Web-Based Group Conversational Intervention on Cognitive Function and Comprehensive Functional Status Among Japanese Older Adults: Protocol for a 6-Month Randomized Controlled Trial.

BACKGROUND: Social communication is a key factor in maintaining cognitive function and contributes to well-being in later life. OBJECTIVE: This study will examine the effects of "Photo-Integrated Conversation Moderated by Application version 2" (PICMOA-2), which is a web-based conversational intervention, on cognitive performance, frailty, and social and psychological indicators among community-dwelling older adults. METHODS: This study is a randomized controlled trial with an open-label, 2-parallel group trial and 1:1 allocation design. Community dwellers aged 65 years and older were enrolled in the trial and divided into the intervention and control groups. The intervention group receives the PICMOA-2 program, a web-based group conversation, once every 2 weeks for 6 months. The primary outcome is verbal fluency, including phonemic and semantic fluency. The secondary outcomes are other neuropsychiatric batteries, including the Mini-Mental State Examination, Logical Memory (immediate and delay), verbal paired associates, and comprehensive functional status evaluated by questionnaires, including frailty, social status, and well-being. The effect of the intervention will be examined using a mixed linear model. As a secondary aim, we will test whether the intervention effects vary with the covariates at baseline to examine the effective target attributes. RESULTS: Recruitment was completed in July 2023. A total of 66 participants were randomly allocated to intervention or control groups. As of January 1, 2024, the intervention is ongoing. Participants are expected to complete the intervention at the end of February 2024, and the postintervention evaluation will be conducted in March 2024. CONCLUSIONS: This protocol outlines the randomized controlled trial study design evaluating the effect of a 6-month intervention with PICMOA-2. This study will provide evidence on the effectiveness of social interventions on cognitive function and identify effective target images for remote social intervention. TRIAL REGISTRATION: UMIN Clinical Trials UMIN000050877; https://tinyurl.com/5eahsy66. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56608.

Motivational Variables as Moderating Effects of a Web-Based Mental Health Program for University Students: Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: Self-guided web-based interventions have the potential of addressing help-seeking barriers and symptoms common among university students, such as depression and anxiety. Unfortunately, self-guided interventions are also associated with less adherence, implicating motivation as a potential moderator for adherence and improvement for such interventions. Previous studies examining motivation as a moderator or predictor of improvement on web-based interventions have defined and measured motivation variably, producing conflicting results. OBJECTIVE: This secondary analysis of data from a randomized controlled trial aimed to examine constructs of motivation as moderators of improvement for a self-guided 8-week web-based intervention in university students (N=1607). METHODS: Tested moderators included internal motivation, external motivation, and confidence in treatment derived from the Treatment Motivation Questionnaire. The primary outcome was an improvement in depression and anxiety measured by the Depression Anxiety Stress Scale-21. RESULTS: Piecewise linear mixed effects models showed that internal motivation significantly moderated symptom change for the intervention group (t1504=-2.94; P=.003) at average and high (+1 SD) motivation levels (t1507=-2.28; P=.02 and t1507=-4.05; P<.001, respectively). Significant results remained even after controlling for baseline severity. The results showed that confidence in treatment did not significantly moderate symptom change for the intervention group (t1504=1.44; P=.15). In this sample, only internal motivation was positively correlated with service initiation, intervention adherence, and intervention satisfaction. CONCLUSIONS: The combination of a web-based intervention and high or moderate internal motivation resulted in greater improvement in the total Depression Anxiety Stress Scale-21 score. These findings highlight the importance of conceptually differentiating motivation-related constructs when examining moderators of improvement. The results suggest that the combination of a web-based intervention and high or moderate internal motivation results in greater improvement. These findings highlight the importance of conceptually differentiating motivation-related constructs when examining moderators of improvement. To better understand the moderating role of internal motivation, future research is encouraged to replicate these findings in diverse samples as well as to examine related constructs such as baseline severity and adherence. Understanding these characteristics informs treatment strategies to maximize adherence and improvement when developing web-based interventions as well as allows services to be targeted to individuals likely to benefit from such interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT04361045; https://clinicaltrials.gov/study/NCT04361045.

Effectiveness of Web-Based Mindfulness-Based Interventions for Patients With Cancer: Systematic Review and Meta-Analyses.

