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Evaluation of the Combined Treatment Approach "Robin" (Standardized Manual and Smartphone App) for Adolescents at Clinical High Risk for Psychosis.

ABSTRACT: 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 ?rst-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.

SUBMITTER: Traber-Walker N

PROVIDER: S-EPMC6562244 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Evaluation of the Combined Treatment Approach "Robin" (Standardized Manual and Smartphone App) for Adolescents at Clinical High Risk for Psychosis.

Traber-Walker Nina N Gerstenberg Miriam M Metzler Sibylle S Joris Maria Raquel MR Karr Markus M Studer Nadja N Zulauf Logoz Marina M Roth Alexander A Rössler Wulf W Walitza Susanne S Franscini Maurizia M

Frontiers in psychiatry 20190606

<b>Introduction:</b> 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 ...[more]

PMID: 31244692

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Project description: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.

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:BackgroundTobacco smoking is the leading cause of preventable death in the United States, and the annual economic burden attributable to smoking exceeds US $300 billion. Obstacles to smoking cessation include limited access and adherence to effective cessation interventions. Technology can help overcome these obstacles; many smartphone apps have been developed to aid smoking cessation, but few that conform to the US clinical practice guideline (USCPG) have been rigorously tested and reported in the literature. Clickotine is a novel smartphone app for smoking cessation, designed to deliver the essential features of the USCPG and engineered to engage smokers by personalizing intervention components.ObjectiveOur objective was to assess the engagement, efficacy, and safety of Clickotine in an initial, single-arm study. Outcomes measured were indicators of engagement with the smartphone app (number of app opens, number of interactions with the Clickotine program, and weeks active with Clickotine), cessation outcomes of 7- and 30-day self-reported abstinence from smoking, and negative health events.MethodsWe recruited US residents between 18 and 65 years of age who owned an iPhone and smoked 5 or more cigarettes daily for the study via online advertising. Respondents were prescreened for eligibility by telephone and, if appropriate, directed to a Web portal to provide informed consent, confirm eligibility, and download the Clickotine app. Participants completed study assessments via the online portal at baseline and after 8 weeks. Data were collected in Amazon S3 with no manual data entry, and access to all data was maximally restrictive, logged, and auditable.ResultsA total of 416 participants downloaded the app and constituted the intention-to-treat (ITT) sample. On average, participants opened the Clickotine app 100.6 times during the 8-week study (median 69), logged 214.4 interactions with the Clickotine program (median 178), and remained engaged with Clickotine for 5.3 weeks (median 5). Among the ITT sample, 45.2% (188/416) reported 7-day abstinence and 26.2% (109/416) reported 30-day abstinence from smoking after 8 weeks. Completer analysis focused on 365 (87.7%) of the 416 enrolled participants who completed the 8-week questionnaire revealed that 51.5% (188/365) of completers reported 7-day abstinence and 29.9% (109/365) reported 30-day abstinence. Few adverse events, mostly consistent with nicotine withdrawal symptoms, were reported and overall no safety signal was detected.ConclusionsIn this initial single-arm trial, Clickotine users appeared to demonstrate encouraging indicators of engagement in terms of the number of app opens, number of program interactions, and continued engagement over time. Clickotine users reported encouraging quit rates while reporting few adverse events. Future research is warranted to assess Clickotine's efficacy in a randomized controlled trial.Trial registrationClinicaltrials.gov NCT02656745; https://clinicaltrials.gov/ct2/show/NCT02656745 (Archived by WebCite at http://www.webcitation.org/6peTT4x60).

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:BackgroundDaytime urinary incontinence (UI) is common in childhood and often persists into adolescence. UI in adolescence is associated with a range of adverse outcomes, including depressive symptoms, peer victimization, poor self-image, and problems with peer relationships. The first-line conservative treatment for UI is bladder training (standard urotherapy) that aims to establish a regular fluid intake and a timed schedule for toilet visits. The success of bladder training is strongly dependent on good concordance, which can be challenging for young people.ObjectiveThis paper aims to describe the development of a smartphone app (URApp) that aims to improve concordance with bladder training in young people aged 11 to 19 years.MethodsURApp was designed by using participatory co-design methods and was guided by the person-based approach to intervention design. The core app functions were based on clinical guidance and included setting a daily drinking goal that records fluid intake and toilet visits, setting reminders to drink fluids and go to the toilet, and recording progress toward drinking goals. The development of URApp comprised the following four stages: a review of current smartphone apps for UI, participatory co-design workshops with young people with UI for gathering user requirements and developing wireframes, the development of a URApp prototype, and the user testing of the prototype through qualitative interviews with 23 young people with UI or urgency aged 10 to 19 years and 8 clinicians. The app functions and additional functionalities for supporting concordance and behavior change were iteratively optimized throughout the app development process.ResultsYoung people who tested URApp judged it to be a helpful way of supporting their concordance with a timed schedule for toilet visits and drinking. They reported high levels of acceptability and engagement. Preliminary findings indicated that some young people experienced improvements in their bladder symptoms, including a reduction in UI. Clinicians reported that URApp was clinically appropriate and aligned with the best practice guidelines for bladder training. URApp was deemed age appropriate, with all clinicians reporting that they would use it within their own clinics. Clinicians felt URApp would be of particular benefit to patients whose symptoms were not improving or those who were not engaging with their treatment plans.ConclusionsThe next stage is to evaluate URApp in a range of settings, including pediatric continence clinics, primary care, and schools. This research is needed to test whether URApp is an effective (and cost-effective) solution for improving concordance with bladder training, reducing bladder symptoms, and improving the quality of life.

