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

• DOI: 10.1186/s12888-015-0404-2
• Publication Date: 2015-02-13T07:40:24Z
• Authors: Danyael Lutgens; Srividya Iyer; Ridha Joober; Thomas G Brown; Ross Norman; Eric Latimer; Norbert Schmitz; Amal Abdel Baki; Sherezad Abadi; Ashok Malla
• Keywords: Adult; Male; Mental Health Services; First episode psychosis; Adolescent; Remission; 150; 610; Case management; 12. Responsible consumption; Study Protocol; Young Adult; 03 medical and health sciences; 0302 clinical medicine; Clinical Protocols; Early Medical Intervention; Humans; Single-Blind Method; Cognitive Behavioral Therapy; Remission Induction; Specialized early intervention; 3. Good health; Treatment; Critical period; Psychiatry and Mental health; Psychotic Disorders; Randomized controlled trial; Family Therapy; Female; Case Management

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