Predictors of initial engagement with an asynchronous cognitive behavioral stress management website among older women with nonmetastatic breast cancer.

PURPOSE: Digital interventions, like websites, offer greater access to psychosocial treatments; however, engagement is often suboptimal. Initial use may be a target to "hook" participants. Few studies examine engagement with cognitive behavioral stress management (CBSM). We tested predictors of engagement in the first week of using a CBSM website among women with breast cancer (BC). METHODS: Older women (≥ 50 years) with nonmetastatic BC enrolled in an on-going trial (8/2016-4/2022, #NCT03955991) and were randomized to receive 10 synchronous, virtual CBSM group sessions immediately (n = 41) or after a 6-month waitlist (n = 34). All received simultaneous access to an asynchronous website, where supplemental videos and resources were released weekly. Engagement was tracked via breadth (features used) and depth (clicks within content). Multilevel modeling tested predictors of engagement (i.e., time, condition, age, daily stress, depression, race, ethnicity, disease stage). RESULTS: Breadth decreased over the first week of CBSM (b = -0.93, p < .01), and women with more advanced stage disease engaged with more breadth (b = 0.52, p < .01) and depth (b = 14.06, p < .01) than women with earlier stage disease. Non-Hispanic (b = -0.59, p = .03) and White (b = -0.97, p < .01) women engaged with more features. Cancer stage and intervention timing interacted. Women with more advanced cancer stage who received CBSM later engaged with the most depth (b = -11.73, p = .04). All other characteristics did not predict engagement. CONCLUSIONS: Disease stage, race, ethnicity, and intervention timing predicted engagement with a CBSM website in older BC patients. IMPLICATIONS FOR CANCER SURVIVORS: Delivering CBSM later in cancer treatment may mitigate competing demands. Fostering greater engagement in racial/ethnic minorities is needed.

Marital status and perceived stress in men with advanced prostate cancer: A randomized-controlled trial of cognitive behavioral stress management.

OBJECTIVE: Relationship status predicts numerous outcomes among medical populations. Few interventions evaluate the role of marital status on response to psychosocial treatment, and no such studies exist within advanced prostate cancer (APC). This study examined whether marital status modified the effect of a cognitive behavioral stress management (CBSM) intervention on perceived stress. METHODS: Men with APC (N = 190) were randomized to 10-week CBSM or a health promotion (HP) intervention (#NCT03149185). The Perceived Stress Scale assessed perceived stress at baseline and 12-month follow-up. Medical status and sociodemographics were captured at enrollment. RESULTS: Participants were mostly White (59.5%), non-Hispanic (97.4%), heterosexual (97.4%) men, 66.8% of whom were partnered. Neither condition nor marital status predicted perceived stress change at follow-up. However, a significant interaction was found between condition and marital status (p = 0.014; Cohen's f = 0.07), such that partnered men who received CBSM and unpartnered men who received HP reported greater reductions in perceived stress. CONCLUSION: This is the first study to assess the impact of marital status on psychosocial intervention effects among men with APC. Partnered men derived greater benefit from a cognitive-behavioral intervention and unpartnered men equally benefitted from a HP intervention. Further research is necessary to understand the mechanisms underlying these relationships.

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.

Pain, cancer-related distress, and physical and functional well-being among men with advanced prostate cancer.

