Chronic PainHABITNCT06246929
Healthy Aging as Black Adults, In It Together: a Comparative Effectiveness Study of Chronic Pain and Cognitive Decline
A study testing MBCT+w and ALED in people with Chronic Pain and Physical Activity, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Pain, Physical Activity, Older Adults
- What is being tested?
- MBCT+w and ALED
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2025to 15 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Mallory Morehead, MPH, 978-580-3153, mmorehead@mgb.org
About this study
Official 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)
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.
Read the detailed description
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.
- Being tested
- MBCT+w, ALED
- Keywords
- Black Older Adults, African Americans, Subjective Cognitive Decline, Memory Related Problems, Pain, Cognition Disorders
- Medical subject headings
- Chronic Pain, Motor Activity, Cognitive Dysfunction, Pain, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBCT+wBehavioural
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.
ALEDBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: ALED |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 Weeks, 12 Weeks, 6 Months
Secondary outcomes (6)
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.
Measured: 0 Weeks, 12 Weeks, 6 Months
Six-minute walk test (6MWT)
Assesses distance walked in 6 minutes.
Measured: 0 Weeks, 12 Weeks, 6 Months
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.
Measured: 0 Weeks, 12 Weeks, 6 Months
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.
Measured: 0 Weeks, 12 Weeks, 6 Months
PROMIS Depression
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.
Measured: 0 Weeks, 12 Weeks, 6 Months
PROMIS Anxiety
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.
Measured: 0 Weeks, 12 Weeks, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start10 Jan 2025
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivia I.Okereke, MD, Massachusetts General Hospital
- Investigators
- Olivia Okereke, MD, MS, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246929
- Sponsor's protocol ID
- 2024P000002
- Acronym
- HABIT
- Status last verified
- Jul 2026
- First submitted
- 30 Jan 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klein KG, Seward M, Harley D, Mace R, Morehead M, Parker RA, Sylvia LG, Bartels SJ, Obler D, Callahan J, Craddock K, Reed R, Atkinson F, Joo JH, Macklin E, Okereke OI, Vranceanu AM. Healthy aging as Black adults, in it together (HABIT): Protocol for a comparative effectiveness trial to address comorbid chronic pain and early cognitive decline among older, community-based Black adults. Contemp Clin Trials. 2026 Jun;165:108292. doi: 10.1016/j.cct.2026.108292. Epub 2026 Mar 26.
PubMed 41903741Mace 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.
PubMed 33159516Mace 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.
PubMed 32601670
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06246929
- Acronym / sponsor ID
- HABIT / 2024P000002
- Keywords
- Black Older Adults, African Americans, Subjective Cognitive Decline, Memory Related Problems, Pain, Cognition Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 15 Dec 2028 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Cognitive Therapy With Walking (MBCT+w) | Experimental | Behavioral: MBCT+wMBCT+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 Living Every Day (ALED) | Active comparator | Behavioral: ALEDALED 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBCT+wMBCT+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. | Behavioural | Mindfulness-Based Cognitive Therapy With Walking (MBCT+w) |
| ALEDALED 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. | Behavioural | Active Living Every Day (ALED) |
Primary outcome
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.
6 secondary outcomes
ActiGraph GT9X Link Accelerometer
Time frame: 0 Weeks, 12 Weeks, 6 Months
Six-minute walk test (6MWT)
Time frame: 0 Weeks, 12 Weeks, 6 Months
Montreal Cognitive Assessment (MoCA)
Time frame: 0 Weeks, 12 Weeks, 6 Months
Everyday Cognitive Scale (eCog-12)
Time frame: 0 Weeks, 12 Weeks, 6 Months
PROMIS Depression
Time frame: 0 Weeks, 12 Weeks, 6 Months
PROMIS Anxiety
Time frame: 0 Weeks, 12 Weeks, 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 41903741Klein KG, Seward M, Harley D, Mace R, Morehead M, Parker RA, Sylvia LG, Bartels SJ, Obler D, Callahan J, Craddock K, Reed R, Atkinson F, Joo JH, Macklin E, Okereke OI, Vranceanu AM. Healthy aging as Black adults, in it together (HABIT): Protocol for a comparative effectiveness trial to address comorbid chronic pain and early cognitive decline among older, community-based Black adults. Contemp Clin Trials. 2026 Jun;165:108292. doi: 10.1016/j.cct.2026.108292. Epub 2026 Mar 26.
- Background: PubMed 33159516Mace 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.
- Background: PubMed 32601670Mace 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.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Not yet recruitingPhase 3
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Chronic Low Back Pain, Musculoskeletal Pain
Not yet recruitingPhase 2
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Chronic Low Back Pain (CLBP), Physical Therapy
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Not yet recruitingPhase 2/3
PRP Versus NP Injections for Chronic Discogenic Low Back Pain
Discogenic Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olivia Okereke, MD, MS principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBCT+w and ALED in people with Chronic Pain and Physical Activity, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mallory Morehead, MPH ((978) 580-3153, mmorehead@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (time frame: 0 Weeks, 12 Weeks, 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06246929, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.