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临床试验/NCT00118430
NCT00118430已完成4 期

Stepped Care for Affective Disorders and Musculoskeletal Pain

Indiana University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2004年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
500
试验地点
1
主要终点
Brief Pain Inventory Interference

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Moderate to severe cognitive impairment
  • Schizophrenia or other psychotic disorders
  • Receiving disability benefits for pain
  • Anticipated life expectancy less than 12 months
  • Pregnancy

研究组 & 干预措施

Stepped Care

Experimental

Stepped care group

干预措施: Stepped Care (Behavioral)

Stepped Care

Experimental

Stepped care group

干预措施: Antidepressants (Drug)

Usual Care

Active Comparator

Treatment as usual group

干预措施: Usual Care (Drug)

结局指标

主要结局

Brief Pain Inventory Interference

时间窗: 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

时间窗: 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)

次要结局

  • Graded Chronic Pain Scale Disability Score(Measured at Year 1)
  • Primary Care Visits(Measured at Year 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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