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O1.1. ETRo: EVALUATION OF THE TREATMENT APPROACH “ROBIN” (STANDARDIZED MANUAL AND SMARTPHONE APP) FOR ADOLESCENTS WITH CLINICAL HIGH RISK FOR DEVELOPING A PSYCHOTIC DISORDER

ABSTRACT: Abstract Background The construct of a clinical high-risk (CHR) state of psychosis has been established to describe potentially prodromal symptoms which typically appear during adolescence and young adulthood. This is a very sensitive developmental period and the clinical high risk (CHR) is associated with increased functional impairment. However, there is a lack of research on age-appropriate treatment strategies for this vulnerable age group. To fill this gap, the experts from the specialized outpatient care unit for early intervention in psychosis at the Department of Child and Adolescent Psychiatry and Psychotherapy, Psychiatric University Hospital, of the University Zürich (CAPS), have developed the combined treatment program “Robin” (standardized manual and smartphone App). The therapy program is targeting at risk-symptoms and aims to improve of quality of life as well as daily functioning. The smartphone application “Robin Z” is an add-on treatment tool to support the patients between the sessions. While a number of trials with smartphone applications in therapy have shown promising effects with adult patient with psychosis, there is little known about using them in the therapy with minor patients. “Robin Z” is one of the first smartphone applications addressing adolescent patients with at risk- symptoms or full-blown psychotic symptoms. Since September 2017, the efficacy of this combined treatment approach is being evaluated with the systematic clinical intervention trial ETRo (Evaluation of the treatment approach “Robin“). The study has been registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT03829527) and the study protocol has been published June 2019 in the journal “Frontiers in Psychiatry”. Methods The ETRo trial is a prospective, naturalistic, follow up study with a matched control design. Participants from a former early recognition study are included for the control condition (treatment as usual). For the intervention condition (16 weekly individual sessions + a minimum 4 family sessions), 30 help seeking CHR adolescents, aged 14–18, are being recruited. At-risk and comorbid symptoms, functioning, self-efficacy and quality of life are monitored at six time points (baseline, during the treatment period, immediately after intervention, and 6, 12, and 24 months later) and compared to the respective measures of the active control group. Results The data from a pilot investigation showed, that “Robin” was accepted by clinicians and patients. Therefore, the authors hypothesize that the “Robin” will enhance the treatment engagement. Within the first 2 years of the systematic evaluation, 18 CHR individuals (61% female, mean age 16.1) have been included in the intervention condition. In Florence, the preliminary results and their implications will be presented. This will include baseline data of the first patients in the intervention group, the intraindividual changes in symptomatology and well-being after 6 months of treatment and data about the treatment satisfaction. Discussion “Robin” is a newly developed treatment approach for adolescents at clinical high risk (CHR) of developing a psychotic disorder combining a standardized treatment manual with a smartphone application. To the best of the author’s knowledge, this is the first controlled trial to test the efficacy of a specific early psychosis treatment in combination with a smartphone application for CHR adolescents. The results of the study are of clinical importance and expected to add essential information in the fields of eMental Health as well as in prevention and early intervention in psychosis.

SUBMITTER: Traber-Walker N

PROVIDER: S-EPMC7233865 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Project description:Introduction: The prevention of schizophrenia and other psychotic disorders has led researchers to focus on early identification of individuals at clinical high risk (CHR) for psychosis and to treat the at-risk symptoms in the pre-psychotic period. Although at-risk symptoms such as attenuated hallucinations or delusions are common in adolescents and associated with a marked reduction in global functioning, the evidence base of effective interventions for adolescents at CHR state and even ﬁrst-episode psychosis is limited. Thus, the present protocol describes a study design that combines therapy modules for CHR adolescents with a smartphone application supporting the young individuals between the therapy sessions. The treatment approach "Robin" is based on existing therapy strategies for adolescents with first episode of psychosis and the available recommendations for adults with at-risk symptoms. Methods: The evaluation aims firstly to compare the efficacy of Robin in 30 CHR adolescents aged 14-18 to an active control group (treatment as usual) from a previous study. Primary outcome measures will be at-risk symptomatology, comorbid diagnosis, functioning, self-efficacy, and quality of life. For the prospective intervention condition (16 weekly individual sessions + a minimum 4 family sessions), help-seeking adolescents with CHR for psychosis, aged 14-18, will be recruited over 3 years. At-risk and comorbid symptoms, functioning, self-efficacy, and quality of life are monitored at six time points (baseline, during the treatment period; immediately after intervention; and 6, 12, and 24 months later) and compared with the respective measures of the active control group. Discussion: To the best of our knowledge, this is the first controlled trial to test the efficacy of a specific early psychosis treatment in combination with a smartphone application for adolescents at CHR for developing psychosis. The results of the study are expected to add information that may substantially decrease the burden of CHR adolescents and increase their resilience. It may offer age-adapted and targeted strategies to guide clinicians in the treatment of these vulnerable individuals. Furthermore, research in the field of early intervention will be enriched by our findings. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT03829527.

