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CompletedNCT00105833DEP-PCUpdated Apr 7, 2015

Improving Outcomes of Depression in Primary Care

An interventional study of Collaborative Care - Depression Decision Support (DDS) in Depression, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2015-04-07.

Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Depression

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03

In context

Depression

8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 400 is above the median of 84 across 6,869 interventional studies indexed under Depression.

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Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 675 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
400 participants (actual)

Study arms

  • Experimental
    Arm 1

    Multifaceted collaborative intervention for depression based in primary care

    Behavioral: Collaborative Care - Depression Decision Support (DDS)

  • No intervention
    Arm 2

    Treatment as usual

Interventions

  • BehavioralCollaborative Care - Depression Decision Support (DDS)

    Multifaceted collaborative intervention for depression based in primary care

    Also known as: Depression Decision Support (DDS)

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What researchers measure

Primary outcomes

  1. Symptom Checklist SCL-20 score

    Time frame: SCL-20 score over 12 months

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Study locations

1 site
  • VA Portland Health Care System, Portland, OR
    Portland, Oregon 97239, United States
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References and documents

Publications

  • 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. PubMed 18071900 ↗
  • 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. PubMed 17336659 ↗
  • 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. PubMed 17250493 ↗
  • 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. PubMed 17015865 ↗
  • 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. PubMed 17634781 ↗
  • 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. PubMed 18071094 ↗
  • 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. PubMed 17029000 ↗
  • 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. PubMed 15609737 ↗
  • 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. PubMed 15785225 ↗
  • 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. PubMed 12556600 ↗
  • 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. PubMed 12850654 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2002, a primary completion of Nov 2004 and a completion of Dec 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2005
First posted
Mar 17, 2005
Start
Jul 2002
Primary completionActual
Nov 2004
CompletionActual
Dec 2008
Last update
Apr 7, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00105833
Responsible party
Sponsor
First posted
Mar 17, 2005
Start date
Jul 2002
Primary completion
Nov 2004
Completion
Dec 2008
Last update
Apr 7, 2015

Study contacts

Steven K. Dobscha, MD
principal investigator · VA Portland Health Care System, Portland, OR
Martha S. Gerrity, MD MPH PhD
principal investigator · VA Portland Health Care System, Portland, OR

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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