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The article comments on a research which examined the use of respiratory waveform analysis for the enhanced efficacy of mechanical insufflation-exsufflation in patients with amyotrophic lateral sclerosis.

Introduction: A bone fracture is a break in the continuity of bone tissue, caused by the action of an external or internal force on the bone. Ankle sprains are one of the most common injuries among athletes. Physically active people who participate in activities that require jumping, changing direction, and turning have an increased risk of ankle sprains. Ankle sprains and the repetitive trauma often associated with this condition can lead to long-term disability, lost time from activity, and financial burdens for athletes. Methods: The work is non-experimental (qualitative research), i.e. a review of scientific literature. The search included an overview of the relevant databases: Medline, PubMed, Google Scholar, Research Gate. The literature review includes 4 randomized clinical trials and 1 randomized single-blind trial. The mentioned databases were searched with the help of keywords: athletes, injury, ankle joint, rehabilitation. Results: Through a scientific review of the literature, the results of the significance and productivity of the application of rehabilitation in athletes with an ankle injury are presented. The results include the presentation and analysis of five published scientific papers in the period 2018-2020. The studies used for this review were published in India, Saudi Arabia, Iran, United States, Austria. Conclusion: By reviewing the scientific literature, it can be concluded that there are improvements in the quality of life of athletes after an ankle injury. The greatest improvements were noted in strength, balance and functional task performance. The application of the rehabilitation program plays an important role in reducing pain and stabilizing the knee joint. [ABSTRACT FROM AUTHOR]

Background: Digital health technologies (DHTs) can facilitate the execution of de-centralized trials that can offer opportunities to reduce the burden on participants, collect outcome data in a real-world setting, and potentially make trial populations more diverse and inclusive. However, DHTs can also be a significant source of electronic waste (e-waste). In recognition of the potential health and environmental impact from DHT use in trials, private and public institutions have recently launched initiatives to help measure and manage this e-waste. But in order to develop sound e-waste management policies, it will be necessary to first estimate the current volume of e-waste that results from the use of DHTs in trials. Materials and Methods: A Web Ontology Language (OWL)-compliant ontology of DHTs was created using a list of 500 DHT device names derived from a mixture of public and private sources. The U.S. clinical trials registry, ClinicalTrials.gov, was then queried to identify and classify trials using any of the devices in the ontology. The ClinicalTrials.gov records from this search were then analyzed to characterize the volume and properties of trials using DHTs, as well as estimating the total volume of individual DHT units that have been provisioned (or are planned to be provisioned) for clinical research. Results: Our ontology-driven search identified 2326 unique clinical trials with a reported "actual" enrollment of 200,947 participants and a "planned" enrollment of an additional 4,094,748 participants. The most-used class of DHTs in our ontology was "wearables," (1852 trials), largely driven by the use of smart watches and other wrist-worn sensors (estimated to involve 149,391 provisioned devices). The most-used subtype of DHTs in trials was "subcutaneous" devices (367 trials), driven by the prevalent use and testing of glucose monitors (estimated to involve 17,666 provisioned devices). Conclusion: Thousands of trials, involving hundreds of thousands of devices, have already been completed, and many more trials (potentially involving millions more devices) are planned. Despite the great opportunities that are afforded by DHTs to the clinical trial enterprise, if the industry lacks the ability to track DHT use with sufficient resolution, the result is likely to be a great deal of e-waste. A new ontology of DHTs, combined with rigorous data science methods like those described in this paper, can be used to provide better information across the industry, and in turn, help create a more sustainable and equitable clinical trials enterprise. [ABSTRACT FROM AUTHOR]

