Active Brains: Managing Pain and Cognitions in Older Adults With Mild Cognitive Impairment (MCI) or Memory Related Problems (MRP) and Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Client Satisfaction Questionnaire 3-Item (CSQ-3): Number of Participants With Scores Above and Below Scale Midpoint
研究概览
简要总结
We aim to conduct a pilot randomized controlled trial comparing 2 symptom management programs for older adults with self-reported memory problems and chronic pain, Active Brains 1 and Active Brains 2. We will assess how each program may help in improving coping with pain and coping with cognitive functioning. We will explore feasibility, acceptability, and credibility and within group changes in physical, emotional and cognitive functioning.
详细描述
We aim to conduct a pilot randomized controlled trial comparing 2 symptom management programs for older adults with self-reported memory problems and chronic pain: Active Brains 1 Active Brains 2. We will assess how each program may help in improving coping with pain and coping with cognitive functioning. We will explore feasibility, acceptability, and credibility and within group changes in physical, emotional and cognitive functioning.
Each group meets for 8 90 minute sessions over a secure video platform. Each group has 5-8 participants. Participants receive a treatment manual. There are 2 assessment points: baseline, and post program. Assessments involve questionnaires, a walk test, and objective step count with ActiGraphs for 1 week.
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
- •Male and female patients, age 60 years or older
- •Have nonmalignant chronic pain for more than 3 months
- •Has MCI or subjective memory related problems
- •Able to perform a 6-minute walk test at an accelerated pace
- •Owns a smartphone with Bluetooth 4.0
- •Willingness and ability to participate in the Active Brains intervention and to comply with the requirements of the study protocol (including weekly sessions and Fitbit use)
- •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
- •Leads a sedentary lifestyle
排除标准
- •Diagnosed with medical illness expected to worsen in the next 6 months
- •Serious mental illness or instability for which hospitalization may be likely in the next 6 months
- •Current suicidal ideation reported on self-report
- •Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, or substance dependence
- •Current substance use disorder, within the past 6 months
- •Practice of yoga/meditation, or other mind-body techniques that elicit the relaxation response, once per week for 45 minutes or more within the last 3 months or less
- •Regular use of Fitbit in the last 3 months
- •Engagement in regular intensive physical exercise for >30 minute daily
- •Unable to walk without use of assistance (e.g., wheelchair, walker)
结局指标
主要结局
Client Satisfaction Questionnaire 3-Item (CSQ-3): Number of Participants With Scores Above and Below Scale Midpoint
时间窗: 8 Weeks
Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction
次要结局
- Rate of Interventionist's Delivering the Programs by Following the Established Session Topics and Skills(0 Weeks, 8 Weeks)
- Numerical Rating Scale(0 Weeks, 8 Weeks)
- WHO Disability Assessment Schedule 2.0(0 Weeks, 8 Weeks)
- PROMIS Emotional Support(0 Weeks, 8 Weeks)
- Pain Self Efficacy Questionnaire (PSEQ)(0 Weeks, 8 Weeks)
- Proportion of Participants With Valid Digital Monitoring Device Wear(0 Weeks, 8 Weeks)
- Proportion of Participants Using Rescue (Non-Narcotic) Analgesics(0 Weeks)
- Measure of Current Status (MOCS-A)(0 Weeks, 8 Weeks)
- The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)(0 Weeks, 8 Weeks)
- Proportion of Participants With Valid Adherence to Homework(0 Weeks, 8 Weeks)
- Percentage of Missing or Low Reliability Measures (Feasibility of Quantitative Measures)(0 Weeks, 8 Weeks)
- Montreal Cognitive Assessment (MoCA)(0 Weeks, 8 Weeks)
- Godin Leisure-Time Exercise Questionnaire(0 Weeks, 8 Weeks)
- Six-Minute Walk Test (6MWT)(0 weeks, 8 weeks)
- Proportion of Participants Using Narcotic Analgesics(0 Weeks)
- Credibility and Expectancy Questionnaire (CEQ): Number of Participants With Scores Above and Below Scale Midpoint(0 Weeks)
- The Measurement of Everyday Cognition (eCog)(0 Weeks, 8 Weeks)
- Pain Catastrophizing Scale (PCS)(0 Weeks, 8 Weeks)
- UCLA Loneliness Scale(0 Weeks, 8 Weeks)
- Chronic Pain Acceptance Questionnaire(0 Weeks, 8 Weeks)
- The Gratitude Questionnaire (GQ-6)(0 Weeks, 8 Weeks)
- PROMIS Physical Function(0 Weeks, 8 Weeks)
- T-Score for PROMIS Depression(0 Weeks, 8 Weeks)
- T-Score for PROMIS Anxiety(0 Weeks, 8 Weeks)
- Self-Compassion Scale (SCS)(0 Weeks, 8 Weeks)
- ActiGraph Average Steps(0 weeks, 8 weeks)
- Tampa Kinesiophobia Scale(0 Weeks, 8 Weeks)
研究者
Ana-Maria Vranceanu, PhD
Associate Professor/Director
Massachusetts General Hospital