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The purpose of the study is to examine the associations of patients' and their informal caregivers' psychosocial resiliency factors with their own and their partners' emotion domains (distress, anxiety, depression, and anger) after admission to the neuroscience intensive care unit (Neuro-ICU). Eighty-three dyads of patients (total n = 87) and their informal caregivers (total n = 99) participated in this observational, cross-sectional study by self-reporting demographics and measures of resiliency factors (mindfulness [Cognitive and Affective Mindfulness Scale Revised], coping [Measure of Coping Status-A], intimate bond [Intimate Bond Measure], self-efficacy [patients: General Self-Efficacy Scale; caregivers: Revised Caregiver Self-Efficacy Scale]) and emotion domains (Emotion Thermometers) within 2 weeks of Neuro-ICU admission. There were no differences between patients' and caregivers' levels of psychosocial resiliency, distress, or anxiety. Patients reported greater depression and anger relative to their caregivers. Overall, roughly half of patients (50.6%) and caregivers (42.4%) reported clinically significant emotional distress. Patients' and caregivers' own psychosocial resiliency factors were associated with their own, but not their partner's, emotion domains. Findings of high distress among both patients and caregivers at admission emphasize the importance of attending to the mental health of both patients and caregivers in the Neuro-ICU. As modifiable psychosocial resiliency factors were associated with emotion domains for both patients and caregivers, interventions to enhance these factors may ameliorate emotional distress among these vulnerable populations.

Background/Objective: Caregivers from the Millennial generation are an emerging and understudied group of unpaid care providers in America who may benefit from digitally delivered support. To inform the design/tailoring of interventions for this group, we aimed to understand how Millennials may differ from other generations of caregivers regarding digital health-related technology use. Methods: Using the Health Information National Trends Survey (HINTS), Version 6, we conducted a cross-sectional study comparing health technology access and use across four generations of unpaid caregivers (n = 545; Millennials, Gen X, Baby Boomers, and Silent Generation) of adults with chronic conditions using chi-square and Kruskal–Wallis non-parametric tests. Results: Compared to Baby Boomer and Silent Generation caregivers, Millennial caregivers more frequently reported having a cellular internet connection, using a wearable activity device, a health/wellness mobile application, choosing telehealth appointments for convenience, and most frequently used social media in general and to view health-related videos (ps < 0.005). Additionally, Millennials were more likely to report possessing a smartphone (compared to Gen X and Silent Generation) and more frequently used social media for peer interaction about health (compared to all older generations; ps < 0.005). Conclusion: Millennials differ from older generations of caregivers regarding health-related technology access and use, which may have implications for intervention design and tailoring.

Older adults with insomnia face considerable challenges accessing treatment given limited availability to first-line therapy (Cognitive-Behavioral Therapy for Insomnia, CBT-I). This study evaluated the efficacy of Sleep Healthy Using the Internet for Older Adults Suffering with Insomnia and Sleeplessness (SHUTi OASIS), a tailored CBT-I internet intervention for older adults with insomnia, in a 3-arm randomized controlled trial (SHUTi OASIS alone, SHUTi OASIS + stepped support, online patient education [PE]). 311 participants (ages 55–95) were randomized to receive SHUTi OASIS (alone n  = 105; with stepped support n  = 102), with both conditions reporting significant improvements across post, 6-month, and 12-month follow-ups in insomnia severity compared to those receiving PE ( n  = 104). Clinically meaningful indices of insomnia response and remission were also higher among those receiving SHUTi OASIS. Those who received SHUTi OASIS also significantly outperformed those receiving PE on secondary outcomes, including sleep onset latency, wake after sleep onset, sleep efficiency, number of awakenings, sleep quality, and fatigue, across most timepoints. Results indicate that digital CBT-I provides important benefits for older adults, offering strong potential to expand access to insomnia treatment for this underserved population.

