At a glance
ClinicalIndex Comparison Record- ✓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
- ✕Moderate to severe cognitive impairment
- ✕Schizophrenia or other psychotic disorders
- ✕Receiving disability benefits for pain
- ✕Anticipated life expectancy less than 12 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Stepped Care for Affective Disorders and Musculoskeletal Pain
In Brief
A Phase 4 clinical trial evaluating Stepped Care, Antidepressants, and 1 other intervention for Pain and Depression. Completed, enrolled 500 participants across 1 site.
Detailed Summary
This study will evaluate the effectiveness of a stepped care approach in treating depression and reducing pain.
Study Details
Timeline
Interventions
Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.
Participants will be assigned to one of the following antidepressant regimens: venlafaxine (37.5 mg, increased to 75, 150, 225 mg); duloxetine (60 mg, increased to 120 mg); fluoxetine (20 mg, increased to 30 to 40 mg); sertraline (50 mg, increased to 100 to 150 mg); citalopram (20 mg, increased to 30 to 40 mg); paroxetine (20 mg, increased to 30 to 40 mg); or nortriptyline (25 mg, increased to 50 to 75 mg).
This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group.