Palliative Care Interventions for Persons With Neurodegenerative Disease: A Scoping Review of Clinical Trial Study Design Features.

Background: Within palliative care research, best practice guidelines to conduct scientifically rigorous clinical trials for neurodegenerative diseases are underexplored. This patient population experiences unique challenges, including fluctuations in cognitive capacity, care partner (CP) and proxy involvement, and high adverse events (AEs), that necessitate special consideration when designing clinical trials. Objective: The objective of this study was to describe and identify clinical trial design features that have been documented in studies involving a neuropalliative intervention for persons with neurodegenerative diseases, highlighting features that have been adapted for this unique patient population. Design: We conducted a scoping review of clinical trials with a neuropalliative intervention for persons with neurodegenerative disease. We searched Cochrane, Web of Science, EMBASE, Scopus, and PubMed (MEDLINE) databases for articles published in English between 1950 and 2023. Two reviewers screened, extracted, and synthesized data from the included articles. A third reviewer adjudicated instances of conflict. The data were analyzed using a thematic framework approach. Results: Of 1025 texts, 44 articles were included. Seven study design features were analyzed: (1) consent, (2) proxies and CPs, (3) recruitment strategies, (4) retention strategies, (5) choice of comparator, (6) AEs, and (7) internal validity. This scoping review found disparities in study design features around structured consent, proxies and CPs, comparators, and AEs. Conclusions: To date, neuropalliative care clinical trials have had varied study designs and the majority of research has focused on dementia. Research guideline development for high-quality neuropalliative care clinical trials is greatly needed across the range of neurodegenerative diseases. To increase the scientific rigor of clinical trials and neuropalliative care, we recommend a standardized capacity assessment for consent, defining conditions for the CP, proxy, and AEs, systematizing appropriate comparators, and outlining preemptive recruitment and retention strategies to address the broader unpredictable challenges of palliative care research.

Minimal clinically important difference in the World Health Organization Quality of Life Brief (WHOQOL-BREF) for adults with neurofibromatosis.

PURPOSE: This study aimed to estimate minimal clinically important difference (MCID) values for the World Health Organization Quality of Life Brief version (WHOQOL-BREF) among adults with neurofibromatosis (NF). An MCID is needed to demonstrate clinical meaningfulness of interventions for NF. METHODS: We estimated MCID for the WHOQOL-BREF: the quality of life (QoL) measure recommended by the Response Evaluation in Neurofibromatosis and Schwannomatosis International Collaboration. We used data from 228 clinical trial participants with NF type 1, NF type 2-related schwannomatosis, or schwannomatosis (SCHWN) who completed 10 weeks of a virtual group mind-body program targeting resiliency or a time- and attention-matched control. Following established guidelines, we estimated MCIDs using both anchor-based and distribution-based methods for physical, psychological, social relationships, and environmental domains of the WHOQOL-BREF. RESULTS: MCID results varied across method and QoL domain. Three anchor-based methods, average change (AC), change difference (CD), and regression (REG), yielded the most consistent and comparable MCID across QoL domains. Based on these methods, we recommend ranges for each QoL domain: Physical QoL (3.9-7.3), Psychological QoL (4.7-8.1), Social QoL (2.6-5.9), and Environmental QoL (4.1-6.6). CONCLUSION: Establishing a rigorous MCID for QoL in NF is a critical step toward evaluating meaningful change in response to psychosocial interventions.

Association Between Subjective Cognitive Decline and Twice-Weekly Muscle-Strengthening Activities in Middle-Aged and Older US Adults: An Analysis of the 2019 Behavioral Risk Factor Surveillance System.

PURPOSE: Adults with subjective cognitive decline (SCD), the self-reported concern of reduced cognitive function, are recommended to do physical activity for its brain health benefits. US adults aged ≥45 with SCD are less likely to meet the American College of Sports Medicine (ACSM) aerobic activity recommendations. Their engagement in muscle-strengthening activities is unknown. We aimed to identify if US adults aged ≥45 with SCD are less likely to do twice-weekly muscle-strengthening activities compared to those without SCD. DESIGN: Secondary analysis of the 2019 Behavioral Risk Factor Surveillance System (BRFSS) data. SAMPLE: 114 164 respondents, representing approximately 59 million US adults aged ≥45. MEASURES: SCD was indicated if the respondent reported confusion or memory loss during the past 12 months (yes/no). Respondents reported the frequency of muscle-strengthening activities, which we categorized as meeting the ACSM's recommendations (2+ times per week) or not (<2 times per week). ANALYSIS: Crude and adjusted logistic regression models controlling for variables associated with SCD and muscle-strengthening activities. The models used sample weights to represent US adults in the included 31 states and Washington D.C. RESULTS: US adults aged ≥45 with SCD were less likely to do twice-weekly muscle-strengthening activities than those without SCD (28.6% [SE: .8%] vs 33.5% [SE: .3%], adjusted OR, .9; 95% CI: .9-1.0). CONCLUSION: Primary care providers should encourage middle-aged and older patients to engage in muscle-strengthening and aerobic activities.

