Objective: To compare the effects of five years of specialised early intervention (SEI) treatment for first episode schizophrenia spectrum disorder with the standard two years of SEI plus three years of treatment as usual.
Design: Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site. Setting: Participants were recruited from six
OPUS teams in Denmark between 2009 and 2012. OPUS teams provide SEI treatment to all patients diagnosed with a schizophrenia spectrum disorder in Denmark. Participants 400 participants (51% women) with a mean age of
25.6 (standard deviation 4.3) were randomised to five years of SEI (experimental intervention; n=197) or to two years of SEI plus three years of treatment as usual (control; n=203). Interventions OPUS treatment consists of three
core elements-modified assertive community treatment, family involvement, and social skill training-with a patientcase manager ratio of no more than 12:1. For participants randomised to five years of OPUS treatment, the treatment was
largely unchanged. Participants randomised to the control group were mostly referred to community health centres after two years of SEI treatment. Main outcomes:Follow-up assessments were conducted five years after start of OPUS
treatment. Primary outcome was negative symptoms measured on the scale for assessment of negative symptoms (avolition-apathy, anhedonia, alogia, and affective blunting). Secondary outcomes were remission of both negative and psychotic symptoms, psychotic
symptoms, suicidal ideation, substance abuse, compliance with medical treatment, adherence with treatment, client satisfaction, days in hospital care, and labour market affiliation. Results Levels of negative symptoms did not
differ between the intervention group and control group (1.72 v 1.81 points; estimated mean difference-0.10 (95% confidence interval 0.33 to 0.13), P=0.39). Participants receiving five years of OPUS treatment were more likely to remain in
contact with specialised mental health services (90.4% v 55.6%, P < 0.001), had higher client satisfaction (estimated mean difference 2.57 points (95% confidence interval 1.36 to 3.79), P< 0.001), and had a stronger working alliance(estimated mean difference 5.56 points (95%confidence interval 2.30 to 8.82), P=0.001) thanthe control group.
Conclusions: This trial tests SEI treatment for upto five years for patients with first episodeschizophrenia spectrum disorder; previous trialshave found treatment effects for programmeslasting from one to three years. The prolongedSEI treatment had few effects, which could bedue to the high level of treatment provided tocontrol participants and the late start ofspecialised treatment.