Clinical trial NCT00118430: Stepped Care for Depression and Musculoskeletal Pain
Official title: Stepped Care for Affective Disorders and Musculoskeletal Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Depression
Keywords: Back Pain
Knee Pain
Hip Pain
Stepped Care
Antidepressant
Relaxation Techniques
Exercise
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-07-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Brief Pain Inventory Interference
timeFrame: Measured at Year 1
measure: HSCL-20 Depression Severity
timeFrame: Measured at Year 1
Secondary outcomes:
measure: Graded Chronic Pain Scale Disability Score
timeFrame: Measured at Year 1
measure: Primary Care Visits
timeFrame: Measured at Year 1
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Kurt Kroenke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.