Stepped Care for Depression and Musculoskeletal Pain

PHASE4CompletedINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

September 30, 2004

Primary Completion Date

July 31, 2008

Study Completion Date

August 31, 2008

Conditions
PainDepression
Interventions
BEHAVIORAL

Stepped Care

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.

DRUG

Antidepressants

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).

DRUG

Usual Care

This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group.

Trial Locations (1)

46202

Indiana University Medical Center, Indianapolis

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Indiana University

OTHER

NCT00118430 - Stepped Care for Depression and Musculoskeletal Pain | Biotech Hunter | Biotech Hunter