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

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 (<i>F</i><sub>1,313</sub>=13.38; <i>P<</i>.001), GAD-7 (<i>F</i><sub>1,313</sub>=5.87; <i>P</i>=.01), RAS (<i>F</i><sub>1,313</sub>=23.42; <i>P<</i>.001), RSES (<i>F</i><sub>1,313</sub>=19.28; <i>P<</i>.001), and SDS (<i>F</i><sub>1,313</sub>=10.73; <i>P</i>=.001). Large effects were observed for the BDI-II (<i>d=</i>0.58), RAS (<i>d=</i>0.61), and RSES (<i>d=</i>0.64); a moderate effect size was observed for the SDS (<i>d=</i>0.44), and a small effect size was observed for the GAD-7 (<i>d=</i>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. CLINICALTRIAL ClinicalTrials.gov NCT04068467; https://clinicaltrials.gov/ct2/show/NCT04068467

Brief cognitive-behavioral training for tinnitus relief using a mobile application: A pilot open trial

“…Although previous RCTs have shown using apps from the GGtude platform was associated with changes in response to behavioral tasks reductions on psychological processes relevant to the targeted problem 23 (e.g., maladaptive beliefs) and significant decreases in symptoms measures. 21,24,38 We cannot exclude the possibility that the outcome found in this study was a mere result of the intervention training users to alter their answers to the THI. It is important to note, however, that the THI is considered the gold standard in evaluating tinnitus-related disability and includes questions mostly relating to symptoms such as difficulty in concentration and distress (e.g.…”

“…Large effect size changes were observed for depression symptoms, self-esteem and recovery attitudes following app use. 21 Other RCTs using the GGtude platform have shown medium--large effect size reductions in pre-post measurements of body dysmorphic disorder symptoms 20,38 and obsessivecompulsive disorder (OCD) symptoms in high-risk and student populations. 23,24 No changes in mood rating were found across the three assessment occasions.…”

“…Indeed, previous studies using the GGtude platform have shown that modules that do not target mood directly (e.g., targeting relationship obsessive compulsive disorder symptoms), 24 do not show significant changes on mood measures. When modules targeting mood are included 21 reductions in depresses mood are found. An alternative explanation is that mood rating in the app reflect momentary changes in affect rather than ongoing mood.…”

“…20 Training with apps on this platform for a duration of 2 weeks have been shown to reduce a range of symptoms and maladaptive beliefs five published randomized controlled trials with non-clinical, high risk, and clinical samples. [20][21][22][23][24] The GGtude platform comprises several elements suggested to reduce users' maladaptive cognitive processes. 20,24,25 For example, psychoeducation elements incorporated throughout the training may encourage users to persevere, and assist in understanding of basic CBT principles.…”

The Promise and Peril of Mental Health Apps

“…The treatment group used CORE, an app designed to teach users to increase their mental flexibility. Following 30 days of CORE, the treatment group improved significantly compared to a waitlist control with a medium effect on symptoms of depression and small effects on symptoms of anxiety (Ben-Zeev et al, 2021).…”