Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT06246929

Conditions

Chronic Pain

Physical Activity

Older Adults

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

MBCT+w

ALED

Study Details

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

Study ID

NCT06246929

Start date

Jan 10, 2025

Status verified date

Jul, 2026

Completion date

Dec 15, 2028

Anticipated

Primary completion date

Dec 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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 and Locations

Central contacts

Mallory Morehead, MPH

(978) 580-3153mmorehead@mgb.org

Adjoa Acquaah, BA

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

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Mallory Morehead, MPH

978-580-3153mmorehead@mgb.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-07-07.