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Abstract Background Digital innovations can reduce the global burden of depression by facilitating timely and scalable interventions. In recent years, the number of commercial Digital Health Interventions for Depression (DHIDs) has been on the rise. However, there is limited knowledge on their content and underpinning scientific evidence. This study aimed to: (i) identify the top-funded companies offering DHIDs and (ii) provide an overview of their interventions, including scientific evidence, psychotherapeutic approaches and use of novel technologies. Methods A systematic search was conducted using two venture capital databases to identify the top-30 funded companies offering DHIDs. In addition, studies related to the DHIDs’ were identified via academic databases and hand-searching. The methodological quality of the publications was evaluated using the Mixed Methods Appraisal Tool. Results The top-30 funded companies offering DHIDs received a total funding of 2,592 million USD. Less than half of the companies produced any scientific research associated with their DHIDs, with a total of 83 publications identified. Twenty-five publications were randomised control trials, of which 15 reported moderate-to-large effects in reducing depression symptoms. Regarding novel technologies, few DHIDs incorporated the use of conversational agents or low-burden sensing technologies. Conclusions Funding received by top-funded companies was not related to the amount of scientific evidence provided on their DHIDs. There was a strong variation in the quantity of evidence produced and an overall need for more rigorous effectiveness trials. Few DHIDs used automated approaches such as conversational agents, limiting their scalability.

BackgroundTo scale up mental health care in low-resource settings, digital interventions must consider cultural fit. Despite the findings that culturally adapted digital interventions have greater effectiveness, there is a lack of empirical evidence of interventions that have been culturally adapted or their adaptation documented. ObjectiveThis study aimed to document the cultural adaptation of the SilverCloud Health Space from Depression and Anxiety program for university students in Colombia and Mexico and evaluate user satisfaction with the adapted program. MethodsA mixed methods process was based on Cultural Sensitivity and Ecological Validity frameworks. In phase 1, the research team added culturally relevant content (eg, expressions, personal stories, photos) for the target population to the intervention. In phase 2, potential users (9 university students) first evaluated the vignettes and photos used throughout the program. We calculated median and modal responses. They then participated in focus groups to evaluate and assess the cultural appropriateness of the materials. Their comments were coded into the 8 dimensions of the Ecological Validity Framework. Phase 3 consisted of choosing the vignettes most highly rated by the potential users and making modifications to the materials based on the student feedback. In the final phase, 765 actual users then engaged with the culturally adapted program and rated their satisfaction with the program. We calculated the percentage of users who agreed or strongly agreed that the modules were interesting, relevant, useful, and helped them attain their goals. ResultsThe potential users perceived the original vignettes as moderately genuine, or true, which were given median scores between 2.5 and 3 (out of a possible 4) and somewhat identified with the situations presented in the vignettes given median scores between 1.5 and 3. The majority of comments or suggestions for modification concerned language (126/218, 57.5%), followed by concepts (50/218, 22.8%). Much less concerned methods (22/218, 10%), persons (9/218, 4.1%), context (5/218, 2.3%), or content (2/218, 0.9%). There were no comments about metaphors or goals. Intervention materials were modified based on these results. Of the actual users who engaged with the adapted version of the program, 87.7%-96.2% of them agreed or strongly agreed that the modules were interesting, relevant, useful, and helped them to attain their goals. ConclusionsWe conclude that the adapted version is satisfactory for this population based on the focus group discussions and the satisfaction scores. Conducting and documenting such cultural adaptations and involving the users in the cultural adaptation process will likely improve the effectiveness of digital mental health interventions in low- and middle-income countries and culturally diverse contexts.

