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Depression Outpatient Cardiology Screening Study (DOCS)

Primary Purpose

Depression, Coronary Heart Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative Care
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • recent history of Acute Coronary Syndrome or other cardiac event or documented heart disease
  • score of 10 or higher on the Patient Health Questionnaire

Exclusion Criteria:

  • suicidal ideation or behavior
  • cognitive impairment or inability to read or speak English
  • schizophrenia, bipolar disorder
  • active substance abuse or alcoholism
  • severe valvular disease, severe congestive heart failure, malignancy
  • physical limitations that would interfere with participation in the study
  • medical contraindications to the use of available antidepressants
  • participation in a competing research protocol
  • physician or patient refusal

Sites / Locations

  • Behavioral Medicine Center at Washington University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care (UC)

Collaborative Care (CC)

Arm Description

Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.

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.

Outcomes

Primary Outcome Measures

Beck Depression Inventory 2
Self report depression symptom inventory. Scale ranges from 0-63. The higher the score the more depression symptoms. A score of 12 or greater is considered to indicate a clinically significant depression.

Secondary Outcome Measures

Treatment Satisfaction Scale.
This one item scale asks patients to rate their satisfaction with their depression treatment on a one (very dissatisfied) to 5 (very satisfied) scale.
PROMIS Physical Functioning Scale 10a Short Form
This is a 10 item questionnaire that assesses the respondent's ability to perform common physical activities as rated on a 1-5 scale. The total score is converted to a T score which expresses where the individual ranks relative to the reference group.

Full Information

First Posted
March 9, 2012
Last Updated
March 16, 2017
Sponsor
Washington University School of Medicine
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT01552889
Brief Title
Depression Outpatient Cardiology Screening Study
Acronym
DOCS
Official Title
Randomized Controlled Trial of Screening for Depression in Cardiac Outpatients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study compares the effects of depression screening and case management to usual care in cardiology outpatients with documented evidence of coronary heart disease. Despite strong evidence that depression is a risk factor for cardiac events, there is insufficient evidence to support the use of depression screening in cardiac patients.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Coronary Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care (UC)
Arm Type
No Intervention
Arm Description
Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
Arm Title
Collaborative Care (CC)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Collaborative Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Beck Depression Inventory 2
Description
Self report depression symptom inventory. Scale ranges from 0-63. The higher the score the more depression symptoms. A score of 12 or greater is considered to indicate a clinically significant depression.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Treatment Satisfaction Scale.
Description
This one item scale asks patients to rate their satisfaction with their depression treatment on a one (very dissatisfied) to 5 (very satisfied) scale.
Time Frame
12 months
Title
PROMIS Physical Functioning Scale 10a Short Form
Description
This is a 10 item questionnaire that assesses the respondent's ability to perform common physical activities as rated on a 1-5 scale. The total score is converted to a T score which expresses where the individual ranks relative to the reference group.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: recent history of Acute Coronary Syndrome or other cardiac event or documented heart disease score of 10 or higher on the Patient Health Questionnaire Exclusion Criteria: suicidal ideation or behavior cognitive impairment or inability to read or speak English schizophrenia, bipolar disorder active substance abuse or alcoholism severe valvular disease, severe congestive heart failure, malignancy physical limitations that would interfere with participation in the study medical contraindications to the use of available antidepressants participation in a competing research protocol physician or patient refusal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert M. Carney, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioral Medicine Center at Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Depression Outpatient Cardiology Screening Study

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