Feasibility Randomized Controlled Trial of a Mind–Body Activity Program for Older Adults With Chronic Pain and Cognitive Decline: The Virtual “Active Brains” Study

Abstract

Background and Objectives Chronic pain (CP) and cognitive decline (CD) are highly co-morbid and debilitating among older adults. We iteratively developed Active Brains–Fitbit (AB-F), a group mind-body activity program aided by a Fitbit that is feasible and associated with improvements in physical, cognitive, and emotional functioning when delivered in person to older adults with CP and CD. We adapted our intervention and methodology for remote delivery to bypass barriers to participation. Here we report on a feasibility randomized controlled trial of the virtual AB-F versus a Health Enhancement Program (HEP) educational control followed by qualitative exit interviews. Research Design and Methods Older adults (age ≥ 60) with CP and CD (2 cohorts) completed eight weeks of AB-F (n = 8) or HEP (n = 11). Study procedures were fully remote via live video. Quantitative analyses explored feasibility and acceptability markers and within group improvements in outcomes. Qualitative analyses were primarily deductive using the Framework Method. Results AB-F met a-priori set feasibility benchmarks, similar to our in-person pilot. Participation in AB-F was associated with preliminary signals of improvement in multimodal physical function, emotional function (anxiety), cognitive function, pain intensity, and coping (e.g., pain self-efficacy, catastrophizing). Participation in HEP was associated with smaller or negligible improvements. Exit interviews confirmed feasibility and satisfaction with our completely remote interventions and methodology. Discussion and Implications Results provide evidence for the feasibility of our completely remote study, and for initial markers of improvement after AB-F. The results will inform a fully powered remote efficacy trial.

Live Video Mind-Body Program for Patients With Knee Osteoarthritis, Comorbid Depression, and Obesity: Development and Feasibility Pilot Study

“…On the basis of our mixed methods results, we will refine the program to increase feasibility for participants (6 sessions, 45 minutes) and more comprehensively target all 3 comorbidities (renamed as GetHealthy-OA ). The next phase will involve a live video pilot RCT (N=60 participants) of the GetHealthy-OA program with a time- and attention-matched health enhancement control (Health Enhancement Program) [ 68 , 109 ]. The study will yield critical information on how participants might engage differently with the intervention and control, as well as definitive information on feasibility, acceptability, and signal of improvement in the intervention before investment of resources in a fully powered efficacy trial.…”

“…Finally, given the positive impressions of technology and to reach patients in rural areas, we optimized the program and study procedures for live video delivery. We have successfully adapted mind-body programs for live video similar populations with chronic pain [ 45 , 68 ]. We considered other approaches to live video, such as asynchronous web platforms, but decided against it because telehealth delivery is preferred by this population and fostering peer contact can directly target stigma and isolation common in this comorbidity.…”

My Healthy Brain: Rationale and Case Report of a Virtual Group Lifestyle Program Targeting Modifiable Risk Factors for Dementia

“…Our methodology follows the procedures reported in the My Healthy Brain development study (Mace et al, 2021). We adapted the program and delivery based on our published protocol for conducting virtual assessments and lifestyle interventions via Zoom , which have been succesful in other older adult populations (Doorley et al, 2021). Prior to the group, we met regularly with interdiciplinary clinical staff from the Osher Center for Integrative Medicine at the Brigham and Women's Hospital to discuss efficient referrals to this virtual program.…”

“…We included older adults with subjective and mild cognitive impairment because both are (1) common in clinics that treat older patients (Rosenbloom et al, 2016), (2) risk factors for future CD (Jessen, 2014;Langa & Levine, 2014;Verlinden et al, 2016), and (3) potentially modifiable through improvements in brain health via lifestyle change (Cadar et al, 2012). This decision was also informed by our similar intervention development studies that did not find differences in outcomes or benefit from program skills by type of CD based on data and clinician observations (Doorley et al;.…”

“…Despite high program adherence and program satisfaction, qualitative feedback from participants revealed several barriers to in-person participation (e.g., transportation, scheduling, COVID-19) that hindered progress toward their lifestyle goals. Our prior work suggests that older adults are motivated to learn Zoom to promote cognitive health (Doorley et al, 2021), highlighting the potential for delivering the My Healthy Brain via live video.…”