Abstract Background Women with a history of gestational diabetes mellitus (GDM) are 12-fold more likely to develop type 2 diabetes (T2D) 4–6 years after delivery than women without GDM. Similarly, GDM is associated with the development of common mental disorders (CMDs) (e.g. anxiety and depression). Evidence shows that holistic lifestyle interventions focusing on physical activity (PA), dietary intake, sleep, and mental well-being strategies can prevent T2D and CMDs. This study aims to assess the effectiveness of a holistic lifestyle mobile health intervention (mHealth) with post-GDM women in preventing T2D and CMDs in a community setting in Singapore. Methods The study consists of a 1-year randomised controlled trial (RCT) with a 3-year follow-up period. Post-GDM women with no current diabetes diagnosis and not planning to become pregnant will be eligible for the study. In addition, participants will complete mental well-being questionnaires (e.g. depression, anxiety, sleep) and their child’s socio-emotional and cognitive development. The participants will be randomised to either Group 1 (Intervention) or Group 2 (comparison). The intervention group will receive the “LVL UP App”, a smartphone-based, conversational agent-delivered holistic lifestyle intervention focused on three pillars: Move More (PA), Eat Well (Diet), and Stress Less (mental wellbeing). The intervention consists of health literacy and psychoeducational coaching sessions, daily “Life Hacks” (healthy activity suggestions), slow-paced breathing exercises, a step tracker (including brisk steps), a low-burden food diary, and a journaling tool. Women from both groups will be provided with an Oura ring for tracking physical activity, sleep, and heart rate variability (a proxy for stress), and the “HAPPY App”, a mHealth app which provides health promotion information about PA, diet, sleep, and mental wellbeing, as well as display body mass index, blood pressure, and results from the oral glucose tolerance tests. Short-term aggregate effects will be assessed at 26/27 weeks (midpoint) and a 1-year visit, followed by a 2, 3, and 4-year follow-up period. Discussion High rates of progression of T2D and CMDs in women with post-GDM suggest an urgent need to promote a healthy lifestyle, including diet, PA, sleep, and mental well-being. Preventive interventions through a holistic, healthy lifestyle may be the solution, considering the inextricable relationship between physical and psychological health. We expect that holistic lifestyle mHealth may effectively support behavioural changes among women with a history of GDM to prevent T2D and CMDs. Trial status The protocol study was approved by the National Healthcare Group in Singapore, Domain Specific Review Board (DSRB) [2023/00178]; June 2023. Recruitment began on October 18, 2023. Trial registration ClinicalTrials.gov NCT05949957. The first submission date is June 08, 2023.

Summary: Background: Good physical and mental health are essential for healthy ageing. Holistic mobile health (mHealth) interventions—including at least three components: physical activity, diet, and mental health—could support both physical and mental health and be scaled to the population level. This review aims to describe the characteristics of holistic mHealth interventions and their effects on related behavioural and health outcomes among adults from the general population. Methods: In this systematic review and meta-analysis, we searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, PsycINFO, Scopus, China National Knowledge Infrastructure, and Google Scholar (first 200 records). The initial search covered January 1, 2011, to April 13, 2022, and an updated search extended from April 13, 2022 to August 30, 2023. Randomised controlled trials (RCTs) and non-randomised studies of interventions (NRSIs) were included if they (i) were delivered via mHealth technologies, (ii) included content on physical activity, diet, and mental health, and (iii) targeted adults (≥18 years old) from the general population or those at risk of non-communicable diseases (NCDs) or mental disorders. Studies were excluded if they targeted pregnant women (due to distinct physiological responses), individuals with pre-existing NCDs or mental disorders (to emphasise prevention), or primarily utilised web, email, or structured phone support (to focus on mobile technologies without exclusive human support). Data (summary data from published reports) extraction and risk-of-bias assessment were completed by two reviewers using a standard template and Cochrane risk-of-bias tools, respectively. Narrative syntheses were conducted for all studies, and random-effects models were used in the meta-analyses to estimate the pooled effect of interventions for outcomes with comparable data in the RCTs. The study was registered in PROSPERO, CRD42022315166. Findings: After screening 5488 identified records, 34 studies (25 RCTs and 9 pre-post NRSIs) reported in 43 articles with 5691 participants (mean age 39 years, SD 12.5) were included. Most (91.2%, n = 31/34) were conducted in high-income countries. The median intervention duration was 3 months, and only 23.5% (n = 8/34) of studies reported follow-up data. Mobile applications, short-message services, and mobile device-compatible websites were the most common mHealth delivery modes; 47.1% (n = 16/34) studies used multiple mHealth delivery modes. Of 15 studies reporting on weight change, 9 showed significant reductions (6 targeted on individuals with overweight or obesity), and in 10 studies reporting perceived stress levels, 4 found significant reductions (all targeted on general adults). In the meta-analysis, holistic mHealth interventions were associated with significant weight loss (9 RCTs; mean difference −1.70 kg, 95% CI −2.45 to −0.95; I2 = 89.00%) and a significant reduction in perceived stress levels (6 RCTs; standardised mean difference [SMD] −0.32; 95% CI −0.52 to −0.12; I2 = 14.52%). There were no significant intervention effects on self-reported moderate-to-vigorous physical activity (5 RCTs; SMD 0.21; 95%CI −0.25 to 0.67; I2 = 74.28%) or diet quality scores (5 RCTs; SMD 0.21; 95%CI −0.47 to 0.65; I2 = 62.27%). All NRSIs were labelled as having a serious risk of bias overall; 56% (n = 14/25) of RCTs were classified as having some concerns, and the others as having a high risk of bias. Interpretation: Findings from identified studies suggest that holistic mHealth interventions may aid reductions in weight and in perceived stress levels, with small to medium effect sizes. The observed effects on diet quality scores and self-reported moderate-to-vigorous physical activity were less clear and require more research. High-quality RCTs with longer follow-up durations are needed to provide more robust evidence. To promote population health, future research should focus on vulnerable populations and those in middle- and low-income countries. Optimal combinations of delivery modes and components to improve efficacy and sustain long-term effects should also be explored. Funding: National Research Foundation, Prime Minister's Office, Singapore, under its Campus for Research Excellence and Technological Enterprise (CREATE) Programme and Physical Activity and Nutrition Determinants in Asia (PANDA) Research Programme.

