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

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.

Expanding the Reach of Research: Quantitative Evaluation of a Web-Based Approach for Remote Recruitment of People Who Hear Voices.

BACKGROUND: Similar to other populations with highly stigmatized medical or psychiatric conditions, people who hear voices (ie, experience auditory verbal hallucinations [AVH]) are often difficult to identify and reach for research. Technology-assisted remote research strategies reduce barriers to research recruitment; however, few studies have reported on the efficiency and effectiveness of these approaches. OBJECTIVE: This study introduces and evaluates the efficacy of technology-assisted remote research designed for people who experience AVH. METHODS: Our group developed an integrated, automated and human complementary web-based recruitment and enrollment apparatus that incorporated Google Ads, web-based screening, identification verification, hybrid automation, and interaction with live staff. We examined the efficacy of that apparatus by examining the number of web-based advertisement impressions (ie, number of times the web-based advertisement was viewed); clicks on that advertisement; engagement with web-based research materials; and the extent to which it succeeded in representing a broad sample of individuals with AVH, assessed through the self-reported AVH symptom severity and demographic representativeness (relative to the US population) of the sample recruited. RESULTS: Over an 18-month period, our Google Ads advertisement was viewed 872,496 times and clicked on 11,183 times. A total amount of US $4429.25 was spent on Google Ads, resulting in 772 individuals who experience AVH providing consent to participate in an entirely remote research study (US $0.40 per click on the advertisement and US $5.73 per consented participant) after verifying their phone number, passing a competency screening questionnaire, and providing consent. These participants reported high levels of AVH frequency (666/756, 88.1% daily or more), distress (689/755, 91.3%), and functional interference (697/755, 92.4%). They also represented a broad sample of diversity that mirrored the US population demographics. Approximately one-third (264/756, 34.9%) of the participants had never received treatment for their AVH and, therefore, were unlikely to be identified via traditional clinic-based research recruitment strategies. CONCLUSIONS: Web-based procedures allow for time saving, cost-efficient, and representative recruitment of individuals with AVH and can serve as a model for future studies focusing on hard-to-reach populations.