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

NCT06246929 | Recruiting DMC

• 1 other identifier: 2024P000002
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Black Older Adults; African Americans; Subjective Cognitive Decline; Memory Related Problems; Pain; Cognition Disorders

Outcome Measures

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.

  0 Weeks, 12 Weeks, 6 Months

Secondary Outcomes (6)

• ActiGraph GT9X Link Accelerometer

  0 Weeks, 12 Weeks, 6 Months

• Six-minute walk test (6MWT)

  0 Weeks, 12 Weeks, 6 Months

• Montreal Cognitive Assessment (MoCA)

  0 Weeks, 12 Weeks, 6 Months

• Everyday Cognitive Scale (eCog-12)

  0 Weeks, 12 Weeks, 6 Months

• PROMIS Depression

  0 Weeks, 12 Weeks, 6 Months

Other Outcomes (5)

• Numerical Rating Scale (NRS)

  0 Weeks, 12 Weeks, 6 Months

• UCLA loneliness scale 8-item (UCLA-8)

  0 Weeks, 12 Weeks, 6 Months

• PROMIS Emotional Support v4a

  0 Weeks, 12 Weeks, 6 Months

Study Arms (2)

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.

Behavioral: MBCT+w

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.

Behavioral: ALED

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.

Mindfulness-Based Cognitive Therapy With Walking (MBCT+w)

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.

Active Living Every Day (ALED)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 33159516 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.

  PMID: 32601670 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Motor Activity; Cognitive Dysfunction; Pain; Cognition Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Neurocognitive Disorders; Mental Disorders

Study Officials

• Olivia Okereke, MD, MS

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mallory Morehead, MPH

CONTACT

(978) 580-3153; mmorehead@mgb.org

Adjoa Acquaah, BA

CONTACT

(617) 726-8103; aacquaah@mgh.hardvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Study Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Geriatric Psychiatry

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: January 10, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: May 26, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)