Dyadic psychosocial interventions have been found beneficial both for people coping with mental or physical health conditions as well as their family members and friends who provide them with support. Delivering these interventions via electronic health (eHealth) may help increase their scalability. This scoping review aimed to provide the first comprehensive overview of dyadic eHealth interventions for individuals of all ages affected by mental or physical illness and their family members or friends who support them. The goal was to understand how dyadic eHealth interventions have been used and to highlight areas of research needed to advance dyadic eHealth intervention development and dissemination. A comprehensive electronic literature search of PubMed, EMBASE, Cochrane, Cumulative Index to Nursing and Allied Health Literature, and PsycINFO was conducted for articles published in the English language through March 2019. Eligible records described a psychosocial eHealth intervention that intervened with both care recipients and their support person. A total of 7113 records were reviewed of which 101 met eligibility criteria. There were 52 unique dyadic eHealth interventions identified, which were tested across 73 different trials. Of the unique interventions, 33 were conducted among dyads of children and their supporting parent, 1 was conducted with an adolescent-young adult care recipient population, and the remaining 18 were conducted among adult dyads. Interventions targeting pediatric dyads most commonly addressed a mental health condition (n=10); interventions targeting adult dyads most commonly addressed cancer (n=9). More than three-fourths of interventions (n=40) required some human support from research staff or clinicians. Most studies (n=64) specified one or more primary outcomes for care recipients, whereas less than one-fourth (n=22) specified primary outcomes for support persons. Where specified, primary outcomes were most commonly self-reported psychosocial or health factors for both care recipients (n=43) and support persons (n=18). Results of the dyadic eHealth intervention tended to be positive for care recipients, but evidence of effects for support persons was limited because of few studies specifying primary outcomes for supporters. Trials of dyadic eHealth interventions were most commonly randomized controlled trials (RCTs; n=44), and RCTs most commonly compared the dyadic eHealth intervention to usual care alone (n=22). This first comprehensive review of dyadic eHealth interventions demonstrates that there is substantial, diverse, and growing literature supporting this interventional approach. However, several significant gaps were identified. Few studies were designed to evaluate the unique effects of dyadic interventions relative to individual interventions. There was also limited assessment and reporting of outcomes for support persons, and there were no interventions meeting our eligibility criteria specifically targeting the needs of older adult dyads. Findings highlight areas of research opportunities for developing dyadic eHealth interventions for novel populations and for increasing access to dyadic care.

Although most survivors of breast cancer report substantial sexual concerns following treatment, few receive support for these concerns. Delivering sexual health care to survivors of breast cancer via the internet could overcome many of the barriers to in-person treatment. Even when delivered remotely, survivor time constraints remain a leading barrier to sexual health intervention uptake. Guided by the multiphase optimization strategy methodological framework, the primary objective of this study is to identify the most efficient internet-delivered sexual health intervention package that is expected to provide survivors of breast cancer the greatest benefit with the fewest (and least-intensive) intervention components. This study aims to determine how intervention components work (mediators) and for whom they work best (moderators). Partnered, posttreatment adult female survivors of breast cancer (N=320) experiencing at least 1 bothersome sexual symptom (ie, pain with sex, vaginal dryness, low sexual desire, and difficulty with orgasm) related to their breast cancer treatment will be enrolled. Clinic-based recruitment will be conducted via the Wake Forest National Cancer Institute Community Oncology Research Program (NCORP) Research Base. Participants will be randomly assigned to 1 of 16 combinations of four intervention components with two levels each in this factorial trial: (1) psychoeducation about cancer-related sexual morbidity (receive either enhanced vs standard versions); (2) communication skills training for discussing concerns with health care providers (received vs not received); (3) communication skills training for discussing concerns with a partner (received vs not received); and (4) intimacy promotion skills training (received vs not received). Cores will be fully automated and implemented using a robust internet intervention platform with highly engaging elements such as animation, video, and automated email prompts. Survivors will complete web-based assessments at baseline (prerandomization time point) and again at 12 and 24 weeks later. The primary study aim will be achieved through a decision-making process based on systematically evaluating the main and interaction effects of components on sexual distress (Female Sexual Distress Scale-Desire, Arousal, Orgasm) and sexual functioning (Female Sexual Function Index) using a generalized linear model approach to ANOVA with effect coding. Mediation analyses will be conducted through a structural equation modeling approach, and moderation analyses will be conducted by extending the generalized linear model to include interaction effects. This protocol has been reviewed and approved by the National Cancer Institute Central Institutional Review Board. Data collection is planned to begin in March 2024 and conclude in 2027. By identifying the combination of the fewest and least-intensive intervention components likely to provide survivors of breast cancer the greatest sexual health benefit, this study will result in the first internet intervention that is optimized for maximum impact on the undertreated, prevalent, and distressing problem of breast cancer-related sexual morbidity. ClinicalTrials.gov NCT06216574; https://clinicaltrials.gov/study/NCT06216574. PRR1-10.2196/57781.

