Stepped Care for Depression and Musculoskeletal Pain

NCT ID: NCT00118430

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2008-08-31

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.

Conditions

Pain; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stepped Care

Stepped care group

Group Type: EXPERIMENTAL

Stepped Care

Intervention Type: 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.

Antidepressants

Intervention Type: 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).

Usual Care

Treatment as usual group

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: DRUG

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

No Treatment

Participants without depression group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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).

Intervention Type: DRUG

Usual Care

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

Intervention Type: DRUG

Other Intervention Names

Standard Care

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kurt Kroenke, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University Medical Center

Indianapolis, Indiana, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21494337 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19470987 (View on PubMed)

Other Identifiers

R01MH071268

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01MH071268

Identifier Type: NIH

Identifier Source: org_study_id

View Link