Abstract Background Changing lifestyle patterns over the last decades have seen growing numbers of people in Asia affected by non-communicable diseases and common mental health disorders, including diabetes, cancer, and/or depression. Interventions targeting healthy lifestyle behaviours through mobile technologies, including new approaches such as chatbots, may be an effective, low-cost approach to prevent these conditions. To ensure uptake and engagement with mobile health interventions, however, it is essential to understand the end-users’ perspectives on using such interventions. The aim of this study was to explore perceptions, barriers, and facilitators to the use of mobile health interventions for lifestyle behaviour change in Singapore. Methods Six virtual focus group discussions were conducted with a total of 34 participants (mean ± SD; aged 45 ± 3.6 years; 64.7% females). Focus group recordings were transcribed verbatim and analysed using an inductive thematic analysis approach, followed by deductive mapping according to perceptions, barriers, facilitators, mixed factors, or strategies. Results Five themes were identified: (i) holistic wellbeing is central to healthy living (i.e., the importance of both physical and mental health); (ii) encouraging uptake of a mobile health intervention is influenced by factors such as incentives and government backing; (iii) trying out a mobile health intervention is one thing, sticking to it long term is another and there are key factors, such as personalisation and ease of use that influence sustained engagement with mobile health interventions; (iv) perceptions of chatbots as a tool to support healthy lifestyle behaviour are influenced by previous negative experiences with chatbots, which might hamper uptake; and (v) sharing health-related data is OK, but with conditions such as clarity on who will have access to the data, how it will be stored, and for what purpose it will be used. Conclusions Findings highlight several factors that are relevant for the development and implementation of mobile health interventions in Singapore and other Asian countries. Recommendations include: (i) targeting holistic wellbeing, (ii) tailoring content to address environment-specific barriers, (iii) partnering with government and/or local (non-profit) institutions in the development and/or promotion of mobile health interventions, (iv) managing expectations regarding the use of incentives, and (iv) identifying potential alternatives or complementary approaches to the use of chatbots, particularly for mental health.

