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 (Responsible Party):
Deborah Levesque, Pro-Change Behavior Systems
ClinicalTrials.gov Identifier:
NCT00497874
First received: July 5, 2007
Last updated: June 11, 2015
Last verified: May 2015
  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: Computer-tailored intervention
Phase 2

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

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

Primary Outcome Measures:
  • Change in Depression Severity [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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, with higher scores representing greater severity. 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 score at baseline and total score at 9 months follow-up.Change scores range from 0-63, with higher scores indicating more improvement


Secondary Outcome Measures:
  • Number of Participants Exhibiting a Reliable and Clinically Significant Change in Depression Severity [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Two statistical criteria (Jacobson & Truax, 1991a; Atkins, Bedics, McGlinchey, & Beauchaine, 2005) were used to define reliable and clinically significant improvement. The first involved selecting a cutoff that represents remission or the absence of symptoms, which was selected to be BDI-II < 9. The second involved selecting a pre-post difference score that represents a statistically reliable change (e.g., how much change—1 point, 5 points, 10 points—is needed to be 95% confident that a real change has occurred, rather than just a chance fluctuation due to the unreliability of the measure?) Using a general formula for calculating reliable change that incorporates test-retest reliability (Jacobson & Truax, 1991b), reliable change for the BDI-II was calculated to be 5.13, and rounded down to 5. Thus, reliable and clinically significant improvement on the BDI-II was defined as a reduction of 5 or more points from baseline to follow-up and a follow-up score < 9.

  • Number of Participants in the Action or Maintenance Stage for Using Effective Methods to Prevent Depression. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Depression prevention was defined as: "Using effective methods to keep depression from occurring, or if it does occur, to keep it as mild and brief as possible." Effective methods were: 1) controlling negative thinking; 2) engaging in healthy, pleasant activities; 3) practicing stress management; 4) exercising; and 5) getting professional help when needed. Patients who reported that they were not currently practicing depression prevention and had no intention of doing so in the next 6 months were classified in the precontemplation stage; those who intended to practice depression prevention in the next 6 months or next 30 days were classified in the contemplation or preparation stage, respectively; those who had been practicing depression prevention for less than 6 months were in the action stage, and those who had been practicing for more than 6 months were in maintenance. This outcome represents the number of participants in the action or maintenance stage at 9 months follow-up.

  • Number Participants Without Major Depression at Baseline Who Experienced the Onset of Major Depression During Follow-up [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    At baseline and follow-up, Major Depression was assessed using 9-item depression module of the Primary Care Evaluation of Mental Disorders Patient Health Questionnaire—PHQ-9 (Spitzer, Kroenke, & Williams, 1999). In this analysis, Major Depression was assessed among participants not meeting criteria for major depression at baseline.

  • Number of Participants Taking Prescribed Antidepressant Medication (Medication Adherence) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    At 9 months follow-up, participants who had been prescribed antidepressant medication were asked if they had started and were still taking it. Participants who were taking their medication or had stopped with their doctor's advice were considered to be adherent.

  • Change in Physical Functioning [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Physical functioning was assessed using the Physical Functioning, Role Functioning, Health Perceptions, and Pain subscales of the 20-item Medical Outcomes Study Short Form survey (SF-20) (Stewart, Hays, & Ware, Jr., 1988). (SF-20 subscales assessing mental health and social functioning were omitted to get a purer measure of physical functioning). Physical functioning was computed by taking the mean of the four subscales after each was linearly transformed to range from 0-100, with higher scores indicating better functioning. The change scores reported here are the difference between the physical functioning scores at baseline and 9 months follow-up.Change scores range from 0-100, with higher scores indicating more improvement


Enrollment: 902
Study Start Date: July 2003
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Computer-tailored intervention
Stage-based manual and three computer-tailored reports
Behavioral: Computer-tailored intervention
Stage-based manual and three computer-tailored reports
Other Name: Roadways to Healthy Living
No Intervention: Usual care
Usual primary care treatment

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
Newton, Massachusetts, United States, 02466
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

Publications:
Responsible Party: Deborah Levesque, Senior Vice President for Research and Product Development, Pro-Change Behavior Systems
ClinicalTrials.gov Identifier: NCT00497874     History of Changes
Other Study ID Numbers: R44MH60522
Study First Received: July 5, 2007
Results First Received: June 22, 2011
Last Updated: June 11, 2015
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
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on July 26, 2015