Depression Outpatient Cardiology Screening Study (DOCS)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized Controlled Trial of Screening for Depression in Cardiac Outpatients|
- Beck Depression Inventory score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Treatment Satisfaction Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- PROMIS physical functioning [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
No Intervention: Usual Care (UC)
Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
Experimental: Collaborative Care (CC)
Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.
Behavioral: Collaborative Care
No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period.
Depression and cardiovascular disease are highly comorbid, and depression is a risk factor for psychosocial morbidity, poor adherence to medical treatment regimens, physical inactivity, poor physical functioning, and medical morbidity and mortality in cardiac patients, especially following an acute coronary syndrome (ACS). The American Heart Association recently recommended that all cardiac patients be screened for depression in order to improve identification and treatment of this risk factor.
Patients are screened for depression during an outpatient cardiology visit and those that screen positive will be contacted for enrollment into this study. Patients are then randomized to receive collaborative care involving the patient, the patient's primary care physician (PCP), the cardiologist and the nurse case manager, or usual care (the patient is informed he/she screened positive for depression and is advised to contact their PCP and/or cardiologist). The PCP and/or cardiologist are free to evaluate, treat and refer that patient to mental health services as they deem necessary.
Patients in both groups will be monitored for depression severity and duration at 3, 6 and 12 months after enrollment. The course of their depression since enrollment or last follow-up includes remissions, new onsets, relapses, recurrences, and treatment will be determined.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552889
|United States, Missouri|
|Behavioral Medicine Center at Washington University|
|St. Louis, Missouri, United States, 63108|
|Principal Investigator:||Robert M. Carney, PhD||Washington University School of Medicine|