BackgroundThe current paper details findings from Elena+: Care for COVID-19, an app developed to tackle the collateral damage of lockdowns and social distancing, by offering pandemic lifestyle coaching across seven health areas: anxiety, loneliness, mental resources, sleep, diet and nutrition, physical activity, and COVID-19 information.MethodsThe Elena+ app functions as a single-arm interventional study, with participants recruited predominantly via social media. We used paired samples T-tests and within subjects ANOVA to examine changes in health outcome assessments and user experience evaluations over time. To investigate the mediating role of behavioral activation (i.e., users setting behavioral intentions and reporting actual behaviors) we use mixed-effect regression models. Free-text entries were analyzed qualitatively.ResultsResults show strong demand for publicly available lifestyle coaching during the pandemic, with total downloads (N = 7′135) and 55.8% of downloaders opening the app (n = 3,928) with 9.8% completing at least one subtopic (n = 698). Greatest areas of health vulnerability as assessed with screening measures were physical activity with 62% (n = 1,000) and anxiety with 46.5% (n = 760). The app was effective in the treatment of mental health; with a significant decrease in depression between first (14 days), second (28 days), and third (42 days) assessments: F2,38 = 7.01, p = 0.003, with a large effect size (η2G = 0.14), and anxiety between first and second assessments: t54 = 3.7, p =

BackgroundNon-communicable diseases (NCDs) and common mental disorders (CMDs) are the leading causes of death and disability worldwide. Lifestyle interventions via mobile apps and conversational agents present themselves as low-cost, scalable solutions to prevent these conditions. This paper describes the rationale for, and development of, “LvL UP 1.0″, a smartphone-based lifestyle intervention aimed at preventing NCDs and CMDs.Materials and MethodsA multidisciplinary team led the intervention design process of LvL UP 1.0, involving four phases: (i) preliminary research (stakeholder consultations, systematic market reviews), (ii) selecting intervention components and developing the conceptual model, (iii) whiteboarding and prototype design, and (iv) testing and refinement. The Multiphase Optimization Strategy and the UK Medical Research Council framework for developing and evaluating complex interventions were used to guide the intervention development.ResultsPreliminary research highlighted the importance of targeting holistic wellbeing (i.e., both physical and mental health). Accordingly, the first version of LvL UP features a scalable, smartphone-based, and conversational agent-delivered holistic lifestyle intervention built around three pillars: Move More (physical activity), Eat Well (nutrition and healthy eating), and Stress Less (emotional regulation and wellbeing). Intervention components include health literacy and psychoeducational coaching sessions, daily “Life Hacks” (healthy activity suggestions), breathing exercises, and journaling. In addition to the intervention components, formative research also stressed the need to introduce engagement-specific components to maximise uptake and long-term use. LvL UP includes a motivational interviewing and storytelling approach to deliver the coaching sessions, as well as progress feedback and gamification. Offline materials are also offered to allow users access to essential intervention content without needing a mobile device.ConclusionsThe development process of LvL UP 1.0 led to an evidence-based and user-informed smartphone-based intervention aimed at preventing NCDs and CMDs. LvL UP is designed to be a scalable, engaging, prevention-oriented, holistic intervention for adults at risk of NCDs and CMDs. A feasibility study, and subsequent optimisation and randomised-controlled trials are planned to further refine the intervention and establish effectiveness. The development process described here may prove helpful to other intervention developers.

Introduction Maintaining physical and mental health is essential for healthy ageing. It can be supported by modifying lifestyle factors such as physical activity and diet. Poor mental health, in turn, contributes to the opposing effect. The promotion of healthy ageing may therefore benefit from holistic interventions integrating physical activity, diet and mental health. These interventions can be scaled up to the population level by using mobile technologies. However, systematic evidence regarding the characteristics and effectiveness of such holistic mHealth interventions remains limited. This paper presents a protocol for a systematic review that aims to provide an overview of the current state of the evidence for holistic mHealth interventions, including their characteristics and effects on behavioural and health outcomes in general adult populations .Methods and analysis We will conduct a comprehensive search for randomised controlled trials and non-randomised studies of interventions published between January 2011 and April 2022 in MEDLINE, Embase, Cochrane Central Register of Controlled Trials, PsycINFO, Scopus, China National Knowledge Infrastructure and Google Scholar (first 200 records). Eligible studies will be mHealth interventions targeting general adult populations with content on physical activity, diet and mental health. We will extract information on all relevant behavioural and health outcomes, as well as those related to intervention feasibility. Screening and data extraction processes will be carried out independently by two reviewers. Cochrane risk-of-bias tools will be used to assess risk of bias. We will provide a narrative overview of the findings from eligible studies. With sufficient data, a meta-analysis will be conducted.Ethics and dissemination Ethical approval is not required because this study is a systematic review based on published data. We intend to publish our findings in a peer-reviewed journal and present the study at international conferences.PROSPERO registration number CRD42022315166.

