NCT00497874

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
902

participants targeted

Target at P75+ for phase_2 depression

Timeline
Completed

Started Jul 2003

Typical duration for phase_2 depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 9, 2007

Completed
8 years until next milestone

Results Posted

Study results publicly available

July 7, 2015

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

2.9 years

First QC Date

July 5, 2007

Results QC Date

June 22, 2011

Last Update Submit

February 12, 2021

Conditions

DepressionDepressive Disorder, Major

Keywords

depressionstage of changeinterventionrandomized clinical trialpopulation-basedexpert system

Outcome Measures

Primary Outcomes (1)

  • Change in Depression Severity

    Depression was assessed using the Beck Depression Inventory, 2nd Edition (BDI-II)(Beck, Steer, \& Brown, 1996). In this self-report measure, 21 symptoms of depression are rated on a 0-3 scale. Scores for the 21 items are summed to yield a total score ranging from 0 to 63. The change scores reported here are the difference between the total BDI-II scores at baseline and 9 months (i.e., 9 months minus baseline). Change scores range from -63 to +63, with larger negative scores indicating greater reduction in depression.

    Baseline, 9 months

Secondary Outcomes (5)

  • Number of Participants Exhibiting a Reliable and Clinically Significant Change in Depression Severity

    9 months

  • Number of Participants in the Action or Maintenance Stage for Using Effective Methods to Prevent Depression.

    9 months

  • Number Participants Without Major Depression at Baseline Who Experienced the Onset of Major Depression During Follow-up

    9 months

  • Number of Participants Taking Prescribed Antidepressant Medication (Medication Adherence)

    9 months

  • Change in Physical Functioning

    Baseline, 9 months

Study Arms (2)

Computer-tailored intervention

EXPERIMENTAL

Stage-based manual and three computer-tailored reports

Behavioral: Computer-tailored intervention

Usual care

NO INTERVENTION

Usual primary care treatment

Interventions

Computer-tailored interventionBEHAVIORAL

Stage-based manual and three computer-tailored reports

Also known as: Roadways to Healthy Living
Computer-tailored intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Younger than age 18
  • Involved in counseling or planning counseling in the next 30 days
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

John H. Stroger Hospital

Chicago, Illinois, 60612, United States

Location

Harvard Vanguard Medical Associates

Newton, Massachusetts, 02466, United States

Location

Related Publications (1)

  • 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.

    PMID: 22040388RESULT

MeSH Terms

Conditions

DepressionDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Limitations and Caveats

1. There was only a single follow up assessment administered at 9 months post-baseline. 2. The study attrition rate was \> 30%.

Results Point of Contact

Title
Deborah A. Levesque, Ph.D.
Organization
Pro-Change Behavior Systems, Inc.
dlevesque@prochange.com
(401) 360-2975

Study Officials

  • Deborah A. Levesque, Ph.D.

    Pro-Change Behavior Systems, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2007

First Posted

July 9, 2007

Study Start

July 1, 2003

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

February 17, 2021

Results First Posted

July 7, 2015

Record last verified: 2021-02

Locations

US(2)