Effectiveness of holistic mobile health interventions on diet, and physical, and mental health outcomes: a systematic review and meta-analysis.

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.

Can digital health researchers make a difference during the pandemic? Results of the single-arm, chatbot-led Elena+: Care for COVID-19 interventional study.

Background: The 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. Methods: The 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. Results: Results 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 = <0.001 with a medium effect size (Cohen d = 0.499). Those that followed the coaching program increased in net promoter score between the first and second assessment: t36 = 2.08, p = 0.045 with a small to medium effect size (Cohen d = 0.342). Mediation analyses showed that while increasing number of subtopics completed increased behavioral activation (i.e., match between behavioral intentions and self-reported actual behaviors), behavioral activation did not mediate the relationship to improvements in health outcome assessments. Conclusions: Findings show that: (i) there is public demand for chatbot led digital coaching, (ii) such tools can be effective in delivering treatment success, and (iii) they are highly valued by their long-term user base. As the current intervention was developed at rapid speed to meet the emergency pandemic context, the future looks bright for other public health focused chatbot-led digital health interventions.

Effective Behavior Change Techniques in Digital Health Interventions for the Prevention or Management of Noncommunicable Diseases: An Umbrella Review.

BACKGROUND: Despite an abundance of digital health interventions (DHIs) targeting the prevention and management of noncommunicable diseases (NCDs), it is unclear what specific components make a DHI effective. PURPOSE: This narrative umbrella review aimed to identify the most effective behavior change techniques (BCTs) in DHIs that address the prevention or management of NCDs. METHODS: Five electronic databases were searched for articles published in English between January 2007 and December 2022. Studies were included if they were systematic reviews or meta-analyses of DHIs targeting the modification of one or more NCD-related risk factors in adults. BCTs were coded using the Behavior Change Technique Taxonomy v1. Study quality was assessed using AMSTAR 2. RESULTS: Eighty-five articles, spanning 12 health domains and comprising over 865,000 individual participants, were included in the review. We found evidence that DHIs are effective in improving health outcomes for patients with cardiovascular disease, cancer, type 2 diabetes, and asthma, and health-related behaviors including physical activity, sedentary behavior, diet, weight management, medication adherence, and abstinence from substance use. There was strong evidence to suggest that credible source, social support, prompts and cues, graded tasks, goals and planning, feedback and monitoring, human coaching and personalization components increase the effectiveness of DHIs targeting the prevention and management of NCDs. CONCLUSIONS: This review identifies the most common and effective BCTs used in DHIs, which warrant prioritization for integration into future interventions. These findings are critical for the future development and upscaling of DHIs and should inform best practice guidelines.

Digital health interventions (DHIs) that use technology to deliver lifestyle support for the prevention or treatment of noncommunicable diseases (NCDs) have grown in popularity and number in recent years. However, it is unclear what aspects make a DHI effective in changing lifestyle behaviors and improving health. The aim of this study was to review the existing scientific evidence to identify effective components in DHIs that address the prevention or management of NCDs and summarize the best available evidence to date. We conducted a comprehensive electronic search for peer-reviewed systematic reviews and meta-analyses published in English between January 1, 2007 and December 31, 2022. We systematically extracted details of the reviews and the intervention components and summarized the effectiveness of components for each health domain, prioritizing the best available evidence. Eighty-five articles, spanning 12 health domains and summarizing evidence from over 865,000 individual participants, were included in the review. We found good evidence that DHIs are effective in preventing and treating NCDs. Specific intervention components that are effective and should be prioritized for inclusion in future DHIs include: using a credible source; social support; prompts and cues; graded tasks; goals and planning, feedback and monitoring, human coaching and personalization.

Development of "LvL UP 1.0": a smartphone-based, conversational agent-delivered holistic lifestyle intervention for the prevention of non-communicable diseases and common mental disorders.

Background: Non-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 Methods: A 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. Results: Preliminary 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. Conclusions: The 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.