Abstract Background Major depressive disorder (MDD) and generalized anxiety disorder (GAD) are highly prevalent among university students and predict impaired college performance and later life role functioning. Yet most students do not receive treatment, especially in low-middle-income countries (LMICs). We aim to evaluate the effects of expanding treatment using scalable and inexpensive Internet-delivered transdiagnostic cognitive behavioral therapy (iCBT) among college students with symptoms of MDD and/or GAD in two LMICs in Latin America (Colombia and Mexico) and to investigate the feasibility of creating a precision treatment rule (PTR) to predict for whom iCBT is most effective. Methods We will first carry out a multi-site randomized pragmatic clinical trial (N = 1500) of students seeking treatment at student mental health clinics in participating universities or responding to an email offering services. Students on wait lists for clinic services will be randomized to unguided iCBT (33%), guided iCBT (33%), and treatment as usual (TAU) (33%). iCBT will be provided immediately whereas TAU will be whenever a clinic appointment is available. Short-term aggregate effects will be assessed at 90 days and longer-term effects 12 months after randomization. We will use ensemble machine learning to predict heterogeneity of treatment effects of unguided versus guided iCBT versus TAU and develop a precision treatment rule (PTR) to optimize individual student outcome. We will then conduct a second and third trial with separate samples (n = 500 per arm), but with unequal allocation across two arms: 25% will be assigned to the treatment determined to yield optimal outcomes based on the PTR developed in the first trial (PTR for optimal short-term outcomes for Trial 2 and 12-month outcomes for Trial 3), whereas the remaining 75% will be assigned with equal allocation across all three treatment arms. Discussion By collecting comprehensive baseline characteristics to evaluate heterogeneity of treatment effects, we will provide valuable and innovative information to optimize treatment effects and guide university mental health treatment planning. Such an effort could have enormous public-health implications for the region by increasing the reach of treatment, decreasing unmet need and clinic wait times, and serving as a model of evidence-based intervention planning and implementation. Trial status IRB Approval of Protocol Version 1.0; June 3, 2020. Recruitment began on March 1, 2021. Recruitment is tentatively scheduled to be completed on May 30, 2024. Trial registration ClinicalTrials.gov NCT04780542 . First submission date: February 28, 2021.

BackgroundMental health interventions delivered through mobile health (mHealth) technologies can increase the access to mental health services, especially among university students. The development of mHealth intervention is complex and needs to be context sensitive. There is currently limited evidence on the perceptions, needs, and barriers related to these interventions in the Southeast Asian context. ObjectiveThis qualitative study aimed to explore the perception of university students and mental health supporters in Singapore about mental health services, campaigns, and mHealth interventions with a focus on conversational agent interventions for the prevention of common mental disorders such as anxiety and depression. MethodsWe conducted 6 web-based focus group discussions with 30 university students and one-to-one web-based interviews with 11 mental health supporters consisting of faculty members tasked with student pastoral care, a mental health first aider, counselors, psychologists, a clinical psychologist, and a psychiatrist. The qualitative analysis followed a reflexive thematic analysis framework. ResultsThe following 6 main themes were identified: a healthy lifestyle as students, access to mental health services, the role of mental health promotion campaigns, preferred mHealth engagement features, factors that influence the adoption of mHealth interventions, and cultural relevance of mHealth interventions. The interpretation of our findings shows that students were reluctant to use mental health services because of the fear of stigma and a possible lack of confidentiality. ConclusionsStudy participants viewed mHealth interventions for mental health as part of a blended intervention. They also felt that future mental health mHealth interventions should be more personalized and capable of managing adverse events such as suicidal ideation.