BACKGROUND: Cancer has emerged as a considerable global health concern, contributing substantially to both morbidity and mortality. Recognizing the urgent need to enhance the overall well-being and quality of life (QOL) of cancer patients, a growing number of researchers have started using online mindfulness-based interventions (MBIs) in oncology. However, the effectiveness and optimal implementation methods of these interventions remain unknown. OBJECTIVE: This study evaluates the effectiveness of online MBIs, encompassing both app- and website-based MBIs, for patients with cancer and provides insights into the potential implementation and sustainability of these interventions in real-world settings. METHODS: Searches were conducted across 8 electronic databases, including the Cochrane Library, Web of Science, PubMed, Embase, SinoMed, CINAHL Complete, Scopus, and PsycINFO, until December 30, 2022. Randomized controlled trials involving cancer patients aged ≥18 years and using app- and website-based MBIs compared to standard care were included. Nonrandomized studies, interventions targeting health professionals or caregivers, and studies lacking sufficient data were excluded. Two independent authors screened articles, extracted data using standardized forms, and assessed the risk of bias in the studies using the Cochrane Bias Risk Assessment Tool. Meta-analyses were performed using Review Manager (version 5.4; The Cochrane Collaboration) and the meta package in R (R Foundation for Statistical Computing). Standardized mean differences (SMDs) were used to determine the effects of interventions. The Reach, Effectiveness, Adoption, Implementation, and Maintenance framework was used to assess the potential implementation and sustainability of these interventions in real-world settings. RESULTS: Among 4349 articles screened, 15 (0.34%) were included. The total population comprised 1613 participants, of which 870 (53.9%) were in the experimental conditions and 743 (46.1%) were in the control conditions. The results of the meta-analysis showed that compared with the control group, the QOL (SMD 0.37, 95% CI 0.18-0.57; P<.001), sleep (SMD -0.36, 95% CI -0.71 to -0.01; P=.04), anxiety (SMD -0.48, 95% CI -0.75 to -0.20; P<.001), depression (SMD -0.36, 95% CI -0.61 to -0.11; P=.005), distress (SMD -0.50, 95% CI -0.75 to -0.26; P<.001), and perceived stress (SMD -0.89, 95% CI -1.33 to -0.45; P=.003) of the app- and website-based MBIs group in patients with cancer was significantly alleviated after the intervention. However, no significant differences were found in the fear of cancer recurrence (SMD -0.30, 95% CI -1.04 to 0.44; P=.39) and posttraumatic growth (SMD 0.08, 95% CI -0.26 to 0.42; P=.66). Most interventions were multicomponent, website-based health self-management programs, widely used by international and multilingual patients with cancer. CONCLUSIONS: App- and website-based MBIs show promise for improving mental health and QOL outcomes in patients with cancer, and further research is needed to optimize and customize these interventions for individual physical and mental symptoms. TRIAL REGISTRATION: PROSPERO CRD42022382219; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=382219.

Web-based occupational stress prevention in German micro- and small-sized enterprises - process evaluation results of an implementation study.

BACKGROUND: Structural and behavioral interventions to manage work-related stress are effective in employees. Nonetheless, they have been implemented insufficiently, particularly in micro- and small-sized enterprises (MSE). Main barriers include a lack of knowledge and limited resources, which could potentially be overcome with simplified web-based alternatives for occupational stress prevention. However, there is a lack of implementation research about web-based prevention in realistic settings of MSE. OBJECTIVE: The aim of this study is to evaluate the implementation process and success of an integrated web-based platform for occupational stress prevention ("System P") and to identify potential barriers for its uptake and use in MSE in Germany. METHODS: This study with a mixed-methods approach investigates eight process-related outcomes in a quantitative part I (adoption, reach, penetration, fidelity/dose, costs, acceptability) and a qualitative part II (acceptability, appropriateness and feasibility). Part I has a pre-post design with two measurements (6 months apart) with 98 individual participants and part II consists of 12 semi-structured interviews with managers and intercorporate stakeholders. RESULTS: Part I revealed shortcomings in the implementation process. Adoption/Reach: Despite extensive marketing efforts, less than 1% of the contacted MSE responded to the offer of System P. A total of 40 MSE registered, 24 of which, characterized by good psychosocial safety climate, adopted System P. Penetration: Within these 24 MSE, 15% of the employees used the system. Fidelity/Dose: 11 MSE started a psychosocial risk-assessment (PRA), and no MSE finished it. The stress-management training (SMT) was started by 25 users and completed by 8. COSTS: The use of System P was free of charge, but the time required to engage with was an indirect cost. Part II added insights on the perception of the web-based intervention: Acceptance of System P by users and stakeholders was good and it was assessed as appropriate for MSE. Results for feasibility were mixed. CONCLUSIONS: Although System P was generally perceived as useful and appropriate, only a small number of contacted MSE implemented it as intended. Prior experience and sensitivity for occupational (stress) prevention were mentioned as key facilitators, while (perceived) indirect costs were a key barrier. Enabling MSE to independently manage stress prevention online did not result in successful implementation. Increasing external support could be a solution. ⁺ FULL PROJECT NAME: "PragmatiKK - Pragmatische Lösungen für die Implementation von Maßnahmen zur Stressprävention in Kleinst- und Kleinbetrieben" (= Pragmatic solutions for the implementation of stress prevention interventions in micro and small-sized enterprises). TRIAL REGISTRATION: German Register of Clinical Studies (DRKS) DRKS00026154, date of registration 2021-09-16.

The long shadow of early-change patterns: a 3-year follow-up after the use of a web-based intervention for mild to moderate depressive symptoms.

Web-based interventions can be effective in treating depressive symptoms. Patients with risk not responding to treatment have been identified by early change patterns. This study aims to examine whether early changes are superior to baseline parameters in predicting long-term outcome. In a randomized clinical trial with 409 individuals experiencing mild to moderate depressive symptoms using the web-based intervention deprexis, three latent classes were identified (early response after registration, early response after screening and early deterioration) based on early change in the first four weeks of the intervention. Baseline variables and these classes were included in a Stepwise Cox Proportional Hazard Multiple Regression to identify predictors associated with the onset of remission over 36-months. Early change class was a significant predictor of remission over 36 months. Compared to early deterioration after screening, both early response after registration and after screening were associated with a higher likelihood of remission. In sensitivity and secondary analyses, only change class consistently emerged as a predictor of long-term outcome. Early improvement in depression symptoms predicted long-term outcome and those showing early improvement had a higher likelihood of long-term remission. These findings suggest that early changes might be a robust predictor for long-term outcome beyond baseline parameters.

Six-Month Outcomes of a Theory- and Technology-Enhanced Physical Activity Intervention for Latina Women (Pasos Hacia La Salud II): Randomized Controlled Trial.

BACKGROUND: More than half (55%) of Latina women do not meet aerobic physical activity (PA) guidelines, and frequently cite time, childcare, and transportation as barriers to PA. In addition to linguistic adaptations for this population, successful PA interventions for Latina women addressed these barriers through remote intervention delivery approaches (eg, mail, phone, or web delivery). OBJECTIVE: We aimed to evaluate 6-month outcomes of a randomized trial comparing a Spanish-language, individually tailored, web-delivered PA intervention (original) to an enhanced version with text messages and additional features (enhanced). Further, we evaluated if increases in PA at 6 months were moderated by baseline activity status. METHODS: In total, 195 Latina women aged 18-65 years participated in a trial comparing the efficacy of the enhanced versus original interventions at initiating PA behavior change. We examined minutes per week of accelerometer-measured PA in the enhanced versus original arms, and the proportion of each arm meeting aerobic PA guidelines (150 min/wk at 6 mo). For moderator analyses, participants were classified as inactive (0 min/wk) or low active (1-90 min/wk) at baseline, measured via the 7 Day Physical Activity Recall interview. RESULTS: PA increased from 19.7 (SD 47.9) minutes per week at baseline to 46.9 (SD 66.2) minutes per week at 6 months in the enhanced arm versus 20.6 (SD 42.7) minutes per week to 42.9 (SD 78.2) minutes per week in the original arm (P=.78). Overall, 30% (31/103) of the enhanced group met aerobic PA guidelines at 6 months, compared to 21% (19/92) of the original group (odds ratio [OR] 1.75, 95% CI 0.87-3.55). Baseline PA (inactive vs low active) moderated treatment effects on PA. For inactive participants, there were no group differences at 6 months (b=7.1; SE 22.8; P=.75), while low-active participants increased more in enhanced than original (b=72.5; SE 27.9; P=.01). For low-active participants, 45% (46/103) of the enhanced group met PA guidelines at 6 months, versus 20% (18/92) of the original arm (OR 3.29, 95% CI 1.05-11.31). For inactive participants, there were no group differences (25/103, 24% vs n=19/92, 21% for enhanced vs original, respectively; OR 1.28, 95% CI 0.54-3.06). CONCLUSIONS: Intervention effects were conditional on baseline PA. For low-active Latina women, the enhanced intervention was more effective at increasing PA. Additional tailored intervention enhancements may be necessary to increase PA for inactive Latina women. TRIAL REGISTRATION: ClinicalTrials.gov NCT03491592; https://www.clinicaltrials.gov/study/NCT03491592. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-022-06575-4.

Booster effects and mechanisms of web-based personalised normative feedback alcohol intervention for college students: A pragmatic randomised controlled trial.

BACKGROUND: To evaluate the effects of booster and no booster versions of web-based alcohol Personalised Normative Feedback (PNF) and whether descriptive norms mediated and/or participant motivation moderated the effectiveness of the intervention in real world conditions (i.e. no financial incentives). METHODS: Pragmatic randomised controlled trial with 1-, 3-, and 6-month assessments. Brazilian college students reporting alcohol use in the last 12 months (N=931) were recruited from May/2020 to December/2022 and allocated to 1) No booster/single PNF(S-PNF); 2) Booster/multiple PNF(M-PNF); or 3) Assessment-only control. We applied Helmert coding [1: Any intervention (S-PNF or M-PNF) vs. Control; and 2: S-PNF vs. M-PNF]. PRIMARY OUTCOMES: typical number of drinks/week and maximum number of drinks/week; secondary outcomes: drinking frequency and number of consequences. Three-months assessment was the primary interval. Descriptive norms were tested as mediator. Interest, importance, and readiness to change were examined as moderators. RESULTS: Compared to control, any intervention did not influence primary outcomes at 3-months or 6-months, but did at 1-month, when reduced typical drinking (IRR:0.77, 95%CI:0.66;0.90) and maximum number of drinks (IRR:0.69, 95%CI:0.58;0.82). There was an intervention effect on the consequences at 3-months. No differences were observed between S-PNF and M-PNF. No mediation effects were found at 3-months. At 6-months, there was an indirect effect on typical drinking through norms at 3-months (b=-0.82, 95%CI:-2.03;-0.12) and effects on maximum drinks through norms at 1-month (b=-0.54, 95%CI:-1.65;-0.02). No support for moderation was found. CONCLUSIONS: Intervention reduced alcohol drinking at 1 month only and was not effective thereafter. Mechanisms of effect remain unclear.

Living Well: Protocol for a web-based program to improve quality of life in rural and urban ovarian cancer survivors.

BACKGROUND: Ovarian cancer (OC) survivors commonly experience chronic symptoms including anxiety, depression, sleep disturbances, fatigue, physical symptoms, poor health-related quality of life (HRQOL), and a generally poor prognosis. Additionally, factors such as social isolation, stress, and depression are associated with key biological processes promoting tumor progression and poorer survival. Accessible psychosocial interventions to improve HRQOL and clinical outcomes are needed. This need is particularly true in rural settings where survivors may have less access to clinic-based support systems. METHODS: The Living Well Study, a cluster-randomized Phase II multi-site clinical trial, is designed to evaluate the efficacy of a group-based, web-delivered psychosocial intervention (Mindful Living) verses a Health Promotion active control (Healthy Lifestyles) in increasing HRQOL and decreasing perceived stress (primary outcomes), depressive mood, anxiety, and fatigue (secondary outcomes) for 256 OC survivors who are <5 years post-primary therapy. Mindful Living targets key concerns of OC survivors and teaches stress reduction skills and coping strategies utilizing cognitive behavioral, mindfulness, and acceptance and commitment therapies. Healthy Lifestyles provides lifestyle information including exercise, nutrition, sleep, and other survivorship topics. Interventions consist of 11 consecutive weekly group sessions lasting 1.5-2 h led by trained facilitators and two booster sessions. Participants complete psychosocial questionnaires at baseline, post-intervention, at 6-months, and at 12-months. A subset completes bloodspots for analysis of inflammatory biology. CONCLUSION: Easily accessible psychosocial interventions addressing key concerns of OC survivors are an unmet need. The Mindful Living intervention has the potential to substantially enhance HRQOL and decrease distress in OC survivors. Trial registrationclinicaltrials.gov Identifier: NCT04533763.

A Web-Based Intervention Using "Five Ways to Wellbeing" to Promote Well-Being and Mental Health: Randomized Controlled Trial.

BACKGROUND: Compromised well-being and mental health problems pose a significant threat to individuals and societies worldwide. Resource-intensive psychological treatments alone cannot alleviate this burden. There is a need for low-cost, evidence-based interventions aimed at preventing illness and promoting well-being. Five activity domains appear to be linked with well-being promotion across populations: connecting with others, being active, taking notice, learning, and being generous/giving. The activities mentioned are part of the Five Ways to Wellbeing framework and the web-based intervention Five Ways to Wellbeing for All (5waysA). OBJECTIVE: This randomized controlled trial aims to test the effects of the 5waysA intervention, a web-based, low-cost, well-being-promoting measure targeting the general population. To date, the Five Ways to Wellbeing framework has not been tested in this specific format. The 5waysA intervention comprises 2 webinars and SMS text message reminders delivered over a 10-week period. METHODS: In 2021, a total of 969 study participants from various regions across Norway were openly recruited through a web page. They were then randomly assigned to either an intervention group or 1 of 2 waiting list control groups, namely, active or passive. Self-reported life satisfaction (Satisfaction With Life Scale [SWLS]), flourishing (Flourishing Scale [FS]), positive emotions, anxiety, and depression symptoms (Hopkins Symptom Checklist-8 [HSCL-8]) were assessed before the intervention, at 4 weeks into the intervention, and 1-2 weeks after the intervention (over 10 weeks). Data analysis was conducted using linear mixed (multilevel) models. RESULTS: After 10 weeks, 453 participants (171 in the intervention group and 282 in the waiting list control group) were assessed on outcome variables, with a dropout rate of 53.2% (516/969). Results revealed a significantly greater increase in the intervention group compared with the controls for SWLS (b=0.13, 95% CI 0.03-0.23; P=.001), FS (b=0.19, 95% CI 0.08-0.30; P=.001), positive emotions (b=0.43, 95% CI 0.27-0.60; P<.001), and these factors combined into a global well-being measure (b=0.28, CI 0.16-0.39; P<.001). Effect sizes (Cohen d) for the well-being outcomes ranged from 0.30 to 0.49. In addition, a significant decrease in anxiety and depressive symptoms was observed (b=-0.17, 95% CI -0.30 to -0.04; P=.001) with an effect size (Cohen d) of -0.20. CONCLUSIONS: The findings suggest that the web-based 5waysA intervention could serve as an effective approach for enhancing well-being and mental health within the general population. This study offers individuals, policy makers, and local stakeholders an accessible and potentially cost-effective well-being intervention that could be easily implemented. TRIAL REGISTRATION: ClinicalTrials.gov NCT04784871; https://clinicaltrials.gov/study/NCT04784871.

Economic Evaluation of a Web Application Implemented in Primary Care for the Treatment of Depression in Patients With Type 2 Diabetes Mellitus: Multicenter Randomized Controlled Trial.

BACKGROUND: Depressive disorder and type 2 diabetes mellitus (T2DM) are prevalent in primary care (PC). Pharmacological treatment, despite controversy, is commonly chosen due to resource limitations and difficulties in accessing face-to-face interventions. Depression significantly impacts various aspects of a person's life, affecting adherence to medical prescriptions and glycemic control and leading to future complications and increased health care costs. To address these challenges, information and communication technologies (eg, eHealth) have been introduced, showing promise in improving treatment continuity and accessibility. However, while eHealth programs have demonstrated effectiveness in alleviating depressive symptoms, evidence regarding glycemic control remains inconclusive. This randomized controlled trial aimed to test the efficacy of a low-intensity psychological intervention via a web app for mild-moderate depressive symptoms in individuals with T2DM compared with treatment as usual (TAU) in PC. OBJECTIVE: This study aimed to analyze the cost-effectiveness and cost-utility of a web-based psychological intervention to treat depressive symptomatology in people with T2DM compared with TAU in a PC setting. METHODS: A multicenter randomized controlled trial was conducted with 49 patients with T2DM, depressive symptoms of moderate severity, and glycosylated hemoglobin (HbA1c) of 7.47% in PC settings. Patients were randomized to TAU (n=27) or a web-based psychological treatment group (n=22). This web-based treatment consisted of cognitive behavioral therapy, improvement of diabetes self-care behaviors, and mindfulness. Cost-effectiveness analysis for the improvement of depressive symptomatology was conducted based on reductions in 3, 5, or 50 points on the Patient Health Questionnaire-9 (PHQ-9). The efficacy of diabetes control was estimated based on a 0.5% reduction in HbA1c levels. Follow-up was performed at 3 and 6 months. The cost-utility analysis was performed based on quality-adjusted life years. RESULTS: Efficacy analysis showed that the web-based treatment program was more effective in improving depressive symptoms than TAU but showed only a slight improvement in HbA1c. Incremental cost-effectiveness ratios of 186.76 for a 3-point reduction in PHQ-9 and 206.31 for reductions of 5 and 50 percentage points were obtained. In contrast, the incremental cost-effectiveness ratio for improving HbA1c levels amounted to €1510.90 (€1=US $1.18 in 2018) per participant. The incremental cost-utility ratio resulted in €4119.33 per quality-adjusted life year gained. CONCLUSIONS: The intervention, using web-based modules incorporating cognitive behavioral therapy tools, diabetes self-care promotion, and mindfulness, effectively reduced depressive symptoms and enhanced glycemic control in patients with T2DM. Notably, it demonstrated clinical efficacy and economic efficiency. This supports the idea that eHealth interventions not only benefit patients clinically but also offer cost-effectiveness for health care systems. The study emphasizes the importance of including specific modules to enhance diabetes self-care behaviors in future web-based psychological interventions, emphasizing personalization and adaptation for this population. TRIAL REGISTRATION: ClinicalTrials.gov NCT03426709; https://clinicaltrials.gov/study/NCT03426709. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/S12888-019-2037-3.

An Exploration of the Goodness of Fit of Web-Based Tools for Maori: Qualitative Study Using Interviews and Focus Groups.

BACKGROUND: Indigenous communities often have poorer health outcomes and services under traditional models of care. In New Zealand, this holds true for Maori people who are tangata whenua (the indigenous people). Several barriers exist that decrease the likelihood of indigenous communities often have poorer health outcomes and poor service fit under traditional models of care, including access issues, systemic and provider racism, and a lack of culturally safe and responsive services. Web-based interventions (WBIs) have been shown to be effective in supporting mental health and well-being and can overcome some of these barriers. Despite the large number of WBIs developed, more investigation is needed to know how well WBIs fit with an indigenous worldview and how they meet the needs of indigenous communities so that a digitally based future does not drive social and health inequities. OBJECTIVE: This study aims to explore the goodness-of-fit of WBIs of Maori individuals, the indigenous people of Aotearoa/New Zealand. METHODS: We used interviews (n=3) and focus groups (n=5) with 30 Maori participants to explore their views about WBIs. Interviews were analyzed using reflexive thematic analysis by members of the research team. RESULTS: Overall, there was a perception that the design of WBIs did not align with the Maori worldview, which centers around people, relationships, spirituality, and holistic views of well-being. A total of 4 key themes and several subthemes emerged, indicating that WBIs were generally considered a poor fit for Maori. Specifically, the themes were as follows: (1) WBIs are disconnected from the core values of te ao Maori (the Maori worldview), (2) WBIs could be helpful in the right context, (3) there are significant barriers that may make it harder for Maori to use WBIs than other groups, and (4) ways to improve WBIs to help engagement with Maori. CONCLUSIONS: While WBIs are often considered a way to reduce barriers to care, they may not meet the needs of Maori when used as a stand-alone intervention. If WBIs are continued to be offered, developers and researchers need to consider how to develop WBIs that are responsive and engaging to the needs of indigenous communities rather than driving inequities. Ideally, WBIs should be developed by the people they are intended for to fit with those populations' world views.

Adapting a Dutch Web-Based Intervention to Support Family Caregivers of People With Dementia in the UK Context: Accelerated Experience-Based Co-Design.

BACKGROUND: Around 700,000 family caregivers provide unpaid care for 900,000 people living with dementia in the United Kingdom. Few family caregivers receive support for their own psychological needs and funding for community respite services has declined. These trends are seen across Europe as demographic and budgetary pressures have intensified due to public spending cuts arising from the 2008 financial crisis and the COVID-19 pandemic. The World Health Organization has prioritized the need to expand the provision of support for caregivers and families of people with dementia by 2025. Web-based interventions have the potential for development as they require modest investment and can be accessed by family caregivers at home. Further cost benefits can be realized by adapting existing interventions with demonstrated effectiveness for new contexts. This paper reports initial findings from the CareCoach study, which is adapting Partner in Balance (PiB), a web-based coaching intervention developed in the Netherlands, for family caregivers in the United Kingdom. OBJECTIVE: This study aims to work with unpaid family caregivers and staff in adapting the Dutch web-based support tool PiB to improve its acceptability and usability for use in the United Kingdom. METHODS: Accelerated Experience-Based Co-Design (AEBCD) was used with caregivers, staff, and core stakeholders. Interviews, workshops, and stakeholder consultations were conducted. Data were analyzed iteratively. Recommendations for the redesign of PiB for use across the United Kingdom were adjudicated by the study Adaptation Working Party. RESULTS: Sixteen caregivers and 17 staff took part in interviews. Thirteen caregivers and 17 staff took part in workshops. Most (n=26) participants were White, female, and retired. All except 4 caregivers (2 male and 2 female) found the PiB's offer of web-based self-help learning acceptable. Caregivers identified complexity and lack of inclusivity in some wording and video resources as problematic. The staff took a stronger perspective on the lack of inclusivity in PiB video resources. Staff and caregivers coproduced new inclusive wording and recommended creating new videos to adapt PiB for the UK context. CONCLUSIONS: AEBCD methods facilitated the engagement of caregivers and staff and advanced the adaptation of the PiB complex intervention. An important addition to the AEBCD method in this process was the work of an Adaptation Working Party, which adjudicated and agreed to new wording where this could not be established in consultation with caregivers and staff. TRIAL REGISTRATION: ISRCTN Registry ISRCTN12540555; https://doi.org/10.1186/ISRCTN12540555.

Examining the Effectiveness of Interactive Webtoons for Premature Birth Prevention: Protocol for a Randomized Controlled Trial.

BACKGROUND: Premature birth poses significant health challenges globally, impacting infants, families, and society. Despite recognition of its contributing factors, efforts to reduce its incidence have seen limited success. A notable gap exists in the awareness among women of childbearing age (WCA) regarding both the risks of premature birth and the preventative measures they can take. Research suggests that enhancing health beliefs and self-management efficacy in WCA could foster preventive health behaviors. Interactive webtoons offer an innovative, cost-effective avenue for delivering engaging, accessible health education aimed at preventing premature birth. OBJECTIVE: This protocol describes a randomized controlled trial to assess the effectiveness and feasibility of a novel, self-guided, web-based intervention-Pregnancy Story I Didn't Know in Interactive Webtoon Series (PSIDK-iWebtoons)-designed to enhance self-management efficacy and promote behaviors preventing premature birth in WCA. METHODS: Using an explanatory sequential mixed methods design, this study first conducts a quantitative analysis followed by a qualitative inquiry to evaluate outcomes and feasibility. Participants are randomly assigned to 2 groups: one accessing the PSIDK-iWebtoons and the other receiving Pregnancy Story I Didn't Know in Text-Based Information (PSIDK-Texts) over 3 weeks. We measure primary efficacy through the self-management self-efficacy scale for premature birth prevention (PBP), alongside secondary outcomes including perceptions of susceptibility, severity, benefits, and barriers based on the health belief model for PBP and PBP intention. Additional participant-reported outcomes are assessed at baseline, the postintervention time point, and the 4-week follow-up. The feasibility of the intervention is assessed after the end of the 3-week intervention period. Outcome analysis uses repeated measures ANOVA for quantitative data, while qualitative data are explored through content analysis of interviews with 30 participants. RESULTS: The study received funding in June 2021 and institutional review board approval in October 2023. Both the PSIDK-iWebtoons and PSIDK-Texts interventions have been developed and pilot-tested from July to November 2023, with the main phase of quantitative data collection running from November 2023 to March 2024. Qualitative data collection commenced in February 2024 and will conclude in May 2024. Ongoing analyses include process evaluation and data interpretation. CONCLUSIONS: This trial will lay foundational insights into the nexus of interactive web-based interventions and the improvement of knowledge and practices related to PBP among WCA. By demonstrating the efficacy and feasibility of a web-based, interactive educational tool, this study will contribute essential evidence to the discourse on accessible and scientifically robust digital platforms. Positive findings will underscore the importance of such interventions in fostering preventive health behaviors, thereby supporting community-wide efforts to mitigate the risk of premature births through informed self-management practices. TRIAL REGISTRATION: Korea Disease Control and Prevention Agency (KDCA) KCT0008931; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=25857. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/58326.

Preliminary Efficacy of a Web-Based Alcohol and Emotion Regulation Intervention on Sexual Risk Behaviors Among College Women.

OBJECTIVE: Using substances before sex may impact sexual decision-making among young women and increase their risk for a variety of negative consequences, including sexual victimization, sexually transmitted infections, and unwanted pregnancies. A brief, web-based intervention combining alcohol reduction strategies with emotion regulation (ER) skills demonstrated initial efficacy at reducing heavy drinking and improving ER abilities among college women with sexual victimization histories. The present study represents a secondary analysis of this intervention to evaluate its preliminary efficacy on reducing sexual risk behaviors, specifically alcohol and drug use before sex. METHOD: The sample comprised 200 heavy drinking college women with histories of sexual victimization randomized to an assessment only control or the intervention consisting of 14 brief online alcohol reduction and ER skill building modules administered daily over a two-week period. The analytic sample included 173 women who reported on their substance use before sex at baseline and at least one of two (1-mo and/or 6-mo) follow-up surveys. RESULTS: Repeated measures mixed models revealed significant time-by-intervention interaction effects on alcohol use. Women who received the intervention had a significant decrease in alcohol use before sex from baseline to 1-month follow-up. Although levels of alcohol use before sex continued to be lower at the 6-month follow-up relative to baseline, differences did not reach statistical significance. Time-by-intervention interaction effects on drug use before sex were not statistically significant. CONCLUSIONS: Skills to reduce alcohol use and improve ER skills may be beneficial in helping women make adaptive decisions surrounding their sexual wellbeing.

Development of Web-Based Education Modules to Improve Carer Engagement in Cancer Care: Design and User Experience Evaluation of the e-Triadic Oncology (eTRIO) Modules for Clinicians, Patients, and Carers.

BACKGROUND: Carers often assume key roles in cancer care. However, many carers report feeling disempowered and ill-equipped to support patients. Our group published evidence-based guidelines (the Triadic Oncology [TRIO] Guidelines) to improve oncology clinician engagement with carers and the management of challenging situations involving carers. OBJECTIVE: To facilitate implementation of the TRIO Guidelines in clinical practice, we aimed to develop, iteratively refine, and conduct user testing of a suite of evidence-based and interactive web-based education modules for oncology clinicians (e-Triadic Oncology [eTRIO]), patients with cancer, and carers (eTRIO for Patients and Carers [eTRIO-pc]). These were designed to improve carer involvement, communication, and shared decision-making in the cancer management setting. METHODS: The eTRIO education modules were based on extensive research, including systematic reviews, qualitative interviews, and consultation analyses. Guided by the person-based approach, module content and design were reviewed by an expert advisory group comprising academic and clinical experts (n=13) and consumers (n=5); content and design were continuously and iteratively refined. User experience testing (including "think-aloud" interviews and administration of the System Usability Scale [SUS]) of the modules was completed by additional clinicians (n=5), patients (n=3), and carers (n=3). RESULTS: The final clinician module comprises 14 sections, requires approximately 1.5 to 2 hours to complete, and covers topics such as carer-inclusive communication and practices; supporting carer needs; and managing carer dominance, anger, and conflicting patient-carer wishes. The usability of the module was rated by 5 clinicians, with a mean SUS score of 75 (SD 5.3), which is interpreted as good. Clinicians often desired information in a concise format, divided into small "snackable" sections that could be easily recommenced if they were interrupted. The carer module features 11 sections; requires approximately 1.5 hours to complete; and includes topics such as the importance of carers, carer roles during consultations, and advocating for the patient. The patient module is an adaptation of the relevant carer module sections, comprising 7 sections and requiring 1 hour to complete. The average SUS score as rated by 6 patients and carers was 78 (SD 16.2), which is interpreted as good. Interactive activities, clinical vignette videos, and reflective learning exercises are incorporated into all modules. Patient and carer consumer advisers advocated for empathetic content and tone throughout their modules, with an easy-to-read and navigable module interface. CONCLUSIONS: The eTRIO suite of modules were rigorously developed using a person-based design methodology to meet the unique information needs and learning requirements of clinicians, patients, and carers, with the goal of improving effective and supportive carer involvement in cancer consultations and cancer care.

Effects of a Web-based Weight Management Education Program on Various Factors for Overweight and Obese Women: Randomized Controlled Trial.

BACKGROUND: Mediated diet and exercise methods yield effective short-term weight loss but are costly and hard to manage. However, web-based programs can serve many participants, offering ease of access and cost-efficiency. OBJECTIVE: This study aimed to compare the effectiveness of a web-based weight management program through web-based education alone (MINE) or combined with tailored video feedback (MINE Plus) with a control (CO) group. METHODS: This intervention included 60 Korean women with overweight and obesity (BMI≥23 kg/m2) aged 19 years to 39 years old. We randomly allocated 60 participants to each of 3 groups: (1) MINE group (web-based education video and self-monitoring app), (2) MINE Plus group (web-based education video, self-monitoring app, and 1:1 tailored video feedback), and (3) CO group (only self-monitoring app). Web-based education included nutrition, physical activity, psychological factors, medical knowledge for weight loss, goal setting, and cognitive and behavioral strategies. Tailored feedback aimed to motivate and provide solutions via weekly 10-minute real-time video sessions. The intervention lasted 6 weeks, followed by a 6-week observation period to assess the education's lasting effects, with evaluations at baseline, 6 weeks, and 12 weeks. A generalized linear mixed model was used to evaluate time and group interactions. RESULTS: In the intention-to-treat analysis including all 60 participants, there were significant differences in weight change at 6 weeks in the MINE and MINE Plus groups, with mean weight changes of -0.74 (SD 1.96) kg (P=.03) and -1.87 (SD 1.8) kg (P<.001), respectively, while no significant change was observed in the CO group, who had a mean weight increase of 0.03 (SD 1.68) kg (P=.91). After 12 weeks, changes in body weight were -1.65 (SD 2.64) kg in the MINE group, -1.59 (SD 2.79) kg in the MINE Plus group, and 0.43 (SD 1.42) kg in the CO group. There was a significant difference between the MINE and MINE Plus groups (P<.001). Significant group × time effects were found for body weight in the MINE and CO groups (P<.001) and in the MINE Plus and CO groups (P<.001), comparing baseline and 12 weeks. Regarding physical activity and psychological factors, only body shape satisfaction and health self-efficacy were associated with improvements in the MINE and MINE Plus groups (P<.001). CONCLUSIONS: This study found that the group receiving education and tailored feedback showed significant weight loss and improvements in several psychological factors, though there were differences in the sustainability of the effects. TRIAL REGISTRATION: Korea Disease Control and Prevention Agency (KDCA) KCT0007780: https://cris.nih.go.kr/cris/search/detailSearch.do/22861.

Effectiveness of a web-based group intervention for internet addiction in university students.

The phenomenon of Internet addiction has been systematically addressed with numerous studies highlighting its association with deficits in self-regulation. Despite the extensive literature elucidating the adverse effects of Internet addiction on university students, the availability of relevant interventions has remained constrained. The current study aimed at evaluating a web-based, group intervention, which aimed to prevent Internet addiction and enhance self-regulation. The sample consisted of 47 undergraduate and postgraduate university students (Ν = 47, Mage=21, SD = 3), who were divided into an intervention (n = 24) and a control group (n = 23). The participants were asked to complete a) the Internet Addiction Test (Young, 1998), and b) the Self-Regulation Questionnaire (Brown et al., 1999), prior to the commencement of the intervention, after its conclusion, and one and a half months after the intervention. The web-based intervention consisted of 6 sessions, over a two-week period. Results indicated an improvement of self-regulation and Internet addiction levels for the intervention group, compared to the control group. These results were maintained at the one and a half months follow-up. Implications for designing and implementing web-based group interventions for Internet addiction are discussed.

A Web-Based and Mobile Intervention Program Using a Spaced Education Approach for Workplace Mental Health Literacy: Cluster Randomized Controlled Trial.

Background: Workplace mental health is an important global health concern. objectives: This unblinded, phase-III, wait-listed cluster randomized controlled trial aimed to examine the effectiveness of a mobile health (mHealth) psychoeducation program using a spaced education approach on mental health literacy (MHL) in the workplace. The main interest of this paper was the immediate and 3-month medium-term effect of the program on the MHL of workers. The purposely built mHealth platform was also evaluated as a health-related app. Methods: The mHealth platform was designed using the principle of spaced education as a psychoeducation intervention program, with various modules of web-based and mobile materials presented to the participant in a progressive manner. Short quizzes at the end of each module ensured adequate learning, and successful completion qualified the learner to progress to the next level. The trial recruited 456 employees of specific industries with high levels of work-related stress. Participants who were nested in different offices or units were allocated into the intervention and wait-listed control groups using a block randomization process, with the office or unit as the cluster. A separate sample of 70 individual raters were used for the evaluation of the mHealth platform. The Australian National MHL and Stigma Survey and the Mobile Apps Rating Scale were completed through a web-based self-reported survey to assess MHL and evaluate the app. The trial and follow-up data were analyzed by a generalized linear latent and mixed model with adjustments for the clustering effect of work sites and repeated measures. Results: Of the 456 participants in the trial, 236 (51.8%) responded to the follow-up survey. Most MHL outcomes obtained significant results immediately after the intervention and across time. After adjusting for the clustering effect, the postintervention weighted mean scores were significantly higher in the intervention group than the control group for correct recognition of a mental health problem, help seeking, and stigmatization by 0.2 (SE 0.1; P=.003), 0.9 (SE 0.2; P<.001), and 1.8 (SE 0.4; P<.001), respectively. After adjusting for the clustering effect, significant differences across time were found in help-seeking intention (P=.01), stigmatization (P<.001), and social distancing (P<.001). The evaluation of the mHealth program resulted in average scores of the 4 major domains ranging from 3.8 to 4.2, with engagement having the lowest score. Conclusions: The mHealth psychoeducation intervention program using this platform had immediate and 3-month medium-term effects of retaining and improving MHL. The platform was evaluated to have satisfactory performance in terms of functionality, aesthetics, information content, and utility in enhancing MHL. It is anticipated that ongoing development in digital health will provide great benefits in improving the mental health of the global population.