Project description:BackgroundText messaging interventions can be an effective and efficient way to improve health behavioral changes. However, most texting interventions are neither tested nor designed with diverse end users, which could reduce their impact, and there is limited evidence regarding the optimal design methodology of health text messages tailored to low-income, low-health literacy populations and non-English speakers.ObjectiveThis study aims to combine participant feedback, crowdsourced data, and researcher expertise to develop motivational text messages in English and Spanish that will be used in a smartphone app-based texting intervention that seeks to encourage physical activity in low-income minority patients with diabetes diagnoses and depression symptoms.MethodsThe design process consisted of 5 phases and was iterative in nature, given that the findings from each step informed the subsequent steps. First, we designed messages to increase physical activity based on the behavior change theory and knowledge from the available evidence. Second, using user-centered design methods, we refined these messages after a card sorting task and semistructured interviews (N=10) and evaluated their likeability during a usability testing phase of the app prototype (N=8). Third, the messages were tested by English- and Spanish-speaking participants on the Amazon Mechanical Turk (MTurk) crowdsourcing platform (N=134). Participants on MTurk were asked to categorize the messages into overarching theoretical categories based on the capability, opportunity, motivation, and behavior framework. Finally, each coauthor rated the messages for their overall quality from 1 to 5. All messages were written at a sixth-grade or lower reading level and culturally adapted and translated into neutral Spanish by bilingual research staff.ResultsA total of 200 messages were iteratively refined according to the feedback from target users gathered through user-centered design methods, crowdsourced results of a categorization test, and an expert review. User feedback was leveraged to discard unappealing messages and edit the thematic aspects of messages that did not resonate well with the target users. Overall, 54 messages were sorted into the correct theoretical categories at least 50% of the time in the MTurk categorization tasks and were rated 3.5 or higher by the research team members. These were included in the final text message bank, resulting in 18 messages per motivational category.ConclusionsBy using an iterative process of expert opinion, feedback from participants that were reflective of our target study population, crowdsourcing, and feedback from the research team, we were able to acquire valuable inputs for the design of motivational text messages developed in English and Spanish with a low literacy level to increase physical activity. We describe the design considerations and lessons learned for the text messaging development process and provide a novel, integrative framework for future developers of health text messaging interventions.

Project description:BackgroundSleep disturbances are common in young people and have consequences for academic, social, emotional, and behavioral development. The most effective treatment is cognitive behavioral therapy for insomnia (CBT-I), with evidence suggesting that it is efficacious even when delivered digitally.ObjectiveThere are no commercially available digitally delivered CBT-I programs for use by young people. The aim of this project was to develop a smartphone app that delivers CBT-I to young people to improve sleep.MethodsTo inform the development of the app, young people (N=21) aged between 12 and 16 years attended one of the 3 focus groups (each with 4-10 participants). These focus groups were conducted at different stages of the development process such that the process could be iterative. Participants were asked the reasons why they might use an app to help them sleep, the kinds of features or functions that they would like to see in such an app, and any concerns they may have in using the app. Data were analyzed using a thematic analysis approach. Of the issues discussed by the participants, the researchers selected themes associated with content, functionality, and accessibility and user experience to examine, as these were most informative for the app design process.ResultsIn terms of content, young people were interested in receiving information about recommended sleep guidelines and personalized information for their age group. They reported that keeping a sleep diary was acceptable, but they should be able to complete it flexibly, in their own time. They reported mixed views about the use of the phone's accelerometer. Young people felt that the functionality of the app should include elements of game playing if they were to remain engaged with the app. Flexibility of use and personalized features were also desirable, and there were mixed views about the schedule of notifications and reminders. Participants reported that for the app to be accessible and usable, it should be from a trusted developer, have engaging aesthetics, have a layout that is easy to navigate, not rely on Internet coverage, and preferably be free. Participants felt that being able to conceal the purpose of the app from peers was an advantage and were willing to provide personal information to use the app if the purpose and use of that information was made clear. Overall, participants endorsed the use of the app for sleep problems among their age group and reported motivation to use it.ConclusionsThe Sleep Ninja is a fully-automated app that delivers CBT-I to young people, incorporating the features and information that young people reported they would expect from this app. A pilot study testing the feasibility, acceptability, and efficacy of the Sleep Ninja is now underway.