BackgroundMobile health (mHealth) apps show vast potential in supporting patients and health care systems with the increasing prevalence and economic costs of noncommunicable diseases (NCDs) worldwide. However, despite the availability of evidence-based mHealth apps, a substantial proportion of users do not adhere to them as intended and may consequently not receive treatment. Therefore, understanding the factors that act as barriers to or facilitators of adherence is a fundamental concern in preventing intervention dropouts and increasing the effectiveness of digital health interventions. ObjectiveThis review aimed to help stakeholders develop more effective digital health interventions by identifying factors influencing the continued use of mHealth apps targeting NCDs. We further derived quantified adherence scores for various health domains to validate the qualitative findings and explore adherence benchmarks. MethodsA comprehensive systematic literature search (January 2007 to December 2020) was conducted on MEDLINE, Embase, Web of Science, Scopus, and ACM Digital Library. Data on intended use, actual use, and factors influencing adherence were extracted. Intervention-related and patient-related factors with a positive or negative influence on adherence are presented separately for the health domains of NCD self-management, mental health, substance use, nutrition, physical activity, weight loss, multicomponent lifestyle interventions, mindfulness, and other NCDs. Quantified adherence measures, calculated as the ratio between the estimated intended use and actual use, were derived for each study and compared with the qualitative findings. ResultsThe literature search yielded 2862 potentially relevant articles, of which 99 (3.46%) were included as part of the inclusion criteria. A total of 4 intervention-related factors indicated positive effects on adherence across all health domains: personalization or tailoring of the content of mHealth apps to the individual needs of the user, reminders in the form of individualized push notifications, user-friendly and technically stable app design, and personal support complementary to the digital intervention. Social and gamification features were also identified as drivers of app adherence across several health domains. A wide variety of patient-related factors such as user characteristics or recruitment channels further affects adherence. The derived adherence scores of the included mHealth apps averaged 56.0% (SD 24.4%). ConclusionsThis study contributes to the scarce scientific evidence on factors that positively or negatively influence adherence to mHealth apps and is the first to quantitatively compare adherence relative to the intended use of various health domains. As underlying studies mostly have a pilot character with short study durations, research on factors influencing adherence to mHealth apps is still limited. To facilitate future research on mHealth app adherence, researchers should clearly outline and justify the app’s intended use; report objective data on actual use relative to the intended use; and, ideally, provide long-term use and retention data.

Abstract Background Despite the widely recognised importance of cultural adaptation to increase the effectiveness of psychological interventions, there is little guidance on its process. Developed based on existing theory, we applied a four-step process to culturally adapt a low-intensity psychological intervention for use in humanitarian settings. Methods The four-step process was applied to adapt a WHO low-intensity psychological intervention (i.e. Problem Management Plus, or PM+) for use with displaced Venezuelans and Colombians in Colombia. First, a rapid desk review was used as an (1) information gathering tool to identify local population characteristics. Next, the results were taken forward for the (2) formulation of adaptation hypotheses, whereby PM+ protocols were screened to identify components for adaptation, drawing on the Ecological Validity Model. Third, the elements flagged for adaptation were taken forward for (3) local consultation to firstly, verify the components identified for adaptation, to identify other areas in need of adaptation, and thirdly, to adapt the intervention protocols. Finally, the adapted intervention protocols were reviewed through (4) external evaluations with local experts. Results The information gathering phase yielded key information on the socioeconomic aspects of the groups targeted for intervention, the availability and need for mental health and psychosocial support, and existing barriers to accessing care. The adaptation hypotheses phase further identified the need for clearer explanations of key concepts, the need for sensitive topics to match local attitudes (e.g., domestic violence, thoughts of suicide), and the identification of culturally appropriate social supports. Building on these first two phases, local consultation subsequently resulted in revised PM+ protocols. The adapted protocols differed from the original format in their focus on the problems unique to these population groups, the way that psychological distress is expressed in this context, and the inclusion of locally available supports. The results of the external evaluation supported the adaptations made to the protocols. Conclusion The proposed four-step process offers a useful guide for how to adapt low-intensity psychological intervention within humanitarian settings. Despite some limitations, we show that even when time and resources are scarce it is possible and necessary to culturally adapt psychological interventions. We invite further testing, replication, and improvements to this methodology.

