search
Back to results

Improving Outcomes of Depression in Primary Care (DEP-PC)

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative Care - Depression Decision Support (DDS)
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

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

Inclusion Criteria: Primary care patients of eligible providers with depression (Patient Health Questionnaire [PHQ-9] depression scores of 10 to 25 or Hopkins Symptom Checklist-20 [SCL-20] scores >= 1.0) Exclusion Criteria: Patients who had received treatment from mental health specialists within the previous 6 months; who had received a diagnosis of psychotic disorder, dementia, or bipolar disorder; or who were considered to be terminally ill

Sites / Locations

  • VA Portland Health Care System, Portland, OR

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm 1

Arm 2

Arm Description

Multifaceted collaborative intervention for depression based in primary care

Treatment as usual

Outcomes

Primary Outcome Measures

Symptom Checklist SCL-20 score

Secondary Outcome Measures

Full Information

First Posted
March 16, 2005
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
search

1. Study Identification

Unique Protocol Identification Number
NCT00105833
Brief Title
Improving Outcomes of Depression in Primary Care
Acronym
DEP-PC
Official Title
Improving Outcomes of Depression in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Depression is common in primary care settings, and associated with substantial physical and psychosocial impairment and increased healthcare utilization. Despite efforts to educate primary care providers, depression is often undetected or undertreated in primary care settings. The main objective of this study was to determine the impact of a low-intensity, care management intervention on depression treatment outcomes of patients in a VA primary care setting.
Detailed Description
OBJECTIVE(S): The primary objective of the study was to determine the impact of a low-intensity, care management intervention on depression treatment outcomes of patients in a VA primary care setting. Secondary objectives were to determine the extent to which primary care clinicians adhere to major depression treatment guidelines, the extent to which the intervention impacts healthcare utilization, and to examine the impact of provider and patient covariates (including pain and adherence) on depression treatment response PLAN: Randomized controlled trial. METHODS: All clinicians first participated in the MacArthur Depression Education Program (DEP). After stratification by discipline and site, clinicians were randomized to receive the Depression Decision Support (DDS) intervention versus usual care (which included an on-site mental health team). Patients were nested within clinician intervention status. DDS intervention clinicians received serial reports of depression severity scores and other clinical data for their enrolled patients. The DDS care manager made one telephone contact with each intervention patient, and invited patients to attend a depression group education session. The DDS team monitored patient depression severity over time, and targeted additional time and effort towards patients not showing improvement. Additional DDS intervention included making further recommendations to primary care clinicians, and in some cases, a one-time consultation with the DDS psychiatrist. Potential subjects were identified from lists of patients due for appointments with primary care clinicians, and were contacted for telephone screening. Patients were enrolled if they had Patient Health Questionnaire (PHQ-9) scores >10 or a Hopkins Symptom Checklist (SCL-20) score of > 1.0 at a subsequent in-person interview. There were no restrictions by age or sex. Patients were excluded if they had psychotic symptoms, dementia, serious suicidal ideation, very severe depression (PHQ-9 >25), or had been treated by mental health clinicians within the previous six months. The intervention lasted 12 months. Depression symptom severity (SCL-20) and health related quality of life (SF-36V) at 6 and 12-months were primary outcomes. Primary analyses employed mixed-model repeated measure analyses of covariance, which include a random effect for clinician and fixed effects for time and intervention status. FINDINGS TO DATE: Five Portland VA clinic sites and 41 clinicians participated. 3,103 patients were screened, and 402 patients were enrolled. Three hundred seventy-five met final eligibility criteria. There were no adverse events. SCL-20 scores improved in both groups over 12 months (slope: -.382; 95% CI -.488, -.276), but there was no effect of the intervention on SCL-20 or Short Form-36V compared to usual care. There was greater initial improvement in PHQ-9 for intervention patients (p=.030); however, this effect diminished over time. At 12 months, intervention patients reported greater satisfaction (p=.002), and were more likely to have received antidepressants. To date, 10 manuscripts supported by the project have been published. One manuscript examining associations between stressful live events and depression outcomes has been submitted for publication.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Multifaceted collaborative intervention for depression based in primary care