Depression Negatively Impacts Dyadic Quality of Life Following Neuro-ICU Admission: A Prospective Study of Cognitively Intact Patients and Caregivers.

BACKGROUND: Admission to a neurological intensive care unit (Neuro-ICU) can increase risk for depressive and anxiety symptoms for both patients and caregivers. To better understand the long-term mental health impact of a Neuro-ICU admission, we examined the dyadic interdependence between depression and anxiety at Neuro-ICU admission with 3-month quality of life (QoL) for patients and caregivers in a longitudinal, observational cohort study. METHOD: We assessed depressive and anxiety symptoms (Hospital Anxiety and Depression Scale; HADS) reported by neurologically intact patients (n = 72) and their caregivers (n = 72) within 2 weeks of Neuro-ICU admission (baseline) and 3-months post-discharge (follow-up). We examined the longitudinal association between dyadic depression and anxiety at Neuro-ICU admission and 3-month QoL (World Health Organization; QOL-BREF) across four domains (Physical, Psychological, Social relationships, and Environmental QoL) in separate actor-partner interdependence models (APIM) for patients and caregivers. RESULTS: In the overall models, patients' own baseline depression levels were negatively associated with their own 3-month QoL in all domains (ß = - 0.53 to - 0.64, p < 0.001), and for caregivers, only in the psychological (ß = - 0.73, p < .001) and social relationships (ß = - 0.56, p < .001) domains. No actor effects were found for one's own baseline anxiety impacting one's own 3-month QoL. Partner effects for one's own depression were significant for caregivers on patients' 3-month psychological (ß = - 0.26, p < .02) and environmental (ß = - 0.29, p < .03) QoL, as well as for patients on caregiver's 3-month psychological QoL (ß = 0.25, p < .02). No partner effects were significant in association with baseline anxiety and 3-month QoL in both patients and caregivers. CONCLUSION: Neuro-ICU patients' and caregivers' baseline depression has significant negative impacts on their own long-term QoL. Caregivers demonstrate significant negative impacts on patient long-term QoL in domains related to emotional distress and caregiver burden. Early identification of mental health symptoms, especially depression, during Neuro-ICU admission may provide an intervention opportunity to improve QoL post-discharge for both dyad members.

Breaking the Disability Spiral: A Case Series Report Illustrating the Delivery of a Brief Skills Based Coaching Intervention to Prevent Chronic Dysfunction and Pain After Orthopedic Injury.

Orthopedic traumas are common, costly, and burdensome - particularly for patients who transition from acute to chronic pain. Psychosocial factors, such as pain catastrophizing and pain anxiety, increase risk for poor outcomes after injury. The Toolkit for Optimal Recovery (TOR) is a novel multi-component mind-body intervention informed by the fear-avoidance model to promote re-engagement in daily activities and prevent transition toward chronic pain and physical dysfunction. The current case series aims to 1) describe the intervention and 2) showcase the treatment course of three TOR completers from diverse geographic locations in the U.S. with distinct injury types and varying personal identities to illustrate how the intervention can be delivered flexibly. Results indicate pre-to-post program improvement in physical function, pain severity, pain catastrophizing, pain anxiety, and other relevant outcomes targeted by the intervention (i.e., depression, mindfulness, coping). Experiences of our three TOR completers suggest that integrating TOR with standard orthopedic care may promote physical recovery after injury.

Exploring mechanisms of improvement in the Active Brains intervention for older adults with chronic pain and early cognitive decline.

