Stepped Care for Depression and Musculoskeletal Pain

NCT00118430 | Completed Phase 4 Results DMC

• 1 other identifier: R01MH071268
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of a stepped care approach in treating depression and reducing pain.

Conditions

Pain; Depression

Keywords

Back Pain; Knee Pain; Hip Pain; Stepped Care; Antidepressant; Relaxation Techniques; Exercise

Outcome Measures

Primary Outcomes (2)

• Brief Pain Inventory Interference

  The BPI interference scale consists of 7 items, each scored from 0 (no interference) to 10 (complete interference), and the total score is the average of the 7 individual item scores. Therefore, the BPI interference score can range from 0 (lowest pain) to 10 (worst or highest pain).

  Measured at Year 1

• HSCL-20 Depression Severity

  This scale consists of 20 items, each scored from 0 (lowest) to 4 (highest or worst). The scale score is the average of the 20 items. Therefore, the HSCL-20 depression severity score can range from 0 (no depression) to 4 (highest or worst depression)

  Measured at Year 1

Secondary Outcomes (2)

• Graded Chronic Pain Scale Disability Score

  Measured at Year 1

• Primary Care Visits

  Measured at Year 1

Study Arms (3)

Stepped Care

EXPERIMENTAL

Stepped care group

Behavioral: Stepped Care; Drug: Antidepressants

Usual Care

ACTIVE COMPARATOR

Treatment as usual group

Drug: Usual Care

No Treatment

NO INTERVENTION

Participants without depression group

Interventions

Stepped Care BEHAVIORAL

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.

Stepped Care

Antidepressants DRUG

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).

Stepped Care

Usual Care DRUG

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

Also known as: Standard Care

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Moderate to severe cognitive impairment
• Schizophrenia or other psychotic disorders
• Receiving disability benefits for pain
• Anticipated life expectancy less than 12 months
• Pregnancy

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

• Dube P, Kurt K, Bair MJ, Theobald D, Williams LS. The p4 screener: evaluation of a brief measure for assessing potential suicide risk in 2 randomized effectiveness trials of primary care and oncology patients. Prim Care Companion J Clin Psychiatry. 2010;12(6):PCC.10m00978. doi: 10.4088/PCC.10m00978blu.

  PMID: 21494337 DERIVED

• Kroenke K, Bair MJ, Damush TM, Wu J, Hoke S, Sutherland J, Tu W. Optimized antidepressant therapy and pain self-management in primary care patients with depression and musculoskeletal pain: a randomized controlled trial. JAMA. 2009 May 27;301(20):2099-110. doi: 10.1001/jama.2009.723.

  PMID: 19470987 DERIVED

MeSH Terms

Conditions

Pain; Depression; Back Pain; Motor Activity

Interventions

Antidepressive Agents; Standard of Care

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Kurt Kroenke
• Organization: Indiana University

kkroenke@regenstrief.org

3172749046

Study Officials

• Kurt Kroenke, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2005
• First Posted: July 11, 2005
• Study Start: September 1, 2004
• Primary Completion: July 1, 2008
• Study Completion: August 1, 2008
• Last Updated: May 9, 2017
• Results First Posted: May 9, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)