Addressing the Chronic Pain-Early Cognitive Decline Comorbidity Among Older Adults: Protocol for the Active Brains Remote Efficacy Trial.

BACKGROUND: Chronic pain and early cognitive decline, which are costly to treat and highly prevalent among older adults, commonly co-occur, exacerbate one another over time, and can accelerate the development and progression of Alzheimer disease and related dementias. We developed the first mind-body activity program (Active Brains [AB]) tailored to the needs of older adults with chronic pain and early cognitive decline. Results from our previous study strongly supported the feasibility of conducting AB remotely and provided evidence for improvements in outcomes. OBJECTIVE: We are conducting a single-blinded, National Institutes of Health stage-2, randomized clinical trial to establish the efficacy of AB versus a time-matched and dose-matched education control (Health Enhancement Program [HEP]) in improving self-reported and objective outcomes of physical, cognitive, and emotional functions in 260 participants. The methodology described in this paper was informed by the lessons learned from the first year of the trial. METHODS: Participants are identified and recruited through multidisciplinary clinician-referred individuals (eg, pain psychologists and geriatricians), the Rally Research platform, social media, and community partnerships. Interested participants complete eligibility screening and electronic informed consent. Baseline assessments include self-report, performance-based measures (eg, 6-min walk test) and objective measures (eg, Repeatable Battery for the Assessment of Neuropsychological Status). Participants are mailed a wrist-worn ActiGraph device (ActiGraph LLC) to passively monitor objective function (eg, steps) during the week between the baseline assessment and the beginning of the programs, which they continue to wear throughout the programs. After baseline assessments, participants are randomized to either AB or HEP and complete 8 weekly, remote, group sessions with a Massachusetts General Hospital psychologist. The AB group receives a Fitbit (Fitbit Inc) to help reinforce increased activity. Assessments are repeated after the intervention and at the 6-month follow-up. Coprimary outcomes include multimodal physical function (self-report, performance based, and objective). Secondary outcomes are cognitive function (self-report and objective), emotional function, and pain. RESULTS: We began recruitment in July 2022 and recruited 37 participants across 4 cohorts. Of them, all (n=37, 100%) have completed the baseline assessment, 26 (70%) have completed the posttest assessment, and 9 (24%) are actively enrolled in the intervention (total dropout: n=2, 5%). In the three cohorts (26/37, 70%) that have completed the AB or HEP, 26 (100%) participants completed all 8 group sessions (including minimal makeups), and watch adherence (1937/2072, 93.48%, average across ActiGraph and Fitbit devices) has been excellent. The fourth cohort is ongoing (9/37, 24%), and we plan to complete enrollment by March 2026. CONCLUSIONS: We aim to establish the efficacy of the AB program over a time-matched and dose-matched control in a live video-based trial and test the mechanisms through theoretically driven mediators and moderators. Findings will inform the development of a future multisite effectiveness-implementation trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT05373745; https://classic.clinicaltrials.gov/ct2/show/NCT05373745. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47319.

Adaptation and virtual feasibility pilot of a mindfulness-based lifestyle program targeting modifiable dementia risk factors in older adults.

OBJECTIVES: We developed a group-based program (My Healthy Brain, MHB) to engage older adults at-risk for dementia in healthy lifestyles. We report on a two-part study to adapt MHB by incorporating mindfulness skills, using mobile health technology to monitor and reinforce behaviors, and delivering it via live video. METHODS: Participants were older adults (age ≥ 60) with subjective cognitive decline (SCD) and at least one lifestyle risk factor. In Aim 1 (n = 11, 2 groups), we conducted focus groups to obtain qualitative feedback on proposed adaptations. In Aim 2 (n = 10), we conducted a virtual open pilot with exit interviews to explore the feasibility and outcomes of the adapted MHB. RESULTS: Thematic analysis revealed: (1) barriers and facilitators to healthy lifestyles, (2) positive impressions of MHB, (3) interest in mindfulness skills, and (4) openness to study technologies. MHB met a-priori feasibility benchmarks and was associated with improvements in cognition, lifestyle (e.g. physical function), and proposed mechanisms (e.g. mindfulness). Exit interviews confirmed high feasibility and satisfaction. CONCLUSION: The integration of mindfulness, live video, and mobile health technologies was feasible and promising for improving healthier lifestyles. The results inform the next feasibility RCT of MHB to prepare for efficacy testing.Supplemental data for this article is available online at http://dx.doi.org/10.1080/13607863.2022.2032600.