A questionnaire which provides desirable reliability and validity has been previously developed to assess the disease awareness of diagnosed chronic kidney disease (CKD) patients. However, conventional paper questionnaires often have disadvantages, including recall bias. To substantially improve this, we therefore aimed to explore the feasibility of developing a smartphone-based electronic version (e-version) based upon its original paper version and subsequently tested its validity, reliability, and applicability. A pilot study was conducted at Guangdong Provincial Hospital of Chinese Medicine in Guangzhou, China, during August 2019. The e-version had identical content to the paper version and was adapted in terms of layout and assisted functions via the Wechat-incorporated Wen-Juan-Xing platform. Eligible patients with diagnosed CKD were invited to participate and were assigned the e-version. Randomly selected respondents received a test-retest of the same e-version 2 weeks after their first completion. In some instances, psychometric properties, including validity and reliability of the e-version, were examined. In others, its clinical application was also tested, which included comparisons among the clinical profiles of patients who had/had not responded to the questionnaire as well as patients with above or below average questionnaire scores. Of the 225 patients screened, 217 were enrolled to participate, with a response rate of 52.5%. Desirable reliability (Cronbachα = 0.962, ICC for total scores = 0.948), while good convergent validity (Cronbachα = 0.962) and low discriminant validity (one extracted component), of the e-version were detected. Performing inter-group comparisons highlighted statistical differences in terms of higher education level (z = −2.436, P = 0.015) and earlier CKD stages (z = −1.978, P = 0.048), with these patients often preferring to respond. No significant differences were detected in the clinical profiles between respondents who obtained an above or below average questionnaire score. The e-version is reliable but was not shown to be a valid approach. Audiences with higher education levels and less advanced disease condition may prefer to respond to the e-version. Adaptation of this e-questionnaire, from its original paper version, may not be a direct transition and meticulous modifications may be required during the transition process. Chinese Clinical Trial Registry (ChiCTR1900024633). [ABSTRACT FROM AUTHOR]

This paper examines the tone register paradigm in Copala Triqui, an Otomanguean language of Mexico. Past literature on tone register changes has attributed tonal variations to seemingly arbitrary classes. Instead, the synchronic account presented here accounts for these changes through underlying floating tones and phonological processes that occur as the result of two cophonologies tied to an upper and lower tone register. [ABSTRACT FROM AUTHOR]

Nowadays cities provide a huge amount of information that can be used not only for city management but also to support citizens. To give proactive and relevant support, services should have access to the gathered information from the corresponding sources. The paper proposes a platform architecture to connect information sources with services through shared knowledge base or directly using the description of the services from the knowledge base. In addition to information and services registry the platform provides facilities to create and manage user profiles – digital identities. Services use these profiles to provide personalized support based on his/her preferences. Also, paper proposes a possible use case of the platform based on driver support. It describes types of information used for support personalization, possible services used as information sources as well as the way of communication between driver and services over the proposed platform. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study is to provide an update as to whether authors in the orthodontic field of research currently report randomized clinical trials (RCTs) adequately as defined by the Consolidated Standards of Reporting Trials (CONSORT) statement. Methods: The American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO), Journal of Orthodontics (JO), European Journal of Orthodontics (EJO) and Angle Orthodontist (AO) were reviewed to identify all articles that reported RCTs published between January 2008 and June 2012.Reports were scored using the CONSORT 37 item checklist. A 10% random sample of the papers was scored by a second examiner to assess inter-examiner reliability of the CONSORT score. Another 10% random sample of the papers was scored a second time by the first examiner 3 months after initial data collection to test intra-examiner reliability. Results: A total of 151 clinical trial reports have been identified out of 3335 articles in the four journals from January 2008 to June 2012.Mean CONSORT score of the four journals was 51.7%. Journal of Orthodontics achieved the highest score of 73.6% and the lowest score was achieved by AO with a score of 44.5%. Overall compliance with CONSORT increased from 47.8 to 56.3% between 2008 and 2012. Conclusion: Clinical trials reports represented < 5% of articles in the four main orthodontic journals between 2008 and 2012. • CONSORT mean score ranged from 44.5 to 73.6% between journals. • CONSORT mean score increased through the period of investigation. [ABSTRACT FROM AUTHOR]

