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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based Cognitive Therapy With Walking (MBCT+w) | Experimental | 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. |
|
| Active Living Every Day (ALED) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBCT+w | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function | Change in participant's self-reported performance of everyday physical activities, with items ranging from 1-4. Higher T scores indicate greater physical function. | 0 Weeks, 12 Weeks, 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| ActiGraph GT9X Link Accelerometer | Measure the change in steps during the 7 days preceding baseline assessment, throughout intervention period, and 7 days preceding 6-month follow-up. | 0 Weeks, 12 Weeks, 6 Months |
| Six-minute walk test (6MWT) |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale (NRS) | Rating of participant's self-reported pain at rest and with activity using a Likert Scale with 0 being no pain and 10 being worst possible pain. | 0 Weeks, 12 Weeks, 6 Months |
| UCLA loneliness scale 8-item (UCLA-8) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mallory Morehead, MPH | Contact | (978) 580-3153 | mmorehead@mgb.org | |
| Adjoa Acquaah, BA | Contact | (617) 726-8103 | aacquaah@mgh.hardvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Olivia Okereke, MD, MS | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41903741 | Background | 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 Trials. 2026 Jun;165:108292. doi: 10.1016/j.cct.2026.108292. Epub 2026 Mar 26. | |
| 33159516 |
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Study Statistician
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|
| ALED | Behavioral | 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. |
|
Assesses distance walked in 6 minutes.
| 0 Weeks, 12 Weeks, 6 Months |
| Montreal Cognitive Assessment (MoCA) | A comprehensive test that assesses eight cognitive abilities (orientation, short-term memory, executive function, clock drawing, animal naming, language abilities, abstraction, and attention). Higher total scores (0-30) indicate greater cognitive functioning. | 0 Weeks, 12 Weeks, 6 Months |
| Everyday Cognitive Scale (eCog-12) | Rating of participant's self-reported cognitively mediated functional abilities, with items ranging 1-5. Scores are calculated by averaging the 12 items, and range 1-5, with higher scores indicating greater cognitive decline. | 0 Weeks, 12 Weeks, 6 Months |
| PROMIS Depression | Rating of participant's self-reported negative mood, social cognition and views of self, with items ranging from 1-5. Higher T scores indicate high levels of depression. | 0 Weeks, 12 Weeks, 6 Months |
| PROMIS Anxiety | Rating of participant's self-reported fear, anxious, hyperarousal and somatic symptoms pertaining to arousal, with items ranging from 1-5. Higher T scores indicate higher levels of anxiety. | 0 Weeks, 12 Weeks, 6 Months |
Rating of participant's self-reported subjective feelings of loneliness and social isolation, with items ranging 0-3. Higher scores indicate higher feelings of loneliness.
| 0 Weeks, 12 Weeks, 6 Months |
| PROMIS Emotional Support v4a | Rating of participant's self-reported subjective feelings of emotional support from others, with items ranging 1-5. Higher T scores indicate higher emotional support. | 0 Weeks, 12 Weeks, 6 Months |
| Zarit Burden Interview (12-item) | Rating of caregiver's self-reported subjective feelings of his or her levels of burden for caring for a person with a particular diagnosis, with items ranging 0-4. Higher scores indicate greater feelings of burden. | 0 Weeks, 12 Weeks, 6 Months |
| Caregiver Strain Questionnaire Short Form | Rating of caregiver's self-reported subjective feelings of strain experienced with sleep, finances, physical movements, and emotional adjustments, with items ranging 0-1. Higher scores indicate greater feelings of strain. | 0 Weeks, 12 Weeks, 6 Months |
| Background |
| 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. |
| 32601670 | Background | 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. |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009043 | Motor Activity |
| D060825 | Cognitive Dysfunction |
| D010146 | Pain |
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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