Holistic mHealth interventions for the promotion of healthy ageing: protocol for a systematic review.

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.

Exploring the potential of mobile health interventions to address behavioural risk factors for the prevention of non-communicable diseases in Asian populations: a qualitative study.

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.

Exploring the Perceptions of mHealth Interventions for the Prevention of Common Mental Disorders in University Students in Singapore: Qualitative Study.

BACKGROUND: Mental 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. OBJECTIVE: This 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. METHODS: We 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. RESULTS: The 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. CONCLUSIONS: Study 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.

Study protocol for pragmatic trials of Internet-delivered guided and unguided cognitive behavior therapy for treating depression and anxiety in university students of two Latin American countries: the Yo Puedo Sentirme Bien study.

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.

Factors Influencing Adherence to mHealth Apps for Prevention or Management of Noncommunicable Diseases: Systematic Review.

BACKGROUND: Mobile 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. OBJECTIVE: This 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. METHODS: A 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. RESULTS: The 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%). CONCLUSIONS: This 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.

Corrigendum: Elena+ Care for COVID-19, a Pandemic Lifestyle Care Intervention: Intervention Design and Study Protocol.

[This corrects the article DOI: 10.3389/fpubh.2021.625640.].

Elena+ Care for COVID-19, a Pandemic Lifestyle Care Intervention: Intervention Design and Study Protocol.

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.

Just-in-Time Adaptive Mechanisms of Popular Mobile Apps for Individuals With Depression: Systematic App Search and Literature Review.

BACKGROUND: The 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. OBJECTIVE: The aim of this study is to systematically assess the use of JITAI mechanisms in popular apps for individuals with depression. METHODS: We 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. RESULTS: None 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. CONCLUSIONS: Promising 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.

Reporting Cultural Adaptation in Psychological Trials - The RECAPT criteria.

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.

Assessing the Efficacy and Acceptability of a Web-Based Intervention for Resilience Among College Students: Pilot Randomized Controlled Trial.

BACKGROUND: College students are at elevated risk for developing mental health problems and face specific barriers around accessing evidence-based treatment. Web-based interventions that focus on mental health promotion and strengthening resilience represent one possible solution. Providing support to users has shown to reduce dropout in these interventions. Further research is needed to assess the efficacy and acceptability of these interventions and explore the viability of automating support. OBJECTIVE: This study investigated the feasibility of a new web-based resilience program based on positive psychology, provided with human or automated support, in a sample of college students. METHODS: A 3-armed closed pilot randomized controlled trial design was used. Participants were randomized to the intervention with human support (n=29), intervention with automated support (n=26), or waiting list (n=28) group. Primary outcomes were resilience and well-being, respectively measured by the Connor-Davidson Resilience Scale and Pemberton Happiness Index. Secondary outcomes included measures of depression and anxiety, self-esteem, and stress. Outcomes were self-assessed through online questionnaires. Intention-to-treat and per-protocol analyses were conducted. RESULTS: All participants demonstrated significant improvements in resilience and related outcomes, including an unexpected improvement in the waiting list group. Within- and between-group effect sizes ranged from small to moderate and within-group effects were typically larger for the human than automated support group. A total of 36 participants began the program and completed 46.46% of it on average. Participants were generally satisfied with the program and found it easy to use. CONCLUSIONS: Findings support the feasibility of the intervention. Preliminary evidence for the equal benefit of human and automated support needs to be supported by further research with a larger sample. Results of this study will inform the development of a full-scale trial, from which stronger conclusions may be drawn. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 11866034; http://www.isrctn.com/ISRCTN11866034. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1016/j.invent.2019.100254.

No implementation without cultural adaptation: a process for culturally adapting low-intensity psychological interventions in humanitarian settings.

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.

A Culturally Adapted Cognitive Behavioral Internet-Delivered Intervention for Depressive Symptoms: Randomized Controlled Trial.