[Background] There is a lack of empirical evidence on the level of cultural adaptation required for psychological interventions developed in Western, Educated, Industrialized, Rich, and Democratic (WEIRD) societies to be effective for the treatment of common mental disorders among culturally and ethnically diverse groups. This lack of evidence is partly due to insufficient documentation of cultural adaptation in psychological trials. Standardised documentation is needed in order to enhance empirical and meta-analytic evidence. [Process] A “Task force for cultural adaptation of mental health interventions for refugees” was established to harmonise and document the cultural adaptation process across several randomised controlled trials testing psychological interventions for mental health among refugee populations in Germany. Based on the collected experiences, a sub-group of the task force developed the reporting criteria presented in this paper. Thereafter, an online survey with international experts in cultural adaptation of psychological interventions was conducted, including two rounds of feedback. [Results] The consolidation process resulted in eleven reporting criteria to guide and document the process of cultural adaptation of psychological interventions in clinical trials. A template for documenting this process is provided. The eleven criteria are structured along A) Set-up; B) Formative research methods; C) Intervention adaptation; D) Measuring outcomes and implementation. [Conclusions] Reporting on cultural adaptation more consistently in future psychological trials will hopefully improve the quality of evidence and contribute to examining the effect of cultural adaptation on treatment efficacy, feasibility, and acceptability.

Background: The current COVID-19 coronavirus pandemic is an emergency on a global scale, with huge swathes of the population required to remain indoors for prolonged periods to tackle the virus. In this new context, individuals' health-promoting routines are under greater strain, contributing to poorer mental and physical health. Additionally, individuals are required to keep up to date with latest health guidelines about the virus, which may be confusing in an age of social-media disinformation and shifting guidelines. To tackle these factors, we developed Elena+, a smartphone-based and conversational agent (CA) delivered pandemic lifestyle care intervention.Methods: Elena+ utilizes varied intervention components to deliver a psychoeducation-focused coaching program on the topics of: COVID-19 information, physical activity, mental health (anxiety, loneliness, mental resources), sleep and diet and nutrition. Over 43 subtopics, a CA guides individuals through content and tracks progress over time, such as changes in health outcome assessments per topic, alongside user-set behavioral intentions and user-reported actual behaviors. Ratings of the usage experience, social demographics and the user profile are also captured. Elena+ is available for public download on iOS and Android devices in English, European Spanish and Latin American Spanish with future languages and launch countries planned, and no limits on planned recruitment. Panel data methods will be used to track user progress over time in subsequent analyses. The Elena+ intervention is open-source under the Apache 2 license (MobileCoach software) and the Creative Commons 4.0 license CC BY-NC-SA (intervention logic and content), allowing future collaborations; such as cultural adaptions, integration of new sensor-related features or the development of new topics.Discussion: Digital health applications offer a low-cost and scalable route to meet challenges to public health. As Elena+ was developed by an international and interdisciplinary team in a short time frame to meet the COVID-19 pandemic, empirical data are required to discern how effective such solutions can be in meeting real world, emergent health crises. Additionally, clustering Elena+ users based on characteristics and usage behaviors could help public health practitioners understand how population-level digital health interventions can reach at-risk and sub-populations.

Background: Culturally adapted psychotherapy (CAP) studies are limited and until now there are few published examples that illustrate the process of cultural adaptation with internet-delivered treatments. Aim: This paper aims to illustrate an integrative approach to the cultural adaptation of an evidence-based internet-delivered cognitive-behavioural therapy intervention for depression (Space from Depression programme). Method: Mixed method approach utilising quantitative and qualitative methods to assist in the cultural adaptation of the Space from Depression programme was used. The adaptation involved a framework for cultural sensitivity (CSF), alongside an ecological validity framework (EVF) and principles from cross-cultural assessment research. The method included the development of a theory-informed measure, the Cultural Relevance Questionnaire (CRQ), designed specifically for this research. Results: The adaptation included an establishment of CSF, which included the incorporation of Colombian cultural expressions. College students' (n = 5) and experts' (n = 7) evaluated the EVF based on cross-cultural assessment principles of a preliminary adapted version through the CRQ, showing reliability in the sample (Cronbach's Alpha 0.744). Qualitative analysis supported the culturally sensitive changes or incorporations made to the programme, such as: personal stories and textual translations from English and these were considered ecologically valid and representative. Conclusions: The research provided support for the idea that CAP can be conducted systematically for internet-delivered interventions. Keywords: Culturally adapted psychotherapy, Internet-delivered treatment, Cultural sensitivity framework, Ecological validity framework, Cultural equivalence, Depression

