Phase 4
N=500
Stepped Care for Depression and Musculoskeletal Pain
Pain · Depression
Bottom Line
View on ClinicalTrials.gov: NCT00118430 ↗Enrolled (actual)
500
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Brief Pain Inventory Interference — 5.0; 6.5; 4.6 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Stepped Care (Behavioral); Antidepressants (Drug); Usual Care (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brief Pain Inventory Interference |
5.0; 6.5; 4.6 | <0.001 sig |
| PRIMARY HSCL-20 Depression Severity |
1.1; 1.7; 0.8 | < 0.001 sig |
| SECONDARY Graded Chronic Pain Scale Disability Score |
52.5; 66.1; 44.8 | <0.001 sig |
| SECONDARY Primary Care Visits |
6.3; 5.9 | <0.001 sig |
Summary
This study will evaluate the effectiveness of a stepped care approach in treating depression and reducing pain.
Eligibility Criteria
Inclusion Criteria
- Moderate or severe pain in the back, hips, or knees for at least 3 months prior to study entry
- History of or current use of at least one medication for pain
- English-speaking
Exclusion Criteria
- Moderate to severe cognitive impairment
- Schizophrenia or other psychotic disorders
- Receiving disability benefits for pain
- Anticipated life expectancy less than 12 months
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT00118430). 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.