Clinical trial
Depression Screening RCT in ACS Patients: Quality of Life and Cost Outcomes
Name
AAAK9253
Description
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.
Trial arms
Trial start
2013-11-01
Estimated PCD
2018-07-31
Trial end
2019-07-31
Status
Completed
Treatment
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 .
Arms:
AHA Depression Screen & Treat
Other names:
Problem Solving Therapy (PST)
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.
Arms:
AHA Depression Screen & Treat
Other names:
Sertraline, Bupropion
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.
Arms:
Depression Screen & Notify Arm Type :
Depressive symptom screener
8-item Patient Health Questionnaire, PHQ-8
Arms:
AHA Depression Screen & Treat, Depression Screen & Notify Arm Type :
Other names:
PHQ-8
No intervention
Arms:
No Depression Screen
Size
1501
Primary endpoint
Quality-Adjusted Life Years (QALYs)
Baseline, 6, 12 and 18 months
Eligibility criteria
Inclusion Criteria:
* With a documented acute coronary syndrome (ACS) within the past 2-12 months
* Over the age of 21 years
* Has access to a phone
Exclusion Criteria:
Medical Exclusions:
* Terminal illness (life expectancy \<1 year as determined by physician/medical record) defined as, but not limited to:
* NYHA class IV, ACC class D CHF requiring inotropes or mechanical assist devices or critical aortic stenosis without plan for correction
* End-stage COPD/emphysema
* Advanced cirrhosis with encephalopathy, varices, severe ascites
* Severe rheumatologic diseases requiring frequent hospitalizations, and multiple cytotoxic agents and/or disease modifying drugs
* Metastatic pancreatic, esophageal, colorectal or stomach cancer
* Metastatic sarcoma, ovarian, melanoma or renal cell cancer
* Metastatic breast cancer with multiple recurrences despite treatment
* Advanced CNS malignancies
* Recurrent hematologic malignancies with multiple recurrences despite treatment
* Persistent AIDS, untreated or treated
Psychiatric Exclusions:
* History of major depression
* Currently receiving depression treatment
* Dementia
* History of bipolar disorder
* History of psychosis
* History of suicide attempt or self-inflicted injuries
* Current alcohol or substance abuse
Other Exclusions:
* Non-English and non-Spanish speaking
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1501, 'type': 'ACTUAL'}}
Updated at
2023-04-14
1 organization
Organization
Columbia University