Trial Outcomes & Findings for An Expert System to Reduce Depression in Primary Care (NCT NCT00497874)
NCT ID: NCT00497874
Last Updated: 2021-02-17
Results Overview
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.
COMPLETED
PHASE2
902 participants
Baseline, 9 months
2021-02-17
Participant Flow
A total of 902 primary care patients were recruited from the 17 clinics of a large multi-specialty medical group practice in Eastern Massachusetts (N=791) and a large health center in Chicago (N=111).
Participant milestones
| Measure |
Intervention
Stage-based manual and three computer-tailored reports
|
Usual Care
Usual primary care treatment
|
|---|---|---|
|
Overall Study
STARTED
|
443
|
459
|
|
Overall Study
COMPLETED
|
296
|
343
|
|
Overall Study
NOT COMPLETED
|
147
|
116
|
Reasons for withdrawal
| Measure |
Intervention
Stage-based manual and three computer-tailored reports
|
Usual Care
Usual primary care treatment
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
48
|
17
|
|
Overall Study
Illness
|
8
|
4
|
|
Overall Study
Death
|
2
|
4
|
|
Overall Study
Unable to contact
|
52
|
67
|
|
Overall Study
Unable to schedule
|
37
|
24
|
Baseline Characteristics
An Expert System to Reduce Depression in Primary Care
Baseline characteristics by cohort
| Measure |
Intervention
n=443 Participants
Stage-based manual and three computer-tailored reports
|
Usual Care
n=459 Participants
Usual primary care treatment
|
Total
n=902 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
391 Participants
n=5 Participants
|
408 Participants
n=7 Participants
|
799 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
52 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Age, Continuous
|
48.0 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 15.3 • n=7 Participants
|
47.5 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
308 Participants
n=5 Participants
|
314 Participants
n=7 Participants
|
622 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
135 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
443 participants
n=5 Participants
|
459 participants
n=7 Participants
|
902 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 9 monthsPopulation: Multiple imputation
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.
Outcome measures
| Measure |
Intervention
n=443 Participants
Usual primary care + computer-tailored intervention
|
Usual Care
n=459 Participants
Usual primary care
|
|---|---|---|
|
Change in Depression Severity
|
-5.4 units on a scale
Standard Deviation 8.8
|
-3.7 units on a scale
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Multiple imputation
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.
Outcome measures
| Measure |
Intervention
n=443 Participants
Usual primary care + computer-tailored intervention
|
Usual Care
n=459 Participants
Usual primary care
|
|---|---|---|
|
Number of Participants Exhibiting a Reliable and Clinically Significant Change in Depression Severity
|
156 Participants
|
114 Participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Multiple imputation
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.
Outcome measures
| Measure |
Intervention
n=443 Participants
Usual primary care + computer-tailored intervention
|
Usual Care
n=459 Participants
Usual primary care
|
|---|---|---|
|
Number of Participants in the Action or Maintenance Stage for Using Effective Methods to Prevent Depression.
|
339 Participants
|
324 Participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Multiple imputation
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.
Outcome measures
| Measure |
Intervention
n=369 Participants
Usual primary care + computer-tailored intervention
|
Usual Care
n=385 Participants
Usual primary care
|
|---|---|---|
|
Number Participants Without Major Depression at Baseline Who Experienced the Onset of Major Depression During Follow-up
|
49 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Multiple imputation
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.
Outcome measures
| Measure |
Intervention
n=195 Participants
Usual primary care + computer-tailored intervention
|
Usual Care
n=194 Participants
Usual primary care
|
|---|---|---|
|
Number of Participants Taking Prescribed Antidepressant Medication (Medication Adherence)
|
121 Participants
|
100 Participants
|
SECONDARY outcome
Timeframe: Baseline, 9 monthsPopulation: Multiple imputation
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.
Outcome measures
| Measure |
Intervention
n=443 Participants
Usual primary care + computer-tailored intervention
|
Usual Care
n=459 Participants
Usual primary care
|
|---|---|---|
|
Change in Physical Functioning
|
3.1 units on a scale
Standard Deviation 16.5
|
1.6 units on a scale
Standard Deviation 16.3
|
Adverse Events
Intervention
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Deborah A. Levesque, Ph.D.
Pro-Change Behavior Systems, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place