Abstract Background Depression is the principal cause of disability in the world. High prevalence rates of depression in general populations and college students have been found worldwide and in various cultural groups. Low-intensity cognitive behavioural internet-delivered treatment has demonstrated efficacy in high-income-countries (HICs). However little is known of their potential for adaptation and efficacy in low and middle-income countries. Methods Study (1) involves the cultural adaptation of the Space from Depression cognitive-behaviour internet-delivered programme with an asynchronous support for depressive symptoms. This includes initial researcher/clinician adaptation and the integration of cultural assessment feedback of the programme by a panel of experts and users through the theoretically-based Cultural Relevance Questionnaire (CRQ). Study (2) describes the implementation of the culturally adapted intervention using a randomised controlled trial methodology. The efficacy trial will include an active treatment group and a waiting-list control group of participants meeting eligibility criteria (mild to moderate depression symptoms). The active condition will consist of 7 weekly modules of internet-delivered cognitive behavioural therapy (iCBT) Space from Depression, with post-session feedback support. The primary outcome will be the Patient Health Questionnaire (PHQ-9). The study also involves collection of client reported significant events and client satisfaction with the internet-delivered treatment. Data will be collected at baseline and at post-treatment (week 7), and at follow-up (week 20/3 months). Analysis will be conducted on the intention-to-treat basis. Discussion The study seeks to establish a theoretically robust methodology for culturally adapting internet-delivered interventions for mental health disorders and to evaluate the efficacy of a culturally adapted internet-delivered treatment for depression in Colombia, with support. The study will be a first contribution to a method for culturally adapting internet-delivered interventions and also a first to examine the efficacy of such an adapted intervention in Latin America. Trial registration Clinical trials NCT03062215. Retrospectively registered 14th February 2017.

BackgroundThe number of smartphone apps that focus on the prevention, diagnosis, and treatment of depression is increasing. A promising approach to increase the effectiveness of the apps while reducing the individual’s burden is the use of just-in-time adaptive intervention (JITAI) mechanisms. JITAIs are designed to improve the effectiveness of the intervention and reduce the burden on the person using the intervention by providing the right type of support at the right time. The right type of support and the right time are determined by measuring the state of vulnerability and the state of receptivity, respectively. ObjectiveThe aim of this study is to systematically assess the use of JITAI mechanisms in popular apps for individuals with depression. MethodsWe systematically searched for apps addressing depression in the Apple App Store and Google Play Store, as well as in curated lists from the Anxiety and Depression Association of America, the United Kingdom National Health Service, and the American Psychological Association in August 2020. The relevant apps were ranked according to the number of reviews (Apple App Store) or downloads (Google Play Store). For each app, 2 authors separately reviewed all publications concerning the app found within scientific databases (PubMed, Cochrane Register of Controlled Trials, PsycINFO, Google Scholar, IEEE Xplore, Web of Science, ACM Portal, and Science Direct), publications cited on the app’s website, information on the app’s website, and the app itself. All types of measurements (eg, open questions, closed questions, and device analytics) found in the apps were recorded and reviewed. ResultsNone of the 28 reviewed apps used JITAI mechanisms to tailor content to situations, states, or individuals. Of the 28 apps, 3 (11%) did not use any measurements, 20 (71%) exclusively used self-reports that were insufficient to leverage the full potential of the JITAIs, and the 5 (18%) apps using self-reports and passive measurements used them as progress or task indicators only. Although 34% (23/68) of the reviewed publications investigated the effectiveness of the apps and 21% (14/68) investigated their efficacy, no publication mentioned or evaluated JITAI mechanisms. ConclusionsPromising JITAI mechanisms have not yet been translated into mainstream depression apps. Although the wide range of passive measurements available from smartphones were rarely used, self-reported outcomes were used by 71% (20/28) of the apps. However, in both cases, the measured outcomes were not used to tailor content and timing along a state of vulnerability or receptivity. Owing to this lack of tailoring to individual, state, or situation, we argue that the apps cannot be considered JITAIs. The lack of publications investigating whether JITAI mechanisms lead to an increase in the effectiveness or efficacy of the apps highlights the need for further research, especially in real-world apps.