Dataset Information

Mobile App-Based Intervention for Adolescents With First-Episode Psychosis: Study Protocol for a Pilot Randomized Controlled Trial.

ABSTRACT: Introduction: Previous studies have shown an improvement in the access to treatment for patients with first-episode psychosis (FEP), specifically young patients, through mobile app-based interventions. The aim of this study is to test the effectiveness of a mobile app-based intervention to improve community functioning in adolescents with FEP. Mobile app-based interventions could increase quality of life and disease awareness, which improve adherence to treatment and reduce the frequency of relapses and rehospitalizations in adolescents with FEP. Methods: This article describes a mobile app treatment and the pilot trial protocol for patients with FEP. We will perform a single-blind randomized clinical trial (RCT) including patients with FEP aged 14-19 years recruited from Gregorio Marañón Hospital, Madrid, Spain. Patients will be randomly assigned to an intervention group, which will receive treatment as usual plus five modules of a psychological intervention through the mobile app (psychoeducation, recognition of symptoms and prevention of relapses, problem solving, mindfulness, and contact wall), or to a control group (standard care). The effectiveness of the intervention will be assessed by means of an extensive battery of clinical tests at baseline and at 3 months of follow-up. The primary outcome is reduction in psychotic and depressive symptoms; secondary outcomes comprise adherence, awareness, use of drugs, and quality of life. Data will be analyzed on an intention-to-treat (ITT) basis. Mixed model repeated-measures analysis will be used to explore the following effect: group × time interaction between the control group and the intervention group for clinical and functional variables during the follow-up period. Discussion: This is an innovative study for the assessment of a psychological intervention through a mobile app for patients with FEP during the critical period. This pilot RCT is intended to be a precursor to larger studies, which in turn could facilitate dissemination of mobile app therapy for patients with FEP. Ethics and Dissemination: The local ethics committee approved the study protocol. All participants must sign the informed consent, to participate. After finalizing the study, the results will be published. Trial registration: NCT03161249. NCT clinicaltrials.gov. Date of registration in primary registry 02 May 2017. clinicaltrials.gov.

SUBMITTER: Barbeito S

PROVIDER: S-EPMC6370739 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Mobile App-Based Intervention for Adolescents With First-Episode Psychosis: Study Protocol for a Pilot Randomized Controlled Trial.

Barbeito Sara S Sánchez-Gutiérrez Teresa T Mayoral María M Moreno Miguel M Ríos-Aguilar Sergio S Arango Celso C Calvo Ana A

Frontiers in psychiatry 20190205

<b>Introduction:</b> Previous studies have shown an improvement in the access to treatment for patients with first-episode psychosis (FEP), specifically young patients, through mobile app-based interventions. The aim of this study is to test the effectiveness of a mobile app-based intervention to improve community functioning in adolescents with FEP. Mobile app-based interventions could increase quality of life and disease awareness, which improve adherence to treatment and reduce the frequency ...[more]

