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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Olivia I.Okereke, MD
Director of Geriatric Psychiatry
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function
Time Frame: 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.
Secondary Outcomes
- 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)