iCogCA to Promote Cognitive Health Through Digital Group Interventions for Individuals Living With a Schizophrenia Spectrum Disorder: Protocol for a Nonrandomized Concurrent Controlled Trial.

backgroundCognitive impairments are a key aspect of schizophrenia spectrum disorders (SSDs), significantly affecting clinical and functional outcomes. The COVID-19 pandemic has heightened concerns about mental health services and cognitive stimulation opportunities. Despite evidence-based interventions like action-based cognitive remediation (ABCR) and metacognitive training (MCT), a research-to-practice gap exists in their application across mental health settings.

objectiveThe iCogCA study aims to address this gap by implementing digital ABCR and MCT through a national Canadian collaborative effort using digital psychological interventions to enhance cognitive health in SSDs.

methodsThe study involves 5 Canadian sites, with mental health care practitioners trained digitally through the E-Cog platform, which was developed by our research group. Over 2.5 years, participants with SSDs will undergo pre- and postintervention assessments for clinical symptoms, cognition, and functioning. Each site will run groups annually for both ABCR and MCT, totaling ~390 participants. A nonrandomized concurrent controlled design will assess effectiveness design, in which one intervention (eg, ABCR) acts as the active control for the other (eg, MCT) and vice versa, comparing cognitive and clinical outcomes between the interventions using generalized linear mixed effect modeling. Implementation strategy evaluation will consider the digital platform's efficacy for mental health care practitioners' training, contextual factors influencing implementation, and sustainability, using descriptive statistics for quantitative data and thematic analysis for qualitative data.

resultsA pilot pragmatic trial has been conducted previously at the Montreal site, evaluating 3 early implementation outcomes: acceptability, feasibility, and engagement. Patient and therapist acceptability was deemed as high and feasible (21/28, 75% of recruited service users completed therapy, rated feasible by therapists). Technology did not appear to significantly impede program participation. Therapist-rated levels of engagement were also satisfactory. In the ongoing study, recruitment is underway (114 participants recruited as of winter 2024), and intervention groups have been conducted at all sites, with therapists receiving training via the E-Cog learning platform (32 enrolled as of winter 2024).

conclusionsAt least 3 significant innovations will stem from this project. First, this national effort represents a catalyst for the use of digital technologies to increase the adoption of evidence-based interventions and will provide important results on the effectiveness of digitally delivered ABCR and MCT. Second, the results of the implementation component of this study will generate the expertise needed to inform the implementation of similar initiatives. Third, the proposed study will introduce and validate our platform to train and supervise mental health care practitioners to deliver these interventions, which will then be made accessible to the broader mental health community.

trial registrationClinicalTrials.gov NCT05661448; https://clinicaltrials.gov/study/NCT05661448. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/63269.