Comorbidity of Chronic Pain and Early Cognitive Decline Among Older, Community-Based Black Adults: Comparative Effectiveness of Mindfulness-Based Cognitive Therapy with walking (MBCT) versus Active Living Every Day (ALED)

Approximately 60% of older adults have chronic pain (pain for over three months). Older adults with chronic pain are two times more likely to have early cognitive decline (changes in memory and thinking that sometimes lead to dementia). Chronic pain and early cognitive decline often co-occur in older adults, starting a disability spiral of more pain; lower physical, emotional and cognitive function; and increased risk for dementia, morbidity and mortality. Older Black adults have the highest rates of pain and cognitive decline and experience disparities with access to adequate care. This study is important because it aims to provide a solution to the high rates and lack of treatments for co-occurring chronic pain and early cognitive decline affecting Black adults in the community. 

The study team will compare two evidence-based programs: 

1. Active Living Every Day (ALED), a program for older adults with pain in the community that is nationally disseminated program but does not address cognition and is not tailored for Black individuals. 
2. Mindfulness-based cognitive therapy with walking (MBCT+w), which employs the widely disseminated, efficacious approach of MBCT and is culturally tailored to address co-occurring chronic pain and cognitive decline among Black older adults. 

The study team aims to determine which program is superior for improving self-reported physical function as the primary outcome, which is most important according to community partners, and emotional and cognitive function and pain as secondary outcomes. The study team will also determine if these improvements last for six months. They will develop a sustainability plan for the best program using a train-the-trainer model, wherein psychologists train community members who become peer coaches and train others. This will ensure that the program will become an enduring part of the Black communities in the Boston area while creating a blueprint for wider national dissemination in other Black communities. 

The study team has partnered with The Wellness Collaborative, Inc. (TWC), a Boston-based community stakeholder/partner co-founded and led by two Black physicians and two Black psychologists. TWC will advise on recruitment strategy and provide collaborative guidance and input throughout the entire study period in conjunction with community partner stakeholder groups in the Black community, including Community Conversations: Sister-to-Sister and St. Paul African Methodist Episcopal Church, with whom the team has established connections. TWC will provide connections to other Black and community organizations as needed, and a range of community partner organizations will provide space to run the sessions and facilitate widespread program uptake. 

The study team will recruit 400 participants and assign them by chance to ALED or MBCT+w and follow them for six months. Participants will be older Black adults 50 years of age or older with chronic pain of any type, except pain from cancer in advanced stages; early cognitive decline, either self-reported or a diagnosis of mild cognitive impairment; functional and physical ability to participate as determined by a Functional Activities Questionnaire score greater than nine and ability to complete a six-minute walk test; and English literacy. Those with severe untreated and/or unstable mental or substance use problems or have active thoughts of suicide will be referred to higher levels of care. Older Black adults will be recruited from greater Boston communities with help from numerous community stakeholder partners. All outcomes are assessed at baseline, post-intervention, and at six months. 

The primary outcome is self-reported physical function (PROMIS-Physical Function). Secondary outcomes include: 

• One-week step count measured by ActiGraph GT9X Link Accelerometer. 
• Distance walked in six minutes, measured by a six-minute walk test, 6MWT 
• Objective cognitive function, as measured by the Montreal Cognitive Assessment. 
• Subjective cognitive concerns, as measured by the ECog performance status scale. 
• Symptoms of depression, as measured by PROMIS-depression. 
• Symptoms of anxiety, as measured by PROMIS-anxiety. 

Using the community-engaged research principles of the established Community Engagement Studio model, all study procedures and community roles and activities in this application have been co-developed alongside community members and partner organizations, who will continue being involved in the study across all stages. Community stakeholders will serve multiple community roles, which were defined with community member input: 

1. Connectors, who will act as community-based key liaisons between community members, stakeholder partners and researchers throughout the study, and coordinate meetings and logistics.  
2. Contributors, who will review all study materials, share lived experiences and discuss study findings. 
3. General Members, who will provide feedback on materials and sessions and provide feedback to community connectors. 
4. Peer Facilitators, who will work with staff to train and eventually facilitate the group sessions and train others to do so. 
5. Community Advisory Council Members, who will provide feedback on overall study progress, frequency of meetings, logistics and resources needed.