Stepped Care for Depression and Musculoskeletal Pain

• ClinicalTrials.gov Identifier: NCT00118430
• Recruitment Status: Completed
• First Posted: July 11, 2005
• Results First Posted: May 9, 2017
• Last Update Posted: May 9, 2017
• Sponsor: Indiana University
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Indiana University

Tracking Information

• First Submitted Date: July 6, 2005
• First Posted Date: July 11, 2005
• Results First Submitted Date: May 23, 2016
• Results First Posted Date: May 9, 2017
• Last Update Posted Date: May 9, 2017
• Study Start Date: September 2004
• Actual Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 28, 2017)

• Brief Pain Inventory Interference [ Time Frame: Measured at Year 1 ]
  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).
• HSCL-20 Depression Severity [ Time Frame: Measured at Year 1 ]
  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)

Original Primary Outcome Measures (submitted: July 6, 2005)

• Pain
• Depressive symptoms

Current Secondary Outcome Measures (submitted: March 28, 2017)

• Graded Chronic Pain Scale Disability Score [ Time Frame: Measured at Year 1 ]
  This scale ranges from 0 (no pain-specific disability) to 100 (highest or worst pain-specific disability)
• Primary Care Visits [ Time Frame: Measured at Year 1 ]

Original Secondary Outcome Measures (submitted: July 6, 2005)

• Quality of life
• Health care usage and cost

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Stepped Care for Depression and Musculoskeletal Pain
• Official Title: Stepped Care for Affective Disorders and Musculoskeletal Pain
• Brief Summary: This study will evaluate the effectiveness of a stepped care approach in treating depression and reducing pain.

Detailed Description

In the United States, pain accounts for nearly 20% of all primary health care visits. In the majority of cases, the pain is musculoskeletal and primarily affects the lower back, hips, and knees. Studies have shown that at least one-third of patients with pain also suffer from depression. It has not been determined whether treatments for depression are effective in patients with comorbid pain and depression. The "Stepped Care for Affective Disorders and Musculoskeletal Pain" (SCAMP) study will determine the most effective treatment for patients with pain and depression.

This study will last 12 months and will comprise depressed and nondepressed participants. Nondepressed participants will receive no treatment. Depressed patients will be randomly assigned to receive standard of care or stepped care for 12 weeks. Standard of care may include cognitive therapy, antidepressant treatment, or other treatments. The stepped care group will receive 12 weeks of antidepressant treatment. Participants who respond to antidepressant treatment will continue their treatment for the duration of the study. Participants who do not respond to the treatment after 12 weeks will receive 6 weekly pain self-management sessions. During these sessions, an educator will teach participants how to manage their pain through exercise and relaxation techniques. Self-report scales and questionnaires will be used to assess participants' pain, depressive symptoms, health care usage and costs, and quality of life. Depressed participants will undergo assessments at study start and at Months 1, 3, 6, and 12. Nondepressed participants will undergo assessments at study start and at Months 3 and 12.

Study hypotheses: 1) Stepped care is more effective than usual care in improving depression and pain. 2) Stepped care is more effective than usual care in improving health-related quality of life, negative pain beliefs and behaviors, reduced opiate use, and health care costs. 3) Patients with musculoskeletal pain who are not depressed at baseline will have an incidence of depression less than 20% over 12 months of follow-up, characteristics that can be identified as risk factors for incident depression, baseline characteristics distinguishing them from depressed patients, and better pain and health status outcomes, compared to depressed patients.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Pain
• Depression

Intervention

• 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.
  Other Name: Standard Care

Study Arms

• Experimental: Stepped Care
  Stepped care group
  Interventions:

  • Behavioral: Stepped Care
  • Drug: Antidepressants
• Active Comparator: Usual Care
  Treatment as usual group
  Intervention: Drug: Usual Care
• No Intervention: No Treatment
  Participants without depression group

Publications *

• 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). pii: PCC.10m00978. doi: 10.4088/PCC.10m00978blu.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 6, 2005): 500
• Original Enrollment: Same as current
• Actual Study Completion Date: August 2008
• Actual Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00118430
• Other Study ID Numbers: R01MH071268( U.S. NIH Grant/Contract ); R01MH071268 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Data has been published in multiple publications. Should others wish access to data for publication reasons, we are willing to share

• Responsible Party: Indiana University
• Study Sponsor: Indiana University
• Collaborators: National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Kurt Kroenke, MD; Indiana University

• PRS Account: Indiana University
• Verification Date: March 2017