A Smartphone-Based Intervention as an Adjunct to Standard-of-Care Treatment for Schizophrenia: Randomized Controlled Trial.

Content Provider	Europe PMC
Author	Ghaemi, S Nassir Sverdlov, Oleksandr van Dam, Joris Campellone, Timothy Gerwien, Robert
Editor	Mavragani, Amaryllis
Copyright Year	2022
Abstract	BackgroundAntipsychotic medications have limited benefits in schizophrenia, and cognitive behavioral therapy may be beneficial as an adjunct. There may be potential for implementing mobile cognitive behavioral therapy–based treatment for schizophrenia in addition to standard antipsychotic medications.ObjectiveThis study aims to determine whether PEAR-004, a smartphone-based investigational digital therapeutic, improves the symptoms of an acute psychotic exacerbation of schizophrenia when it is added to standard treatments.MethodsThis was a 12-week, multicenter, randomized, sham-controlled, rater-blinded, parallel group proof‑of‑concept study of 112 participants with moderate acute psychotic exacerbation in schizophrenia. This study was conducted in 6 clinical trial research sites in the United States from December 2018 to September 2019. The primary outcome, change in Positive and Negative Syndrome Scale (PANSS) from baseline to week 12 or the last available visit, was analyzed using the mixed-effects regression model for repeated measures, applied to an intent-to-treat sample.ResultsThe total PANSS scores slightly decreased from baseline over the study period in both groups; the treatment difference at day 85 between PEAR-004 and sham was 2.7 points, in favor of the sham (2-sided P=.09). The secondary scales found no benefit, except for transient improvement in depressive symptoms with PEAR-004. Application engagement was good, and patient and clinical investigator satisfaction was high. No safety concerns were observed. There was some evidence of study site heterogeneity for the onboarding processes and directions on PEAR-004 product use at baseline and throughout the study. However, these differences did not affect the efficacy results.ConclusionsIn the largest-to-date randomized, sham-controlled study of a digital therapeutic in schizophrenia, PEAR-004 did not demonstrate an effect on the primary outcome—total PANSS scores—when compared with a nonspecific digital sham control. The secondary and exploratory results also did not demonstrate any notable benefits, except for possible temporary improvement in depressive symptoms. This study provided many useful scientific and operational insights that can be used in the further clinical development of PEAR-004 and other investigational digital therapeutics.Trial RegistrationClinicalTrials.gov NCT03751280; https://clinicaltrials.gov/ct2/show/NCT03751280
Journal	JMIR Formative Research
Volume Number	6
PubMed Central reference number	PMC9002609
Issue Number	3
PubMed reference number	35343910
e-ISSN	2561326X
DOI	10.2196/29154
Language	English
Publisher	JMIR Publications
Publisher Date	2022-03-28
Publisher Place	Toronto, Canada
Access Restriction	Open
Rights License	This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Formative Research, is properly cited. The complete bibliographic information, a link to the original publication on https://formative.jmir.org, as well as this copyright and license information must be included. ©S Nassir Ghaemi, Oleksandr Sverdlov, Joris van Dam, Timothy Campellone, Robert Gerwien. Originally published in JMIR Formative Research (https://formative.jmir.org), 28.03.2022.
Subject Keyword	digital therapeutics schizophrenia smartphones randomized controlled trial mobile phone
Content Type	Text
Resource Type	Article
Subject	Health Informatics Medicine