Background: When we were unable to identify an electronic data capture (EDC) package that supported our requirements for clinical research in resource-limited regions, we set out to build our own reusable EDC framework. We needed to capture data when offline, synchronize data on demand, and enforce strict eligibility requirements and complex longitudinal protocols. Based on previous experience, the geographical areas in which we conduct our research often have unreliable, slow internet access that would make web-based EDC platforms impractical. We were unwilling to fall back on paper-based data capture as we wanted other benefits of EDC. Therefore, we decided to build our own reusable software platform. In this paper, we describe our customizable EDC framework and highlight how we have used it in our ongoing surveillance programs, clinic-based cross-sectional studies, and randomized controlled trials (RCTs) in various settings in India and Ecuador.Objective: This paper describes the creation of a mobile framework to support complex clinical research protocols in a variety of settings including clinical, surveillance, and RCTs.Methods: We developed ConnEDCt, a mobile EDC framework for iOS devices and personal computers, using Claris FileMaker software for electronic data capture and data storage.Results: ConnEDCt was tested in the field in our clinical, surveillance, and clinical trial research contexts in India and Ecuador and continuously refined for ease of use and optimization, including specific user roles; simultaneous synchronization across multiple locations; complex randomization schemes and informed consent processes; and collecting diverse types of data (laboratory, growth measurements, sociodemographic, health history, dietary recall and feeding practices, environmental exposures, and biological specimen collection).Conclusions: ConnEDCt is customizable, with regulatory-compliant security, data synchronization, and other useful features for data collection in a variety of settings and study designs. Furthermore, ConnEDCt is user friendly and lowers the risks for errors in data entry because of real time error checking and protocol enforcement. [ABSTRACT FROM AUTHOR]

Clinical trials designed to answer treatment-related questions typically compare an intervention group that receives a drug or other intervention to a control group that serves as a standard against which results of the intervention are evaluated. An observed divergence from this trend in research papers on breastfeeding led us to hypothesize that the majority of breastfeeding research designs assign breastfed children to an intervention group rather than the control group, although breastfeeding is a physiological way of feeding infants that may be considered as a general standard. Headlines and abstracts of 760 publications identified in 2 databases were checked, and a total of 68 systematic reviews were included in our review with the goal to see if breastfed children were mostly considered as the intervention or control group. Our review showed that in 79,41% of papers breastfed children were regarded as the intervention group. The results of these papers were usually presented in a manner to show breastfeeding was beneficial in comparison to formula-feeding - as if breastfeeding was a health intervention. This way of data presentation probably helps to form attitude that formula-feeding is the norm and breastfeeding an optional choice, a "superstandard" with certain health benefits. Therefore, all available studies that regard breastfeeding should be interpreted with caution. We suggest that authors, while conducting and reporting clinical trials, regard breastfed children as the control group, and non-breastfed children as the intervention group. [ABSTRACT FROM AUTHOR]

Background: Machine learning systems are part of the field of artificial intelligence that automatically learn models from data to make better decisions. Natural language processing (NLP), by using corpora and learning approaches, provides good performance in statistical tasks, such as text classification or sentiment mining.Objective: The primary aim of this systematic review was to summarize and characterize, in methodological and technical terms, studies that used machine learning and NLP techniques for mental health. The secondary aim was to consider the potential use of these methods in mental health clinical practice.Methods: This systematic review follows the PRISMA (Preferred Reporting Items for Systematic Review and Meta-analysis) guidelines and is registered with PROSPERO (Prospective Register of Systematic Reviews; number CRD42019107376). The search was conducted using 4 medical databases (PubMed, Scopus, ScienceDirect, and PsycINFO) with the following keywords: machine learning, data mining, psychiatry, mental health, and mental disorder. The exclusion criteria were as follows: languages other than English, anonymization process, case studies, conference papers, and reviews. No limitations on publication dates were imposed.Results: A total of 327 articles were identified, of which 269 (82.3%) were excluded and 58 (17.7%) were included in the review. The results were organized through a qualitative perspective. Although studies had heterogeneous topics and methods, some themes emerged. Population studies could be grouped into 3 categories: patients included in medical databases, patients who came to the emergency room, and social media users. The main objectives were to extract symptoms, classify severity of illness, compare therapy effectiveness, provide psychopathological clues, and challenge the current nosography. Medical records and social media were the 2 major data sources. With regard to the methods used, preprocessing used the standard methods of NLP and unique identifier extraction dedicated to medical texts. Efficient classifiers were preferred rather than transparent functioning classifiers. Python was the most frequently used platform.Conclusions: Machine learning and NLP models have been highly topical issues in medicine in recent years and may be considered a new paradigm in medical research. However, these processes tend to confirm clinical hypotheses rather than developing entirely new information, and only one major category of the population (ie, social media users) is an imprecise cohort. Moreover, some language-specific features can improve the performance of NLP methods, and their extension to other languages should be more closely investigated. However, machine learning and NLP techniques provide useful information from unexplored data (ie, patients' daily habits that are usually inaccessible to care providers). Before considering It as an additional tool of mental health care, ethical issues remain and should be discussed in a timely manner. Machine learning and NLP methods may offer multiple perspectives in mental health research but should also be considered as tools to support clinical practice. [ABSTRACT FROM AUTHOR]

