A five-year randomized parallel and blinded clinical trial of an extended specialized early intervention vs. regular care in the early phase of psychotic disorders: study protocol

Danyael Lutgens, Srividya Iyer, Ridha Joober, Thomas G Brown, Ross Norman, Eric Latimer, Norbert Schmitz, Amal Abdel Baki, Sherezad Abadi, Ashok Malla

Specialized Early Intervention services (SEI) for first episode psychosis are shown to be effective for the treatment of positive and negative symptoms, medication adherence, rates of relapse, substance abuse disorders, functional outcome and quality of life at two-year treatment follow up. However, it is also reported that these benefits are not maintained when SEI is not sustained. The objective of this trial is to test the efficacy of a 3-year extension of a SEI service (following 2 years of SEI prior to randomization) for the maintenance and consolidation of therapeutic gains as compared to regular care in the community. Following an initial 2 years of SEI, patients are randomized to receive either 3-years of continued SEI or regular care. SEI provided at three sites within the McGill network of SEI services, using a model of treatment comprised of: modified assertive case management; psycho education for families; multiple family intervention; cognitive behavioural therapy; and substance abuse treatment and monitoring. Blinded research assistants conduct ongoing evaluation of the outcome variables every three months. The primary outcome measure is remission status measured both as the proportion of patients in complete remission and the mean length of remission achieved following randomization during the additional three years of follow up. Based on preliminary data, it is determined that a total of 212 patients are needed to achieve adequate statistical power. Intent to treat with the last observation carried forward will be the primary method of statistical analysis. The "critical period" hypothesis posits that there is a five year window during which the effects of the nascent psychotic illness can be countered and the impact of the disorder on symptomatic and functional outcomes can be offset through active and sustained treatment. Providing SEI throughout this critical period may solidify the benefits of treatment such that gains may be more sustainable over time as compared to intervention delivered for a shorter period. Findings from this study will have implications for service provision in first episode psychosis. ISRCTN11889976.