Digital mental health intervention for schizophrenia spectrum and psychotic disorders: Protocol for a pragmatic feasibility study of Horyzons-Canada.

Background: Schizophrenia spectrum and other psychotic disorders (SSPD) are among the most debilitating of all mental disorders. While the evidence for psychosocial interventions such as cognitive behavioral therapy and peer support has significantly improved, access to these services remains limited. This paper describes a protocol for a pragmatic feasibility study of a digital mental health intervention (HoryzonsCa) that provides access to evidence-based psychosocial interventions, social networking, and clinical and peer support services through a secured, web-based platform for adults diagnosed with SSPD.
Objective: The objectives are: (1) Adapt and translate HoryzonsCa for implementation in English and French; (2) Develop an implementation and training strategy; (3) Assess the acceptability, safety, and demand of HoryzonsCa; (4) Assess clinical outcomes and perceived impacts; (5) Examine the experiences and process of adapting and implementing HoryzonsCa; (6) Explore the role of sociocultural and demographic factors on HoryzonsCa outcomes and implementation.
Methods: This feasibility study will use a single-group, pre-post, mixed-methods (QUAN-QUAL convergent) research design, with assessments at baseline and 12 weeks. The study aims to recruit 100 individuals (ages 18-50) diagnosed with SSPD from two healthcare settings in Canada. Data collection includes interview-based psychometric measures, self-reports, focus groups, and interviews with participants. The study will also collect qualitative data from moderators and the research team, and will be conducted entirely remotely.
Conclusions: This study has been prospectively registered and is underway. It will provide timely information on the feasibility and potential impacts of using digital mental health services for individuals with chronic mental health conditions.
Trial Registration: ISRCTN12561259; https://doi.org/10.1186/ISRCTN12561259 (250/max 250 words).
Competing Interests: Shalini Lal reports a research grant from Hoffman-La Roche, partially supporting this Phase 3 study on the implementation and evaluation of HoryzonsCa; Mario Alvarez-Jimenez, John F. Gleeson, and Ridha Joober are coinvestigators on this grant. Ridha Joober served as speaker and member of advisory board committees for Pfizer, Janssen, Bristol Myers Squibb, Sunovian, Myelin and Associates, Otsuka, Lundbeck, Shire, and Perdue. He also received grants from Janssen, Bristol Myers Squibb, Otsuka, Lundbeck, Astra Zeneca, and HLS Therapeutics Inc. All of these are unrelated to this study. Martin Lepage reports grants from Otsuka Lundbeck Alliance, diaMentis, Roche, personal fees from Otsuka Canada, personal fees from Lundbeck Canada, grants and personal fees from Janssen, and personal fees from Boehringer-Ingelheim outside the submitted work. Martin Lepage also reports a grant from Hoffman-La Roche (partially supporting this Phase 3 study on implementing and evaluating HoryzonsCa). All other authors declare no financial or nonfinancial competing interests.
(© The Author(s) 2024.)