About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
MBCT+w
BehavioralMBCT+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.
ALED
BehavioralALED 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Six-minute walk test (6MWT)
Assesses distance walked in 6 minutes.
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.
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.
Other outcomes
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.
UCLA loneliness scale 8-item (UCLA-8)
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.
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.
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.
Sponsors and contacts
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