RecruitingNot ApplicableNCT06246929

Healthy Aging as Black Adults, In It Together: a Comparative Effectiveness Study of Chronic Pain and Cognitive Decline

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)

Sponsor

Massachusetts General Hospital

Enrollment

400 participants

Start Date

Jan 10, 2025

Study Type

INTERVENTIONAL

Conditions

Older Adults Physical Activity Chronic Pain Mild Cognitive Impairment

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.

Eligibility

Min Age: 50 Years

Inclusion Criteria8

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 Criteria6

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

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Interventions

BEHAVIORALMBCT+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.

BEHAVIORALALED

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.