Project description:Background: Actissist is a smartphone app designed to deliver an intervention grounded in cognitive behavior therapy for early psychosis. Actissist was developed by a multidisciplinary team of academics, clinicians, experts by experience and software engineers. Actissist has been tested in two trials, the first a proof-of-concept trial where Actissist was safe, acceptable and feasible, the second, a powered randomized controlled trial. Objective: This article describes how our multidisciplinary team designed and developed Actissist. This article describes: (i) how Actissist was informed by initial qualitative interviews and focus groups and an expert reference group; (ii) refinements made to the app based on ongoing user feedback; (iii) successes and challenges encountered; and (iv) learning points and recommendations for involving stakeholders in digital health interventions. Methods: Expert reference group meetings informed the development of Actissist and design of subsequent trials, which included individuals with lived experience of psychosis, clinicians, academics, computer scientists and software engineers. Person-centered stakeholder involvement was promoted using focus groups and qualitative interviews prior to the development of the app, which informed version one of Actissist. Interviews were carried out with participants who had used Actissist. Two further versions of Actissist were developed following additional rounds of testing. Results: Multidisciplinary working throughout the Actissist project led to the development, inclusion and improvement of the app design and content. These changes and features included non-directive and compassionate content, co-designed recovery videos, relaxation exercises, psychoeducation material, ability to "favorite" areas of the app that users found helpful, and goal-setting. Challenges to collaborative working included discrepancies between what stakeholders want and what is technically possible to deliver, resource pressures, trying to deliver desired features within the boundaries of fundamental trial design considerations, and power imbalances associated with multidisciplinary working. Conclusions: The involvement of stakeholders in the design and development and delivery of Actissist has been fundamental to our development approach. Through this collaborative process, we have identified different perspectives and ideas that would have not been generated by the research team alone. Clinical Trial Registrations: Proof-of-concept trial: http://www.isrctn.com/ISRCTN34966555 Fully-powered randomized controlled trial: https://www.isrctn.com/ISRCTN76986679.

Project description:BackgroundUnderstanding how users engage with electronic screening and brief intervention (eSBI) is a critical research objective to improve effectiveness of app-based interventions to reduce harmful alcohol consumption. Although quantitative measures of engagement provide a strong indicator of how the user engages with an app at the group level, they do not elucidate finer-grained details of how apps function from an individual, experiential perspective and why, or how, users engage with an intervention in a particular manner.ObjectiveThe aim of this study was to (1) understand why and how participants engaged with the BRANCH app, (2) explore facilitators and barriers to engagement with app features, (3) explore how the BRANCH app impacted drinking behavior, (4) use these data to identify typologies of users of the BRANCH app in terms of engagement behaviors, and (5) identify future eSBI app design implications.MethodsIn total, 20 one-to-one semistructured telephone interviews were conducted with participants recruited from a randomized controlled trial, which evaluated the effectiveness of engagement-promoting strategies in the BRANCH app targeting harmful drinking in young adults (aged 18-30 years). The topic guide explored users' current engagement levels with existing health promotion apps, their views toward the effectiveness of such apps, and what they liked and disliked about BRANCH, specifically focusing on how they engaged with the app. Framework analysis was used to develop typologies of user engagement.ResultsThe study identified 3 typologies of engagers. Trackers were defined by their motivations to use health-tracking apps to monitor and understand quantified self-data. They did not have intentions necessarily to cut down and predominantly used only the drinking diary. Cut-downers were motivated to use the app because they wanted to reduce their alcohol consumption Unlike Trackers, they did not use a range of different health apps daily, but saw the BRANCH app as an opportunity to test out a different method of trying to cut down their alcohol use. This typology used more features than Trackers, such as the goal setting function. Noncommitters were characterized as a group of users who were initially enthusiastic about using the app; however, this enthusiasm quickly waned and they gained no benefit from it.ConclusionsThis was the first study to identify typologies of user engagement with eSBI apps. Although in need of replication, it provides a first step in understanding independent categories of eSBI users, who may benefit from apps tailored to a user's typology or motivation. It also provides new evidence to suggest that apps may be used more effectively as a tool to raise awareness of drinking, instead of reducing alcohol use, and be a step in the care pathway, identifying at-risk individuals and signposting them to more intensive treatment.Trial registrationInternational Standard Randomised Controlled Trial Number ISRCTN70980706; http://www.isrctn.com /ISRCTN70980706 (Archived by WebCite at http://www.webcitation.org/73vfDXYEZ).

