An Expert System to Reduce Depression in Primary Care

This study has been completed.
Sponsor:
Collaborators:
Harvard Vanguard Medical Associates
John H. Stroger Hospital
Information provided by:
Pro-Change Behavior Systems
ClinicalTrials.gov Identifier:
NCT00497874
First received: July 5, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

The purpose of this study is to determine whether a home-based intervention matched to stage of change (readiness) for using effective methods to prevent or reduce depression can improve depression outcomes in primary care.


Condition Intervention Phase
Depression
Depressive Disorder, Major
Behavioral: Stage-based manual and three expert system-generated reports
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: An Expert System to Reduce Depression in Primary Care

Resource links provided by NLM:


Further study details as provided by Pro-Change Behavior Systems:

Primary Outcome Measures:
  • Change in depression severity [ Time Frame: 9 months ]
  • Reliable and clinically significant change in depression severity [ Time Frame: 9 months ]
  • Stage of change for using effective methods or prevent or reduce depression [ Time Frame: 9 months ]
  • Onset of major depression (if experiencing only subclinical depression at baseline) [ Time Frame: 9 months ]
  • Medication adherence [ Time Frame: 9 months ]

Secondary Outcome Measures:
  • Change in physical functioning [ Time Frame: 9 months ]
  • Disability [ Time Frame: 9 months ]
  • Job absenteeism [ Time Frame: 9 months ]
  • Healthcare utilization [ Time Frame: 9 months ]

Enrollment: 902
Study Start Date: July 2003
Study Completion Date: June 2006
Detailed Description:

A variety of effective interventions exist for people who are willing to seek help for depression. However, there is a lack of interventions for individuals who are not willing to seek help or follow through with treatment recommendations. This is the first population-based intervention for depression that is appropriate for individuals in all stages of change—not merely the minority who are prepared to take action. Two primary care samples were included: 1) patients at risk for or experiencing depression but not involved in or planning treatment (Untreated Sample), and 2) patients newly prescribed antidepressant medication (Antidepressant Sample). Patients from both samples were randomly assigned to receive the intervention consisting of telephone assessments, a stage-based workbook, and three individualized, computer-generated reports mailed to the home (n=443), or usual care (n=459). Primary outcomes, assessed at 9 months, were change in depression severity, reliable and clinically significant change in depression severity, stage of change for using effective methods or prevent or reduce depression, onset of major depression if experiencing only subclinical symptoms at baseline, and medication adherence. The study design included an examination of whether the intervention effect was moderated by primary care sample, baseline use of effective methods to prevent or reduce depression, and level of depression.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At risk for or experiencing depression (i.e., Beck Depression Inventory-II (BDI) score of 10 or higher; current major depression, minor depression, or dysthymia; or past major depression, minor depression, or dysthymia)

Exclusion Criteria:

  • Younger than age 18
  • Involved in counseling or planning counseling in the next 30 days
  • Taking antidepressant medication or planning to take antidepressants in the next 30 days (exclusion criterion for Untreated Sample only)
  • Suicidal ideation
  • Severe depression (BDI > 28) and deemed inappropriate for study by site clinician
  • BDI <10 and in the Maintenance stage for using effective methods to prevent or reduce depression
  • History of bipolar disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497874

Locations
United States, Illinois
John H. Stroger Hospital
Chicago, Illinois, United States, 60612
United States, Massachusetts
Harvard Vanguard Medical Associates
17 primary care clinics in S.E. Massachusetts, Massachusetts, United States, 02184
Sponsors and Collaborators
Pro-Change Behavior Systems
Harvard Vanguard Medical Associates
John H. Stroger Hospital
Investigators
Principal Investigator: Deborah A. Levesque, Ph.D. Pro-Change Behavior Systems, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00497874     History of Changes
Other Study ID Numbers: R44MH60522
Study First Received: July 5, 2007
Last Updated: July 5, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Pro-Change Behavior Systems:
depression
stage of change
intervention
randomized clinical trial
population-based
expert system

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014