A Smartphone Intervention for People With Serious Mental Illness: Fully Remote Randomized Controlled Trial of CORE

Abstract

Background People with serious mental illness (SMI) have significant unmet mental health needs. Development and testing of digital interventions that can alleviate the suffering of people with SMI is a public health priority. Objective The aim of this study is to conduct a fully remote randomized waitlist-controlled trial of CORE, a smartphone intervention that comprises daily exercises designed to promote reassessment of dysfunctional beliefs in multiple domains. Methods Individuals were recruited via the web using Google and Facebook advertisements. Enrolled participants were randomized into either active intervention or waitlist control groups. Participants completed the Beck Depression Inventory-Second Edition (BDI-II), Generalized Anxiety Disorder-7 (GAD-7), Hamilton Program for Schizophrenia Voices, Green Paranoid Thought Scale, Recovery Assessment Scale (RAS), Rosenberg Self-Esteem Scale (RSES), Friendship Scale, and Sheehan Disability Scale (SDS) at baseline (T1), 30-day (T2), and 60-day (T3) assessment points. Participants in the active group used CORE from T1 to T2, and participants in the waitlist group used CORE from T2 to T3. Both groups completed usability and accessibility measures after they concluded their intervention periods. Results Overall, 315 individuals from 45 states participated in this study. The sample comprised individuals with self-reported bipolar disorder (111/315, 35.2%), major depressive disorder (136/315, 43.2%), and schizophrenia or schizoaffective disorder (68/315, 21.6%) who displayed moderate to severe symptoms and disability levels at baseline. Participants rated CORE as highly usable and acceptable. Intent-to-treat analyses showed significant treatment×time interactions for the BDI-II (F1,313=13.38; P<.001), GAD-7 (F1,313=5.87; P=.01), RAS (F1,313=23.42; P<.001), RSES (F1,313=19.28; P<.001), and SDS (F1,313=10.73; P=.001). Large effects were observed for the BDI-II (d=0.58), RAS (d=0.61), and RSES (d=0.64); a moderate effect size was observed for the SDS (d=0.44), and a small effect size was observed for the GAD-7 (d=0.20). Similar changes in outcome measures were later observed in the waitlist control group participants following crossover after they received CORE (T2 to T3). Approximately 41.5% (64/154) of participants in the active group and 60.2% (97/161) of participants in the waitlist group were retained at T2, and 33.1% (51/154) of participants in the active group and 40.3% (65/161) of participants in the waitlist group were retained at T3. Conclusions We successfully recruited, screened, randomized, treated, and assessed a geographically dispersed sample of participants with SMI entirely via the web, demonstrating that fully remote clinical trials are feasible in this population; however, study retention remains challenging. CORE showed promise as a usable, acceptable, and effective tool for reducing the severity of psychiatric symptoms and disability while improving recovery and self-esteem. Rapid adoption and real-world dissemination of evidence-based mobile health interventions such as CORE are needed if we are to shorten the science-to-service gap and address the significant unmet mental health needs of people with SMI during the COVID-19 pandemic and beyond. Trial Registration ClinicalTrials.gov NCT04068467; https://clinicaltrials.gov/ct2/show/NCT04068467

Cognitive training using a mobile app as a coping tool against COVID-19 distress: A crossover randomized controlled trial

“…Although, previous studies have shown the effects of GGtude platform interventions remain for at least one month ( e.g. , Aboody et al, 2020 ; Ben-Zeev et al, 2021 ), our results were assessed at 12 days. Future studies would benefit assessing the effects of such intervention over a longer follow up periods.…”

“…Use of mHealth apps has also been shown to be associated with reductions in anxiety, depression, self-harm and negative body image ( e.g. , Ben-Zeev et al, 2021 ; Burns et al, 2011 ; Chandrashekar, 2018 ; Firth et al, 2017a ; Melia et al, 2020 ; Rodgers et al, 2018 ).…”

“…, Gordon et al, 2021 ; Mira et al, 2020 ; Moulaei et al, 2021 ; Sun et al, 2021 ). One mobile mental health platform with relatively robust empirical support including 6 published randomized controlled trials (RCTs) is GGtude ( Aboody et al, 2020 ; Akin-Sari et al, 2022 ; Ben-Zeev et al, 2021 ; Cerea et al, 2020 , Cerea et al, 2021 ; Roncero et al, 2019 ).…”

“…Several elements of the GGtude platform have been theorized to be implicated in the reduction of users' maladaptive cognitions and associated symptoms ( Aboody et al, 2020 ; Ben-Zeev et al, 2021 ; Giraldo-O'Meara and Doron, 2021 ; Roncero et al, 2018 , Roncero et al, 2019 ). These include 1) psychoeducation to increase users' motivation and provide knowledge of basic CBT principles, 2) daily categorization exercises to promote users' awareness of their inner monologue, 3) repeated exposure to adaptive self-statements to increase cognitive availability of such self-statements, and 4) concurrent priming of maladaptive beliefs and exposure to unanticipated competing appraisals to accelerate adjustive reflective processing.…”

“…Although previous findings assessed the effectiveness of cognitive training exercises on various psychopathological symptoms ( e.g. , Ben-Zeev et al, 2021 ; Cerea et al, 2020 ; Roncero et al, 2019 ), the effectiveness of such exercises on COVID-19 related distress has yet to be assessed. An additional aim of the study was to assess the effectiveness of this intervention in a Turkish sample of individuals showing high levels of COVID-19 related distress.…”