Clinical trial NCT00497874: An Expert System to Reduce Depression in Primary Care
Official title: An Expert System to Reduce Depression in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Depressive Disorder, Major
Keywords: depression
stage of change
intervention
randomized clinical trial
population-based
expert system
Lead sponsor: Pro-Change Behavior Systems
Sponsor class: OTHER
Collaborators: name: Harvard Vanguard Medical Associates
name: Cook County Health
First posted: 2007-07-09
Enrollment: 902
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Change in Depression Severity
timeFrame: Baseline, 9 months
Secondary outcomes:
measure: Number of Participants Exhibiting a Reliable and Clinically Significant Change in Depression Severity
timeFrame: 9 months
measure: Number of Participants in the Action or Maintenance Stage for Using Effective Methods to Prevent Depression.
timeFrame: 9 months
measure: Number Participants Without Major Depression at Baseline Who Experienced the Onset of Major Depression During Follow-up
timeFrame: 9 months
measure: Number of Participants Taking Prescribed Antidepressant Medication (Medication Adherence)
timeFrame: 9 months
measure: Change in Physical Functioning
timeFrame: Baseline, 9 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: John H. Stroger Hospital
state: Illinois
city: Newton
country: United States
facility: Harvard Vanguard Medical Associates
state: Massachusetts
Study officials:
affiliation: Pro-Change Behavior Systems, Inc.
name: Deborah A. Levesque, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levesque DA, Van Marter DF, Schneider RJ, Bauer MR, Goldberg DN, Prochaska JO, Prochaska JM. Randomized trial of a computer-tailored intervention for patients with depression. Am J Health Promot. 2011 Nov-Dec;26(2):77-89. doi: 10.4278/ajhp.090123-QUAN-27.