Contemporary clinical trials · 2026
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.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Klein Kirsten G, Seward Morgan, Harley Dumichel, Mace Ryan, Morehead Mallory, Parker Robert A, Sylvia Louisa G, Bartels Stephen J, Obler Dita, Callahan Jeanette, Craddock Karen, Reed Robin, Atkinson Fanta, Joo Jin Hui, Macklin Eric, Okereke Olivia I, Vranceanu Ana-Maria
Аннотация
BACKGROUND: Chronic pain (CP) and early cognitive decline (ECD) disproportionately impact older Black adults. Our team developed and adapted Active Brains, our evidence-based program that uses mindfulness-based cognitive therapy (MBCT), using cultural tailoring for older Black adults with CP-ECD comorbidity. This protocol paper describes Healthy Aging as Black Adults, In It Together (HABIT), a comparative-effectiveness trial of two evidence-based intervention programs - our culturally tailored adaptation of Active Brains, called MBCT with walking (MBCT+w), and Active Living Every Day (ALED). Our aim is to test which of the two comparators will be superior in improving health outcomes (physical, emotional, and cognitive function) among older Black adults with the CP-ECD comorbidity, and we will assess whether improvements are maintained over a 6-month follow-up.
METHODS: We aim to recruit (N = 400) older, community-dwelling Black adults with CP-ECD comorbidity. Eligible participants are 50 years or older, with CP for 3 months or more, and meet screening criteria for early cognitive decline (ECD). Patients will be randomized to either culturally tailored MBCT+w or ALED, which are matched in intervention dosage, at 12 contact hours over 12 weeks (i.e., 720 min of group intervention), and delivered in person in group format. Data will be collected pre- and post-intervention and 6-months follow-up. We will conduct linear mixed effect models to estimate between-group differences for health outcomes over time.
CONCLUSION: Findings will support the implementation of the superior program (MBCT+w or ALED) into community settings through a peer delivery modality to support older, community-dwelling Black adults with CP-ECD comorbidity. Clinical trial registration ClinicalTrials.gov Identifier #NCT06246929.
METHODS: We aim to recruit (N = 400) older, community-dwelling Black adults with CP-ECD comorbidity. Eligible participants are 50 years or older, with CP for 3 months or more, and meet screening criteria for early cognitive decline (ECD). Patients will be randomized to either culturally tailored MBCT+w or ALED, which are matched in intervention dosage, at 12 contact hours over 12 weeks (i.e., 720 min of group intervention), and delivered in person in group format. Data will be collected pre- and post-intervention and 6-months follow-up. We will conduct linear mixed effect models to estimate between-group differences for health outcomes over time.
CONCLUSION: Findings will support the implementation of the superior program (MBCT+w or ALED) into community settings through a peer delivery modality to support older, community-dwelling Black adults with CP-ECD comorbidity. Clinical trial registration ClinicalTrials.gov Identifier #NCT06246929.