OBJECTIVES: We iteratively developed, optimized, and established the feasibility of a virtual, group-based, mind-body activity program (Active Brains, AB), supported by Fitbit for older adults with chronic pain (CP) and early cognitive decline (ECD). Guided by the principles of the NIH stage model we 1) explore signals of improvement in AB outcomes and hypothesized mechanisms of action and 2) explore relationships between changes in outcomes with changes in mechanisms. METHODS: Participants were N = 15 older adults (age ≥ 60) with CP-ECD from two NIH stage 1 pilot studies of AB. We conducted paired t-tests to explore pre-post improvements, and correlations to investigate associations between changes in outcomes and mechanisms. RESULTS: We observed small to large improvements across co-primary and secondary outcomes (d = 0.24-1.09). We observed small to medium improvements in 4 out of 5 hypothesized mechanisms (d = 0.23-0.47). Overall, improvements in outcomes had moderate to large associations with improvements in hypothesized mechanisms. CONCLUSION: AB was associated with improvements across several co-primary and secondary outcomes, and hypothesized mechanisms. Pain-specific coping and general coping skills are promising treatment targets to address the CP-ECD comorbidity among older adults.

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.

Increasing the Repertoire for Depression Care: Methods and Challenges of a Randomized Controlled Trial of Peer Support for Vulnerable Older Adults.

OBJECTIVE: Low-income White and older adults of color face barriers to depression care. Our purpose is to describe the methods and challenges encountered during the implementation of a randomized controlled trial to test the effectiveness of a peer support depression care intervention for low-income White and older adults of color during the COVID-19 pandemic. METHODS: Peer Enhanced Depression Care (Peers) is an 8-week community-based intervention that uses peer mentors who are trained and supervised to provide social support and self-care skills to depressed older adults. The effectiveness of the intervention in reducing depression will be evaluated by following a sample of older adults recruited in the community over a 12-month period. Target enrollment is 160 older adults. We hypothesize that participants randomized to the Peer Enhanced Depression Care intervention will experience greater decrease in depressive symptoms compared to participants randomized to the social interaction control. We provide lessons learned regarding the recruitment of BIPOC and White low-income older adults and peer mentors during the COVID-19 pandemic. RESULTS: Recruitment challenges occurred in primary care clinics that were unable to accommodate recruitment efforts during the pandemic. This led to focused outreach to community-based organizations serving older adults. Challenges to participant recruitment have included barriers related to stigma, distrust, as well as unfamiliarity with research. Peer mentor recruitment was facilitated by existing government-supported resources. CONCLUSIONS: This study will provide knowledge regarding the effectiveness, mechanism, and processes of delivering an informal psychosocial intervention such as peer support to a vulnerable older adult population.

Association of Osteoarthritis and Functional Limitations With Cognitive Impairment Among Older Adults in the United States.

Objective: Given overlapping pathophysiology, this study sought to assess the association between osteoarthritis (OA), functional impairment, and cognitive impairment in the aging population. Methods: The National Health and Nutrition Examination Survey was used to identify participants >60 years of age. We analyzed multivariable associations of grouped participants that underwent cognitive function testing using linear and logistic regression, adjusting for sex, age, race, and ethnicity. Results: Of 2776 identified participants representing a population of 50,242,917, 40% did not report OA or functional limitations; 21% had OA but not functional limitations; 15% did not have OA but had functional limitations; 17% had OA and related functional limitations; and 7% had OA and non-arthritic functional limitations. OA was not independently associated with cognitive impairment. Contrarily, functional limitations were associated with cognitive impairment regardless of OA diagnosis. Discussion: Cognitive impairment is not associated with OA, but rather functional limitations, potentially guiding future intervention.

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.

The Recovering Together study protocol: A single-blind RCT to prevent chronic emotional distress in patient-cargiver dyads in the Neuro-ICU.

