Efficacy of cognitive behavioural therapy for individuals at ultra-high-risk of first episode of psychosis: a randomised controlled trial

Growing attention has been dedicated by researchers and practitioners to early identification and intervention on young individuals considered as at ultra-high-risk (UHR) of a first psychosis episode. Cognitive behavioural therapy (CBT) has shown to be the first-line treatment strategy. However, there is a small number of trials on its efficacy. UHR groups who do not make transition frequently report poor functioning and secondary symptoms, such as depression and anxiety. Existing trials focused on psychosis prevention as a dichotomous outcome without sufficiently targeting additional outcomes. Despite it has been linked with frank psychosis, worry has not been considered as outcome. Primary objective of the current study was (a) to assess whether a CBT modular protocol was able to reduce or delay risk of transition to psychosis in a group of UHR help-seeking individuals after 6 months (post-treatment) and 14-months (follow-up) compared with treatment as usual as a control condition. Secondary objectives were (b) to compare the CBT intervention with the control condition on secondary outcomes, including depression, anxiety, worry and global functioning. Participants were included if they were 16-35-year old and met criteria for At-Risk-Mental State (ARMS) at the Comprehensive Assessment of At-Risk-Mental States (CAARMS). Fifty-eight individuals recruited from mental health services (mean age= 25.51, SD= 6, 67.20% males) were randomly assigned to CBT or control condition. The CBT modular protocol consisted of 30 weekly sessions with multiple components including engagement and goal setting, psychoeducation on psychotic experiences, (meta)cognitive restructuring, intervention on depression, worry, social anxiety and skills. Kaplan-Meier survival statistics were used to analyse the primary outcome. Participants lost to followup were coded conservatively as non-converters. In the group that did not make transition, secondary outcomes were analysed by ANCOVA. Overall, 7 participants (12.10%) at post-treatment and 11 (19%) at 14-month follow-up cumulatively made the conversion to psychosis. In the CBT group, the number of individuals who made cumulative conversion to psychosis (n= 4, 10.30%) at 14-month follow-up was lower than in the control group (n= 8, 27.60%), despite this difference was at a borderline significance level (Log rank test χ2(1)= 3.66, p= 0.05). In the CBT group, a higher number of participants achieved remission than in the control group on secondary outcomes at post-treatment (75% vs 38.10% for both depression and anxiety) [χ²(1)= 6.25, p< 0.05] and also at follow-up. However, a significantly greater effect of CBT than control condition on depression, anxiety, worry and functioning was not found when these outcomes were considered as continuous. CBT seems to be an option of intervention able to reduce drop out among UHR individuals and to some extent also prevent the risk of a first episode with some benefits on secondary outcomes such as anxiety and depression when levels on these outcomes are clinically significant. Further research is required to examine additional strategies targeting worry and functioning. Clinical implications, limitations and future directions are discussed.