NCT01552889

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
10 months until next milestone

Results Posted

Study results publicly available

April 27, 2017

Completed
Last Updated

April 27, 2017

Status Verified

March 1, 2017

Enrollment Period

4.5 years

First QC Date

March 9, 2012

Results QC Date

January 25, 2017

Last Update Submit

March 16, 2017

Conditions

DepressionCoronary Heart Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (2)

  • Treatment Satisfaction Scale.

    12 months

  • PROMIS Physical Functioning Scale 10a Short Form

    12 months

Study Arms (2)

Usual Care (UC)

NO INTERVENTION

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

Collaborative Care (CC)

EXPERIMENTAL

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

Interventions

Collaborative CareBEHAVIORAL

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.

Collaborative Care (CC)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavioral Medicine Center at Washington University

St Louis, Missouri, 63108, United States

Location

MeSH Terms

Conditions

DepressionCoronary Disease

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Results Point of Contact

Title
Dr. Robert Carney
Organization
Washington University School of Medicine
carneyr@wustl.edu
314-286-1313

Study Officials

  • Robert M. Carney, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

March 9, 2012

First Posted

March 13, 2012

Study Start

January 1, 2012

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

April 27, 2017

Results First Posted

April 27, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)