An Expert System to Reduce Depression in Primary Care

NCT ID: NCT00497874

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 902 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2006-06-30

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.

Conditions

Depression; Depressive Disorder, Major

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Computer-tailored intervention

Stage-based manual and three computer-tailored reports

Group Type: EXPERIMENTAL

Computer-tailored intervention

Intervention Type: BEHAVIORAL

Stage-based manual and three computer-tailored reports

Usual care

Usual primary care treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Computer-tailored intervention

Stage-based manual and three computer-tailored reports

Intervention Type: BEHAVIORAL

Other Intervention Names

Roadways to Healthy Living

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harvard Vanguard Medical Associates

OTHER

Sponsor Role: collaborator

Cook County Health

OTHER_GOV

Sponsor Role: collaborator

Pro-Change Behavior Systems

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deborah A. Levesque, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Pro-Change Behavior Systems, Inc.

Locations

John H. Stroger Hospital

Chicago, Illinois, United States

Harvard Vanguard Medical Associates

Newton, Massachusetts, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22040388 (View on PubMed)

Other Identifiers

R44MH060522

Identifier Type: NIH

Identifier Source: org_study_id

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