INTRODUCTION: Patients admitted to the Neuroscience Intensive Care Unit (Neuro-ICU) with acute neurological illnesses (ANI; e.g., stroke, tumor, TBI) and their informal caregivers experience high rates of anxiety, depression, and posttraumatic stress. To address this need, we previously developed the Recovering Together (RT) dyadic intervention to help prevent chronic emotional distress in both patients and caregivers. Currently, we are conducting a fully-powered, single-blind randomized clinical trial (RCT) to evaluate the efficacy of RT versus an attention matched health education control. Here, we describe the protocol and current status of this RCT. METHODS: We aim to recruit 194 at risk patient-caregiver dyads from the Neuro-ICU at MGH. Eligible dyads include patients diagnosed with ANI, cognitively intact, at least one partner endorses emotional distress (on Hospital Anxiety and Depression Scale), English speaking, age 18 or older. Dyads are randomized to the intervention (RT-1) or control condition (RT-2) (both six sessions). RT-1 teaches resiliency (e.g., coping, mindfulness) and interpersonal skills. RT-2 provides education on health-related topics (e.g., stress, self-care, adhering to medical recommendations). Blinded research assistants collect measures at baseline, post-intervention, and three months follow-up. We will conduct mixed linear, mediation, and actor-partner interdependence models to examine changes in dyads' outcomes across time. RESULTS: We have recruited 41 dyads and aim to recruit 194 total. DISCUSSION: If successful, we plan to test RT in a large-scale, multisite hybrid effectiveness-implementation study in Neuro-ICUs across the country. Enhancing psychosocial supports for patients and families could improve health outcomes, healthcare efficiency, and the culture of these units.

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.

Baseline characteristics of adults with neurofibromatosis enrolled on a psychosocial randomized controlled trial.

PURPOSE: Neurofibromatosis (NF) is an incurable genetic neurological condition. Psychosocial interventions that promote resiliency are a promising approach to address the high emotional distress and low quality of life (QoL) associated with NF. However, no studies have examined the psychosocial needs of treatment-seeking adults with NF. Our goal was to explore, using data from the largest efficacy trial of a psychosocial intervention for NF, differences in QoL, emotional distress, resiliency, and pain-related outcomes compared to other chronic medical populations and within subtypes (NF1, NF2, schwannomatosis; SCHW). METHODS: Enrolled participants (N = 228) were geographically diverse adults with NF and elevated stress. We performed secondary analysis on baseline measures of QoL, emotional distress, resiliency, and pain-related outcomes. We reported descriptive statistics and normative comparisons to understand the psychosocial characteristics of the overall sample and performed between-group analyses to explore differences within NF type. RESULTS: Our sample endorsed worse QoL, emotional distress, resilience, and pain-related outcomes than similar chronic illness populations. Within NF types, participants with NF1 reported lower QoL and resilience compared to those with NF2. Participants with SCHW reported higher pain intensity than those with NF1. Participants with SCHW reported higher pain interference and lower physical QoL compared to those with NF1 and NF2. CONCLUSIONS: Our findings support the urgent need for psychosocial interventions targeting deficits in QoL, emotional distress, resilience, and pain-related outcomes in adults with NF. We recommend efforts to enhance sample diversity, prepare clinicians to provide high-levels of support, and attune skills training to each NF type. TRIAL REGISTRATION: ClinicalTrials.gov NCT03406208; https://clinicaltrials.gov/ct2/show/NCT03406208 (Archived by WebCite at http://www.webcitation.org/72ZoTDQ6h ).

Fitbit Activity, Quota-Based Pacing, and Physical and Emotional Functioning Among Adults With Chronic Pain.

Physical activity can improve function in patients with chronic pain, however, adherence is low, in part due to inconsistent activity patterns. Smart wearable activity trackers, such as Fitbits, may help promote activity. In our program for chronic pain, we examined: 1) Fitbit activity patterns (ie, step count, moderate-to-vigorous physical activity (MVPA), sedentary behavior), and 2) whether achievement of weekly, individualized Fitbit step goals was associated with functional outcomes. We conducted a secondary analysis of Fitbit data from our 10-week mind-body activity program for chronic pain (GetActive-Fitbit arm, N = 41). Participants self-reported emotional and physical function and completed performance-based and accelerometer-based assessments. From week 1 to week 10, 30% of participants increased >800 steps; 32.5% increased MVPA; and 30% decreased sedentary behavior. Only step count significantly changed across time with mean steps peaking at week 8 (M = +1897.60, SD = 467.67). Fitbit step goal achievement was associated with improvements in anxiety (ß = -.35, CI [-2.80, -.43]), self-reported physical function (ß = -.34, CI [-5.17, 8.05]), and performance-based physical function (ß = .29, CI [-71.93, 28.38]), but not accelerometer-based physical function or depression. Adhering to individualized Fitbit step goals in the context of a mind-body activity program may improve anxiety and self-reported and performance-based physical function. PERSPECTIVE: We examine Fitbit activity patterns and the association between quota-based pacing and functional outcomes within a mind-body activity program for adults with chronic pain. Complementing quota-based pacing and coping skills with Fitbits may be a useful approach to promote activity engagement and behavior change in chronic pain populations.

