TY - JOUR
T1 - Cognitive remediation plus standard treatment versus standard treatment alone for individuals at ultra-high risk of developing psychosis
T2 - Results of the FOCUS randomised clinical trial
AU - Glenthøj, Louise B.
AU - Mariegaard, Lise S.
AU - Fagerlund, Birgitte
AU - Jepsen, Jens R.M.
AU - Kristensen, Tina D.
AU - Wenneberg, Christina
AU - Krakauer, Kristine
AU - Medalia, Alice
AU - Roberts, David L.
AU - Hjorthøj, Carsten
AU - Nordentoft, Merete
N1 - Funding Information:
The trial was funded by The Danish Council for Independent Research (DFF-4004-00314); TrygFoundation (ID 108119); the Mental Health Services in the Capital Region of Denmark; the research fund of the Capital Region of Denmark; the Lundbeck Foundation Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS (R155-2013-16337). We thank the participants and clinical staff for their participation.
Funding Information:
The study has been funded through The Danish Council for Independent Research (grant number DFF-4004-00314 ); TrygFonden (grant number ID 108119 ); the Mental Health Services in the Capital Region of Denmark ; the research fund of the Capital Region of Denmark ; the Lundbeck Foundation Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS (grant number R155-2013-16337 ). The funding source had no role in any aspect of the study.
Publisher Copyright:
© 2020 Elsevier B.V.
PY - 2020/10
Y1 - 2020/10
N2 - 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.
AB - 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.
KW - Clinical high risk
KW - Cognitive rehabilitation
KW - Cognitive remediation
KW - Early intervention
KW - Ultra-high risk
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U2 - 10.1016/j.schres.2020.08.016
DO - 10.1016/j.schres.2020.08.016
M3 - Article
C2 - 32873460
AN - SCOPUS:85089959362
VL - 224
SP - 151
EP - 158
JO - Schizophrenia Research
JF - Schizophrenia Research
SN - 0920-9964
ER -