NCT00373477

Brief Summary

This project will enable the investigators to conduct a randomized clinical trial to demonstrate the value of generalist care managers in the treatment of depression in Medicaid patients seen in primary health care practices. Depressed patients will be recruited at two primary care practices in Western North Carolina and randomly assigned to either generalist care management or usual care. Patients in each condition will be assessed at baseline and six months follow-up. Outcomes will include depressive symptoms, level of functioning, and cost-effectiveness measures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Jul 2003

Shorter than P25 for not_applicable major-depressive-disorder

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2006

Completed
Last Updated

September 8, 2006

Status Verified

September 1, 2006

First QC Date

September 6, 2006

Last Update Submit

September 6, 2006

Conditions

Major Depressive Disorder

Keywords

DepressionPrimary CareCare Manager

Outcome Measures

Primary Outcomes (1)

  • Baseline, 3 and 6-month Patient Health Questionnaire (PHQ9) scores

Secondary Outcomes (1)

  • Baseline and 6-month Short Form (SF)-12 scores, Medicaid claims data; patient perception of treatment by self-report; review of GCM case notes, physician and office staff time study; physician and office staff focus groups

Interventions

Generalist Care Manager vs Usual CarePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • scoring 10 or greater on PHQ-9 and primary care physician verification of major depression by clinical exam; and
  • willing to begin or continue antidepressant medication

You may not qualify if:

  • bipolar disorder, psychotic symptoms, or active suicidal ideation requiring psychiatric admission (

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mountain Area Health Education Center (MAHEC)

Asheville, North Carolina, 28804, United States

Location

Hot Springs Health Program

Marshall, North Carolina, 28753, United States

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Suzanne Landis, MD, MPH

    University of North Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 8, 2006

Study Start

July 1, 2003

Study Completion

February 1, 2005

Last Updated

September 8, 2006

Record last verified: 2006-09

Locations

US(2)