A paper by Drs Okada and Sengoku that appears in this issue of TIRS shows how data from Clinicaltrials.gov can be used for research on the pharmaceutical industry. This commentary identifies several challenges associated with using these data for research and concludes with 3 recommendations from a statistical perspective. [ABSTRACT FROM AUTHOR]

The article offers information on the journal including the journal continues to receive increasing numbers of submissions, reaching 1539 major manuscripts in 2018; mentions peer review is laborious and complex but its benefits are worthwhile, foremost for improving the quality of the papers; and also mentions the digital presence also continues to expand and in 2018 the number of Twitter and Facebook social media followers rose to 46000.

Background: In Cameroon, the coverage, completeness, and timeliness of the Expanded Programme on Immunization (EPI) vaccines administration in children have remained heterogeneous and below the national and districts targets in several districts. In an effort to solve this problem, many interventions have been tested but none has shown significant improvement of the situation. Objective: This trial aims to test whether involving Community Volunteers to assess children vaccination status and demographic movements and using recorded data to plan catch-up immunization sessions can improve children vaccination timeliness, completeness and coverage. Methods: Communities of the Foumban Health district, West region of Cameroon will be selected and assigned to either intervention or control groups using a restricted randomization of 2. In the intervention group, one Community Volunteer per community will be trained to visit households and record EPI-targeted children in a register, record their demographic movements, and assess their immunization status monthly for a year. The information recorded will be snapped and sent to the competent health center immunization team through WhatsApp. These will be used to plan and implement monthly community catch up immunization sessions in collaboration with the community volunteer. In the control group, the routine immunization sessions will be conducted with health centers organizing either weekly vaccination sessions for communities situated not farther than 5 kilometers away from the health facility or monthly vaccination sessions in communities situated more than 5 kilometers away from the health center. Baseline, mid-term and end-line surveys will be conducted to assess and compare immunization coverage, timeliness, and completeness. Results: Funded in 2018, data collection started in 2018 and has been completed. Data analysis and reporting are ongoing. Conclusions: This trial is expecting to test an innovative approach to improving children's immunization timeliness, completeness and coverage of immunization by tracking EPI targeted population vaccination status and denominator at household level and building collaboration between the community and health facilities vaccination teams to organize monthly community-based response vaccination sessions. This intervention is expected to improve children sustainable access to EPI vaccination as it offers assessing and responding to their immunization needs at monthly basis using low cost local human resources. Trial Registration: Pan African Clinical Trials Registry ID PACTR201808527428720; tinyurl.com/u058qnse International Registered Report Identifier (IRRID): DERR1-10.2196/21734 JMIR Res Protoc 2021;10(2):e21734 doi:10.2196/21734 We help JMIR researchers to raise funds to pursue their research and development aimed at tackling important health and technology challenges. If you would like to show your support for this author, please donate using the button below. The funds raised will directly benefit the corresponding author of this article (minus 8% admin fees). Your donations will help this author to continue publishing open access papers in JMIR journals. Donations of over $100 may also be acknowledged in future publications. Submit Suggested contribution levels: $20/$50/$100 [ABSTRACT FROM AUTHOR]

