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An Expert System to Reduce Depression in Primary Care

Pro-Change Behavior Systems logo

Pro-Change Behavior Systems

Status and phase

Completed
Phase 2

Conditions

Depressive Disorder, Major
Depression

Treatments

Behavioral: Computer-tailored intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT00497874
R44MH060522

Details and patient eligibility

About

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.

Full 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.

Enrollment

902 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

902 participants in 2 patient groups

Computer-tailored intervention
Experimental group
Description:
Stage-based manual and three computer-tailored reports
Treatment:
Behavioral: Computer-tailored intervention
Usual care
No Intervention group
Description:
Usual primary care treatment

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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