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NCT Number: NCT06246929

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

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.

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Key information

Conditions

Chronic Pain Behavior Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Cognitive Impairment Motor Activity Neurocognitive Disorders Neurologic Manifestations Older Adults Pain Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Mallory Morehead, MPH

CONTACT

[email protected]

978-580-3153

About this study

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 or 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 outcomes. The investigators will also assess whether improvements in outcomes from the two programs are maintained through a 6-month follow-up.

The program MBCT+w is focused on learning about managing chronic pain and early cognitive decline and strategies to become more active. The ALED program focuses on learning and understanding the process of successful lifestyle change, incorporating physical activity in your day-to-day life, and strategies to manage daily activity.

The MBCT+w group meets in person for eight sessions for 90-minutes, and the ALED group meets in person for twelve sessions for 60-minutes. Each group has up to 10-12 participants. Participants receive a treatment manual. The investigators will assess how each program may help in improving physical, cognitive, and emotional function outcomes. Outcomes will be assessed at 3 points: baseline, post program, and 6-month follow-up. Assessments involve self-report questionnaires, a walk test, and a neuropsychological exam. The investigators will assess whether improvements in outcomes from the two programs are maintained through a 6-month follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function

    Time frame: 0 Weeks, 12 Weeks, 6 Months

    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

  1. ActiGraph GT9X Link Accelerometer

    Time frame: 0 Weeks, 12 Weeks, 6 Months

    Measure the change in steps during the 7 days preceding baseline assessment, throughout intervention period, and 7 days preceding 6-month follow-up.

  2. Six-minute walk test (6MWT)

    Time frame: 0 Weeks, 12 Weeks, 6 Months

    Assesses distance walked in 6 minutes.

  3. Montreal Cognitive Assessment (MoCA)

    Time frame: 0 Weeks, 12 Weeks, 6 Months

    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.

  4. Everyday Cognitive Scale (eCog-12)

    Time frame: 0 Weeks, 12 Weeks, 6 Months

    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.

  5. PROMIS Depression

    Time frame: 0 Weeks, 12 Weeks, 6 Months

    Rating of participant's self-reported negative mood, social cognition and views of self, with items ranging from 1-5. Higher T scores indicate high levels of depression.

  6. PROMIS Anxiety

    Time frame: 0 Weeks, 12 Weeks, 6 Months

    Rating of participant's self-reported fear, anxious, hyperarousal and somatic symptoms pertaining to arousal, with items ranging from 1-5. Higher T scores indicate higher levels of anxiety.

Other outcomes

  1. Numerical Rating Scale (NRS)

    Time frame: 0 Weeks, 12 Weeks, 6 Months

    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.

  2. UCLA loneliness scale 8-item (UCLA-8)

    Time frame: 0 Weeks, 12 Weeks, 6 Months

    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.

  3. PROMIS Emotional Support v4a

    Time frame: 0 Weeks, 12 Weeks, 6 Months

    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.

  4. Zarit Burden Interview (12-item)

    Time frame: 0 Weeks, 12 Weeks, 6 Months

    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.

  5. Caregiver Strain Questionnaire Short Form

    Time frame: 0 Weeks, 12 Weeks, 6 Months

    Rating of caregiver's self-reported subjective feelings of strain experienced with sleep, finances, physical movements, and emotional adjustments, with items ranging 0-1. Higher scores indicate greater feelings of strain.

Study contacts

Contact information is provided by the study sponsor or research team.

Adjoa Acquaah, BA

CONTACT

[email protected]

(617) 726-8103

Mallory Morehead, MPH

CONTACT

[email protected]

(978) 580-3153

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Comorbidity of Chronic Pain and Early Cognitive Decline Among Older, Community-Based Black Adults: Comparative Effectiveness of Mindfulness-Based Cognitive Therapy With Walking (MBCT+w) vs Active Living Every Day (ALED)

Acronym: HABIT

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 7, 2024
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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