Investigation of the Effect of Acceptance and Commitment Therapy and Exercise in Older Adults With Chronic Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Change from baseline pain intensity and interference at 8 weeks
研究概览
简要总结
The goal of this trial is to learn if combining Acceptance and Commitment Therapy (ACT) and exercise works to reduce pain intensity, pain interference, and depressive symptoms in older adults with chronic pain and depressive symptoms.
Researchers will compare ACT + exercise intervention (ACEx) to ACT + art intervention (Art+Ex) and usual care to see if ACT + exercise intervention works to reduce pain intensity, pain interference, and depressive symptoms.
Participants will receive ACEx program, Art+Ex program, or usual care for 8 weeks and complete tests before and after the programs.
详细描述
Chronic pain is classified as persistent or recurrent pain for more than 3 months associated with physical disability, depression and poor psychosocial functioning among older adults; causing a dependence on medication and decreasing their quality of life. There are various treatment options from chronic pain, but the benefits on pain outcomes are minimal and rather short term. Psychological interventions, such as acceptance and commitment therapy (ACT), have shown positive effect on older adults with chronic pain. Using the three core elements of psychological flexibility, older adults are encouraged to establish a different relationship with pain: 1) be present; 2) do what matters; and 3) open up. Growing studies are exploring the application of biopsychosocial model in pain management, using multidisciplinary interventions. This RCT aims to explore the effectiveness of combining ACT and exercise with two arms: 1) art and exercise; and 2) treatment as usual.
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
- Single (Participant)
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 years or above; and
- •have depressive symptoms of mild level or above (PHQ > 5)
- •have chronic pain (>3 months)
- •able to give informed consent to participate
排除标准
- •known history of autism, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia
- •(temporary exclusion criteria) imminent suicidal risk difficulty in communication
- •have had stroke, fracture, cardiovascular disease, cardiovascular surgery, artery disease, surgery on vertebrae, and knee replacement in the past 6 months
- •physical activity prohibited by a medical professional
结局指标
主要结局
Change from baseline pain intensity and interference at 8 weeks
时间窗: Baseline(T0) and 8 weeks after baseline (T1)
Brief pain inventory (BPI) is used to measure pain intensity and interference, it is a 11 items scale, using an 11-point rating, of which 0 indicates not interference and 10 as interferes completely. The higher the numbers, the greater the pain intensity and pain interference.
Change from baseline depression at 8 weeks
时间窗: Baseline(T0) and 8 weeks after baseline (T1)
The Patient Health Questionnaire (PHQ-9) is used to measure depression, it is a 9-item instrument, PHQ-9 scores of 5-9, 10-14, 15-19, 20 and above represent mild, moderate, moderately severe, and severe depression. Scores range between 0 and 27.
Change from baseline pain intensity and interference at 8 weeks
时间窗: Baseline(T0) and 8 weeks after baseline (T1)
Brief pain inventory (BPI) is used to measure pain intensity and interference, it is a 11 items scale, using an 11-point rating, of which 0 indicates not interference and 10 as interferes completely. The higher the numbers, the greater the pain intensity and pain interference.
次要结局
- Change from baseline anxiety at 8 weeks(Baseline(T0) and 8 weeks after baseline (T1))
- Change from baseline psychological flexibility at 8 weeks(Baseline(T0) and 8 weeks after baseline (T1))
- Change from baseline pain self-efficacy at 8 weeks(Baseline(T0) and 8 weeks after baseline (T1))
- Change from baseline health-related quality of life at 8 weeks(Baseline(T0) and 8 weeks after baseline (T1))
- Change from baseline gait speed at 8 weeks(Baseline(T0) and 8 weeks after baseline (T1))
- Change from baseline physical balance at 8 weeks(Baseline(T0) and 8 weeks after baseline (T1))
- Change from baseline lower body strength at 8 weeks(Baseline(T0) and 8 weeks after baseline (T1))
- Change from baseline upper body functioning at 8 weeks(Baseline(T0) and 8 weeks after baseline (T1))
- Change from baseline aerobic fitness at 8 weeks(Baseline(T0) and 8 weeks after baseline (T1))
- Change from baseline anxiety at 8 weeks(Baseline(T0) and 8 weeks after baseline (T1))
研究者
Professor Terry Y.S. Lum
Henry G. Leong Professor in Social Work and Social Administration; Principal Investigator of the JC JoyAge project
The University of Hong Kong