Family caregivers are more likely to experience insomnia relative to noncaregivers but have significant barriers to accessing gold standard cognitive behavioral therapy for insomnia treatment. Delivering interventions to caregivers through the internet may help increase access to care, particularly among higher-intensity caregivers who provide assistance with multiple care tasks over many hours per week. Although there are existing internet interventions that have been thoroughly studied and demonstrated as effective in the general population, the extent to which these interventions may be effective for caregivers without tailoring to address this population's unique psychosocial needs has not been studied. The goal of this trial is to determine what tailoring may be necessary for which caregivers to ensure they receive optimal benefit from an existing evidence-based, internet-delivered cognitive behavioral therapy for insomnia program named Sleep Healthy Using the Internet (SHUTi). Specifically, we will test the association between caregivers' engagement with SHUTi and their caregiving context characteristics (ie, caregiving strain, self-efficacy, and guilt) and environment (ie, proximity to care recipient; functional status, cognitive status, and problem behavior of care recipient; and type of care provided). Among caregivers using the program, we will also test the associations between change in known treatment mechanisms (sleep beliefs and sleep locus of control) and caregiving context factors. A total of 100 higher-intensity caregivers with significant insomnia symptoms will be recruited from across the United States to receive access to SHUTi in an open-label trial with mixed methods preassessments and postassessments. At postassessment (9 weeks following preassessment completion), participants will be categorized according to their engagement with the program (nonusers, incomplete users, or complete users). Study analyses will address 3 specific aims: to examine the association between caregivers' engagement with SHUTi and their caregiving context (aim 1a); to describe caregivers' barriers to and motivations for SHUTi engagement from open-ended survey responses (aim 1b); and among caregivers using SHUTi, to determine whether cognitive mechanisms of change targeted by SHUTi are associated with differences in caregiving context (aim 2). Institutional review board approvals have been received. Data collection is anticipated to begin in December 2021 and is expected to be completed in 2023. Findings will inform the next research steps for tailoring and testing SHUTi for optimal impact and reach among caregivers. Beyond implication to the SHUTi program, the findings will be translatable across intervention programs and will hold significant promise to reduce inefficiencies in developing digital health interventions for caregivers while also increasing their impact and reach for this underserved population. ClinicalTrials.gov; NCT04986904; https://clinicaltrials.gov/ct2/show/NCT04986904?term=NCT04986904. PRR1-10.2196/34792.

Abstract Study Objectives To present development considerations for online sleep diary systems that result in robust, interpretable, and reliable data; furthermore, to describe data management procedures to address common data entry errors that occur despite those considerations. Methods The online sleep diary capture component of the Sleep Healthy Using the Internet (SHUTi) intervention has been designed to promote data integrity. Features include diary entry restrictions to limit retrospective bias, reminder prompts and data visualizations to support user engagement, and data validation checks to reduce data entry errors. Despite these features, data entry errors still occur. Data management procedures relying largely on programming syntax to minimize researcher effort and maximize reliability and replicability. Presumed data entry errors are identified where users are believed to have incorrectly selected a date or AM versus PM on the 12-hour clock. Following these corrections, diaries are identified that have unresolvable errors, like negative total sleep time. Results Using the example of one of our fully-powered, U.S. national SHUTi randomized controlled trials, we demonstrate the application of these procedures: of 45,598 total submitted diaries, 487 diaries (0.01%) required modification due to date and/or AM/PM errors and 27 diaries (<0.001%) were eliminated due to unresolvable errors. Conclusion To secure the most complete and valid data from online sleep diary systems, it is critical to consider the design of the data collection system and to develop replicable processes to manage data. Clinical Trial Registration Sleep Healthy Using The Internet for Older Adult Sufferers of Insomnia and Sleeplessness (SHUTiOASIS); https://clinicaltrials.gov/ct2/show/NCT03213132; ClinicalTrials.gov ID: NCT03213132 Graphical Abstract Graphical Abstract

