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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Depression, Depressive Disorder, Major
- 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 group | Role | What they receive |
|---|---|---|
| Computer-tailored intervention | Experimental | Stage-based manual and three computer-tailored reports Receives: Behavioral: Computer-tailored intervention |
| Usual care | No intervention | Usual primary care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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.
- First posted9 Jul 2007 (estimated)
- Study startJul 2003
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Pro-Change Behavior Systems
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Vanguard Medical Associates, Cook County Health
- Responsible party
- Sponsor
- Investigators
- Deborah A. Levesque, Ph.D., Principal investigator, Pro-Change Behavior Systems, Inc.
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expert System to Reduce Depression in Primary Care
- ClinicalTrials.gov ID
- NCT00497874
- Acronym / sponsor ID
- R44MH060522
- Conditions
- Depression, Depressive Disorder, Major
- Keywords
- depression, stage of change, intervention, randomized clinical trial, population-based, expert system
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 902 participants (actual)
- Lead sponsor
- Pro-Change Behavior SystemsUniversity, hospital or other
- Collaborators
- Harvard Vanguard Medical Associates, Cook County Health
- Study start
- Jul 2003
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 9 Jul 2007 (estimated)
- Results
- Posted 7 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer-tailored intervention | Experimental | Behavioral: Computer-tailored interventionStage-based manual and three computer-tailored reports |
| Usual care | No intervention | –Usual primary care treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-tailored interventionAlso: Roadways to Healthy LivingStage-based manual and three computer-tailored reports | Behavioural | Computer-tailored intervention |
Primary outcome
Change in Depression Severity
Time frame: Baseline, 9 months
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.
5 secondary outcomes
Number of Participants Exhibiting a Reliable and Clinically Significant Change in Depression Severity
Time frame: 9 months
Number of Participants in the Action or Maintenance Stage for Using Effective Methods to Prevent Depression.
Time frame: 9 months
Number Participants Without Major Depression at Baseline Who Experienced the Onset of Major Depression During Follow-up
Time frame: 9 months
Number of Participants Taking Prescribed Antidepressant Medication (Medication Adherence)
Time frame: 9 months
Change in Physical Functioning
Time frame: Baseline, 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22040388Levesque 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah A. Levesque, Ph.D. principal investigator
Pro-Change Behavior Systems, Inc.
2 sites in 1 country: see every site and its status.
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.