JMIR Publications

ABSTRACT

Background:

People with Serious Mental Illness (SMI) have significant unmet mental health needs. Development and testing of digital interventions that can help alleviate the suffering of people with SMI is a public health priority.

Objective:

To conduct a fully-remote randomized waitlist-controlled trial of CORE, a smartphone intervention that consists of daily exercises designed to promote re-assessment of beliefs that impede recovery, exacerbate symptoms, and block treatment seeking.

Methods:

Participants were recruited online using Google Ads and Facebook Ads. Interested individuals were directed to the project website where they found details about the study, completed a screener, and provided informed consent. Enrolled participants were randomized to either active intervention or waitlist control groups. All participants completed self-report measures of depression, anxiety, auditory hallucinations, paranoid thinking, recovery, self-esteem, social isolation, and functional disability at baseline (T1), 30-day (T2), and 60-day (T3) assessments points. Participants in the active condition used CORE from T1 to T2 and participants in the waitlist control condition used CORE from T2 to T3. Both groups completed usability and accessibility measures after they concluded their intervention periods.

Results:

A total of 315 individuals from 45 states participated in the study. The sample consisted of individuals with bipolar disorder (n= 111, 35%), major depressive disorder (n= 136, 43%), and schizophrenia or schizoaffective disorder (n= 68, 22%) who reported moderate to severe psychiatric symptoms and disability levels at baseline. Participants rated CORE to be highly usable and acceptable. Intent-to-treat analyses showed significant treatment x time interactions for measures of depression, anxiety, recovery, self-esteem, and disability, indicating treatment gains in participants using the CORE app after 30-days compared to waitlist-control (T1 to T2). Similar changes on outcome measures were later observed in the waitlist control participants following crossover, after they received CORE (T2 to T3). Forty-two percent of participants in the active condition and 60% of participants in the waitlist group were retained at T2 and 33% of participants in the active condition and 40% of individuals in the waitlist group were retained at T3.

Conclusions:

We successfully recruited, randomized, treated, and assessed a diverse sample of participants with SMI entirely online, demonstrating that fully-remote clinical trials are feasible with this population, but study retention remains challenging. The CORE intervention proved to be usable, acceptable, and effective in reducing the severity of psychiatric symptoms and disability while improving recovery and self-esteem. Rapid adoption and real-world dissemination of evidence-based mHealth 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. Clinical Trial: ClinicalTrials.gov NCT04068467