Comparing two programs for managing chronic pain and cognitive decline in Black older adults
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)
This study is testing two different programs to see which one helps Black older adults with chronic pain and early cognitive decline feel better overall.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06246929 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare two symptom-management programs, Mindfulness-Based Cognitive Therapy with Walking (MBCT+w) and Active Living Every Day (ALED), for Black older adults experiencing early cognitive decline and chronic pain. Participants will be randomly assigned to one of the two programs, which focus on improving physical, cognitive, and emotional functions through structured sessions. The effectiveness of each program will be evaluated at baseline, post-program, and after a 6-month follow-up using self-report questionnaires, walk tests, and neuropsychological exams. The study seeks to determine which program is more beneficial for the participants' overall well-being.
Who should consider this trial
Good fit: Ideal candidates are Black adults aged 50 or older with chronic musculoskeletal pain and early cognitive decline.
Not a fit: Patients diagnosed with dementia or neurodegenerative diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective management strategies for chronic pain and cognitive decline in Black older adults, improving their quality of life.
How similar studies have performed: Other studies have shown promise in using mindfulness and active living programs for similar populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Olivia Okereke, MD, MS — Massachusetts General Hospital
- Study coordinator: Mallory Morehead, MPH
- Email: mmorehead@mgb.org
- Phone: (978) 580-3153
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.