Healthy Aging as Black Adults, In It Together: a Comparative Effectiveness Study of Chronic Pain and Cognitive Decline
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MBCT+w, ALED.
- Who it may be relevant to
- Registry conditions: Chronic Pain, Physical Activity, Older Adults, Mild Cognitive Impairment. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Interventions
- Behavioral MBCT+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 - Behavioral ALED
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-b
Primary outcome measures
- Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function [Time frame: 0 Weeks, 12 Weeks, 6 Months]
Secondary outcome measures (6)
- ActiGraph GT9X Link Accelerometer [Time frame: 0 Weeks, 12 Weeks, 6 Months]
- Six-minute walk test (6MWT) [Time frame: 0 Weeks, 12 Weeks, 6 Months]
- Montreal Cognitive Assessment (MoCA) [Time frame: 0 Weeks, 12 Weeks, 6 Months]
- Everyday Cognitive Scale (eCog-12) [Time frame: 0 Weeks, 12 Weeks, 6 Months]
- PROMIS Depression [Time frame: 0 Weeks, 12 Weeks, 6 Months]
- PROMIS Anxiety [Time frame: 0 Weeks, 12 Weeks, 6 Months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Publications
- Klein KG, Seward M, Harley D, Mace R, Morehead M, Parker RA, Sylvia LG, Bartels SJ, Obler D, Callahan J, Craddock K, Reed R, Atkinson F, Joo JH, Macklin E, Okereke OI, Vranceanu AM. Healthy aging as Black adults, in it together (HABIT): Protocol for a comparative effectiveness trial to address comorbid chronic pain and early cognitive decline among older, community-based Black adults. Contemp Clin PMID 41903741
- 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. PMID 33159516
- 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. PMID 32601670
Identifiers
NCT: NCT06246929 · 2024P000002