BACKGROUND: Internet-delivered treatments for depressive symptoms have proved to be successful in high-income Western countries. There may be potential for implementing such treatments in low- and middle-income countries such as Colombia, where access to mental health services is limited. OBJECTIVE: The objective of this study was to assess the efficacy of a culturally adapted cognitive behavioral internet-delivered treatment for college students with depressive symptoms in Colombia. METHODS: This was a randomized controlled trial with a 3-month follow-up. The program comprised seven modules. A total of 214 Colombian college students were recruited. They were assessed and randomly assigned to either the treatment group (n=107) or a waiting list (WL) control group (n=107). Participants received weekly support from a trained supporter. The primary outcome was symptoms of depression, as measured by the Patient Health Questionnaire - 9, and the secondary outcomes were anxiety symptoms assessed by the Generalized Anxiety Disorder questionnaire - 7. Other measures, including satisfaction with treatment, were evaluated after 7 weeks. RESULTS: Research attrition and treatment dropouts were high in this study. On average, 7.6 sessions were completed per user. The mean time spent on the program was 3 hours and 18 min. The linear mixed model (LMM) showed significant effects after treatment (t197.54=-5.189; P<.001) for the treatment group, and these effects were maintained at the 3-month follow-up (t39.62=4.668; P<.001). Within-group results for the treatment group yielded a large effect size post treatment (d=1.44; P<.001), and this was maintained at the 3-month follow-up (d=1.81; P<.001). In addition, the LMM showed significant differences between the groups (t197.54=-5.189; P<.001). The results showed a large effect size between the groups (d=0.91; P<.001). In the treatment group, 76.0% (16/107) achieved a reliable change, compared with 32.0% (17/107) in the WL control group. The difference between groups was statistically significant (X22=10.5; P=.001). CONCLUSIONS: This study was the first contribution to investigating the potential impact of a culturally adapted internet-delivered treatment on depressive symptoms for college students as compared with a WL control group in South America. Future research should focus on identifying variables associated both with premature dropout and treatment withdrawal at follow-up. TRIAL REGISTRATION: ClinicalTrials.gov NCT03062215; https://clinicaltrials.gov/ct2/show/NCT03062215.

Adapting an internet-delivered intervention for depression for a Colombian college student population: An illustration of an integrative empirical approach.

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.

Assessing the efficacy of a culturally adapted cognitive behavioural internet-delivered treatment for depression: protocol for a randomised controlled trial.

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.

Factores biológicos y psicológicos de la dermatitis atópica / Biological and psychological factors of atopic dermatitis

Este trabajo aborda la relación existente entre los factores biológicos y psicológicos en la dermatitis atópica. Esta es una enfermedad crónica que tiene graves secuelas en el funcionamiento psicológico del individuo, así mismo esta patología esta mediada por el sistema inmune, en la que los factores psicológicos tales como la ansiedad y la depresión influyen desde diversas vías: el sistema nervioso central, el sistema nervioso periférico y los factores hormonales, así como en las secreciones de sustancias como el cortisol y también la hiperreactividad de sistema inmune. Todo esto, en conjunto incide en el desarrollo de la sintomatología asociada a esta enfermedad y de la vulnerabilidad a la misma. Esta revisión permite mostrar la relevancia del trabajo interdisciplinario, así como la necesidad de considerar el tratamiento psicológico para el control y manejo de los síntomas.

This article addresses the relationship between biological and psychological factors of atopic dermatitis. This illness is considered as a chronic disease and has serious psychological consequences for the functioning of the individual. This is a disease mediated by the immune system, in which psychological factors such as anxiety and depression have an influence through various channels, such as the central nervous system, peripheral nervous system and hormonal factors, as well as the secretion of substances such as cortisol and hyperreactivity of the immune system. All of this, together greatly influences the development of symptoms associated with this disease and vulnerability to it. This review allows us to see the importance of interdisciplinary work, as well as the need to consider psychological treatment for the control and management of symptoms.