Healthy Aging as Black Adults, In It Together: a Comparative Effectiveness Study of Chronic Pain and Cognitive Decline

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorMassachusetts General Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Mindfulness-Based Cognitive Therapy With Walking (MBCT+w)Experimental treatment 1 intervention
Group B: Active Living Every Day (ALED)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
0 Weeks, 12 Weeks, 6 Months

Secondary outcomes

1

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.

Time frame
0 Weeks, 12 Weeks, 6 Months
2

Six-minute walk test (6MWT)

Assesses distance walked in 6 minutes.

Time frame
0 Weeks, 12 Weeks, 6 Months
3

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.

Time frame
0 Weeks, 12 Weeks, 6 Months
4

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.

Time frame
0 Weeks, 12 Weeks, 6 Months

Other outcomes

1

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.

Time frame
0 Weeks, 12 Weeks, 6 Months
2

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.

Time frame
0 Weeks, 12 Weeks, 6 Months
3

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.

Time frame
0 Weeks, 12 Weeks, 6 Months
4

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.

Time frame
0 Weeks, 12 Weeks, 6 Months

Sponsors and contacts

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