Abstract
ObjectiveWe adapted and evaluated a transdiagnostic psychosocial intervention, the Optimal Health Program (OHP), to meet the unique mental health needs of youth at clinical high risk for psychosis (CHR). This study aimed to establish the acceptability of OHP for CHR (OHP-CHR), the feasibility of conducting a confirmatory clinical trial, and the preliminary efficacy of the intervention in improving clinical and functional outcomes.MethodsIn this single-arm clinical trial, youth aged 16-29 years meeting CHR criteria were recruited between September 2023 and August 2024. Nine OHP-CHR sessions were delivered over 12 weeks. Acceptability of the intervention was assessed through session attendance rates and the Client Satisfaction Questionnaire (CSQ-8). Feasibility of conducting a confirmatory clinical trial was informed by recruitment, retention, adherence, intervention fidelity, and completion of the outcome schedule. Psychiatric symptoms, resilience, and functioning were assessed at baseline and after 12 weeks.ResultsAcceptability of OHP-CHR was demonstrated by high session attendance (n = 26; 86.7% attended all nine sessions) and participant satisfaction scores (CSQ-8: mean = 28.35, SD = 3.68). Feasibility of conducting a confirmatory clinical trial was supported by strong recruitment over 12 months (n = 30; rate of 2-3/month) high retention (n = 26; 86.7% at 12 weeks), intervention fidelity, and ease of completing the clinical assessment schedule. Preliminary indicators of clinical efficacy were demonstrated by a decrease in psychiatric symptoms, improvement in resilience, and enhanced functioning.ConclusionsOHP-CHR is a promising psychosocial intervention co-designed by CHR youth. Our data support the acceptability of the intervention, the feasibility of conducting a confirmatory clinical trial, and preliminary evidence of efficacy in improving clinical and functional outcomes.Trial is registered at ClinicalTrials.gov NCT05757128.