Comorbidity of Chronic Pain and Early Cognitive Decline Among Older, Community-Based Black Adults: Comparative Effectiveness of Mindfulness-Based Cognitive Therapy With Walking (MBCT+w) vs Active Living Every Day (ALED)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function
研究概览
简要总结
The investigators aim to conduct a randomized controlled trial to compare two symptom-management programs for Black older adults with early cognitive decline (self-reported confirmed by testing) and chronic pain. The programs are Mindfulness-Based Cognitive Therapy with Walking (MBCT+w) and Active Living Every Day (ALED). The investigators will assess how each program may help in improving physical, cognitive, and emotional function. The investigators will also assess whether improvements in outcomes from the two programs are maintained through a 6-month follow-up.
详细描述
The investigators aim to conduct a randomized controlled trial to compare two symptom-management programs for Black older adults with early cognitive decline (self-reported or confirmed by testing) and chronic pain. The programs are Mindfulness-Based Cognitive Therapy with Walking (MBCT+w) and Active Living Every Day (ALED). The investigators will assess how each program may help in improving physical, cognitive, and emotional function outcomes. The investigators will also assess whether improvements in outcomes from the two programs are maintained through a 6-month follow-up.
The program MBCT+w is focused on learning about managing chronic pain and early cognitive decline and strategies to become more active. The ALED program focuses on learning and understanding the process of successful lifestyle change, incorporating physical activity in your day-to-day life, and strategies to manage daily activity.
The MBCT+w group meets in person for eight sessions for 90-minutes, and the ALED group meets in person for twelve sessions for 60-minutes. Each group has up to 10-12 participants. Participants receive a treatment manual. The investigators will assess how each program may help in improving physical, cognitive, and emotional function outcomes. Outcomes will be assessed at 3 points: baseline, post program, and 6-month follow-up. Assessments involve self-report questionnaires, a walk test, and a neuropsychological exam. The investigators will assess whether improvements in outcomes from the two programs are maintained through a 6-month follow-up.
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 (Participant)
盲法说明
Study Statistician
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Black adults, male and females, age 50 or older
- •Have nonmalignant musculoskeletal chronic pain for more than three months
- •Reports early cognitive decline (subjective and objective)
- •Telephone Interview for Cognitive Status-41 score greater than or equal to 31
- •Functional Activities Questionnaire score less than 9
- •English fluency/literacy
- •Free of concurrent psychotropic or pain medication for at least 2 weeks prior to initiation of treatment, OR stable on current psychotropic or pain medication for a minimum of 6 weeks and willing to maintain stable dose
- •Cleared by medical doctor for study participation and no self-reported concerns about physical functioning on the revised Physical Activity Readiness Questionnaire (PAR-Q; score 0)
排除标准
- •Diagnosed with dementia or neurodegenerative disease
- •Regular use of nonpharmacological pain management
- •Diagnosed with serious mental illness or substance abuse
- •Current suicidal ideation on self-report
- •Engagement of regular exercise for more than 30 minutes daily
- •Unable to walk
研究组 & 干预措施
Mindfulness-Based Cognitive Therapy With Walking (MBCT+w)
MBCT+w uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions and weekly practice assignments (homework). The MBCT+w sessions teach skills and strategies to manage early cognitive concerns and chronic pain. The format is an 8-week program with 90-minute weekly meetings that will focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions. MBCT+w uses a wrist-worn digital monitoring device (ActiGraph) for recording of physical activity.
干预措施: MBCT+w (Behavioral)
Active Living Every Day (ALED)
ALED is a behavior change program. ALED offers different options to traditional exercise program to help participants overcome barriers to physical activity and increase their physical activity. The format is a 12-week program with 60-minute sessions that include a short lecture and group discussions to help participants set goals, decrease barriers to exercise, and find an activity they enjoy. The ALED program is conducted in the same format as MBCT+w, but participants are not taught the mind-body, walking or cognitive-behavioral skills. ALED will also use a wrist-worn digital monitoring device (ActiGraph) for recording of physical activity.
干预措施: ALED (Behavioral)
结局指标
主要结局
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function
时间窗: 0 Weeks, 12 Weeks, 6 Months
Change in participant's self-reported performance of everyday physical activities, with items ranging from 1-4. Higher T scores indicate greater physical function.
次要结局
- ActiGraph GT9X Link Accelerometer(0 Weeks, 12 Weeks, 6 Months)
- Six-minute walk test (6MWT)(0 Weeks, 12 Weeks, 6 Months)
- PROMIS Depression(0 Weeks, 12 Weeks, 6 Months)
- PROMIS Anxiety(0 Weeks, 12 Weeks, 6 Months)
- Montreal Cognitive Assessment (MoCA)(0 Weeks, 12 Weeks, 6 Months)
- Everyday Cognitive Scale (eCog-12)(0 Weeks, 12 Weeks, 6 Months)
研究者
Olivia I.Okereke, MD
Director of Geriatric Psychiatry
Massachusetts General Hospital