Background: Excessive digital screen exposure (≥1 hour per day) is associated with limited growth and development in children. Objective: This study aims to develop and assess a multicomponent intervention program's effectiveness in reducing excessive screen time among children aged 2-5 years. Methods: A theory-based multicomponent intervention known as Program to Lower Unwanted Media Screens (PLUMS) at the household level has been developed. It is based on the social cognitive theory for children and self-determination theory for caregivers. After pretesting, a randomized control trial will be conducted to assess this intervention's effectiveness among healthy children aged 2-5 (±3 months) years and their primary caregivers who have at least one digital media gadget at home in zone three of Chandigarh (population of 2,730,035). A sample size of 428 children is estimated per arm. PLUMS includes disseminating specific information, education, communication in the form of videos and posters to the primary caregivers, and conducting motivational interviewing as and when needed. Children will be provided suggestions for playful activities as alternatives to digital media gadgets. The primary outcome is the mean change in the duration of screen time, and secondary outcomes are sleep duration and patterns, emotional-behavioral problems, and level of physical activity of the children. Per-protocol and intention-to-treat analyses will be conducted using SPSS for Macintosh, Version 25.0. Results: The intervention package will be disseminated once a week for 8 weeks to the participants via the caregivers' preferred means of communication. The endline assessment will be done immediately postintervention and after the 6 months of follow-up. The Institute's ethics committee, Postgraduate Institute of Medical Education and Research, Chandigarh, India, has approved this study (INT/IEC/2019/000711). The Indian Council of Medical Research, New Delhi (3/1/3/Next-100/JRF-2015/HRD), and PGIMER, Chandigarh (71/2-Edu-16/92, Dated 08/01/2018) funded this study. Conclusions: PLUMS might be effective in reducing excessive screen time among children aged 2-5 years in a North Indian Union Territory. Trial Registration: Clinical Trial Registry India CTRI/2017/09/009761; https://tinyurl.com/53q6dpjs International Registered Report Identifier (IRRID): DERR1-10.2196/24106 JMIR Res Protoc 2021;10(2):e24106 doi:10.2196/24106 We help JMIR researchers to raise funds to pursue their research and development aimed at tackling important health and technology challenges. If you would like to show your support for this author, please donate using the button below. The funds raised will directly benefit the corresponding author of this article (minus 8% admin fees). Your donations will help this author to continue publishing open access papers in JMIR journals. Donations of over $100 may also be acknowledged in future publications. Submit Suggested contribution levels: $20/$50/$100 [ABSTRACT FROM AUTHOR]

Background: Relapse is common in people who experience psychosis and is associated with many negative consequences, both societal and personal. People who relapse often exhibit changes (early warning signs [EWS]) in the period before relapse. Successful identification of EWS offers an opportunity for relapse prevention. However, several known barriers impede the use of EWS monitoring approaches. Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) is a complex digital intervention that uses a mobile app to enhance the detection and management of self-reported changes in well-being. This is currently being tested in a pilot cluster randomized controlled trial. As digital interventions have not been widely used in relapse prevention, little is known about their implementation. Process evaluation studies run in parallel to clinical trials can provide valuable data on intervention feasibility. Objective: This study aims to transparently describe the protocol for the process evaluation element of the EMPOWER trial. We will focus on the development of a process evaluation framework sensitive to the worldview of service users, mental health staff, and carers; the aims of the process evaluation itself; the proposed studies to address these aims; and a plan for integration of results from separate process evaluation studies into one overall report. Methods: The overall process evaluation will utilize mixed methods across 6 substudies. Among them, 4 will use qualitative methodologies, 1 will use a mixed methods approach, and 1 will use quantitative methodologies. Results: The results of all studies will be triangulated into an overall analysis and interpretation of key implementation lessons. EMPOWER was funded in 2016, recruitment finished in January 2018. Data analysis is currently under way and the first results are expected to be submitted for publication in December 2019. Conclusions: The findings from this study will help identify implementation facilitators and barriers to EMPOWER. These insights will inform both upscaling decisions and optimization of a definitive trial. Trial Registration: ISRCTN Registry ISRCTN99559262; http://www.isrctn.com/ISRCTN99559262 International Registered Report Identifier (IRRID): DERR1-10.2196/15634 We help JMIR researchers to raise funds to pursue their research and development aimed at tackling important health and technology challenges. If you would like to show your support for this author, please donate using the button below. The funds raised will directly benefit the corresponding author of this article (minus 8% admin fees). Your donations will help this author to continue publishing open access papers in JMIR journals. Donations of over $100 may also be acknowledged in future publications. Suggested contribution levels: $20/$50/$100 [ABSTRACT FROM AUTHOR]