Abstract Background Individuals with advanced, incurable cancer often experience high physical and psychological symptom burden. Family and friend caregivers are at risk for emotional distress. Purpose The aim of the study is to investigate the interrelationship of distress in patient-caregiver dyads at the time of newly diagnosed incurable cancer. Methods From May 2011 to July 2015, within 8 weeks of diagnosis of advanced lung or noncolorectal gastrointestinal cancer, 350 patients and 275 family caregivers were enrolled in a randomized controlled trial of early palliative care. Actor–partner interdependence modeling was used to examine relationships between dyad's self-reported anxiety and depressive symptoms on the Hospital Anxiety and Depression Scale at baseline. Results Comparing patients with caregivers, patients reported more depressive symptoms (Mdiff = .84; t[274] = 3.17, p = .002, d = .22) and caregivers reported more anxiety symptoms (Mdiff =1.62, t[274] = 4.91, p < .001, d = .39). Dyads' anxiety symptoms were positively associated, as were depressive symptoms (rs = .21, ps ≤ .001). Actor–partner interdependence modeling showed that patients' anxiety symptoms were positively associated with their own depressive symptoms, with an equal effect for caregivers (actor effect βs = 0.52, ps < .001). Patients' own anxiety was concurrently positively associated with their caregivers' depressive symptoms, with an equal effect for caregivers to patients (partner effect βs=0.08, ps=.008). Conclusions In the context of newly diagnosed incurable cancer, caregivers experience more pronounced anxiety, while patients report greater depressive symptoms. Findings indicate that anxiety and depressive symptoms are interrelated among dyads facing newly diagnosed incurable disease. Results emphasize the importance of addressing distress in both patients and caregivers. Future research should discern when dyadic versus individual psychosocial interventions would be optimal. Trial Registration Number The trial was registered with the ClinicalTrials.gov database (NCT02349412) https://clinicaltrials.gov/ct2/show/NCT02349412.

Background/Objective Anxiety is common in patients experiencing neurocritical illness and their family caregivers. Resilience factors like mindfulness and coping skills may be protective against symptoms of emotional distress, including anxiety. Less is known about the interplay of anxiety symptoms and resilience factors between patients and caregivers. The purpose of this study is to examine the trajectory of anxiety symptoms among dyads of neurocritical care patients without major cognitive impairment and their family caregivers and to elucidate the relationship between resiliency (e.g., mindfulness and coping) and anxiety in these dyads. Methods Prospective, longitudinal study of adults admitted to the neurological intensive care unit (Neuro-ICU) and their caregivers. Dyads of patients ( N  = 102) and family caregivers ( N  = 103) completed self-report measures of mindfulness (Cognitive Affective Mindfulness Scale-Revised) and coping (Measure of Current Status-Part A) during Neuro-ICU hospitalization and anxiety symptoms (anxiety subscale of the Hospital Anxiety and Depression Scale) during hospitalization and at 3- and 6-month follow-up. We used actor–partner interdependence modeling to predict the effect of one’s own baseline characteristics on one’s own and one’s partner’s future anxiety symptoms. Results Rates of clinically significant anxiety symptoms were 40% for patients and 42% for caregivers at baseline. Of these, 20% of patients and 23% of caregivers showed moderate and severe symptoms. Approximately, one-third of patients and caregivers reported clinically significant anxiety symptoms at 3- and 6-month follow-ups, with more than 20% endorsing moderate or severe symptoms. Patients’ own baseline mindfulness, coping, and anxiety symptoms were associated with lower anxiety symptoms at all time points ( ps  < 0.001)—this was also true for caregivers. For both patients and caregivers, one’s own baseline mindfulness predicted their partner’s anxiety symptoms 3 months later ( p  = 0.008), but not at 6-month follow-up. Conclusions Anxiety symptoms in Neuro-ICU patient–caregiver dyads are high through 6 months following admission. Mindfulness is interdependent and protective against anxiety in dyads at 3-month but not 6-month follow-up. Early, dyad-based interventions may prevent the development of chronic anxiety in patients without major cognitive impairment and caregivers.