CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,501 enrolled
Drug / intervention
Antidepressant Medication +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01993017
NCT01993017N/ACompleted

Depression Screening RCT in ACS Patients: Quality of Life and Cost Outcomes

Columbia University·interventional·Posted Nov 25, 2013·Updated Apr 14, 2023

In Brief

A clinical study evaluating Cognitive Behavioral Therapy (CBT), Antidepressant Medication, and 3 other interventions for Acute Coronary Syndrome and Depressive Symptoms. Completed, enrolled 1,501 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 25, 2013
Enrollment StartNov 1, 2013
Primary CompletionJul 31, 2018
Study CompletionJul 31, 2019
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 12.6 years ago

Interventions

Cognitive Behavioral Therapy (CBT)other

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 .

Antidepressant Medicationdrug

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.

Standard Careother

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.

Depressive symptom screenerother

8-item Patient Health Questionnaire, PHQ-8

No interventionother