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

BACKGROUND: Knee osteoarthritis (KOA) is the most common joint disorder in the United States and a leading cause of disability. Depression and obesity are highly comorbid with KOA and accelerate knee degeneration and disability through biopsychosocial mechanisms. Mind-body physical activity programs can engage biological, mechanical, and psychological mechanisms to improve outcomes in KOA, but such programs are not currently available. OBJECTIVE: This mixed methods study aims to adapt a mind-body activity program for the unique needs of patients with KOA, depression, and obesity (GetActive-OA) delivered via live video. METHODS: Participants were adults (aged ≥45 years) from rural Kentucky with obesity (BMI≥30 kg/m2), idiopathic KOA with mild to moderate radiographic changes, and elevated depressive symptoms (9-item Patient Health Questionnaire ≥10) recruited from 2 orthopedic centers. In phase 1, we developed GetActive-OA and the study protocol using qualitative focus group feedback from the study population (N=9; 2 focus groups, 90 minutes) and multidisciplinary expertise from clinical psychologists and orthopedic researchers. In phase 2, we explored the initial feasibility, credibility, and acceptability of GetActive-OA, live video delivery, and study procedures via an open pilot with exit interviews (N=5; 1 group). This research was guided by National Institutes of Health (NIH) model stage IA. RESULTS: Phase 1 qualitative analyses revealed nuanced information about challenges with coping and increasing activity, high interest in a mind-body activity program, program participation facilitators (flexibility with technology) and barriers (amotivation and forgetfulness), and perceived challenges with data collection procedures (blood and urine samples and homework). Phase 2 quantitative analyses showed that GetActive-OA met most a priori feasibility markers: acceptability (80%), expectancy (100%), credibility (100%), clinician adherence (90%), homework adherence (80%), questionnaire data collection (100%), program satisfaction (100%), and safety (100%). Adherence to ActiGraph wear (80% baseline, 20% posttest) and collection of blood samples (60%) were low. Participation in GetActive-OA was associated with signals of improvements in general coping (Cohen d=2.41), pain catastrophizing (Cohen d=1.24), depression (Cohen d=0.88), anxiety (Cohen d=0.78), self-efficacy (Cohen d=0.73), pain (Cohen d=0.39), and KOA symptoms (Cohen d=0.36). Qualitative exit interviews confirmed quantitative findings and provided valuable information to optimize the program and protocol. CONCLUSIONS: Patients with KOA, depression, and obesity from rural Kentucky were interested in a live video mind-body activity program. GetActive-OA shows promise; however, the program and protocol require further NIH stage I refinement before formal efficacy testing (NIH model stage II). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1016/j.conctc.2021.100720.

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

Nearly half of dementia cases may be explained by modifiable lifestyle risk factors. Multidomain interventions are needed to bypass cognitive decline (CD) and aging-related barriers to sustained healthy lifestyles in at-risk older adults. We iteratively developed  My Healthy Brain, a group-based lifestyle program (8 weeks, 90 min sessions) delivered via live video that applies behavioral principles to target multiple risk factors for dementia. We describe the program structure, virtual delivery, and outcomes for a group of older adults with subjective CD or mild cognitive impairment and lifestyle risk factors (e.g., sedentary, poor sleep or diet). We also conducted a group exit interview to qualitatively assess participant experiences and elicit feedback to improve My Healthy Brain. This case report demonstrates that delivering evidence-based brain health education and behavior change skills in a group setting via live video is feasible, acceptable, and has the potential to improve lifestyle, cognitive, and psychosocial outcomes in older adults with CD.

Emotional distress in neuro-ICU survivor-caregiver dyads: The recovering together randomized clinical trial.

