Cognitive remediation plus standard treatment versus standard treatment alone for individuals at ultra-high risk of developing psychosis: Results of the FOCUS randomised clinical trial.

BACKGROUND: Individuals at ultra-high risk (UHR) for psychosis have significant cognitive deficits that can impede functional recovery. Applying cognitive remediation (CR) before the onset of frank psychosis may improve the cognitive and functional prognosis of UHR individuals, however, little is known about the feasibility and efficacy of CR for this population. METHODS: In this randomised, clinical trial 146 individuals at UHR for psychosis aged 18-40 years were randomly assigned to treatment as usual (TAU) or TAU plus cognitive remediation. The CR targeted neurocognitive and social cognitive remediation. Assessments were carried out at 6- and 12-months post baseline. RESULTS: A total of 73 UHR individuals were assigned to TAU and 73 assigned to TAU + cognitive remediation. Compared to the control group, cognitive remediation did not result in significant improvement on the primary outcome; the Brief Assessment of Cognition in Schizophrenia composite score at 6-month follow-up (b = -0.125, 95%CI: -0.23 to 0.172, p = 0.41). Nor did the intervention improve secondary outcomes in clinical symptoms or functioning. Exploratory analyses found emotion recognition latencies to be significantly more reduced in the intervention group at 6-months. At 12-months, the intervention group exhibited significantly better performance on two measures of executive function and visual memory. CONCLUSION: The 20-session treatment protocol was not well received in the UHR group, and unsurprisingly global measures did not improve. The benefit found in isolated neuro- and social cognitive measures after even a few sessions points to a potential for cognitive malleability if people can be engaged sufficiently to practice the skills. Trial registration ClinicalTrial.gov identifier: NCT02098408.