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NCT01201967 · ClinicalTrials.gov registry record · Phase 4
A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 183
- Enrollment target
NCT01201967: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT01201967 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 183 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01201967, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 183 participants
- Enrollment target
Study 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 con
Interventions
- OTHER Usual care
- OTHER Collaborative care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2010-09 |
| Est. Completion | 2013-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01201967
The ClinicalTrials.gov registry entry for NCT01201967 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 183 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Usual care is the first listed.
NCT01201967 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01201967 about?
NCT01201967 is a clinical study titled "A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients". 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...
What is the current status of trial NCT01201967?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 183 participants. The study started on 2010-09. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01201967?
The interventions under investigation include: Usual care (OTHER), Collaborative care (OTHER).
Who is sponsoring clinical trial NCT01201967?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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