Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00105833
First received: March 16, 2005
Last updated: February 6, 2014
Last verified: March 2009

March 16, 2005
February 6, 2014
July 2002
November 2004   (final data collection date for primary outcome measure)
Symptom Checklist SCL-20 score [ Time Frame: SCL-20 score over 12 months ] [ Designated as safety issue: No ]
Depression symptom severity (SCL-20 score) and health related quality of life (SF-36V) at 6- and 12-months
Complete list of historical versions of study NCT00105833 on ClinicalTrials.gov Archive Site
Not Provided
Measures of VA healthcare utilization, and provider adherence to VA Major Depression Guidelines
Not Provided
Not Provided
 
Improving Outcomes of Depression in Primary Care
Improving Outcomes of Depression in Primary Care

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Depression
Behavioral: Collaborative Care - Depression Decision Support (DDS)
Multifaceted collaborative intervention for depression based in primary care
Other Name: Depression Decision Support (DDS)
  • Experimental: Arm 1
    Multifaceted collaborative intervention for depression based in primary care
    Intervention: Behavioral: Collaborative Care - Depression Decision Support (DDS)
  • No Intervention: Arm 2
    Treatment as usual

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
December 2008
November 2004   (final data collection date for primary outcome measure)

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

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00105833
MHI 20-020
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Steven K. Dobscha, MD VA Medical Center, Portland
Principal Investigator: Martha S. Gerrity, MD MPH PhD Portland VA Medical Center
Department of Veterans Affairs
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP