Clinical trial NCT06246929: Healthy Aging as Black Adults, In It Together: a Comparative Effectiveness Study of Chronic Pain and Cognitive Decline
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Physical Activity
Older Adults
Mild Cognitive Impairment
Keywords: Black Older Adults
African Americans
Subjective Cognitive Decline
Memory Related Problems
Pain
Cognition Disorders
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function
timeFrame: 0 Weeks, 12 Weeks, 6 Months
Secondary outcomes:
measure: ActiGraph GT9X Link Accelerometer
timeFrame: 0 Weeks, 12 Weeks, 6 Months
measure: Six-minute walk test (6MWT)
timeFrame: 0 Weeks, 12 Weeks, 6 Months
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 0 Weeks, 12 Weeks, 6 Months
measure: Everyday Cognitive Scale (eCog-12)
timeFrame: 0 Weeks, 12 Weeks, 6 Months
measure: PROMIS Depression
timeFrame: 0 Weeks, 12 Weeks, 6 Months
measure: PROMIS Anxiety
timeFrame: 0 Weeks, 12 Weeks, 6 Months
Other outcomes:
measure: Numerical Rating Scale (NRS)
timeFrame: 0 Weeks, 12 Weeks, 6 Months
measure: UCLA loneliness scale 8-item (UCLA-8)
timeFrame: 0 Weeks, 12 Weeks, 6 Months
measure: PROMIS Emotional Support v4a
timeFrame: 0 Weeks, 12 Weeks, 6 Months
measure: Zarit Burden Interview (12-item)
timeFrame: 0 Weeks, 12 Weeks, 6 Months
measure: Caregiver Strain Questionnaire Short Form
timeFrame: 0 Weeks, 12 Weeks, 6 Months
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Olivia Okereke, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mace RA, Gates MV, Popok PJ, Kulich R, Quiroz YT, Vranceanu AM. Feasibility Trial of a Mind-Body Activity Pain Management Program for Older Adults With Cognitive Decline. Gerontologist. 2021 Nov 15;61(8):1326-1337. doi: 10.1093/geront/gnaa179.
citation: Mace RA, Gates MV, Bullard B, Lester EG, Silverman IH, Quiroz YT, Vranceanu AM. Development of a Novel Mind-Body Activity and Pain Management Program for Older Adults With Cognitive Decline. Gerontologist. 2021 Apr 3;61(3):449-459. doi: 10.1093/geront/gnaa084.