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.

Improving social functioning in people with schizophrenia-spectrum disorders via mobile experimental interventions: Results from the CLIMB pilot trial.

“…In both experimental approaches, group session attendance and EMAs completion rates aligned with those found in the proof-of-concept trial and by other mobile health studies conducted in SSD ( Barbeito et al, 2019 ; Biagianti et al, 2016a ; Fulford et al, 2020 ; Granholm et al, 2013 ; Schlosser et al, 2018 ); high enrolment, retention, and remote assessment completion rates were comparable to those reported by studies testing mobile apps in patients with psychotic disorders ( Barbeito et al, 2019 ; Bucci et al, 2018 ; Fulford et al, 2020 ; Kumar et al, 2018 ; Meyer et al, 2018 ; Niendam et al, 2018 ; Schlosser et al, 2018 )—which corroborates the feasibility of remotely delivering assessments and treatments to people with SSD. Engagement with SCT or GCT exercises, however, was lower than anticipated across both groups, likely attributed to being encouraged, but not required, to complete 2 h of weekly training.…”

Smartphone Apps to Support Coordinated Specialty Care for Prodromal and Early Course Schizophrenia Disorders: Systematic Review

“…When planning the Psychotherapy app, Barbeito et al [24] wrote a protocol for a focus group, to gain insight into the opinions of young people with psychosis in Spain [24]. The app, comprised of five modules outlined in Table 1, will be studied to assess its ability to decrease the number of relapses and rehospitalizations in 50 patients with first-episode psychosis, aged 14-19 years, when compared to treatment as usual.…”

“…Many of the apps reviewed offered social and peer support as their main feature or intervention [17,22-24,26,35]. For example, HORYZONS incorporates peer moderators in the “café” feature where youth with mental illness can share their lived experiences to help participants navigate issues they may be facing.…”

Clinical Effects of Mindfulness-Based Intervention in Patients With First Episode Psychosis and in Individuals With Ultra-High Risk for Transition to Psychosis: A Review

“…Among the 13 full-text articles read, 4 articles were excluded. The first excluded study was a pilot study evaluating the effect of a multimodal smartphone application (psychoeducation, cognitive remediation, peer discussion forum) of which the mindfulness-based intervention represented only a small part that could not be evaluated without substantial bias (26). One study did not provide any details about the mindfulness-based intervention, and one study included patients with chronic schizophrenia.…”