Integrated Care for Depression and Chronic Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Depression patient health questionnaire
研究概览
简要总结
This study will determine the effectiveness of an intervention consisting of combined strategies in reducing the symptoms of both depression and chronic back pain.
详细描述
The relationship between depression and back pain is complex. Depression is the most common mental condition associated with chronic back pain. Despite this relationship, many patients with depression and back pain seek treatment only for one of the two conditions, which can worsen the untreated condition. An intervention that reduces the symptoms of both depression and back pain is needed. This study will determine the effectiveness of an integrated intervention in reducing both back pain and depression symptoms.
Participants will be randomly assigned to receive either an integrated intervention or standard of care for 6 months. Participants in the integrated intervention group will receive cognitive behavioral therapy for back pain and antidepressants and/or problem solving therapy for depression. Study visits will initially occur once a week and then taper to once every 2 weeks for the 6-month duration; the time of tapering will depend on participant response to treatment and will be at the investigator's discretion. Depression and back pain symptoms will be assessed in all participants at study entry, at the end of treatment, and 6 months after the end of treatment. The study entry and study completion assessments will occur during study visits. The last assessment will be a telephone interview.
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
- 25 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Roland back pain score of 7 or greater
- •Diagnosis of major depression
- •Plan to stay enrolled in Group Health Cooperative for the duration of the study and 1 year after the study
排除标准
- •Prior surgery
- •Cauda equina syndrome (compression and paralysis of nerve roots)
- •Schizophrenia or bipolar disorder treatment within 2 years prior to study entry
- •Current or prior psychiatric or psychological care for back pain or depression
- •At high risk for suicide
研究组 & 干预措施
Integrated Intervention
Participants will receive cognitive behavioral therapy for back pain and antidepressants and/or problem solving therapy for depression. Study visits will initially occur once a week and then taper to once every 2 weeks for the 6-month duration.
干预措施: Cognitive behavioral therapy (Behavioral)
Integrated Intervention
Participants will receive cognitive behavioral therapy for back pain and antidepressants and/or problem solving therapy for depression. Study visits will initially occur once a week and then taper to once every 2 weeks for the 6-month duration.
干预措施: Antidepressants (Drug)
Integrated Intervention
Participants will receive cognitive behavioral therapy for back pain and antidepressants and/or problem solving therapy for depression. Study visits will initially occur once a week and then taper to once every 2 weeks for the 6-month duration.
干预措施: Problem solving therapy (Behavioral)
结局指标
主要结局
Depression patient health questionnaire
时间窗: Measured at study entry, at the end of treatment, and 6 months after the end of treatment
Back pain limitations
时间窗: Measured at study entry, at the end of treatment, and 6 months after the end of treatment
Roland disability score
时间窗: Measured at study entry, at the end of treatment, and 6 months after the end of treatment
次要结局
未报告次要终点