A Pilot Randomized Controlled Evaluation of “Extended Specialized Early Intervention Service” vs. “Regular Care” for Longterm Management of Early Psychosis

Abstract

Introduction:

Short term benefits of Specialized Early Intervention (SEI) services for treatment of first episode of psychosis (FEP) are not sustained after transfer to regular care. Optimum length of SEI services remains to be determined.

Objective:

To carry out a randomized controlled trial (RCT) of extending SEI service for an additional three years compared to “regular” care after both groups have received two years of SEI treatment.

Hypothesis:

The experimental group (extended SEI) will have better clinical (remission length and proportion) and functional outcomes and be cost effective compared to the control group (regular care).

Methods:

Remission (length and proportion in remission) are the primary outcomes. We aim to randomize a total of 212 patients following two years of SEI service for their FEP. Outcome evaluations to assess symptoms, functioning and service utilization are carried out at entry and every three months. In this presentation we will report only the method and preliminary results (success of urn randomization, drop out and relapse rates) on the sample recruited thus far.

Results:

Of the 58 patients approached 50 (86%) agreed to be randomized. Patients were young (mean age 25), mostly male (with a diagnosis of Schizophrenia Spectrum Psychosis (71%). The average length of follow up to date is 13.2 months (s.d. = 5.4). Treatment discontinuation in the experimental and control conditions were 0 and 4 (15%), respectively.

Conclusion:

The pilot results show the feasibility for carrying out such a study. The methodological challenges of conducting this long term RCT will be discussed.