Project description:Importance:Individuals with psychotic disorders have increased mortality, and recent research suggests a marked increase shortly after diagnosis. Objective:To use population-based data to examine overall and cause-specific mortality after first diagnosis of a psychotic disorder. Design, Setting, and Participants:This cohort study used records from 5 integrated health systems that serve more than 8 million members in 5 states. Members aged 16 through 30 years who received a first lifetime diagnosis of a psychotic disorder from September 30, 2009, through September 30, 2015, and 2 comparison groups matched for age, sex, health system, and year of diagnosis were selected from all members making an outpatient visit (general outpatient group) and from all receiving a first diagnosis of unipolar depression (unipolar depression group). Exposures:First recorded diagnosis of schizophrenia, schizoaffective disorder, mood disorder with psychotic symptoms, or other psychotic disorder in any outpatient, emergency department, or inpatient setting. Main Outcomes and Measures:Death within 3 years after the index diagnosis or visit date, ascertained from health system electronic health records, insurance claims, and state mortality records. Results:A total of 11 713 members with first diagnosis of a psychotic disorder (6976 [59.6%] men and 4737 [40.4%] women; 2368 [20.2%] aged 16-17 and 9345 [79.8%] aged 18-30 years) were matched to 35 576 outpatient service users and 23 415 members with a first diagnosis of unipolar depression. During the year after the first diagnosis, all-cause mortality was 54.6 (95% CI, 41.3-68.0) per 10 000 in the psychotic disorder group compared with 20.5 (95% CI, 14.7-26.3) per 10 000 in the unipolar depression group and 6.7 (95% CI, 4.0-9.4) per 10 000 in the general outpatient group. After adjustment for race, ethnicity, and preexisting chronic medical conditions, the relative hazard of death in the psychotic disorder group compared with the general outpatient group was 34.93 (95% CI, 8.19-149.10) for self-inflicted injury or poisoning and 4.67 (95% CI, 2.01-10.86) for other type of injury or poisoning. Risk of death due to heart disease or diabetes did not differ significantly between the psychotic disorder and the general outpatient groups (hazard ratio, 0.78; 95% CI, 0.15-3.96). Between the first and third years after diagnosis, all-cause mortality in the psychotic disorder group decreased from 54.6 to 27.1 per 10 000 persons and injury and poisoning mortality decreased from 30.6 to 15.1 per 10 000 persons. Both rates, however, remained 3 times as high as in the general outpatient group (9.0 per 10 000 for all causes; 4.8 per 10 000 for injury or poisoning). Conclusions and Relevance:Increases in early mortality underscore the importance of systematic intervention for young persons experiencing the first onset of psychosis. Clinicians should attend to the elevated suicide risk after the first diagnosis a psychotic disorder.

Project description:BackgroundAdolescent pregnancies and sexually-transmitted infections continue to impact 15 - 19-year-olds across the globe. The lack of sexual reproductive health information (SRH) in resource-limited settings due to cultural and societal attitudes towards adolescent SRH could be contributing to the negative outcomes. Innovative approaches, including mobile phone technologies, are needed to address the need for reliable adolescent SRH information.ObjectiveThe study aimed to co-design a Unstructured Supplementary Service Data (USSD) based mobile app prototype to provide confidential adolescent SRH information on-demand and evaluate the mobile app's usability and user experience.MethodsA human-centered design methodology was applied. This practice framework allowed the perspectives and feedback of adolescent users to be included in the iterative design process. To participate, an adolescent must have been 15 to 19 years old, resided in Kibra and would be able to access a mobile phone. Adolescents were enrolled for the alpha and field testing of the app prototype at different time-points. The Mobile Application Rating Scale (MARS) a multidimensional mobile phone evaluation tool was used to access the functionality, engagement, aesthetics and quality of information in the app. Responses from the MARS were reported as mean scores for each category and a mean of the aggregate scores making the app's quality score. The MARS data was also evaluated as categorical data, A Chi square test of independence was carried out to show significance of any observed differences using cumulative and inverse cumulative distribution functions.ResultsDuring the usability test, 62/109 (54.9%) of the adolescents that were followed-up had used the app at least once, 30/62 (48.4%) of these were male participants and 32/62 (51.6%) female. On engagement, the app had a mean score of 4.3/5 (SD 0.44), 4.6/5 (SD 0.38) on functionality, 4.3/5 (SD 0.57) on aesthetics and 4.4/5 (SD 0.60) on the quality of information. The overall app quality mean score was 4.4/5 (SD 0.31). The app was described as 'very interesting' to use by 44/62 (70.9%) of the participants, 20/44 males and 24/44 females. The content was deemed to be either 'perfectly' or 'well targeted' on sexual reproductive health by 60/62 (96.7%) adolescents, and the app was rated 'best app' by 45/62 (72.6%) adolescents, 27/45 females and 18/45 males, with a p-value = 0.011.ConclusionsAdolescents need on-demand, accurate and trusted SRH information. A mobile phone app is a feasible and acceptable way to deliver adolescent SRH information in resource-limited settings. The USSD mobile phone technology shows promise in the delivery of much needed adolescent SRH information on-demand..

Dataset Information

O1.1. ETRo: EVALUATION OF THE TREATMENT APPROACH “ROBIN” (STANDARDIZED MANUAL AND SMARTPHONE APP) FOR ADOLESCENTS WITH CLINICAL HIGH RISK FOR DEVELOPING A PSYCHOTIC DISORDER

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