Stepped Care for Depression and Musculoskeletal Pain

Phase 4

Completed

Conditions: Pain
Depression

Interventions: Drug: Usual Care
Behavioral: Stepped Care
Drug: Antidepressants

Registration Number: NCT00118430

Lead Sponsor: Indiana University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 500

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Treatment as usual group
Stepped Care	Stepped Care	Stepped care group
Stepped Care	Antidepressants	Stepped care group

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory Interference	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	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)

Secondary Outcome Measures

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