PMID: 30804818

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Project description:BackgroundAdolescents and young adults (AYAs) with cancer are at risk of poor psychosocial outcomes. AYAs grew up with the internet and digital technology, and mobile Health (mHealth) psychosocial interventions have the potential to overcome care access barriers.ObjectiveThis pilot randomized controlled trial (RCT) aimed to establish the feasibility, acceptability, and preliminary efficacy of a fully automated mobile app version of the Promoting Resilience in Stress Management intervention (mPRISM). Promoting Resilience in Stress Management is an evidence-based intervention developed in collaboration with AYAs, based on stress and coping theory, resilience theory, and evidence-based coping strategies. We hypothesized that mPRISM would be feasible, acceptable, and appropriate.MethodsThis is a parallel, 2-arm, single-site pilot RCT with a waitlist control design. The study will recruit 80 AYAs with cancer from a clinic. Eligible AYAs are aged 12 to 25 years, within 12 months of a new cancer diagnosis, receiving chemotherapy or radiation therapy, speak, read, or write in English, and are cognitively able to participate in study procedures. Recruitment by clinical research coordinators will occur remotely by phone, video, or text. Participants will be randomized to psychosocial usual care (UC) alone or UC plus mPRISM for an 8-week intervention period, and will remain unblinded to study condition. Enrolled participants will complete surveys at baseline before randomization, 8 weeks, and 3-month follow-up. Using a waitlist design, the UC arm will receive mPRISM upon completion of 3-month follow-up surveys. Those in the UC arm will complete 2 additional measurement points at immediate posttreatment and 3 months later. The primary outcomes of interest are feasibility, defined as ≥60% enrollment and ≥70% retention (ie, percentage of participants who completed the study), and "feasibility, acceptability, and appropriateness" as defined by cut-off scores ≥4/5 on 3 brief validated implementation outcome measures (feasibility of implementation measure, acceptability of intervention measure [AIM], intervention appropriateness measure [IAM]). We will apply top-box scoring for the implementation measures. Exploratory outcomes of interest include patient-reported health-related quality of life, resilience, distress, anxiety, depression, pain, and sleep. We will conduct an intention-to-treat analysis to compare the outcomes of the mPRISM arm versus the control arm with covariate-adjusted regression models. We will summarize individual digital usage metrics using descriptive statistics.ResultsSince September 2023, we have enrolled 20 participants and recruitment is ongoing.ConclusionsAlthough our previous work suggests AYAs with cancer are interested in mHealth psychosocial interventions, such interventions have not yet been sufficiently evaluated or implemented among AYA oncology patients. mPRISM may serve as a potential mHealth intervention to fill this gap. In this study, we will test the feasibility, acceptability, and preliminary efficacy of mPRISM. This work will inform future larger-scale RCTs powered for efficacy outcomes.Trial registrationClinicalTrials.gov NCT05842902; https://clinicaltrials.gov/study/NCT05842902.International registered report identifier (irrid)DERR1-10.2196/57950.

Project description:BackgroundPersistent pain in adolescence adversely affects everyday life and is an important public health problem. The primary aim was to determine the feasibility of an 8-week app-based self-management intervention to reduce pain and improve health-related quality of life in a community-based population of adolescents with persistent pain. A secondary aim was to explore differences in health outcomes between the intervention and control groups.MethodsA sample of 73 adolescents aged 16-19 years with persistent pain from a community-based population were randomized into 2 groups. The intervention group received the Norwegian culturally adapted version of the iCanCope with PainTM app, which includes symptom tracking, goal setting, self-management strategies, and social support. The attention control group received a symptom tracking app. Feasibility was assessed as attrition rates and level of engagement (interactions with the app). The secondary outcomes included pain intensity, health-related quality of life, self-efficacy, pain self-efficacy, perceived social support from friends, anxiety and depression, and patient global impression. Statistical analyses were conducted using SPSS.ResultsDemographic and baseline outcome variables did not differ between the 2 groups. No differences were found between the participants completing the study and those who withdrew. Twenty-eight adolescents completed the intervention as planned (62% attrition). Both groups had a low level of app engagement. Intention-to-treat analysis (n = 19 + 14) showed no significant differences in outcomes between groups. However, the large effect size (Cohen's d = .9) for depression suggested a lower depression score in the intervention group.ConclusionsHigh treatment attrition and low engagement indicate the need for changes in trial design in a full-scale randomized controlled trial to improve participant retention.Trial registrationThe iCanCope with Pain Norway trial was retrospectively registered in Clinical Trials.gov (ID: NCT03551977 ). Registered 6 June 2018.

Dataset Information

Mobile App-Based Intervention for Adolescents With First-Episode Psychosis: Study Protocol for a Pilot Randomized Controlled Trial.

Publications

Mobile App-Based Intervention for Adolescents With First-Episode Psychosis: Study Protocol for a Pilot Randomized Controlled Trial.

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