NCT06246929 · Massachusetts General Hospital
Healthy Aging as Black Adults, In It Together: a Comparative Effectiveness Study of Chronic Pain and Cognitive Decline
(HABIT)
What this study is about
The investigators aim to conduct a randomly assigned 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).
View original scientific 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 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.
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 monitoring device (ActiGraph) for recording of physical activity.
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-body, walking or cognitive-behavioral skills. ALED will also use a wrist-worn digital monitoring device (ActiGraph) for recording of physical activity.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Boston, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations