A Digital Behavioral Activation Intervention (JuNEX) for Pregnant Women With Subclinical Depression Symptoms: Explorative Co-Design Study.

BACKGROUND: Digital interventions are gaining increasing interest due to their structured nature, ready availability, and self-administered capabilities. Perinatal women have expressed a desire for such interventions. In this regard, behavioral activation interventions may be particularly suitable for digital administration. OBJECTIVE: This study aims to exploratorily investigate and compare the feasibility of the internet-based self-help guided versus unguided version of the Brief Behavioral Activation Treatment for Depression-Revised, an empirically supported in-person behavioral activation protocol, targeting pregnant women with subclinical depression symptoms. A user-centered design is used, whereby data are collected with the intent of evaluating how to adjust the intervention in line with pregnant women's needs. Usability and user engagement were evaluated. METHODS: A total of 11 Italian pregnant women with subclinical depressive symptoms based on the Patient Health Questionnaire-9 (scoring<15) participated in this study; of them, 6 (55%) women were randomly assigned to the guided group (age: mean 32.17, SD 4.36 years) and 5 (45%) to the unguided group (age: mean 31, SD 4.95 years). The Moodle platform was used to deliver the interventions in an e-learning format. It consisted of 6 core modules and 3 optional modules; the latter aimed at revising the content of the former. In the guided group, each woman had weekly chats with their assigned human guide to support them in the homework revisions. The intervention content included text, pictures, and videos. Semistructured interviews were conducted, and descriptive statistics were analyzed. RESULTS: Collectively, the data suggest that the guided intervention was better accepted than the unguided one. However, the high rates of dropout (at T6: guided group: 3/6, 50%; unguided: 4/5, 80%) suggest that a digital replica of Behavioral Activation Treatment for Depression-Revised may not be feasible in an e-learning format. The reduced usability of the platform used was reported, and homework was perceived as too time-consuming and effort-intensive. Moreover, the 6 core modules were deemed sufficient for the intervention's goals, suggesting that the 3 optional modules could be eliminated. Nevertheless, participants from both groups expressed satisfaction with the content and found it relevant to their pregnancy experiences. CONCLUSIONS: Overall, the findings have emphasized both the intervention's merits and shortcomings. Results highlight the unsuitability of replicating an in-person protocol digitally as well as of the use of nonprofessional tools for the implementation of self-help interventions, ultimately making the intervention not feasible. Pregnant women have nonetheless expressed a desire to receive psychological support and commented on the possibilities of digital psychosocial supports, particularly those that are app-based. The information collected and the issues identified here are important to guide the development and co-design of a more refined platform for the intervention deployment and to tailor the intervention's content to pregnant women's needs.

Personalized Stress Detection Using Biosignals from Wearables: A Scoping Review.

Stress is a natural yet potentially harmful aspect of human life, necessitating effective management, particularly during overwhelming experiences. This paper presents a scoping review of personalized stress detection models using wearable technology. Employing the PRISMA-ScR framework for rigorous methodological structuring, we systematically analyzed literature from key databases including Scopus, IEEE Xplore, and PubMed. Our focus was on biosignals, AI methodologies, datasets, wearable devices, and real-world implementation challenges. The review presents an overview of stress and its biological mechanisms, details the methodology for the literature search, and synthesizes the findings. It shows that biosignals, especially EDA and PPG, are frequently utilized for stress detection and demonstrate potential reliability in multimodal settings. Evidence for a trend towards deep learning models was found, although the limited comparison with traditional methods calls for further research. Concerns arise regarding the representativeness of datasets and practical challenges in deploying wearable technologies, which include issues related to data quality and privacy. Future research should aim to develop comprehensive datasets and explore AI techniques that are not only accurate but also computationally efficient and user-centric, thereby closing the gap between theoretical models and practical applications to improve the effectiveness of stress detection systems in real scenarios.

Personalized Virtual Reality Compared With Guided Imagery for Enhancing the Impact of Progressive Muscle Relaxation Training: Pilot Randomized Controlled Trial.

BACKGROUND: Empirical evidence has shown that virtual reality (VR) scenarios can increase the effects of relaxation techniques, reducing anxiety by enabling people to experience emotional conditions in more vivid settings. OBJECTIVE: This pilot randomized controlled study aims to investigate whether the progressive muscle relaxation technique (PMRT) associated with a personalized scenario in VR promotes psychological well-being and facilitates the recall of relaxing images more than the standard complementary intervention that involves the integration of PMRT and guided imagery (GI). METHODS: On the basis of a longitudinal, between-subject design, 72 university students were randomly exposed to one of two experimental conditions: (1) standard complementary procedure (PMRT and GI exposure) and (2) experimental procedure (PMRT and personalized VR exposure). Individuals were assessed by a therapist before and after 7 training sessions based on measures investigating anxiety, depression, quality of life, coping strategies, sense of presence, engagement, and side effects related to VR exposure. Heart rate data were also collected. RESULTS: Differences in changes between the 2 groups after the in vivo PMRT session conducted by the psychotherapist (T1) were statistically significant for state anxiety (F1,67=30.56; P<.001) and heart rate (F1,67=4.87; P=.01). Individuals in the VR group obtained lower scores both before (t67=-2.63; P=.01; Cohen d=0.91) and after (t67=-7.23; P<.001; Cohen d=2.45) the relaxation session when it was self-administered by participants (T2). A significant reduction in perceived state anxiety at T1 and T2 was observed for both groups (P<.001). After the VR experience, individuals reported feeling higher engagement in the experience than what was mentioned by participants in the GI group (F1,67=2.85; P=.03; ηp2=0.15), and they experienced the environment as more realistic (F1,67=4.38; P=.003; ηp2=0.21). No differences between groups regarding sense of presence were found (F1,67=1.99; P=.11; ηp2=0.11). Individuals exposed before to the VR scenario (T1) referred to perceiving the scenario recalled in-imagination at T2 as more realistic than what those in the GI group experienced (F1,67=3.21; P=.02; ηp2=0.12). The VR group had lower trait anxiety levels than the GI group after the relaxation session during session 7 (T2; t67=-2.43; P=.02). CONCLUSIONS: Personalized relaxing VR scenarios can contribute to improving relaxation and decreasing anxiety when integrated with PMRT as a complementary relaxation method. TRIAL REGISTRATION: ClinicalTrials.gov NCT05478941; https://classic.clinicaltrials.gov/ct2/show/NCT05478941. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/44183.

Co-Design of a Virtual Reality Multiplayer Adventure Game for Adolescents With Autism Spectrum Disorder: Mixed Methods Study.

BACKGROUND: Virtual reality (VR) adventure games can offer ideal technological solutions for training social skills in adolescents with autism spectrum disorder (ASD), leveraging their support for multisensory and multiplayer interactions over distance, which may lower barriers to training access and increase user motivation. However, the design of VR-based game environments for social skills training is still understudied and deserves the deployment of an inclusive design approach to ensure its acceptability by target users. OBJECTIVE: We aimed to present the inclusive design process that we had followed to develop the Zentastic VR adventure game to foster social skills training in adolescents with ASD and to investigate its feasibility as a training environment for adolescents. METHODS: The VR game supports multiplayer training sessions involving small groups of adolescents and their therapists, who act as facilitators. Adolescents with ASD and their therapists were involved in the design and in an explorative acceptability study of an initial prototype of the gaming environment, as well as in a later feasibility multisession evaluation of the VR game final release. RESULTS: The feasibility study demonstrated good acceptability of the VR game by adolescents and an enhancement of their social skills from baseline to posttraining. CONCLUSIONS: The findings provide preliminary evidence of the benefits that VR-based games can bring to the training of adolescents with ASD and, potentially, other neurodevelopmental disorders.

Customized virtual reality naturalistic scenarios promoting engagement and relaxation in patients with cognitive impairment: a proof-of-concept mixed-methods study.

Being immersed in a natural context has a beneficial and pervasive impact on well-being. Virtual Reality (VR) is a technology that can help expose people to naturalistic scenarios virtually, overcoming obstacles that prevent them from visiting real natural environments. VR could also increase engagement and relaxation in older adults with and without cognitive impairment. The main aim of this study is to investigate the feasibility of a customized naturalistic VR scenario by assessing motion-sickness effects, engagement, pleasantness, and emotions felt. Twenty-three individuals with a diagnosis of cognitive impairment living in a long-term care home participated in our study. At the end of the entire VR experimental procedure with older adults, five health staff operators took part in a dedicated assessment phase focused on evaluating the VR procedure's usability from their individual perspectives. The tools administered were based on self-reported and observational tools used to obtain information from users and health care staff professionals. Feasibility and acceptance proved to be satisfactory, considering that the VR experience was well-tolerated and no adverse side effects were reported. One of the major advantages emerged was the opportunity to deploy customized environments that users are not able to experience in a real context.Trial Registration: National Institute of Health (NIH) U.S. National Library of Medicine, ClinicalTrials.gov NCT05863065 (17/05/2023).