PURPOSE: Men with advanced prostate cancer (APC) experience high levels of pain, which contribute to poor psychosocial and functional outcomes. Cancer-related distress explains the relationship between pain severity and interference, yet specificity of distress characteristics (e.g., hyperarousal, intrusive, or avoidant symptoms) in explaining associations between pain experiences and well-being has not been explored within APC. This study examined men with APC entering a clinical trial and tested associations of baseline pain, cancer-related distress, and physical and functional well-being. METHODS: One hundred ninety men with APC enrolled in a randomized-controlled trial and were assessed prior to randomization. The McGill Pain Questionnaire assessed pain severity, and the Functional Assessment of Cancer Therapy-General captures physical and functional well-being. The Impact of Events Scale-Revised measured cancer-specific distress symptoms, including hyperarousal, avoidance, and intrusion symptoms. Controlling for age, cancer stage at diagnosis, income, education, and race/ethnicity, mediation models (SPSS PROCESS, model 4) tested whether cancer-specific distress accounted for the associations between pain severity and physical and functional well-being. RESULTS: Men were on average 68 years of age, White non-Hispanic, with stage IV cancer. Pain severity was related to poorer physical (p < .001) and functional well-being (p < .001). Associations between pain severity and physical and functional well-being were partially mediated by greater intrusive and hyperarousal symptoms but not avoidant symptoms. CONCLUSION: For men with APC, intrusive and hyperarousal symptoms may partially explain the relationship between pain severity and decrements in physical and functional well-being. APC pain management should attend to such distress symptoms, which may contribute to interference if left unaddressed. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03149185.

Effects of a randomized-controlled trial of cognitive behavioral stress management: Psychosocial adaptation and immune status in men with early-stage prostate cancer.

OBJECTIVE: Targets of intervention in cognitive behavioral stress management (CBSM), such as benefit finding (BF) and perceived stress management skills (PSMS), may counteract stress-related changes that impact the immune system. This study tested whether BF, PSMS, and optimism influence the effects of CBSM on immune status in men with prostate cancer. METHODS: Men with prostate cancer were randomized to receive CBSM or a psychoeducation (PE) control comparison (NCT05486754). Life Orientation Test-Revised assessed baseline optimism. The Benefit Finding Scale and Measure of Current Status measured BF and PSMS after CBSM. T-cells and T-helper cells captured immune status change at baseline and 6-months post-CBSM. MPlus and SPSS (PROCESS) tested condition effects and moderated mediation, controlling for covariates. RESULTS: 256 primarily middle-aged, White Non-Hispanic or Hispanic men enrolled. PSMS mediated CBSM effects on T-cell and T-helper cell percentage, such that T-cell and T-helper cell percentages were reduced in men in CBSM versus PE via PSMS. Optimism moderated this mediation with the mediating effect of PSMS only observed among men with average optimism versus those with low or high optimism. CONCLUSION: Baseline psychological characteristics, as well as limited specificity of immune measurement, could explain the conditional effects in this sample. TRIAL REGISTRATION: NCT05486754.

Investigating Strategies of Emotion Regulation As Mediators of Occupational Stressors and Mental Health Outcomes in First Responders.

The aim of this study was to investigate whether two emotion regulation strategies, expressive suppression or cognitive reappraisal, mediated the development of posttraumatic stress disorder (PTSD), major depression (MD), and generalized anxiety disorder (GAD) in first responders (FR) who experienced occupational stressors, using cross-sectional data. An aggregate of 895 first responders (M = 37.32, SD = 12.09, 59.2% male, 91.3% Caucasian) who were recruited through professional organizations and social media sites across North and South American states participated in an online Qualtrics survey. Bivariate correlation analyses demonstrated that occupational stressors were positively correlated with expressive suppression and each mental health outcome but were not significantly correlated with cognitive reappraisal. Mediation analyses demonstrated expressive suppression as a significant mediator between occupational stressors and PTSD, MD, and GAD symptoms, but not cognitive reappraisal. Even though these findings are in purview of a cross-sectional research design, they suggest the importance of practices that bolster first responders' ability to use more effective and adaptive emotion regulation strategies such as emotion expression, effective communication, and cognitive reappraisal that might help enhance psychological resilience.

Orthopedic Providers' Preferences for Education and Training on Psychosocial Clinical Research Initiatives: A Qualitative Investigation.