Project description:Emerging evidence supports the use of smartphone apps for smoking cessation, especially in young adults given their high smoking rates and high smartphone ownership rates. Although evaluative evidence is encouraging for supporting smoking cessation, there remains a paucity of research describing the design and development processes of mobile health (mHealth) interventions.The aim of this paper was to describe the process of developing Crush the Crave (CTC), an evidence-informed app to support smoking cessation in young adults, and the results of a formative evaluation of app usage behavior, as part of a broader program of research that seeks to establish the effectiveness of the CTC app.The Spiral Technology Action Research (STAR) 5-cycle model (listen, plan, do, act, and study) was employed to guide the development, implementation, and dissemination of CTC. The approach to development and formative evaluation included focus groups with young adult smokers (n=78) across 2 phases, analysis of the content of existing apps, 2 sessions with content experts, and Google Analytics to assess user behavior during a 12-month pilot.LISTEN-focus groups revealed young adult smoker preferences of (1) positive reinforcement, (2) personalization, (3) social support, (4) quit support, (5) tracking the behavior, and (6) tracking quit benefits. PLAN-informed by evidence for smoking cessation, young adult preferences and an assessment of popular cessation apps, content experts produced a mind map and a storyboard describing app content and structure. DO-focus groups with young adult smokers provided feedback on the first version of the app with opinions on content and suggestions for improvement such as providing alerts and distractions from craving. ACT-refinements were made, and app content was organized using the 4 key design components informed by principles of persuasive technology for behavior change: credibility, task support, dialogue support, and social support. CTC was launched in April 2013 and piloted from the period July 2013 to June 2014 where 1987 Android users had 18,567 sessions, resulting in 59,384 page views and 89.58% (1780/1987) of users returning within the same day to use CTC. STUDY-a pragmatic randomized controlled trial of CTC was launched in August 2014 to demonstrate that including mHealth technology as a population-based intervention can help young adult smokers to quit. The results of this phase will be presented in a subsequent publication.CTC is one of the first smoking cessation apps designed to meet the needs of young adult smokers. The development was informed by the inclusion of young adults in the design and the systematic application of multiple stakeholder input, scientific evidence, and theory. The STAR model approach was followed from the beginning of intervention development, which should facilitate optimization of mHealth interventions in the future.ClinicalTrials.gov NCT01983150; http://clinicaltrials.gov/ct2/show/NCT01983150 (Archived by WebCite at http://www.webcitation.org/6VGyc0W0i).

Project description:BackgroundMySurgery is a smartphone app designed to increase patient and carer involvement in behaviors that contribute toward safety in surgical care.ObjectiveThis study presents a pilot evaluation of MySurgery in which we evaluated surgical patients' perceptions of the app in terms of its content, usability, and potential impacts on communication and safety.MethodsA participatory action research (PAR) approach was used to formulate a research steering group consisting of 5 public representatives and 4 researchers with equal decision-making input. Surgical patients were recruited from the community using multiple approaches, including Web based (eg, social media, recruitment websites, and charitable or voluntary organizations) and face to face (via community centers). Participants referred to MySurgery before, during, and after their surgery and provided feedback via an embedded questionnaire and using reflective notes.ResultsA diverse mix of 42 patients took part with good representation from 2 "seldom heard" groups: those with a disability and those from a black, Asian, or minority ethnic group. Most were very supportive of MySurgery, particularly those with previous experience of surgery and those who felt comfortable to be involved in conversations and decisions around their care. The app showed particular potential to empower patients to become involved in their care conversations and safety-related behaviors. Perceptions did not differ according to age, ethnicity, or length of hospital stay. Suggestions for improving the app included how to make it more accessible to certain groups, for example, those with a disability.ConclusionsMySurgery is a novel technology-driven approach for empowering patients to play a role in improving surgical safety that seems feasible for use within the United Kingdom's National Health Service. Adopting a PAR approach and the use of a diversity strategy considerably enhanced the research process in terms of gaining diverse participant recruitment and patient and public involvement. Further testing with stakeholder groups will follow.

Dataset Information

Evaluation of the Combined Treatment Approach "Robin" (Standardized Manual and Smartphone App) for Adolescents at Clinical High Risk for Psychosis.

Publications

Evaluation of the Combined Treatment Approach "Robin" (Standardized Manual and Smartphone App) for Adolescents at Clinical High Risk for Psychosis.

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