Effectiveness of a Web-Based Individual Coping and Alcohol Intervention Program for Children of Parents With Alcohol Use Problems: Randomized Controlled Trial.

BACKGROUND: Children whose parents have alcohol use problems are at an increased risk of several negative consequences, such as poor school performance, an earlier onset of substance use, and poor mental health. Many would benefit from support programs, but the figures reveal that only a small proportion is reached by existing support. Digital interventions can provide readily accessible support and potentially reach a large number of children. Research on digital interventions aimed at this target group is scarce. We have developed a novel digital therapist-assisted self-management intervention targeting adolescents whose parents had alcohol use problems. This program aims to strengthen coping behaviors, improve mental health, and decrease alcohol consumption in adolescents. OBJECTIVE: This study aims to examine the effectiveness of a novel web-based therapist-assisted self-management intervention for adolescents whose parents have alcohol use problems. METHODS: Participants were recruited on the internet from social media and websites containing health-related information about adolescents. Possible participants were screened using the short version of the Children of Alcoholics Screening Test-6. Eligible participants were randomly allocated to either the intervention group (n=101) or the waitlist control group (n=103), and they were unblinded to the condition. The assessments, all self-assessed, consisted of a baseline and 2 follow-ups after 2 and 6 months. The primary outcome was the Coping With Parents Abuse Questionnaire (CPAQ), and secondary outcomes were the Center for Epidemiological Studies Depression Scale, Alcohol Use Disorders Identification Test (AUDIT-C), and Ladder of Life (LoL). RESULTS: For the primary outcome, CPAQ, a small but inconclusive treatment effect was observed (Cohen d=-0.05 at both follow-up time points). The intervention group scored 38% and 46% lower than the control group on the continuous part of the AUDIT-C at the 2- and 6-month follow-up, respectively. All other between-group comparisons were inconclusive at either follow-up time point. Adherence was low, as only 24% (24/101) of the participants in the intervention group completed the intervention. CONCLUSIONS: The findings were inconclusive for the primary outcome but demonstrate that a digital therapist-assisted self-management intervention may contribute to a reduction in alcohol consumption. These results highlight the potential for digital interventions to reach a vulnerable, hard-to-reach group of adolescents but underscore the need to develop more engaging support interventions to increase adherence. TRIAL REGISTRATION: ISRCTN Registry ISRCTN41545712; https://www.isrctn.com/ISRCTN41545712?q=ISRCTN41545712. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/1471-2458-12-35.

Efficacy of a web-based psychoeducational intervention, Fex-can sex, for young adult childhood cancer survivors with sexual dysfunction: A randomized controlled trial.

Background: No web-based interventions addressing sexual problems are available for young adult survivors of childhood cancer. Aim: This study aimed to test the efficacy of a web-based psychoeducational intervention, Fex-Can Sex, to alleviate sexual problems in young adults treated for cancer during childhood. Method: This randomized controlled trial tested the effects of a 12-week, self-help, web-based intervention. Young adults (aged 19-40) reporting sexual dysfunction were drawn from a population-based national cohort of childhood cancer survivors and randomized to either an intervention group (IG, n = 142) or a wait-list control group (CG, n = 136). The primary outcome was 'Satisfaction with sex life' assessed by the PROMIS® SexFS v 2.0. Secondary outcomes included other SexFS domains, body image (BIS), emotional distress (HADS), health-related quality of life (EORTC QLQ-C30), and sex-related self-efficacy. Surveys were completed at baseline (T0), directly after the intervention (T1), and three months later (T2). The effects of the intervention were tested using t-test and linear mixed models, including intention-to-treat (ITT) and subgroups analysis. Adherence was based on log data extracted from the website system. The intervention included an open-ended question about perceived sexual problems. Results: No effect of the intervention was found in the primary outcome. Regarding secondary outcomes, the IG reported less vaginal dryness (Lubrication subscale) than the CG at T1 (p = 0.048) and T2 (p = 0.023). Furthermore, at T1, the IG reported less emotional distress than the CG (p = 0.047). Subgroup analyses showed that those with greater sexual problems at T0 improved over time (T1 and T2), regardless of group allocation. Overall, adherence to the intervention was low and participants' activity levels did not change the results. Additionally, some members of the IG reported increased understanding and acceptance of their sexual problems. Conclusion: The Fex-Can Sex intervention shows potential to improve sexual function, especially among those with greater dysfunction. To increase adherence and effect, we recommend the intervention to be further developed including more tailored content. Clinical trial registration: ISRCTN Registry, trial number: 33081791 (registered on November 27, 2019).