INTRODUCTION: Psychosocial factors (e.g., depression, anxiety) increase risk for chronic pain, disability, and other health complications following acute orthopedic traumatic injury. Orthopedic providers lack skills to address these factors. Education around psychosocial factors of recovery and psychosocial clinical and research initiatives could address this gap. The purpose of this study was to understand orthopedic trauma providers' preferences for the design and distribution of educational materials to facilitate psychosocial initiative implementation. METHODS: We conducted live-video, semi-structured focus groups with outpatient orthopedic trauma providers across three Level 1 Trauma Centers, using a hybrid inductive-deductive approach to analyze qualitative data and extract themes and subthemes characterizing providers' recommendations for appropriate psychosocial education. RESULTS: Four themes described providers' recommendations for receiving educational materials: (1) provide foundational knowledge and tools about psychosocial factors; (2) provide information regarding a psychosocial initiative's purpose and procedures; (3) leverage educational materials to maximize buy-in to psychosocial clinical research initiatives; and (4) deliver information concisely, clearly, and electronically. CONCLUSION: Orthopedic providers recommended ways to optimize design and dissemination of education on psychosocial care. Optimizing knowledge of psychosocial factors and clinical and research initiatives facilitates providers' ability to appropriately target the often-underdressed psychosocial component of recovery in orthopedics.

One Diagnosis, Two Perspectives: Lived Experiences of Persons With Young-Onset Dementia and Their Care-Partners.

BACKGROUND AND OBJECTIVES: Young-onset dementias (YODs) are a set of progressive illnesses that are stressful for both persons with the diagnosis and their care-partners. Although the stressors differ based on their roles and individual experiences, both individuals are at risk for heightened emotional distress (e.g., depression and anxiety). Understanding the unique stressors for each partner and adaptive coping strategies to manage these stressors is important for informing individual and couples-based psychosocial interventions. RESEARCH DESIGN AND METHODS: We conducted open-ended individual interviews with persons with YOD (N = 12) and their care-partners (i.e., romantic partner; N = 17) over live video. We utilized a hybrid of deductive and inductive analysis techniques to extract individual-level themes and subthemes regarding stressors and adaptive coping strategies. RESULTS: Persons with YOD identified stressors including burden of YOD symptoms, loss of familial roles, resentment toward partner, isolation, and fear of the future. Care-partners identified stressors including managing their partners' symptoms, increased responsibilities, caregiving role, loss of intimacy, social isolation, and grief. For adaptive coping strategies, persons with YOD endorsed use of acceptance, promotion of independence, social support, and engaging in pleasurable activities. Care-partners endorsed value of learning about the diagnosis, using resources, optimism, social support, and self-care. DISCUSSION AND IMPLICATIONS: Findings highlight the unique experiences of persons with YOD and their care-partners. Identified themes can be used to inform role-specific psychosocial interventions for both individuals and couples coping with YOD.

The Strategies for Quantitative and Qualitative Remote Data Collection: Lessons From the COVID-19 Pandemic.

The COVID-19 pandemic has necessitated a rapid shift to web-based or blended design models for both ongoing and future clinical research activities. Research conducted virtually not only has the potential to increase the patient-centeredness of clinical research but may also further widen existing disparities in research participation among underrepresented individuals. In this viewpoint, we discuss practical strategies for quantitative and qualitative remote research data collection based on previous literature and our own ongoing clinical research to overcome challenges presented by the shift to remote data collection. We aim to contribute to and catalyze the dissemination of best practices related to remote data collection methodologies to address the opportunities presented by this shift and develop strategies for inclusive research.

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.

Psychosocial treatment preferences of persons living with young-onset dementia and their partners.