Older adults can use technology: why healthcare professionals must overcome ageism in digital health.

Older adults rapidly adopted technology for healthcare, known as digital health, during the COVID-19 pandemic. Older adults are increasingly using telehealth, smartphone apps, and other digital health technologies to reduce barriers to care, maintain patient-provider communication, and promote disease self-management. Yet, many healthcare professionals have maintained outdated beliefs rooted in societal ageism that digital health and older adults are incompatible. As a result, older adults have been disproportionally excluded from health services and clinical trials that use digital health relative to their younger counterparts. In this commentary, we urge all healthcare disciplines to challenge ageist beliefs and practices that have contributed to the "digital health divide" among older patients. We provide examples of evidence-based strategies and current scientific initiatives that can promote digital health inclusion in research, clinical practice, and training. By achieving digital health inclusion, we can increase access, provide preventative and comprehensive care, and decrease healthcare costs for older patients.

The use of technology among older adults (age ≥ 65) increased during the COVID-19 pandemic. Many older adults are using computers, smartphones, wearable devices, and other technologies for healthcare purposes, known as "digital health". Digital health is valuable for older patients because it eliminates barriers to treatments, such as cost, travel, and access to doctors. Yet, many professionals in healthcare believe that their older patients are unwilling or unable to use digital health. We believe that these harmful beliefs are explained by ageism that is deeply rooted in our society (e.g., "you can't teach an old dog new tricks"). Clinicians do not receive training to teach older patients new technology. In research, technology is developed for younger patients because older adults are excluded from studies. As a result, older adults are getting left behind in our increasingly technical healthcare system. The goal of this article is to raise our colleagues' awareness to this problem and to support older adults' use of digital health. We provide solutions for researchers, clinicians, and educators. A growing number of older adults recognize the potential of digital health and time for healthcare professionals to join them.

Mechanisms of change in depression and anxiety within a mind-body activity intervention for chronic pain.

BACKGROUND: Chronic pain is challenging and costly to treat. Depression and anxiety co-occur with chronic pain. Identifying psychosocial mechanisms contributing to emotional outcomes among chronic pain patients can inform future iterations of this intervention. METHODS: We examined explanatory mechanisms of change in emotional distress following a mind-body and activity intervention among 82 participants (21 - 79 years old, 65.85% female, 80.48% White). With depression and anxiety as outcomes, we hypothesized that potential mediators would include pain catastrophizing, mindfulness, and pain resilience. We used mixed-effects modeling to assess the indirect effects of time on each outcome variable through hypothesized mediators simultaneously. RESULTS: Improvements in depression from baseline to post-treatment were most explained by pain catastrophizing (b = -2.53, CI = [-3.82, -1.43]), followed by mindfulness (b = -1.21, CI = [-2.15, -0.46]), and pain resilience (b = -0.76, CI = [-1.54, -1.66]). Improvements in anxiety from baseline to post-treatment were most explained by pain catastrophizing(b = -2.16, CI = [-3.45, -1.08]) and mindfulness (b = -1.51, CI = [-2.60, -0.65]), but not by pain resilience, (b = -0.47, CI = [-1.26, 0.17]). LIMITATIONS: Findings are limited by the lack of a control group, relatively small sample, and two timepoints. However, findings can guide future mind-body intervention efficacy testing trials. CONCLUSIONS: Pain catastrophizing and mindfulness appear to be important intervention targets to enhance emotional functioning for chronic pain patients, and should be considered simultaneously in interventions for chronic pain.

Live Video Adaptations to a Mind-Body Activity Program for Chronic Pain and Cognitive Decline: Protocol for the Virtual Active Brains Study.

