From Baseline to 24 Weeks
2.2; 1.70 0.28
SECONDARY
Number of Rehospitalizations From Baseline to 24 Weeks
29; 30 0.83
SECONDARY
Change in Health Status From Baseline to 24 Weeks
0.16; 0.18 0.029 sig
SECONDARY
Change in Physical Function From Baseline to 24 Weeks
8.96; 9.52 0.005 sig
SECONDARY
Change in Physical Health-related Quality of Life From Baseline to 24 Weeks
2.75; 4.21 0.11

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01201967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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