[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06246929":3,"trial-entities:NCT06246929":136,"trial-summary:NCT06246929":140},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":49,"secondary_outcomes":54,"sex":73,"minimum_age":74,"maximum_age":75,"healthy_volunteers":76,"eligibility_criteria":77,"std_ages":95,"locations":98,"central_contacts":113,"overall_officials":120,"references":124,"see_also_links":135},"NCT06246929","2024P000002","Healthy Aging as Black Adults, In It Together: a Comparative Effectiveness Study of Chronic Pain and Cognitive Decline","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)","RECRUITING","2028-12-15","2026-07","2026-07-07","2025-01-10","Massachusetts General Hospital","OTHER",true,"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.","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.\n\nThe 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.\n\nThe 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.",[19,20,21,22],"Chronic Pain","Physical Activity","Older Adults","Mild Cognitive Impairment",[24,25,26,27,28,29],"Black Older Adults","African Americans","Subjective Cognitive Decline","Memory Related Problems","Pain","Cognition Disorders","INTERVENTIONAL","TREATMENT",[33],"NA",{"count":35,"type":36},400,"ESTIMATED",[38,44],{"type":39,"name":40,"description":41,"armGroupLabels":42},"BEHAVIORAL","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.",[43],"Mindfulness-Based Cognitive Therapy With Walking (MBCT+w)",{"type":39,"name":45,"description":46,"armGroupLabels":47},"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.",[48],"Active Living Every Day (ALED)",[50],{"measure":51,"description":52,"timeFrame":53},"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",[55,58,61,64,67,70],{"measure":56,"description":57,"timeFrame":53},"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.",{"measure":59,"description":60,"timeFrame":53},"Six-minute walk test (6MWT)","Assesses distance walked in 6 minutes.",{"measure":62,"description":63,"timeFrame":53},"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.",{"measure":65,"description":66,"timeFrame":53},"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.",{"measure":68,"description":69,"timeFrame":53},"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.",{"measure":71,"description":72,"timeFrame":53},"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.","ALL","50 Years",null,false,{"inclusion":78,"exclusion":87,"raw_text":94},[79,80,81,82,83,84,85,86],"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\u002Fliteracy","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)",[88,89,90,91,92,93],"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","Inclusion Criteria:\n\n* Black adults, male and females, age 50 or older\n* Have nonmalignant musculoskeletal chronic pain for more than three months\n* Reports early cognitive decline (subjective and objective)\n* Telephone Interview for Cognitive Status-41 score greater than or equal to 31\n* Functional Activities Questionnaire score less than 9\n* English fluency\u002Fliteracy\n* 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\n* 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)\n\nExclusion Criteria:\n\n* Diagnosed with dementia or neurodegenerative disease\n* Regular use of nonpharmacological pain management\n* Diagnosed with serious mental illness or substance abuse\n* Current suicidal ideation on self-report\n* Engagement of regular exercise for more than 30 minutes daily\n* Unable to walk",[96,97],"ADULT","OLDER_ADULT",[99],{"facility":13,"status":8,"city":100,"state":101,"zip":102,"country":103,"contacts":104,"geoPoint":110},"Boston","Massachusetts","02114","United States",[105],{"name":106,"role":107,"phone":108,"email":109},"Mallory Morehead, MPH","CONTACT","978-580-3153","mmorehead@mgb.org",{"lat":111,"lon":112},42.35843,-71.05977,[114,116],{"name":106,"role":107,"phone":115,"email":109},"(978) 580-3153",{"name":117,"role":107,"phone":118,"email":119},"Adjoa Acquaah, BA","(617) 726-8103","aacquaah@mgh.hardvard.edu",[121],{"name":122,"affiliation":13,"role":123},"Olivia Okereke, MD, MS","PRINCIPAL_INVESTIGATOR",[125,129,132],{"pmid":126,"type":127,"citation":128},"41903741","BACKGROUND","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\u002Fj.cct.2026.108292. Epub 2026 Mar 26.",{"pmid":130,"type":127,"citation":131},"33159516","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\u002Fgeront\u002Fgnaa179.",{"pmid":133,"type":127,"citation":134},"32601670","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\u002Fgeront\u002Fgnaa084.",[],{"nct_id":4,"conditions":137,"biomarkers":139},[19,138],"Mild cognitive disorder",[],{"nct_id":4,"found":15,"summary":141,"prompt_version":151},{"design":142,"status":143,"heading":144,"summary":145,"follow_up":146,"word_count":147,"commitments":148,"compensation":149,"drugs_mentioned":150},"This is a randomized controlled trial comparing two programs. It plans to enroll 400 participants.","completed","Healthy Aging for Black Adults with Chronic Pain and Cognitive Decline","This study is for Black adults, aged 50 and older, who experience chronic pain and early memory problems. It compares two programs: Mindfulness-Based Cognitive Therapy with Walking (MBCT+w) and Active Living Every Day (ALED). MBCT+w teaches skills to manage pain and cognitive concerns, while ALED helps you become more physically active. Researchers want to see if these programs improve your physical, mental, and emotional well-being. They will measure your physical function at the start, after 12 weeks, and again at 6 months to see how well the programs work and if the benefits last. The study aims to enroll 400 participants.","Participants will be followed for 6 months after the program ends.",101,"You would participate in either an 8-session program (MBCT+w, 90 minutes per session) or a 12-session program (ALED, 60 minutes per session). Outcomes will be assessed at the beginning, after the program, and 6 months later.","Not stated in the trial record.",[40,45],"v2"]