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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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

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 repr

Interventions

  • OTHER Usual care
  • OTHER Collaborative care

Trial Details

FieldValue
Enrollment Target 183 participants
Start Date 2010-09
Est. Completion 2013-06
Phase Phase 4
Massachusetts General Hospital

2,032 total trials

What the finished NCT01201967 record still lists

NCT01201967 is an interventional study that assigns participants to a tested intervention. The registered 183 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (65% lower).

The record links to 0 conditions, and to 2 interventions - of which Usual care is the first listed.

NCT01201967 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01201967's enrollment target sits among peer trials

183 463rd of 2000 higher than 1,537 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01201967, the US trial registry maintained by the National Library of Medicine. NCT01201967 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.