Background: Borderline personality disorder (BPD) is a disorder characterized by difficulties with regulating emotions and impulsive behavior. Long-term monitoring of progress during BPD psychotherapy constitutes a challenge using paper and pencil registration. Hence, a mobile app assessing emotions and progress in treatment may be useful. Objective: The aim of this study was to examine the feasibility of using the mDiary app as an adjunct to dialectical behavior therapy (DBT) for the treatment of BPD. Methods: A total of 9 focus group interviews were conducted and analyzed according to the grounded theory approach. Furthermore, the usability of the mDiary app was examined using the System Usability Scale (SUS). The app was implemented in a standard DBT program as an adjunct to DBT. In total, 16 patients (age range 19-41 years) and 23 therapists (age range 25-64 years) from 5 Danish public outpatient psychiatric treatment facilities participated in the study. Results: Overall, patients were satisfied with the mDiary app, as it was "easy to use" and "always there." Inside-out innovation, meaning new work tasks generated during implementation and communication of modifications needed in the app, was found to influence the perceived usability negatively among the interviewed therapists. The patients rated the usability as high (mean SUS score 81.2, SD 9.9), whereas therapists rated the mDiary app at an average level (mean 68.3, SD 14.3). Older age of the users correlated with lower usability ratings on the SUS score (Pearson r =−0.60). Conclusions: The mDiary app was considered as an acceptable and relevant way of registering DBT diary data for both patients and therapists generating increased long-term overview. Older users were overall more reluctant to accept this new technology in clinical practice. Time to align expectations among involved parties needs to be set aside when implementing this new approach to patient monitoring. Here, the focus should be on the realistic use of resources and expected impact on present clinical work. [ABSTRACT FROM AUTHOR]

Background: In 2017, approximately 3.7 billion downloads of health apps were made on mobile phones and tablets. In this sense, a massive number of people could benefit by electronic mobile–based health interventions, making information available even with the lack of material and human resources. Hence, the use of electronic apps for dental education might be extremely useful for the prevention of early childhood caries (ECC). Objective: This study aims to evaluate the effectiveness of messages sent via mobile phones as an adjuvant method for the prevention of ECC. Methods: A single-blinded, randomized, and parallel-group clinical trial will be conducted with dyads of parents or caregivers and children aged between 36 and 60 months, recruited from kindergartens and schools of Bauru, São Paulo. The determination of sample size resulted in a total of 104 dyads of parents and children, considering a power of 80%, a significance level of 5%, and an attrition of 30%. This sample will be randomly assigned to test and control groups, being divided in 52 dyads per group according to the health literacy levels of parents and the age, gender, and oral health status of children. Every 2 weeks, only participants in the test group will receive messages via WhatsApp containing preventive and education-related ECC information. The dyads will visit the dentist every 3 months during a year for the assessment of primary outcomes (sugar consumption and the International Caries Detection and Assessment System, visible plaque, and community periodontal indices) and to receive dental care measures. Secondary outcomes (electronic health literacy and general perceived self-efficacy) will be determined only at baseline and after 12-month follow-up. The quality of randomization will be evaluated throughout the study, comparing the test and control groups systematically by Student t tests for continuous variables and chi-square tests for categorical variables. Listwise deletion method will be applied in cases of dropouts, if the missing values satisfy the criteria of missing completely at random; otherwise, multiple imputation data strategy will be conducted. The Kolmogorov-Smirnov and Levene tests will be used to determine the normality and homogeneity of data, respectively, which will indicate further statistical analyses for elucidating significant differences between groups (P<.05). A Student t test or Mann-Whitney U test will be employed for parametric or nonparametric analyses, respectively. Results: The project was funded in 2018, and enrollment was completed in August 2019. Allocation is currently under way and the first results are expected to be submitted for publication in 2020. Conclusions: The results will contribute to understanding the importance of educational mobile messages toward the adoption of healthy behaviors for the prevention of ECC in a given population. Trial Registration: Brazilian Registry of Clinical Trials Universal Trial Number U1111-1216-1393; http://www.ensaiosclinicos.gov.br/rg/RBR-2b6r7q/ International Registered Report Identifier (IRRID): PRR1-10.2196/13656 We help JMIR researchers to raise funds to pursue their research and development aimed at tackling important health and technology challenges. If you would like to show your support for this author, please donate using the button below. The funds raised will directly benefit the corresponding author of this article (minus 8% admin fees). Your donations will help this author to continue publishing open access papers in JMIR journals. Donations of over $100 may also be acknowledged in future publications. Suggested contribution levels: $20/$50/$100 [ABSTRACT FROM AUTHOR]