BACKGROUND: Chronic pain (CP) and cognitive decline (CD) are costly, challenging to treat, prevalent among older adults, and worsen each other over time. We are iteratively developing Active Brains-Fitbit (AB-F), a live video program for older adults with CP and CD that teaches mind-body skills and gradual increases in step count. AB-F has demonstrated feasibility; acceptability; and signs of improvement in emotional, physical, and cognitive functions when delivered in person to older adults. OBJECTIVE: We are conducting a feasibility randomized controlled trial (RCT) of AB-F versus a time- and dose-matched educational control (health enhancement program [HEP]) in older adults with CP and CD. Here, we describe virtual adaptions to our study protocol, manualized treatments, evaluation plan, and study design in response to feedback from former participants and COVID-19. We will evaluate the feasibility benchmarks and the potential of AB-F to improve physical, emotional, and cognitive functions. METHODS: This is a single-blind pilot RCT. Participants are randomized to AB-F or HEP. Patients are recruited through pain clinic referrals, institutional registries, and flyers. Interested participants are screened for eligibility via telephone and provide electronic informed consent. After randomization, participants are mailed all study documents, including their treatment manual, an ActiGraph accelerometer, and a Fitbit (separate envelope for AB-F only). Both conditions are manualized and delivered over 8 weekly sessions via Zoom. Participants complete self-report and performance-based (6-min walk test and Montreal Cognitive Assessment) outcome measures via Zoom at baseline and post intervention. Primary outcomes are a priori set feasibility (recruitment, quantitative measures, and adherence), acceptability, credibility, expectancy, and satisfaction benchmarks. Secondary outcomes are physical, cognitive, and emotional functions as well as intervention targets (social function, pain intensity, pain-specific coping, and mindfulness). RESULTS: The trial is ongoing. We have recruited 21 participants (10 AB-F and 11 HEP) across 2 rounds. Only 2 participants have withdrawn (1 before baseline and 1 before the first session). All 19 remaining participants have completed the baseline assessment. In the first round, attendance is high (11 out of 12 participants completed all 4 sessions so far), and AB-F participants are adherent to their Fitbit and step goals (5 out of 6 participants). CONCLUSIONS: Preliminary findings are promising for the feasibility of our completely virtual AB-F intervention. However, these findings need to be confirmed at the trial conclusion. This study will answer important questions about the feasibility of delivering a completely virtual mind-body activity program to older adults with comorbid CP and CD, which, to our knowledge, is unprecedented. Details on integrating multiple digital platforms for virtual assessments and intervention delivery will inform treatment development for older adults and those with comorbid CP and CD, which is crucial during the COVID-19 pandemic. TRIAL REGISTRATION: ClinicalTrials.gov NCT04044183; https://clinicaltrials.gov/ct2/show/NCT04044183. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25351.

First report of quality of life in adults with neurofibromatosis 2 who are deafened or have significant hearing loss: results of a live-video randomized control trial.

PURPOSE: To test the feasibility, acceptability, and preliminary efficacy of a mind-body program for patients with neurofibromatosis 2 (NF2) who are deaf or have significant hearing loss (d3RP-NF2) against an attention placebo control (dHEP-NF2) in a single-blind randomized control trial. Both were delivered using Communication Access Real-Time Translation and live group videoconferencing. METHODS: Forty-five adults with NF2 were randomized. Co-primary outcomes were physical quality of life (QoL) and psychological QoL and secondary outcomes were social QoL and environmental QoL, all measured with the World Health Organization Quality of Life Abbreviated Instrument (WHOQOL-BREF). Assessments were conducted at baseline, post-treatment, and six-month follow-up. RESULTS: Forty-one participants (91%) completed the intervention, and 29 (64%) completed the six-month follow up. Participants in the d3RP-NF2 showed significantly greater improvements from baseline to post-treatment on physical QoL (14.79, 95% CI 5.41-24.18; p ≤ 0.001), psychological QoL (18.77, 95% CI 7.09-30.44, p ≤ 0.001), and environmental QoL (13.25, 95% CI 1.10-25.39, p = 0.03) compared to the dHEP-NF2. Social QoL also significantly increased in the d3RP-NF2 (16.32, 95% CI 6.66-25.97, p = 0.001), but improvement was not beyond the dHEP-NF2. Gains in QoL were clinically meaningful and maintained at the 6-month follow-up for d3RP-NF2 participants across all QoL domains. There were more treatment responders in the d3RP-NF2 compared to the dHEP-NF2. CONCLUSIONS: The d3RP-NF2 was well accepted, highly feasible, and resulted in sustained improvements in QoL in patients with NF2 who are deaf or have significant hearing loss.