Arm Title
Arm 2
Arm Type
No Intervention
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Collaborative Care - Depression Decision Support (DDS)
Other Intervention Name(s)
Depression Decision Support (DDS)
Intervention Description
Multifaceted collaborative intervention for depression based in primary care
Primary Outcome Measure Information:
Title
Symptom Checklist SCL-20 score
Time Frame
SCL-20 score over 12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary care patients of eligible providers with depression (Patient Health Questionnaire [PHQ-9] depression scores of 10 to 25 or Hopkins Symptom Checklist-20 [SCL-20] scores >= 1.0) Exclusion Criteria: Patients who had received treatment from mental health specialists within the previous 6 months; who had received a diagnosis of psychotic disorder, dementia, or bipolar disorder; or who were considered to be terminally ill
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven K. Dobscha, MD
Organizational Affiliation
VA Portland Health Care System, Portland, OR
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martha S. Gerrity, MD MPH PhD
Organizational Affiliation
VA Portland Health Care System, Portland, OR
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18071900
Citation
Snyder K, Dobscha SK, Ganzini L, Hoffman WF, Delorit MA. Clinical outcomes of integrated psychiatric and general medical care. Community Ment Health J. 2008 Jun;44(3):147-54. doi: 10.1007/s10597-007-9117-4. Epub 2007 Dec 11.
Results Reference
result
PubMed Identifier
17336659
Citation
Williams JW Jr, Gerrity M, Holsinger T, Dobscha S, Gaynes B, Dietrich A. Systematic review of multifaceted interventions to improve depression care. Gen Hosp Psychiatry. 2007 Mar-Apr;29(2):91-116. doi: 10.1016/j.genhosppsych.2006.12.003.
Results Reference
result
PubMed Identifier
17250493
Citation
Dobscha SK, Corson K, Pruitt S, Crutchfield M, Gerrity MS. Measuring depression and pain with home health monitors. Telemed J E Health. 2006 Dec;12(6):702-6. doi: 10.1089/tmj.2006.12.702.
Results Reference
result
PubMed Identifier
17015865
Citation
Dobscha SK, Corson K, Hickam DH, Perrin NA, Kraemer DF, Gerrity MS. Depression decision support in primary care: a cluster randomized trial. Ann Intern Med. 2006 Oct 3;145(7):477-87. doi: 10.7326/0003-4819-145-7-200610030-00005.
Results Reference
result
PubMed Identifier
17634781
Citation
Gerrity MS, Corson K, Dobscha SK. Screening for posttraumatic stress disorder in VA primary care patients with depression symptoms. J Gen Intern Med. 2007 Sep;22(9):1321-4. doi: 10.1007/s11606-007-0290-5. Epub 2007 Jul 17.
Results Reference
result
PubMed Identifier
18071094
Citation
Dobscha SK, Corson K, Gerrity MS. Depression treatment preferences of VA primary care patients. Psychosomatics. 2007 Nov-Dec;48(6):482-8. doi: 10.1176/appi.psy.48.6.482.
Results Reference
result
PubMed Identifier
17029000
Citation
Dobscha SK, Winterbottom LM, Snodgrass LS. Reducing drug costs at a Veterans Affairs hospital by increasing market-share of generic fluoxetine. Community Ment Health J. 2007 Feb;43(1):75-84. doi: 10.1007/s10597-006-9062-7. Epub 2006 Sep 22.
Results Reference
result
PubMed Identifier
15609737
Citation
Corson K, Gerrity MS, Dobscha SK. Screening for depression and suicidality in a VA primary care setting: 2 items are better than 1 item. Am J Manag Care. 2004 Nov;10(11 Pt 2):839-45.
Results Reference
result
PubMed Identifier
15785225
Citation
Dobscha SK, Corson K, Solodky J, Gerrity MS. Use of videoconferencing for depression research: enrollment, retention, and patient satisfaction. Telemed J E Health. 2005 Feb;11(1):84-9. doi: 10.1089/tmj.2005.11.84.
Results Reference
result
PubMed Identifier
12556600
Citation
Dobscha SK, Anderson TA, Hoffman WF, Winterbottom LM, Turner EH, Snodgrass LS, Hauser P. Strategies to decrease costs of prescribing selective serotonin reuptake inhibitors at a VA Medical Center. Psychiatr Serv. 2003 Feb;54(2):195-200. doi: 10.1176/appi.ps.54.2.195.
Results Reference
result
PubMed Identifier
12850654
Citation
Dobscha SK, Gerrity MS, Corson K, Bahr A, Cuilwik NM. Measuring adherence to depression treatment guidelines in a VA primary care clinic. Gen Hosp Psychiatry. 2003 Jul-Aug;25(4):230-7. doi: 10.1016/s0163-8343(03)00020-3.
Results Reference
result

Learn more about this trial

Improving Outcomes of Depression in Primary Care

We'll reach out to this number within 24 hrs