Improving Social Functioning in People With Schizophrenia-Spectrum Disorders via Mobile Experimental Interventions: Results from the CLIMB Pilot Trial. (Preprint)

BACKGROUND Patients with Schizophrenia Spectrum Disorder (SSD) demonstrate poor social functioning and lack the ability to engage in meaningful social interactions. While several integrated, behavioral approaches have shown long-term improvements, access to group-based treatment is limited. Digital platforms, however, are a promising mechanism to overcome barriers to treatment delivery. Though little research has been conducted to assess the feasibility of group-based, mobile-delivered interventions, evidence suggests that technology-based solutions may be leveraged to personalize and improve treatment quality and delivery, increase adherence, and promote transfer of skills in real-world settings. OBJECTIVE The goal of this study was to test the effects of two experimental mobile approaches in people with SSD, in hopes to reduce negative symptoms and enhance social functioning. in a parallel arm, double-blind, randomized, controlled clinical trial, we compared a clinician-assisted, adjunct to treatment, mobile intervention that included computerized social cognition training (SCT), ecological momentary assessments, group tele-therapy, and moderated peer-to-peer messaging (CLIMB), with another mobile treatment serving as an active control that included general cognitive training (GCT) program, unstructured support groups, and unmoderated peer-to-peer messaging. METHODS Participants were recruited through the Internet and engaged in remote study and intervention activities. Participants used iOS devices to attend remote weekly CLIMB or unstructured group sessions, connect with peers and access up to 18 hours of their respective cognitive training. Primary outcomes were negative symptoms, social functioning, and quality of life. Participant engagement was analyzed to assess mediation effects. Given the small sample size of our study population, a Propensity Score Model was used to ensure balanced baseline covariates. Mixed-effects models examined change over time. RESULTS Twenty-four participants completed the study and were equally randomized into the CLIMB and control conditions. As a group, participants showed significant improvements in social functioning (p = 0.046), with no between-group differences. Intent-to-treat analyses indicated greater improvements in quality of life (p = 0.025) for the active control participants. There were no significant between-group differences in engagement—participants in CLIMB attended a median of 8 sessions (IQR=2), completed a median of 2.83 hours of SCT(IQR=7.5), and 2710 EMAs, while those in the control attended a median of 9 sessions (IQR=3), and completed a median of 2.2hours of GCT (IQR=7.9). CONCLUSIONS Our results demonstrate that digital platforms are a feasible mechanism for delivering group-based mobile interventions to individuals with SSD. Notably, EMAs prove to be an innovative feature that maintain inter-session engagement, build participant self-awareness and inform clinician led group-therapy sessions. Across groups, participants were highly engaged in remote intervention activities, and even participants in the control appear to benefit from social interactions through unstructured group sessions. However, it is unclear whether SCT or GCT are more effective in this treatment model. Further research is required to evaluate group-based mobile interventions and implications for improving quality of life in individuals with SSD. CLINICALTRIAL ClinicalTrials.gov NCT03317769; http://clinicaltrials.gov/ct2/show/NCT03317769