RAPID: Reducing Pain; Preventing Depression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Patient Global Impression of Change for Knee Pain
研究概览
简要总结
The primary question addressed by this prevention study is to explore if improving pain and disability reduces episodes of Major Depression among seniors with knee osteoarthritis (OA) and mild depressive symptoms.
详细描述
In this Sequential Multiple Assignment Randomized (SMART) Trial, the investigators care comparing Cognitive Behavioral Therapy for Pain (CBT-P) with EXERCISE (knee-specific Physical Therapy) delivered individually and sequentially. A subset of participants will receive enhanced care as usual in which their primary care physicians will receive information about pharmacological management of knee osteoarthritis. The active phase of the study may be up to 16 weeks, and the follow-up period lasts 12 months.
Stage 1, Specific Aim 1: To test if Cognitive Behavioral Therapy for Pain (CBT-P) results in more improvement in pain and disability than those receiving knee-specific Physical Therapy (EXERCISE).
Stage 1, Hypothesis 1: At week 8, subjects randomized to CBT-P will have more improvement in pain and disability than those randomized to EXERCISE.
Stage 2, Specific Aim 2: For non-responders to Stage 1, to explore which sequence of interventions leads to greater improvement in pain and disability.
Stage 2, Hypothesis 2: Compared to the other sequenced interventions (see Figure), subjects randomized to CBT-P and then EXERCISE will have the most improvement in pain and disability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>/= age 60
- •meets accepted clinical criteria for knee OA based on the American College of Rheumatology 1986 clinical criteria guidelines.
- •Western Ontario and McMaster University Arthritis Index (WOMAC) pain subscale score in the range of 7-15 (to minimize including subjects with knee OA so severe they may be better served by arthroplasty)
- •PHQ-9 scores 1-9, with at least one of the cardinal symptoms of depression (low mood or anhedonia) endorsed.
- •Modified Mini Mental State (3MS) Examination >/=
- •Has or is willing to establish care with a personal physician prior to any experimental procedures.
排除标准
- •Major Depressive Episode or anxiety disorder within the past 1 year
- •Currently taking an antidepressant
- •History of bipolar or schizophrenia
- •Drug or alcohol use disorder within the past 12 months
- •Receiving knee-related workers compensation or involved in knee pain-related litigation.
- •Currently taking an anti-anxiety medicine > 4 times/week for the past 4 weeks.
研究组 & 干预措施
Physical Therapy
8-12 sessions of knee-focused physical therapy and a home-based conditioning program.
干预措施: Physical Therapy for knee OA (Procedure)
Cognitive Behavioral Therapy for Pain
8-12 session pain-focused Cognitive Behavioral Therapy
干预措施: Cognitive Behavioral Therapy for Pain CBT-P (Behavioral)
Enhanced Treatment as Usual
Information about state-of-the-art pharmacotherapy for osteoarthritis is communicated to the primary care physicians of participants.
干预措施: Enhanced Treatment as Usual (Other)
结局指标
主要结局
Patient Global Impression of Change for Knee Pain
时间窗: Assessed after the 8-16 week intervention
次要结局
未报告次要终点
研究者
Jordan F. Karp
Associate Professor
University of Pittsburgh