Addressing the Chronic Pain-Early Cognitive Decline Comorbidity Among Older Adults; The Active Brains Study
概览
- 阶段
- 不适用
- 干预措施
- Active Brains 1
- 疾病 / 适应症
- Chronic Pain
- 发起方
- Massachusetts General Hospital
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Change in six-minute walk test (6MWT)
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
概览
简要总结
The investigators aim to conduct a fully powered randomized controlled trial to compare the efficacy of two symptom management programs for older adults with early cognitive decline (either self-reported or confirmed by testing) and chronic pain, Active Brains 1 and Active Brains 2. The investigators will assess how each program may help in improving multimodal physical, cognitive and emotional function. The investigators will also assess whether improvements in outcomes from the two programs are maintained through 6-months follow-up. The investigators will also explore whether improvements in outcomes are mediated by nonadaptive pain reactions, adaptive coping, social factors and compensatory strategies and modified by demographic and clinical predictors. Both programs will be delivered virtually (Zoom).
详细描述
The investigators aim to conduct a fully powered randomized controlled trial to establish efficacy of two symptom management programs for older adults with early cognitive decline (either self-reported or confirmed by testing) and chronic pain, Active Brains 1 and Active Brains 2. The investigators will assess how the two programs may help in improving multimodal physical, cognitive and emotional function. The investigators will also assess whether improvements in outcomes are maintained through 6-months follow-up. The investigators will also explore whether improvements in outcomes are mediated by nonadaptive pain reactions, adaptive coping, social factors and compensatory strategies and modified by demographic and clinical predictors, and type of early cognitive decline. Both programs will be delivered virtually (Zoom). Each group meets for eight, 90 minutes sessions over the secure Zoom platform. Each group has 5-8 participants. Participants receive a treatment manual. There are 3 assessment points: baseline, post program and 6-month follow-up. Assessments involve self-report questionnaires, a walk test and a neuropsychological evaluation.
研究者
Ana-Maria Vranceanu, PhD
Associate Professor/Director
Massachusetts General Hospital
入排标准
入选标准
- •Male and female outpatients, age 60 years or older
- •Have nonmalignant chronic pain for more than 3 months
- •Reports early cognitive decline (subjective or objective)
- •Telephone Interview for Cognitive Status-30 score greater than or equal to 17
- •Functional Activities Questionnaire score less than 9
- •Able to perform a 6-minute walk test at an accelerated pace
- •English fluency/literacy
- •Willingness and ability to participate and use an ActiGraph watch and smartphone app to view and sync the step count and sleep data
- •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 a stable dose
- •Cleared by a 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
- •Diagnosed with medical illness expected to worsen in the next 6 months
- •Diagnosed with serious untreated mental illness (i.e., schizophrenia) or untreated substance use disorder
- •Current suicidal ideation reported on self-report
- •Engaging in regular mindfulness practice \> 45 min/week or has completed a course of cognitive behavioral therapy in the past 3 months
- •Regular use of a digital-monitoring device
- •Engagement in regular intensive physical exercise for \>30 minute daily
研究组 & 干预措施
Active Brains 1
Active Brains 1 uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions and weekly practice assignments (homework). The Active Brains sessions teach skills and strategies to manage early cognitive concerns and chronic pain. The format is an 8-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions. Active Brains 1 uses a wrist-worn digital monitoring device (ActiGraph) for recording of physical activity.
干预措施: Active Brains 1
Active Brains 2
This active comparison condition controls for the effect of time spent, group member support/feedback and interventionist support/feedback. Active Brains 2 addresses population-specific challenges of chronic pain and early cognitive decline symptoms. Participants also receive lifestyle education consistent from public health recommendations and standards for health promotion (e.g., "Sleep", "Nutrition", "Healthy Weight" and "Medical appointments". The Active Brains 2 program consists on 8 group sessions (each session is 90 minutes) that occur concurrently with the active intervention condition. The Active Brains 2 is conducted in the same format as Active Brains 1, but participants are not taught the mind-body, walking or cognitive-behavioral skills. Active Brains 2 uses a wrist-worn digital monitoring device (ActiGraph) for recording of physical activity.
干预措施: Active Brains 2
结局指标
主要结局
Change in six-minute walk test (6MWT)
时间窗: 0 Weeks, 8 Weeks, 6 Months
Assesses distance walked in 6 minutes.
Change in PROMIS Physical Function
时间窗: 0 Weeks, 8 Weeks, 6 Months
Change in rate of a participant's capability rather than performance of physical activities, with items ranging from 1-4. Higher T scores indicate greater physical function.
Change in Step Count via the ActiGraph wGT3X-BTLE Accelerometer
时间窗: 0 Weeks, 8 Weeks, 6 Months
Measures the change in steps during the 7 days preceding baseline assessment, throughout the intervention period, and 7 days preceding 6-month follow-up.
次要结局
- PROMIS Depression(0 Weeks, 8 Weeks, 6 Months)
- PROMIS Anxiety(0 Weeks, 8 Weeks, 6 Months)
- Everyday Cognition Scale (eCog-12)(0 Weeks, 8 Weeks, 6 Months)
- Numerical Rating Scale(0 Weeks, 8 Weeks, 6 Months)
- Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(0 Weeks, 8 Weeks, 6 Months)