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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06246929
Status
Recruiting
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Conditions

  • Chronic Pain
  • Mild Cognitive Impairment
  • Older Adults
  • Physical Activity

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jan 10, 2025
Status verified
May 2025
Primary completion
Aug 1, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mindfulness-Based Cognitive Therapy With Walking (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.
  • Active Comparator: Active Living Every Day (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 Measure

Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function [ Time Frame: 0 Weeks, 12 Weeks, 6 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Mallory Morehead, MPH
[email protected]
978-580-3153

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By research site
Massachusetts General Hospital· Boston, MA

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