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DepressionPhase 2NCT00497874

An Expert System to Reduce Depression in Primary Care

A Phase 2 study testing Computer-tailored intervention in people with Depression and Depressive Disorder, Major, run by Pro-Change Behavior Systems at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression, Depressive Disorder, Major
What is being tested?
Computer-tailored intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
902 participants
Where
2 sitesUnited States
Study dates
Jul 2003to Jun 2006
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

United States2 sites
  • John H. Stroger Hospital

    Chicago, Illinois, 60612

  • Harvard Vanguard Medical Associates

    Newton, Massachusetts, 02466

Other trials in United States

About this study

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.

Read the 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.

Being tested
Computer-tailored intervention
Keywords
depression, stage of change, intervention, randomized clinical trial, population-based, expert system
Medical subject headings
Depression, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computer-tailored interventionBehavioural

    Also called Roadways to Healthy Living

    Stage-based manual and three computer-tailored reports

Study groups in NCT00497874
Study groupRoleWhat they receive
Computer-tailored interventionExperimentalStage-based manual and three computer-tailored reports
Receives: Behavioral: Computer-tailored intervention
Usual careNo interventionUsual primary care treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 9 months

Secondary outcomes (5)
  1. Number of Participants Exhibiting a Reliable and Clinically Significant Change in Depression Severity

    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.

    Measured: 9 months

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

    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.

    Measured: 9 months

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

    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.

    Measured: 9 months

  4. Number of Participants Taking Prescribed Antidepressant Medication (Medication Adherence)

    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.

    Measured: 9 months

  5. Change in Physical Functioning

    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. The change scores reported here are the difference between the physical functioning scores at baseline and 9 months (i.e., 9 months minus baseline). Change scores range from -100 to +100, with higher positive scores indicating more improvement in physical functioning.

    Measured: Baseline, 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2007 (estimated)
  2. Study startJul 2003
  3. Primary completionJun 2006
  4. Study completionJun 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
902 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00497874
Sponsor's protocol ID
R44MH060522
Status last verified
Feb 2021
First submitted
5 Jul 2007
Last updated
17 Feb 2021
Data monitoring committee
No

Publications

  • 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.

    PubMed 22040388

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Computer-tailored intervention in people with Depression and Depressive Disorder, Major, run by Pro-Change Behavior Systems at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Depression Severity (time frame: Baseline, 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00497874, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.

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