Persons living with young-onset dementia and their partners often experience elevated emotional distress as they cope with an unexpected progressive illness during an active life stage (typically ages 45-64 years). Despite their heightened emotional distress, psychosocial resources are both limited and lack the specificity to meet the unique needs of both partners. Our aim was to gain an in-depth understanding of the psychosocial treatment preferences of persons with young-onset dementia and their partners-an important first step in developing a tailored intervention. We conducted semi-structured dyadic interviews with persons with young-onset dementia and their partners (N = 23) and used a hybrid deductive-inductive approach to thematic analysis. We identified 12 themes across four domains: (1) perceptions of available and lacking resources, (2) preferences for program content, (3) preferences for program format, and (4) barriers and facilitators to participation. Couples indicated there is a lack of specific and family-oriented resources, which can create more stress and relationship strain. Couples endorsed support for a virtual, dyadic intervention delivered shortly after diagnosis focused on providing tools to cope with difficult emotions and symptom progression and enhance communication and meaningful daily living. They also identified potential barriers to program participation and offered suggestions to promote engagement. By using a qualitative approach, we were able to gather nuanced information that can be used to directly inform a feasible, accepted, and person-centered psychosocial intervention for persons with young-onset dementia and their partners.

Stopping to Listen: Using Qualitative Methods to Inform a Web-Based Platform for Adults With Neurofibromatosis.

Introduction: Psychosocial care for people with neurofibromatosis (NF) is challenging to access. Therefore, we sought to develop a self-guided web-based treatment platform for people with NF based on the live video relaxation response resiliency program for NF (3RP-NF). Here we report on qualitative interviews with adult patients who participated in the 3RP-NF to: (a) understand participant perceptions of the 3RP-NF program and (b) gather feedback for a self-guided web-based treatment platform (i.e., NF-Web). Methods: We conducted individual semistructured interviews (N = 23; videoconferencing). We utilized both the Framework method and a hybrid deductive and inductive approach to analyze qualitative data. Results: We examined findings within the following themes for both 3RP-NF and NF-Web: (a) general attitudes, (b) barriers and facilitators, and (c) program-specific factors. Participants endorsed positive attitudes towards the 3RP-NF and NF-Web and described unique barriers and facilitators to each and provided suggestions regarding technology, NF-specific needs, and ways to promote social support virtually. Conclusions: This study highlights the importance of gathering participant feedback when designing novel, illness-specific interventions. In future studies, we aim to provide people with NF effective and efficient access to psychosocial support that matches their needs and life context. Results are informing NF-Web development.

A qualitative investigation of activity measurement and change following a mind-body activity program for chronic pain.

Increasing activity is important yet challenging among people with chronic pain. Objective assessment of activity using accelerometers (i.e., ActiGraph) has gained popularity, but reactivity to assessment and non-adherence to wearing the ActiGraph may bias data. We explored: 1) experiences of wearing the ActiGraph to identify ways to increase adherence and facilitate accurate assessment of activity; and 2) barriers and facilitators to increasing activity following two mind-body activity programs to optimize future interventions. We conducted semi-structured exit interviews with 13 participants with heterogenous chronic pain who completed a randomized controlled trial of two mind-body activity programs. We analyzed transcripts using a framework approach to generate themes. Participants indicated that receiving reminders increased ActiGraph wear adherence and reported that program skills such as gratitude, pacing, mindfulness, and deep breathing were facilitators to increasing activity, while medical problems were barriers. Interventions aiming to increase activity may benefit from emphasizing mind-body skills and sending ActiGraph wear reminders.

Thematic Analysis of Dyadic Coping in Couples With Young-Onset Dementia.

