Comparison of Depression Identification After Acute Coronary Syndrome: Quality of Life and Cost Outcomes

NCT01993017 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1501

Last updated 2023-04-14

Study results available
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Summary

The purpose of this study is to examine, in a randomized controlled trial, the benefits and costs of the American Heart Association's (AHA) advisory for depression screen and treatment of post-acute coronary syndrome patients.

Conditions

  • Acute Coronary Syndrome
  • Depressive Symptoms

Interventions

OTHER

Cognitive Behavioral Therapy (CBT)

The main intervention is the impact of screening on quality of life and health care costs. CBT is provided only if depressive symptoms are detected and participant prefers this type of treatment. CBT will be centrally telephone-administered by a trained CBT treatment specialist. The treatment specialist will work with local team members throughout a participant's involvement in the study, and will closely follow each participant until he or she has reached a requisite level of improvement .

DRUG

Antidepressant Medication

The main intervention is the impact of screening on quality of life and health care costs. Antidepressant Medication is provided only if depressive symptoms are detected and patient prefers this type of treatment. Antidepressants should be started at the lowest dose, but should be adjusted upward to be within the therapeutic range within 1 week, with further adjustment higher in the therapeutic range possible at 3-4 weeks. Dosage of the first medication selected will be in the therapeutic range by 3 weeks of the initial step, as tolerated.

OTHER

Standard Care

Participants will receive standard care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.

OTHER

Depressive symptom screener

8-item Patient Health Questionnaire, PHQ-8

OTHER

No intervention

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • Duke University

    collaborator OTHER
  • HealthPartners Institute

    collaborator OTHER
  • Kaiser Foundation Research Institute

    collaborator OTHER
  • Columbia University

    lead OTHER

Principal Investigators

  • Ian M Kronish, MD, MPH · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2018-07-31
Completion
2019-07-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01993017 on ClinicalTrials.gov