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Background Mobile health (mHealth) interventions have the potential to expand the reach of smoking cessation interventions. However, it is unknown if people using the same cessation mHealth intervention but living in different places have similar program engagement, satisfaction, and outcomes. The objective of this study was to explore the potential need to enhance existing interventions for rural populations by examining program engagement, satisfaction, and outcomes by rurality for the publicly available cessation text messaging intervention, SmokefreeTXT. Methods Participants were adults interested in quitting smoking from Virginia ( N  = 49), with recruitment stratified by county-level rurality ( n  = 23 rural, n  = 26 non-rural). Participants completed a 7-week version of SmokefreeTXT and completed assessments at baseline, immediately post-intervention, and three- and six-months from enrollment. Descriptive statistics compared program engagement, satisfaction, and seven-day point prevalence abstinence at all time points by rurality. Multivariable logistic regression models assessed the association between rurality and cessation at all time points. Results Overall, seven-day abstinence rates were 32.6%, 28.6%, and 36.7%, and among participants from rural counties rates were 39.1%, 30.4%, and 43.5% at post-intervention, three-, and six-months, respectively. Participants from rural counties had higher use of real-time support for mood and cravings and reported this support to be more useful than participants from non-rural counties (Ps < 0.05). Conclusions mHealth cessation interventions may work well for people living in rural counties, potentially providing good support for adults attempting to quit smoking but lacking easy access to traditional cessation support services. Modifications to enhance support for craving and mood may be particularly relevant for people living in rural areas. Trial registration ClinicialTrials.gov: NCT05055778, Registration date: 9/14/2021.

Insomnia treatment using an internet-based cognitive-behavioural therapy for insomnia (CBT-I) program reduces depression symptoms, anxiety symptoms and suicidal ideation. However, the speed, longevity and consistency of these effects are unknown. To test the following: whether the efficacy of online CBT-I was sustained over 18 months; how rapidly the effects of CBT-I emerged; evidence for distinct trajectories of change in depressive symptoms; and predictors of these trajectories. A randomised controlled trial compared the 6-week Sleep Healthy Using the Internet (SHUTi) CBT-I program to an attention control program. Adults ( =1149) with clinical insomnia and subclinical depression symptoms were recruited online from the Australian community. Depression, anxiety and insomnia decreased significantly by week 4 of the intervention period and remained significantly lower relative to control for >18 months (between-group Cohen's =0.63, 0.47, 0.55, respectively, at 18 months). Effects on suicidal ideation were only short term. Two depression trajectories were identified using growth mixture models: improving (95%) and stable/deteriorating (5%) symptoms. More severe baseline depression, younger age and limited comfort with the internet were associated with reduced odds of improvement. Online CBT-I produced rapid and long-term symptom reduction in people with subclinical depressive symptoms, although the initial effect on suicidal ideation was not sustained. P.J.B. has received grants from the National Health and Medical Research Council (NHMRC) during the conduct of the study. H.C. has received grants from the NHMRC and the Australian Research Council during the conduct of the study. L.M.R. receives research funding from the National Institutes of Health (NIH) that, in part, focuses on insomnia. F.P.T. and L.M.R. have equity ownership in BeHealth Solutions (Charlottesville, VA, USA), a company that develops and makes available products related to the research reported in this manuscript. BeHealth Solutions has licensed the SHUTi program and the software platform on which it was built from the University of Virginia. The terms of this arrangement have been reviewed and approved by the University of Virginia in accordance with its conflict of interest policy. N.G. has received grants from the NHMRC during the conduct of the study and personal fees from Lundbeck, Servier and Janssen outside the submitted work. © The Royal College of Psychiatrists 2017. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) license.

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.