Importance: A diagnosis of young-onset dementia (YOD) is a life-altering event for both persons with dementia and their spousal caregivers. Dyadic coping (DC) theoretical models acknowledge that dyads cope with stressors as a unit, but these models have yet to be used in YOD. Objective: To explore the lived experiences of couples managing YOD using an integrated DC model. Design, Setting, and Participants: This qualitative study recruited couples from a single major medical setting and through social media. Eligibility criteria included cohabitation, 1 partner diagnosed with YOD and able to participate, and both partners willing to participate. Live online video interviews were conducted from March to June 2020. Exposures: One semistructured interview, which was recorded and subsequently transcribed. Recruitment was stopped once thematic saturation was reached. Main Outcomes and Measures: Five themes were deductively derived based on the integrated DC framework, including stress communication, positive individual DC, positive conjoint DC, negative individual DC, and negative conjoint DC. Within each theme, subthemes were inductively identified to further characterize couples' dyadic coping experiences with YOD. Results: A total of 23 couples were interviewed, comprising persons with dementia (11 women [48%]; mean [SD] age, 61.3 [4.65] years; mean [SD] time from diagnosis, 3.11 [3.85]) years; and spousal caregivers (13 women [57%]; mean [SD] age, 60.5 [5.40] years). Data supported the 5 a priori DC themes and novel subthemes describing couples' experiences with YOD. Specifically, couples enacted positive conjoint DC by approaching challenges using a teamwork approach to problem solving and relying on collaborative communication. In contrast, couples engaged in negative conjoint DC through mutual avoidance, leading to increased negative communication and conflict. Couples described initially engaging in avoidance and withdrawal to navigate YOD-related stressors. While these strategies provided short-term relief from challenging emotions, they prevented engagement in adaptive coping (eg, acceptance and collaborative problem-solving) to promote long-term adjustment. Conclusions and Relevance: This study used an evidence-based integrated DC approach to identify the positive and negative coping behaviors of couples managing YOD. To our knowledge, this is the first study to use a DC framework to guide qualitative analysis, and it provides valuable insights into DC strategies used by couples navigating YOD-related stressors. Findings can inform the development of dyadic psychosocial services for couples managing YOD and have implications for other progressive illnesses.

Can a Dyadic Resiliency Program Improve Quality of Life in Cognitively Intact Dyads of Neuro-ICU Survivors and Informal Caregivers? Results from a Pilot RCT.

BACKGROUND: Neuro-ICU hospitalization for an acute neurological illness is often traumatic and associated with heightened emotional distress and reduced quality of life (QoL) for both survivors and their informal caregivers (i.e., family and friends providing unpaid care). In a pilot study, we previously showed that a dyadic (survivor and caregiver together) resiliency intervention (Recovering Together [RT]) was feasible and associated with sustained improvement in emotional distress when compared with an attention placebo educational control. Here we report on changes in secondary outcomes assessing QoL. METHODS: Survivors (n = 58) and informal caregivers (n = 58) completed assessments at bedside and were randomly assigned to participate together as a dyad in the RT or control intervention (both 6 weeks, two in-person sessions at bedside and four sessions via live video post discharge). We measured QoL domain scores (physical health, psychological, social relations, and environmental), general QoL, and QoL satisfaction using the World Health Organization Quality of Life Abbreviated Instrument at baseline, post treatment, and 3 months' follow-up. We conducted mixed model analyses of variance with linear contrasts to estimate (1) within-group changes in QoL from baseline to post treatment and from post treatment to 3 months' follow-up and (2) between-group differences in changes in QoL from baseline to post treatment and from post treatment to 3 months' follow-up. RESULTS: We found significant within-group improvements from baseline to post treatment among RT survivors for physical health QoL (mean difference 1.73; 95% confidence interval [CI] 0.39-3.06; p = 0.012), environmental QoL (mean difference 1.29; 95% CI 0.21-2.36; p = 0.020), general QoL (mean difference 0.55; 95% CI 0.13-0.973; p = 0.011), and QoL satisfaction (mean difference 0.87; 95% CI 0.36-1.37; p = 0.001), and those improvements sustained through the 3-month follow-up. We found no significant between-group improvements for survivors or caregivers from baseline to post treatment or from post treatment to 3 months' follow-up for any QoL variables (i.e., domains, general QoL, and QoL satisfaction together). CONCLUSIONS: In this pilot study, we found improved QoL among survivors, but not in caregivers, who received RT and improvements sustained over time. These RT-related improvements were not significantly greater than those observed in the control. Results support a fully powered randomized controlled trial to allow for a definitive evaluation of RT-related effects among dyads of survivors of acute brain injury and their caregivers.

