Comparing three‐year extension of early intervention service to regular care following two years of early intervention service in first‐episode psychosis: a randomized single blind clinical trial

Abstract

This study aimed to determine if, following two years of early intervention service for first-episode psychosis, three-year extension of that service was superior to three years of regular care. We conducted a randomized single blind clinical trial using an urn randomization balanced for gender and substance abuse. Participants were recruited from early intervention service clinics in Montreal. Patients (N5220), 18-35 years old, were randomized to an extension of early intervention service (EEIS; N5110) or to regular care (N5110). EEIS included case management, family intervention, cognitive behaviour therapy and crisis intervention, while regular care involved transfer to primary (community health and social services and family physicians) or secondary care (psychiatric outpatient clinics). Cumulative length of positive and negative symptom remission was the primary outcome measure. EEIS patients had a significantly longer mean length of remission of positive symptoms (92.5 vs. 63.6 weeks, t54.47, p<0.001), negative symptoms (73.4 vs. 59.6 weeks, t52.84, p50.005) and both positive and negative symptoms (66.5 vs. 56.7 weeks, t52.25, p50.03) compared to regular care patients. EEIS patients stayed in treatment longer than regular care patients (mean 131.7 vs. 105.3 weeks, t53.98, p<0.001 through contact with physicians; 134.8 6 37.7 vs. 89.8 6 55.2, t56.45, p<0.0001 through contact with other health care providers) and received more units of treatment (mean 74.9 vs. 39.9, t54.21, p<0.001 from physicians, and 57.3 vs. 28.2, t54.08, p<0.001 from other health care professionals). Length of treatment had an independent effect on the length of remission of positive symptoms (t52.62, p50.009), while number of units of treatment by any health care provider had an effect on length of remission of negative symptoms (t522.70, p50.008) as well as total symptoms (t522.40, p50.02). Post-hoc analysis showed that patients randomized to primary care, based on their better clinical profile at randomization, maintained their better outcome, especially as to remission of negative symptoms, at the end of the study. These data suggest that extending early intervention service for three additional years has a positive impact on length of remission of positive and negative symptoms compared to regular care. This may have policy implications for extending early intervention services beyond the current two years.

PROFIP: A Portuguese early intervention programme for first‐episode psychosis in Lisbon

“…This will be very demanding, mainly due to the high number of patients compared to the relatively small team of PROFIP. Some studies have shown that the major advantages of early intervention stop when it ends, suggesting that longer interventions then the initial 2 to 3 years (eg, 5 years) would be advantageous (Chang et al, , ; Malla et al, ). According to this evidence, and balancing it with the known dimensions of our team, we think that 5 years will be feasible.…”

Short duration of untreated psychosis enhances negative symptom remission in extended early intervention service for psychosis

“…A further challenge for effective service designs is that the benefits gained from EIS may not be maintained once the initial 2 years of intensive care is withdrawn . In response to this observation, recent controlled studies have examined whether an extension of EIS (EEIS) over 1–3 years (subsequent to the first 2 years of EIS) results in improved outcomes in symptoms and functioning compared to transfer to regular care . Our recent randomized controlled trial (RCT) showed that a 3‐year EEIS produced longer lengths of remission for positive, negative and total symptoms compared to three additional years of regular care .…”

“…In response to this observation, recent controlled studies have examined whether an extension of EIS (EEIS) over 1–3 years (subsequent to the first 2 years of EIS) results in improved outcomes in symptoms and functioning compared to transfer to regular care . Our recent randomized controlled trial (RCT) showed that a 3‐year EEIS produced longer lengths of remission for positive, negative and total symptoms compared to three additional years of regular care . On the other hand, another RCT (OPUS II) failed to show such extended benefits when using a different index for the outcome (i.e.…”

“…It is possible that these mixed results may be related to the primary outcome of each RCT (i.e. length of symptom remission and level of negative symptoms respectively) as well as to the vast differences in DUP distribution of the respective samples (PEPP median DUP: 8.3 weeks for EEIS and 12.7 weeks for regular care; OPUS II median DUP: 52 weeks for EEIS and 69 weeks for regular care) . Indeed, the latter possibility is supported by a post hoc analysis of the OPUS II trial, in which patients with shorter DUP tended to respond better to the EEIS in reducing negative symptoms compared to those with longer DUP .…”

Applying economic models to estimate local economic benefits of improved coverage of early intervention for psychosis

“…The study assumed that since 36% of people with CHR‐P developed FEP after 3 years (Fusar‐Poli et al, ) although since then, a review found that 20% of people with CHR‐P developed FEP after 3 years (Fusar‐Poli, Rutigliano, et al, ), number of new cases of CHR‐P was at least two times higher than number of FEP although no studies exist to confirm this assumption. A further assumption made by our study is that all people with a FEP required a 3‐year EIP service provision although new service models are emerging to challenge a “one‐size‐fits‐all” approach, recognizing some individuals require shorter service support and others may benefit from longer service exposure, perhaps with a step down in intensity of service provision (Malla et al, ). Furthermore, a purely cost benefit exploration cannot take account of benefits that service users express in terms of greater satisfaction (Lester et al, ).…”