Objective This study investigates a 6-month short message service (SMS) intervention to reduce adolescent sugar-sweetened beverage (SSB) intake. The objectives are to describe caregiver retention and SMS engagement as well as explore differences by caregiver characteristics. Methods Caregivers completed a baseline survey then messages were sent two times per week. Message types included the following: SSB intake assessments, educational information, infographic URLs, and strategies. Engagement was measured through interaction with these messages and included: assessment completion, reminders needed, number of strategies chosen, and URLs clicked. Results Caregivers (n = 357) had an average baseline SSB intake of 23.9 (SD = 26.8) oz/day. Of those, 89% were retained. Caregivers with a greater income and education were retained at a higher rate. Average engagement included: 4.1 (SD = 1.3) of 5 assessments completed with few reminders needed [4.1 (SD = 3.7) of 14 possible], 3.2 (SD = 1.1) of 4 strategies selected, and 1.2 (SD = 1.6) of 5 URLs clicked. Overall, average engagement was relatively high, even where disparities were found. Demographic characteristics that were statistically related to lower engagement included younger age, lower income, lower educational attainment, single caregivers, lower health literacy. Furthermore, caregivers with a reduced intention to change SSB behaviors completed fewer assessments and needed more reminders. Higher baseline SSB intake was associated with lower engagement across all indicators except URL clicks. Conclusions Results can be used to develop targeted retention and engagement strategies (e.g., just-in-time and/or adaptive interventions) in rural SMS interventions for identified demographic subsets. Trial registration Clincialtrials.gov: NCT03740113.

Although gamification continues to be a popular approach to increase engagement, motivation, and adherence to behavioral interventions, empirical studies have rarely focused on this topic. There is a need to empirically evaluate gamification models to increase the understanding of how to integrate gamification into interventions. The model of gamification principles for digital health interventions proposes a set of five independent yet interrelated gamification principles. This study aimed to examine the validity and reliability of this model to inform its use in Web- and mobile-based apps. A total of 17 digital health interventions were selected from a curated website of mobile- and Web-based apps (PsyberGuide), which makes independent and unbiased ratings on various metrics. A total of 133 independent raters trained in gamification evaluation techniques were instructed to evaluate the apps and rate the degree to which gamification principles are present. Multiple ratings (n≥20) were collected for each of the five gamification principles within each app. Existing measures, including the PsyberGuide credibility score, mobile app rating scale (MARS), and the app store rating of each app were collected, and their relationship with the gamification principle scores was investigated. Apps varied widely in the degree of gamification implemented (ie, the mean gamification rating ranged from 0.17≤m≤4.65 out of 5). Inter-rater reliability of gamification scores for each app was acceptable (κ≥0.5). There was no significant correlation between any of the five gamification principles and the PsyberGuide credibility score (P≥.49 in all cases). Three gamification principles (supporting player archetypes, feedback, and visibility) were significantly correlated with the MARS score, whereas three principles (meaningful purpose, meaningful choice, and supporting player archetypes) were significantly correlated with the app store rating. One gamification principle was statistically significant with both the MARS and the app store rating (supporting player archetypes). Overall, the results support the validity and potential utility of the model of gamification principles for digital health interventions. As expected, there was some overlap between several gamification principles and existing app measures (eg, MARS). However, the results indicate that the gamification principles are not redundant with existing measures and highlight the potential utility of a 5-factor gamification model structure in digital behavioral health interventions. These gamification principles may be used to improve user experience and enhance engagement with digital health programs.

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.

Background Insomnia is common in primary care medical practices. Although behavioral treatments for insomnia are safe, efficacious, and recommended in practice guidelines, they are not widely-available, and their effects on comorbid medical conditions remain uncertain. We are conducting a pragmatic clinical trial to test the efficacy of two cognitive behavioral treatments for insomnia (Brief Behavioral Treatment for Insomnia (BBTI) and Sleep Healthy Using the Internet (SHUTi)) versus an enhanced usual care condition (EUC). Methods/Design The study is a three-arm, parallel group, randomized controlled trial. Participants include 625 adults with hypertension and insomnia, recruited via electronic health records from primary care practices affiliated with a large academic medical center. After screening and baseline assessments, participants are randomized to treatment. BBTI is delivered individually with a live therapist via web-interface/telehealth sessions, while SHUTi is a self-guided, automated, interactive, web-based form of cognitive behavioral therapy for insomnia. Participants in EUC receive an individualized sleep report, educational resources, and an online educational video. Treatment outcomes are measured at 9 weeks, 6 months, and 12 months. The primary outcome is patient-reported sleep disturbances. Secondary outcomes include other self-reported sleep measures, home blood pressure, body mass index, quality of life, health functioning, healthcare utilization, and side effects. Discussion This randomized clinical trial compares two efficacious insomnia interventions to EUC, and provides a cost-effective and efficient examination of their similarities and differences. The pragmatic orientation of this trial may impact sleep treatment delivery in real world clinical settings and advance the dissemination and implementation of behavioral sleep interventions. Trial registration ClinicalTrials.gov (Identifier: NCT02508129 ; Date Registered: July 21, 2015).