OBJECTIVE: Emotional distress is common in both survivors and their informal caregivers following admission to a neuroscience intensive care unit (Neuro-ICU) and can negatively affect their individual recovery and quality of life. Neuro-ICU survivor-caregiver dyads can influence each other's emotional distress over time, but whether such influence emerges during dyadic treatment remains unknown. The present study involved secondary data analysis of Neuro-ICU dyads enrolled in a randomized clinical trial of a dyadic resiliency intervention, Recovering Together (RT), versus a health education attention placebo control to test dyadic similarities in emotional distress before and after treatment. METHOD: Data were collected from 58 dyads following Neuro-ICU admission. Emotional distress (depression, anxiety, and posttraumatic stress) was assessed at baseline, 6 weeks (postintervention), and 12 weeks later. Nonindependence within survivor-caregiver dyads was examined (i.e., correlations between cross-sectional symptoms and changes in symptoms over time); mutual influence of emotional functioning over time (i.e., "partner effects") was examined using cross-lagged path analyses. RESULTS: There were strong, positive cross-sectional correlations between survivor and caregiver distress at postintervention and follow-up and between changes in survivor and caregiver distress from baseline to postintervention and postintervention to follow-up. There were no partner effects. CONCLUSIONS: Neuro-ICU survivors and their informal caregivers show similar changes in emotional distress after treatment. These findings highlight the potential benefits of intervening on both survivor and caregiver distress following Neuro-ICU admission. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

My Healthy Brain: a multimodal lifestyle program to promote brain health.

BACKGROUND: Promoting brain health depends on sustaining healthy behaviors across the lifespan. Yet, public adoption of lifestyle behaviors and knowledge of cognitive decline (CD) prevention remains poor. Our multidisciplinary team developed My Healthy Brain (MHB) to promote a healthy lifestyle (e.g. diet, exercise, alcohol, sleep) and build cognitive reserve (e.g. memory compensatory strategies). Our objective was to demonstrate early proof-of-concept for MHB by exploring the feasibility, acceptability, and improvement in primary lifestyle outcomes as well as secondary outcomes of self-determination and subjective wellbeing. MATERIALS AND METHODS: Older adults with subjective (self-report only) or objective (confirmed by cognitive testing) CD, referred by neurologists to modify lifestyle risk factors (e.g. sedentary), participated in a non-randomized open pilot of MHB (N = 24). Participants completed the 8-week MHB group (90 min each) and pre-post outcome measures. RESULTS: MHB met all a-priori set benchmarks, including good feasibility of recruitment (71% of patients screened) and enrollment (75% completed baseline), and good acceptability of treatment (75% completed 6 of 8 sessions and post-testing). Program satisfaction was excellent (100% of participants) and no adverse events were reported. We also observed improvements in primary lifestyle outcomes as well as secondary outcomes of self-determination and subjective well-being. DISCUSSION: While MHB demonstrated preliminary feasibility and the potential to modify lifestyle risk factors for CD, the program can be improved. Future work will explore the integration of mindfulness skills with behavioral principles to bolster multidomain lifestyle change, and the live video delivery format to bypass barriers to participation.

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

BACKGROUND AND OBJECTIVES: Chronic pain (CP) and cognitive decline (CD) are highly comorbid 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 (aged ≥60) with CP and CD (2 cohorts) completed 8 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. CLINICAL TRIAL REGISTRATION: NCT04044183.

Psychological resiliency explains the relationship between emotional distress and quality of life in neurofibromatosis.

PURPOSE: Neurofibromatoses (NF; NF1, NF2, and schwannomatosis) are incurable tumor suppressor syndromes with heterogeneous symptoms. Emotional distress (e.g., depression, anxiety, stress) is common in NF and impairs quality of life (QoL). Several modifiable dimensions of resiliency can contribute to enhanced QoL in medical populations but have been overlooked as treatment mechanisms for NF. Our goal was to determine, using data from an ongoing efficacy RCT testing a mind-body program for NF, if resiliency explains the relationship between emotional distress and QoL. METHODS: We performed structural equation modeling mediation analysis on baseline measures of QoL (physical health, psychological, social relationships, environmental), emotional distress (depression, anxiety, stress), and resiliency (gratitude, optimism, coping, mindfulness, empathy) completed by adults with NF (N = 228). We controlled for variables known to impact psychosocial functioning in NF (age, diagnosis, learning disability, and education). RESULTS: After adjusting for covariates, resiliency had a significant and large indirect effect on the negative relationship between emotional distress and QoL (CSIE = - 0.31, 95% CI = - 0.59 to - 0.19, p = .001). The direct effect of emotional distress on QoL was smaller but remained significant (ß = - 0.23, 95% CI = - 0.44 to - 0.03, p = .03), suggesting partial mediation through resiliency. CONCLUSIONS: Resiliency may buffer the high rates of emotional distress in NF. Mind-body interventions targeting multiple modifiable resiliency factors may be a promising path toward promoting QoL in adults with NF. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT03406208.