Pragmatic cluster randomized controlled trial evaluating the effectiveness and cost effectiveness of the early youth engagement intervention in early intervention in psychosis services

ABSTRACT

Background: Early Intervention in Psychosis services improve outcomes for young people with psychosis but a significant proportion disengage with potential costs to their mental health. Method(s) This study evaluated effectiveness and cost-effectiveness of the EYE-2 intervention, a motivational engagement intervention, delivered by EIP clinicians, compared to standardized EIP (sEIP) in a cluster RCT in 20 EIP teams in 5 sites across England. Participants were 1027 young people with first episode psychosis. The primary outcome was time to disengagement. Economic outcomes were NHS mental health and wider societal costs, clinical and social outcomes and cost-effectiveness. Result(s) The adjusted hazard ratio for EYE-2 + sEIP versus sEIP alone was 1.07, (95% CI 0.76 to 1.49;p = .713). Disengagement was 16% with no observed differences between arms for any secondary outcomes. The health economic evaluation indicated lower average mental health costs [-543 (95% CI -2715 to 1628)] and marginally improved mental health states, with a 63% probability of the EYE-2 intervention being dominant in cost-effectiveness compared to usual care. There were very tentative indications of lower societal costs and better social outcomes with 30 more days per year spent in education and training (95% CI 1.52 to 53.68;probability positive outcome for the intervention 99%) in a sub-sample of 22% of participants. Conclusion(s) Cost-effectiveness analyses revealed estimates in the direction of dominance of EYE-2, but 95% confidence limits ruled out a reduction of more than 24% in the risk of disengagement. Implementation, fidelity and COVID-19 impacts are discussed.