Personalized, Naturalistic Virtual Reality Scenarios Coupled With Web-Based Progressive Muscle Relaxation Training for the General Population: Protocol for a Proof-of-Principle Randomized Controlled Trial.

BACKGROUND: Virtual reality (VR) is an innovative tool that can facilitate exposure to either stressful or relaxing stimuli and enables individuals who have difficulties visualizing scenes to be involved in a more realistic sensorimotor experience. It also facilitates multisensory stimulation, a sense of presence, and achievement of relaxation. VR scenarios representing visual and auditory elements of natural relaxing environments can facilitate the learning of relaxation techniques such as the progressive muscle relaxation technique (PMRT). A complementary standardized technique deployed to reduce anxiety symptoms is the integration of PMRT and guided imagery (GI). Exposure to a pleasant imaginary environment helps the establishment of an association between a relaxing scenario and the relaxation technique, consequently promoting relaxation. Empirical evidence has shown that VR scenarios can increase the effects of relaxation techniques by enabling people to experience emotional conditions in more vivid settings. OBJECTIVE: The main aim of this pilot study protocol is to investigate the impact on state anxiety of PMRT, associated with a personalized relaxing scenario in VR, and the role of VR scenarios in facilitating the recall of relaxing images and a sense of presence. A secondary aim is to understand if relaxing sessions administered via Zoom are more effective for managing anxiety and stress than a procedural setting based on audio-track guidance. METHODS: Based on a longitudinal, between-subject design, 108 university students will be randomly exposed to one of three experimental conditions: (1) PMRT via Zoom and GI exposure, (2) PMRT via Zoom and personalized VR exposure, and (3) PMRT based on audio-track guidance and personalized VR exposure. Individuals are assessed before and after 7 training sessions based on self-report questionnaires investigating anxiety, depression, quality of life, coping strategies, sense of presence, engagement, and side effects related to VR exposure. Heart rate data are also detected by an Mi Band 2 sensor. RESULTS: The experimental procedure is ongoing. In this paper, preliminary data from a sample of 40 participants will be illustrated. The experimental phase is expected to conclude in May 2023, and the final results of the research will be presented in June 2023. CONCLUSIONS: The results of this study will help shape the experimental design to apply it on a subsequent randomized controlled trial, also considering clinical samples. This work is expected to measure whether VR is a more engaging and helpful technique in promoting relaxation and decreasing anxiety levels than GI, by making the visualization process easier and by helping people to face more realistic sensory experiences. Assessing the efficacy of the PMRT in alternative delivery modes may extend its applications, especially in situations where the standard procedure is more challenging to be administered. To our knowledge, no equivalent study has been published so far on this matter. TRIAL REGISTRATION: ClinicalTrials.gov NCT05478941; https://clinicaltrials.gov/ct2/show/NCT05478941. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44183.

Digital Behavioral Activation Interventions During the Perinatal Period: Scoping Review.

BACKGROUND: Pregnancy is a complex period that implies many biopsychosocial changes, and the way women adapt to these changes impacts their well-being and the chances of developing mental health problems. During the perinatal period, women have expressed a preference for support delivered on the web. In this regard, interventions such as behavioral activation (BA), which are brief and structured psychosocial interventions, seem particularly suited to be delivered through digital solutions. OBJECTIVE: This study aimed to map the literature investigating digital BA interventions deployed during the perinatal period. We paid particular attention to the methodological underpinnings of the studies, the potential impact of BA interventions on symptoms other than depression, and the existence of differences occurring when these interventions were administered during pregnancy versus the postpartum period. METHODS: A systematic search compliant with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews) guidelines was conducted considering 5 bibliographic databases; reference lists and key journals were also screened by 2 independent authors following a double-blind approach. RESULTS: A total of 7 studies published between 2013 and 2022 were included. In total, 2 studies were protocols for randomized controlled trials, 5 were empirical studies, and 1 was a qualitative study. All studies focused on the postpartum period, except for 1 that focused on the broader perinatal period. Promising effects on depression symptoms were reported but not on other psychosocial symptoms. Low intervention adherence has emerged, whereas the usability associated with the digital means used to deploy interventions was scarcely addressed; moreover, information on the digital platforms used was poorly reported overall. CONCLUSIONS: Our findings highlight the scarcity and preliminary nature of digital BA interventions deployed during the perinatal period, where the focus seems more on treatment rather than prevention. Moreover, future studies should also consider and address usability and user engagement, given their relevance to intervention efficacy.

The Efficacy of Digital Cognitive-Behavioral Interventions in Supporting the Psychological Adjustment and Sleep Quality of Pregnant Women with Sub-Clinical Symptoms: A Systematic Review and Meta-Analysis.

The present meta-analysis investigated the overall and differential efficacy of digital cognitive-behavioral therapies (CBTs) vs. third-generation CBTs deployed to pregnant women in reducing sub-clinical depression, anxiety, and stress symptoms while fostering sleep quality and quality of life. A PRISMA-guided systematic search was used, including randomized controlled trials (RCTs) evaluating the above-mentioned interventions. Data were pooled using either the mean difference (MD) or standardized MD (SMD). Sub-group analyses were carried out when appropriate. The primary outcomes were depression, anxiety, and stress symptoms, as well as sleep quality and quality of life. The interventions' acceptability was evaluated through the odds ratio (OR) of drop-out rates. Seven RCTs were included, comprising 1873 pregnant women. The results showed the interventions' efficacy in terms of reducing depression symptoms (SMD = -0.36, CI = 0.61, -0.11, k = 9) at the endpoint, although it was not maintained at follow-up during the postpartum period. The interventions' efficacy in terms of reducing anxiety symptoms (SMD = 1.96, CI = -2.72, -1.21, k = 3) at the endpoint was also significant, while having no effect on sleep quality. The interventions were well accepted (OR = 1.68; 95% CI = 0.84, 3.35; k = 7). Although no sound conclusions can be drawn concerning the joint or differential efficacy of the considered interventions, this study was useful in highlighting the need to develop evidence-based digital prevention programs for pregnant women with sub-clinical symptoms.

The Role of Personalization in the User Experience, Preferences and Engagement with Virtual Reality Environments for Relaxation.

Virtual Reality Environments (VREs) are widely deployed in mental health treatments, often associated with relaxation techniques. The personalization of natural VR-based scenarios is a key element that can further facilitate users' sense of presence and relaxation. This study explored the role of VREs' personalization in the user experience with an environment supporting relaxation, by deploying mixed methods. METHODS: A non-clinical sample of 20 individuals participated in exposure to a supportive body-scan-guided relaxation VRE. In the personalized conditions, the participants had the option of choosing the context (e.g., sea, mountain, or countryside) and including in the scenario different types of sounds, visual elements, and changing the time of day and weather. In the standard conditions, individuals were exposed to a relaxing VRE, but they could choose neither the context nor the auditory and visual elements. The order of presentation of the personalized vs non-personalized environments was randomized. Measures regarding relaxation, state-anxiety perceived levels, VRE-related symptoms, the usability of the Virtual Reality (VR) setting, sense of presence, pleasure, activation, engagement, and level of immersion experienced were collected before and after exposure to the VR environments. RESULTS: Findings showed that personalized VREs were preferred by users. Participants generally preferred to experience a greater immersivity, pleasure, engagement, and relaxation in the personalized virtual settings. CONCLUSION: The study further confirms the role of personalization as a component positively contributing to relaxation and engagement. Future research may further assess this effect in the context of large-scale controlled studies involving clinical and non-clinical populations.

Early Development of a Virtual Coach for Healthy Coping Interventions in Type 2 Diabetes Mellitus: Validation Study.

BACKGROUND: Mobile health solutions aimed at monitoring tasks among people with diabetes mellitus (DM) have been broadly applied. However, virtual coaches (VCs), embedded or not in mobile health, are considered valuable means of improving patients' health-related quality of life and ensuring adherence to self-care recommendations in diabetes management. Despite the growing need for effective, healthy coping digital interventions to support patients' self-care and self-management, the design of psychological digital interventions that are acceptable, usable, and engaging for the target users still represents the main challenge, especially from a psychosocial perspective. OBJECTIVE: This study primarily aims to test VC interventions based on psychoeducational and counseling approaches to support and promote healthy coping behaviors in adults with DM. As a preliminary study, university students have participated in it and have played the standardized patients' (SPs) role with the aim of improving the quality of the intervention protocol in terms of user acceptability, experience, and engagement. The accuracy of users' role-playing is further analyzed. METHODS: This preliminary study is based on the Obesity-Related Behavioral Intervention Trial model, with a specific focus on its early phases. The healthy coping intervention protocol was initially designed together with a team of psychologists following the main guidelines and recommendations for psychoeducational interventions for healthy coping in the context of DM. The protocol was refined with the support of 3 experts in the design of behavioral intervention technologies for mental health and well-being, who role-played 3 SPs' profiles receiving the virtual coaching intervention in a Wizard of Oz setting via WhatsApp. A refined version of the healthy coping protocol was then iteratively tested with a sample of 18 university students (mean age 23.61, SD 1.975 years) in a slightly different Wizard of Oz evaluation setting. Participants provided quantitative and qualitative postintervention feedback by reporting their experiences with the VC. Clustering techniques on the logged interactions and dialogs between the VC and users were collected and analyzed to identify additional refinements for future VC development. RESULTS: Both quantitative and qualitative analyses showed that the digital healthy coping intervention was perceived as supportive, motivating, and able to trigger self-reflection on coping strategies. Analyses of the logged dialogs showed that most of the participants accurately played the SPs' profile assigned, confirming the validity and usefulness of this testing approach in preliminary assessments of behavioral digital interventions and protocols. CONCLUSIONS: This study outlined an original approach to the early development and iterative testing of digital healthy coping interventions for type 2 DM. Indeed, the intervention was well-accepted and proved its effectiveness in the definition and refinement of the initial protocol and of the user experience with a VC before directly involving real patients in its subsequent use and testing.

A Virtual Coach (Motibot) for Supporting Healthy Coping Strategies Among Adults With Diabetes: Proof-of-Concept Study.

BACKGROUND: Motivation is a core component of diabetes self-management because it allows adults with diabetes mellitus (DM) to adhere to clinical recommendations. In this context, virtual coaches (VCs) have assumed a central role in supporting and treating common barriers related to adherence. However, most of them are mainly focused on medical and physical purposes, such as the monitoring of blood glucose levels or following a healthy diet. OBJECTIVE: This proof-of-concept study aims to evaluate the preliminary efficacy of a VC intervention for psychosocial support before and after the intervention and at follow-up. The intent of this VC is to motivate adults with type 1 DM and type 2 DM to adopt and cultivate healthy coping strategies to reduce symptoms of depression, anxiety, perceived stress, and diabetes-related emotional distress, while also improving their well-being. METHODS: A total of 13 Italian adults with DM (18-51 years) interacted with a VC, called Motibot (motivational bot) using the Telegram messaging app. The interaction covered 12 sessions, each lasting 10 to 20 minutes, during which the user could dialogue with the VC by inputting text or tapping an option on their smartphone screen. Motibot is developed within the transtheoretical model of change to deliver the most appropriate psychoeducational intervention based on the user's motivation to change. RESULTS: Results showed that over the 12 sessions, there were no significant changes before and after the intervention and at follow-up regarding psychosocial factors. However, most users showed a downward trend over the 3 time periods in depression and anxiety symptoms, thereby presenting good psychological well-being and no diabetes-related emotional distress. In addition, users felt motivated, involved, encouraged, emotionally understood, and stimulated by Motibot during the interaction. Indeed, the analyses of semistructured interviews, using a text mining approach, showed that most users reported a perceived reduction in anxiety, depression, and/or stress symptoms. Moreover, users indicated the usefulness of Motibot in supporting and motivating them to find a mindful moment for themselves and to reflect on their own emotions. CONCLUSIONS: Motibot was well accepted by users, particularly because of the inclusion of mindfulness practices, which motivated them to adopt healthy coping skills. To this extent, Motibot provided psychosocial support for adults with DM, particularly for those with mild and moderate symptoms, whereas those with severe symptoms may benefit more from face-to-face psychotherapy.

Relevance of well-being, resilience, and health-related quality of life to mental health profiles of European adolescents: results from a cross-sectional analysis of the school-based multinational UPRIGHT project.

PURPOSE: The existing evidence suggests that a complete evaluation of mental health should incorporate both psychopathology and mental well-being indicators. However, few studies categorize European adolescents into subgroups based on such complete mental health data. This study used the data on mental well-being and symptoms of mental and behavioral disorders to explore the mental health profiles of adolescents in Europe. METHODS: Data collected from adolescents (N = 3767; mean age 12.4 [SD = 0.9]) from five European countries supplied the information on their mental well-being (personal resilience, school resilience, quality of life, and mental well-being) and mental and behavioral disorder symptoms (anxiety, depression, stress, bullying, cyber-bullying, and use of tobacco, alcohol, or cannabis). Multiple correspondence analysis and cluster analysis were combined to classify the youths into mental health profiles. RESULTS: Adolescents were categorized into three mental health profiles. The "poor mental health" profile (6%) was characterized by low levels of well-being and moderate symptoms of mental disorders. The "good mental health" profile group (26%) showed high well-being and few symptoms of mental disorders, and the "intermediate mental health" profile (68%) was characterized by average well-being and mild-to-moderate symptoms of mental disorders. Groups with higher levels of well-being and fewer symptoms of mental disorders showed lower rates of behavioral problems. Mental well-being indicators strongly contributed to this classification. CONCLUSION: Adolescents with the "intermediate" or "poor" mental health profiles may benefit from interventions to improve mental health. Implications for school-based interventions are discussed. TRIAL REGISTRATION NUMBER (TRN) AND DATE OF REGISTRATION: ClinicalTrials.gov Identifier: NCT03951376. Registered 15 May 2019.

School Interventions for Bullying-Cyberbullying Prevention in Adolescents: Insights from the UPRIGHT and CREEP Projects.

BACKGROUND: Several challenges and emotional demands characterize adolescence, affecting the mental well-being of youths. Among these, bullying and cyberbullying are recognized nowadays as a major social problem, affecting more than one-third of adolescents, with extensive negative consequences for the victims involved, such as lower self-esteem, increased loneliness, depression, and anxiety. School programs and interventions that foster resilience, coping, and well-being are particularly important during adolescence as protective and preventive factors against the consequences of (cyber)bullying. The paper presents two recent co-designed interventions for (cyber)bullying prevention deployed in Europe, targeting early adolescents and their school communities. METHODS: The UPRIGHT project developed an evidence-based, whole-school intervention to train resilience as a protective factor to promote mental well-being in adolescents, in a cross-national perspective. The CREEP project designed and implemented digital interventions to support schools in (i) early detection of cyberbullying events on social media and (ii) coaching adolescents (victims, bullies, bystanders) on how to cope with (cyber)bullying behaviors. RESULTS: The main challenges and insights collected during the design and implementation of both interventions are discussed to inform future research and practice. CONCLUSION: The feasibility and acceptance of prevention programs are key to the reducing risk of (cyber)bullying and improving the psychological well-being of early adolescents.

Efficacy of eHealth Interventions for Adults with Diabetes: A Systematic Review and Meta-Analysis.

The aim is to provide meta-analytical evidence on eHealth interventions' efficacy in supporting the psychosocial and physical well-being of adults with type 1 or type 2 Diabetes Mellitus (DM), and to investigate differences in interventions primarily targeted at providing glycemic control vs. psychosocial support. A PRISMA-guided systematic search was conducted. Randomized Controlled Trials (RCTs) regarding eHealth interventions for adults (18-65 years) with DM were included. Data were pooled using Standard Mean Difference (SMD); sub-group analysis and meta-regressions were performed when appropriate. Outcomes were Hemoglobin A1c (HbA1c), diabetes distress, quality of life, anxiety, stress, and depression. Intervention acceptability was assessed performing the Odds Ratio (OR) of drop-out rates. Thirteen RCTs comprising 1315 participants were included (52.09% females; Mage = 46.18, SD = 9.98). Analyses showed intervention efficacy on HbA1c (SMD = -0.40; 95% CI = -0.70, -0.12; k = 13) and depressive symptoms (SMD = -0.18; 95% CI = -0.33, -0.02; k = 6) at RCTs endpoint and were well accepted (OR = 1.43; 95% CI = 0.72, 2.81; k = 10). However, efficacy on HbA1c was not maintained at follow-up (SMD = -0.13; 95% CI = -0.31, 0.05; k = 6). eHealth interventions providing medical support were acceptable and effective in fostering glycemic control and decreasing depressive symptoms in the short-term only. Digital solutions should be developed on multiple levels to fully support the psychophysical well-being of people with DM.

Engagement and Effectiveness of a Healthy-Coping Intervention via Chatbot for University Students During the COVID-19 Pandemic: Mixed Methods Proof-of-Concept Study.

BACKGROUND: University students are increasingly reporting common mental health problems, such as stress, anxiety, and depression, and they frequently face barriers to seeking psychological support because of stigma, cost, and availability of mental health services. This issue is even more critical in the challenging time of the COVID-19 pandemic. Digital mental health interventions, such as those delivered via chatbots on mobile devices, offer the potential to achieve scalability of healthy-coping interventions by lowering cost and supporting prevention. OBJECTIVE: The goal of this study was to conduct a proof-of-concept evaluation measuring the engagement and effectiveness of Atena, a psychoeducational chatbot supporting healthy coping with stress and anxiety, among a population of university students. METHODS: In a proof-of-concept study, 71 university students were recruited during the COVID-19 pandemic; 68% (48/71) were female, they were all in their first year of university, and their mean age was 20.6 years (SD 2.4). Enrolled students were asked to use the Atena psychoeducational chatbot for 4 weeks (eight sessions; two per week), which provided healthy-coping strategies based on cognitive behavioral therapy, positive psychology, and mindfulness techniques. The intervention program consisted of conversations combined with audiovisual clips delivered via the Atena chatbot. Participants were asked to complete web-based versions of the 7-item Generalized Anxiety Disorder scale (GAD-7), the 10-item Perceived Stress Scale (PSS-10), and the Five-Facet Mindfulness Questionnaire (FFMQ) at baseline and postintervention to assess effectiveness. They were also asked to complete the User Engagement Scale-Short Form at week 2 to assess engagement with the chatbot and to provide qualitative comments on their overall experience with Atena postintervention. RESULTS: Participants engaged with the Atena chatbot an average of 78 (SD 24.8) times over the study period. A total of 61 out of 71 (86%) participants completed the first 2 weeks of the intervention and provided data on engagement (10/71, 14% attrition). A total of 41 participants out of 71 (58%) completed the full intervention and the postintervention questionnaires (30/71, 42% attrition). Results from the completer analysis showed a significant decrease in anxiety symptoms for participants in more extreme GAD-7 score ranges (t39=0.94; P=.009) and a decrease in stress symptoms as measured by the PSS-10 (t39=2.00; P=.05) for all participants postintervention. Participants also improved significantly in the describing and nonjudging facets, based on their FFMQ subscale scores, and asked for some improvements in the user experience with the chatbot. CONCLUSIONS: This study shows the benefit of deploying a digital healthy-coping intervention via a chatbot to support university students experiencing higher levels of distress. While findings collected during the COVID-19 pandemic show promise, further research is required to confirm conclusions.

Measuring Resilience Across Participating Regions in the UPRIGHT EU Horizon 2020 Project: Factor Structure and Psychometric Properties of the Resilience Scale for Adolescents.

Resilience is the process and outcome of healthy adaptation despite significant adversity. Proliferation of research on the resilience construct has led to scientific concerns about the operationalization and measurement of resilience for assessment science and practice. Various studies that have investigated the psychometric properties and construct validity of the Resilience Scale for Adolescents (READ) have yielded inconsistent findings, which could partly be due to variations in the methodological approaches. This study investigated the factor structure and construct validity of the READ in four European regions participating in the Universal Preventive Resilience Intervention Globally Implemented in Schools to Improve and Promote Mental Health for Teenagers (UPRIGHT) project. Participants included adolescents aged 10-15 years from Spain (n = 391, females = 51%), Iceland (n = 379, females = 55%), Italy (n = 460, females = 55%), and Poland (n = 316, females = 51%). The five-factor model of the READ was similar across gender and participating regions. Construct validity of the READ was supported. After establishing construct separability, incremental validity was supported (except for the social competence subscale). The READ is a valid and reliable measure of protective factors involved in resilience and demonstrates promise for cross-cultural applicability. Recommendations for measuring resilience and validating the READ in future investigations are provided.

Assessment of Psychological Distress in Adults With Type 2 Diabetes Mellitus Through Technologies: Literature Review.

BACKGROUND: The use of technological devices can support the self-management of individuals with type 2 diabetes mellitus (T2DM), particularly in addressing psychological distress. However, there is poor consistency in the literature regarding the use of psychological instruments for the web-based screening of patients' psychological distress and subsequent monitoring of their psychological condition during digital interventions. OBJECTIVE: This study aims to review previous literature on the types of psychological instruments delivered in digital interventions for assessing depression, anxiety, and stress in patients with T2DM. METHODS: The literature review was conducted using the PsycINFO, CINAHL and PubMed databases, in which the following terms were considered: diabetes mellitus, measure, assessment, self-care, self-management, depression, anxiety, stress, technology, eHealth, mobile health, mobile phone, device, and smartphone. RESULTS: In most studies, psychological assessments were administered on paper. A few studies deployed self-reporting techniques employing automated telephonic assessment, a call system for screening and monitoring patients' conditions and preferences, or through telephone interviews via interactive voice response calls, a self-management support program leveraging tailored messages and structured emails. Other studies used simple telephone interviews and included the use of apps for tablets and smartphones to assess the psychological well-being of patients. Finally, some studies deployed mood rating scales delivered through tailored text message-based support systems. CONCLUSIONS: The deployment of appropriate psychological tools in digital interventions allows researchers and clinicians to make the screening of anxiety, stress, and depression symptoms faster and easier in patients with T2DM. Data from this literature review suggest that mobile health solutions may be preferred tools to use in such digital interventions.

A Chatbot-Based Coaching Intervention for Adolescents to Promote Life Skills: Pilot Study.

BACKGROUND: Adolescence is a challenging period, where youth face rapid changes as well as increasing socioemotional demands and threats, such as bullying and cyberbullying. Adolescent mental health and well-being can be best supported by providing effective coaching on life skills, such as coping strategies and protective factors. Interventions that take advantage of online coaching by means of chatbots, deployed on Web or mobile technology, may be a novel and more appealing way to support positive mental health for adolescents. OBJECTIVE: In this pilot study, we co-designed and conducted a formative evaluation of an online, life skills coaching, chatbot intervention, inspired by the positive technology approach, to promote mental well-being in adolescence. METHODS: We co-designed the first life skills coaching session of the CRI (for girls) and CRIS (for boys) chatbot with 20 secondary school students in a participatory design workshop. We then conducted a formative evaluation of the entire intervention-eight sessions-with a convenience sample of 21 adolescents of both genders (mean age 14.52 years). Participants engaged with the chatbot sessions over 4 weeks and filled in an anonymous user experience questionnaire at the end of each session; responses were based on a 5-point Likert scale. RESULTS: A majority of the adolescents found the intervention useful (16/21, 76%), easy to use (19/21, 90%), and innovative (17/21, 81%). Most of the participants (15/21, 71%) liked, in particular, the video cartoons provided by the chatbot in the coaching sessions. They also thought that a session should last only 5-10 minutes (14/21, 66%) and said they would recommend the intervention to a friend (20/21, 95%). CONCLUSIONS: We have presented a novel and scalable self-help intervention to deliver life skills coaching to adolescents online that is appealing to this population. This intervention can support the promotion of coping skills and mental well-being among youth.

UPRIGHT, a resilience-based intervention to promote mental well-being in schools: study rationale and methodology for a European randomized controlled trial.

BACKGROUND: Adolescence is crucial period for laying the foundations for healthy development and mental well-being. The increasing prevalence of mental disorders amongst adolescents makes promotion of mental well-being and prevention interventions at schools important. UPRIGHT (Universal Preventive Resilience Intervention Globally implemented in schools to improve and promote mental Health for Teenagers) is designed as a whole school approach (school community, students and families) to promote a culture of mental well-being and prevent mental disorders by enhancing resilience capacities. The present article aims at describing the rationale, conceptual framework, as well as methodology of implementation and evaluation of the UPRIGHT intervention. METHODS: UPRIGHT project is a research and innovation project funded by the European Union's Horizon 2020 Research and Innovation programme under grant agreement No. 754919 (Duration: 48 months). The theoretical framework has been developed by an innovative and multidisciplinary approach using a co-creation process inside the UPRIGHT Consortium (involving seven institutions from Spain, Italy, Poland, Norway, Denmark, and Iceland). Resulted is the UPRIGHT programme with 18 skills related to 4 components: Mindfulness, Coping, Efficacy and Social and Emotional Learning. Among the five Pan-European regions, 34 schools have been currently involved (17 control; 17 intervention) and around 6000 adolescents and their families are foreseen to participate along a 3-year period of evaluation. Effectiveness of the intervention will be evaluated as a randomized controlled trial including quantitative and qualitative analysis in the five Pan-European regions representative of the cultural and socioeconomic diversity. The cost-effectiveness assessment will be performed by simulation modelling methods. DISCUSSION: We expect a short- to medium-term improvement of mental well-being in adolescents by enhancing resilience capacities. The study may provide robust evidence on intrapersonal, familiar and social environmental resilience factors promoting positive mental well-being. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03951376 . Registered 15 May 2019.