Sustainability of Improvements in Adaptive Coping Following Mind-Body and Activity Training for Chronic Pain.

BACKGROUND: The strategies patients use to cope with chronic pain are key determinants of pain-related treatment outcomes and are often targeted in psychosocial interventions for chronic pain. However, improvements in coping often fade after intervention completion. Here, we test whether previously reported improvements in coping following two novel mind-body and activity interventions are maintained 3 months after completion. METHODS: Eighty-two patients with heterogeneous chronic pain were randomized to two identical mind-body and activity interventions, one with the addition of a Fitbit device (GetActive-Fitbit) and one without it (GetActive; n = 41 each). Participants completed measures of pain-catastrophizing, kinesiophobia, mindfulness, adaptive coping, and pain-resilience at baseline, post-intervention, and at 3-month follow-up. RESULTS: At follow-up, participants in both groups exhibited sustained improvements in all five coping measures compared to baseline (significant in both groups for all measures except for p = .05 in kinesiophobia in GetActive and p = .07 in pain resilience in GetActive-Fitbit). CONCLUSIONS: Overall, GetActive and GetcActive-Fitbit are promising interventions to sustainably improve coping with chronic pain. TRIAL REGISTRATION: This trial is registered under ClinicalTrials.gov identifier NCT03412916.

Development of a mind body program for obese knee osteoarthritis patients with comorbid depression.

Knee osteoarthritis (OA) is the most common joint disorder in the U.S. and a leading cause of disability. Depression and obesity are highly comorbid among knee OA patients, and the combination of obesity and depression is associated with decreased physical activity, higher pain and disability, and more rapid cartilage degradation. Depression, obesity and OA exacerbate one another and share a common pathophysiology involving systemic inflammation and pro-inflammatory cytokines, reflecting a complex mind-body interaction. Current treatments for knee OA offer little to no benefit over placebo, and do not emphasize mind-body practices or physical activity to target the underlying pathophysiology. Mind-body interventions to lessen depressive symptoms and increase physical activity offer the ability to target biological, mechanical and psychological mechanisms of OA progression. Our long-term goals are to evaluate the mechanisms by which the Relaxation Response Resiliency Program (3RP) delivered via secure telehealth, and adapted for patients with depression, obesity and knee OA (GetActive-OA) promotes increases in physical activity and improved knee health. We hypothesize that the synergistic interaction between mindfulness, adaptive thinking, positive psychology and healthy living skills of the GetActive-OA will slow the progression of symptomatic knee OA by reducing pro-inflammatory cytokine expression and promoting optimal mechanical loading of the cartilage. Here we present the protocol for a mixed methods study that will adapt the 3RP for the needs of knee OA patients with depression and obesity with a focus on increasing physical activity (GetActive-OA), and iteratively maximize the feasibility, credibility and acceptability of the programs and research procedures.

Getting Active Mindfully: Rationale and Case Illustration of a Group Mind-body and Activity Program for Chronic Pain.

Chronic pain is associated with substantial decreases in physical and emotional health. Psychosocial and physical restoration interventions, although potentially helpful, typically show small-to-moderate improvements that are limited to the short term, and often exhibit problematic adherence. Here, we present GetActive-Fitbit, a novel 10-week group program that integrates mind-body skills, pain coping and gradual increases in activity reinforced by a commercially available digital monitoring device (Fitbit). We illustrate the program among a group of 4 adults with heterogeneous chronic pain. We also highlight pre to post-program improvements in physical function (objective, performance-based and self-report), emotional function (depression and anxiety) and other relevant outcomes targeted by the program (e.g., pain intensity, catastrophizing, mindfulness, coping, kinesiophobia, emotional support, social isolation, pain resilience, program satisfaction and impression of change). Group participants' experiences suggest that GetActive-Fitbit is credible, useful, and shows potential to improve physical and emotional function among this challenging population.Clinical trial number: NCT03412916.

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.