Background: There is a growing understanding that well-being and mental illness are 2 separate dimensions of mental health. High well-being is associated with decreased risk of disease and mental illness and increased longevity. Objective: This study aims to test the efficacy of a mobile phone–based intervention on positive mental health. Methods: We are conducting a 2-armed randomized controlled trial of university students in Sweden. Recruitment will last for 6 months by digital advertising (eg, university websites). Participants will be randomly allocated to either an intervention (fully automated mobile phone–based mental health intervention) or control group (treatment as usual). The primary outcome will be self-assessed positive mental health (Mental Health Continuum Short Form). Secondary outcomes will be self-assessed depression anxiety symptomatology (Hospital Anxiety Depression Scale). Outcomes will be investigated at baseline, at 3, 6, and 12 months after randomization. Mediators (positive emotions and thoughts) will be investigated at baseline, midintervention, and at follow-ups using 2 single face-valid items. Results: Data will be collected between autumn 2018 and spring 2019. Results are expected to be published in 2020. Conclusions: Strengths of the study include the use of a validated comprehensive instrument to measure positive mental health. Mechanisms of change are also investigated. A potential challenge could be recruitment; however, by setting a prolonged recruitment period, we believe that the study will recruit a sufficient sample. Trial Registration: International Standard Randomized Controlled Trial Number: 54748632; http://www.isrctn.com/ ISRCTN54748632 International Registered Report Identifier (IRRID): PRR1-10.2196/12396 We help JMIR researchers to raise funds to pursue their research and development aimed at tackling important health and technology challenges. If you would like to show your support for this author, please donate using the button below. The funds raised will directly benefit the corresponding author of this article (minus 8% admin fees). Your donations will help this author to continue publishing open access papers in JMIR journals. Donations of over $100 may also be acknowledged in future publications. Suggested contribution levels: $20/$50/$100 [ABSTRACT FROM AUTHOR]

Background: Shared decision making (SDM) is recognized as a person-centered approach to improving health care quality and outcomes. Few digital interventions to improve SDM have been tested in child and adolescent mental health (CAMH) settings. One such intervention is Power Up, a mobile phone app for young people (YP), which has shown some evidence of promise that YP who received Power Up reported greater levels of SDM. However, even though parents play a critical role in CAMH care and treatment, they often feel excluded from services. Objective: This protocol is for a pilot trial to determine the feasibility of a large-scale randomized trial to develop and evaluate a Web app called Power Up for Parents (PUfP) to support parents and promote involvement in CAMH decisions. Methods: A 2-stage process, consisting of the development stage and pilot-testing stage of the initial PUfP prototype, will be conducted. At the development stage, a qualitative study with parents and clinicians will be conducted. The interviews will aim to capture the experience of making CAMH decisions, preferences for involvement in SDM, and determine situations within which PUfP can be useful. At the pilot-testing stage, up to 90 parents and their clinicians will be invited to participate in the testing of the prototype. Parents will be randomly allocated to receive the intervention or be part of the control group. This study design will allow us to assess the acceptability and usefulness of PUfP in addition to examining the feasibility of a prospective randomized trial. Clinicians' perceptions of the prototype and how it has influenced parents' involvement in SDM will also be examined. Results: Recruitment began in January 2019 and is scheduled to last for 10 months. Interviews and baseline data collection are currently in progress. To date, 11 CAMH sites have been recruited to take part in the study. It is anticipated that data collection will be completed by October 2019. Conclusions: The lack of parents' involvement in CAMH care and treatment can lead to higher rates of dropout from care and lower adherence to therapeutic interventions. There are significant benefits to be gained globally if digital SDM interventions are adopted by parents and shown to be successful in CAMH settings. Trial Registration: ISRCTN Registry ISRCTN39238984; http://www.isrctn.com/ISRCTN39238984 International Registered Report Identifier (IRRID): DERR1-10.2196/14571 We help JMIR researchers to raise funds to pursue their research and development aimed at tackling important health and technology challenges. If you would like to show your support for this author, please donate using the button below. The funds raised will directly benefit the corresponding author of this article (minus 8% admin fees). Your donations will help this author to continue publishing open access papers in JMIR journals. Donations of over $100 may also be acknowledged in future publications. Suggested contribution levels: $20/$50/$100 [ABSTRACT FROM AUTHOR]