Phase 2
N=902
An Expert System to Reduce Depression in Primary Care
Depression · Depressive Disorder, Major
Bottom Line
View on ClinicalTrials.gov: NCT00497874 ↗Enrolled (actual)
902
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Change in Depression Severity — -5.4; -3.7 units on a scale — p=.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Computer-tailored intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pro-Change Behavior Systems
- Primary completion
- Jun 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Depression Severity |
-5.4; -3.7 | .003 sig |
| SECONDARY Number of Participants Exhibiting a Reliable and Clinically Significant Change in Depression Severity |
156; 114 | .002 sig |
| SECONDARY Number of Participants in the Action or Maintenance Stage for Using Effective Methods to Prevent Depression. |
339; 324 | .04 sig |
| SECONDARY Number Participants Without Major Depression at Baseline Who Experienced the Onset of Major Depression During Follow-up |
49; 72 | .07 |
| SECONDARY Number of Participants Taking Prescribed Antidepressant Medication (Medication Adherence) |
121; 100 | .05 |
| SECONDARY Change in Physical Functioning |
3.1; 1.6 | .13 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00497874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.