Stepped Care for Depression and Musculoskeletal Pain

Indiana University

Status and phase: Completed; Phase 4

Conditions: Depression; Pain

Treatments: Behavioral: Stepped Care; Drug: Usual Care; Drug: Antidepressants

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00118430

R01MH071268 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 3 patient groups

Stepped Care

Experimental group

Description:

Stepped care group

Treatment:

Behavioral: Stepped Care

Drug: Antidepressants

Usual Care

Active Comparator group

Description:

Treatment as usual group

Treatment:

Drug: Usual Care

No Treatment

No Intervention group

Description:

Participants without depression group