Trial reportTrials2015
The FOCUS trial: cognitive remediation plus standard treatment versus standard treatment for patients at ultra-high risk for psychosis: study protocol for a randomised controlled trial.
Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Network Meta-Analysis Indicates Superior Effects of Omega-3 Polyunsaturated Fatty Acids in Preventing the Transition to Psychosis in Individuals at Clinical High-Risk.The international journal of neuropsychopharmacology · 2024Pooled it
- Interventions for prodromal stage of psychosis.The Cochrane database of systematic reviews · 2019Pooled it
- Widespread higher fractional anisotropy associates to better cognitive functions in individuals at ultra-high risk for psychosis.Human brain mapping · 2019Trial
- Individualized Metacognitive Training (MCT+) Reduces Delusional Symptoms in Psychosis: A Randomized Clinical Trial.Schizophrenia bulletin · 2019Trial
- Five years of specialised early intervention versus two years of specialised early intervention followed by three years of standard treatment for patients with a first episode psychosis: randomised, superiority, parallel group trial in Denmark (OPUS II).BMJ (Clinical research ed.) · 2017Trial
- Intensive Auditory Cognitive Training Improves Verbal Memory in Adolescents and Young Adults at Clinical High Risk for Psychosis.Schizophrenia bulletin · 2016Trial
- Whole-brain functional connectivity predicts ultra-high risk for psychosis status and level of functioning.Schizophrenia (Heidelberg, Germany) · 2026Article
- Tunisian Adolescents at CHR for Psychosis: A Pilot Study of Cognitive Remediation in a LMIC.Early intervention in psychiatry · 2025Article
- White matter microstructure and sleep-wake disturbances in individuals at ultra-high risk of psychosis.Frontiers in human neuroscience · 2022Article
- Self-perceived cognitive impairments in psychosis ultra-high risk individuals: associations with objective cognitive deficits and functioning.NPJ schizophrenia · 2020Article
- Effectiveness of cognitive remediation in the ultra-high risk state for psychosis.World psychiatry : official journal of the World Psychiatric Association (WPA) · 2020Article
- Baseline measures of cerebral glutamate and GABA levels in individuals at ultrahigh risk for psychosis: Implications for clinical outcome after 12 months.European psychiatry : the journal of the Association of European Psychiatrists · 2020Article
- No Effects of Cognitive Remediation on Cerebral White Matter in Individuals at Ultra-High Risk for Psychosis-A Randomized Clinical Trial.Frontiers in psychiatry · 2020Article
- The Global Functioning: Social and Role Scales-Further Validation in a Large Sample of Adolescents and Young Adults at Clinical High Risk for Psychosis.Schizophrenia bulletin · 2019Article
- The effect of cognitive remediation in individuals at ultra-high risk for psychosis: a systematic review.NPJ schizophrenia · 2017Article
- Social cognition in patients at ultra-high risk for psychosis: What is the relation to social skills and functioning?Schizophrenia research. Cognition · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCognitive deficits are a distinct feature among people at ultra-high risk (UHR) for psychosis and pose a barrier to functional recovery. Insufficient evidence exists on how to ameliorate these cognitive deficits in patients at UHR for psychosis and hence improve daily living and quality of life. The aim of the trial is to investigate whether cognitive remediation can improve cognitive and psychosocial function in patients at UHR for psychosis.
methodsThe FOCUS trial (Function and Overall Cognition in Ultra-high risk States) is a randomised, parallel group, observer-blinded clinical trial enrolling 126 patients meeting the standardised criteria of being at UHR for psychosis. Patients are recruited from psychiatric in- and outpatient facilities in the Copenhagen catchment area. Patients are randomised to one of the two treatment arms: cognitive remediation plus standard treatment versus standard treatment. The cognitive remediation consists of 24 weekly group-based and manualised sessions targeting neurocognition and social cognition. In addition to the group sessions, the patients will be offered 12 individual sessions aiming at maximising the transfer of the effects of the cognitive training to their everyday lives. Follow-up assessments will be conducted at 6 and 12 months after randomisation. The primary outcome is the composite score on the Brief Assessment of Cognition in Schizophrenia at cessation of treatment after 6 months. Secondary outcomes are social and daily functioning, psychosis-like symptoms, negative symptomatology, and depressive symptomatology as measured with the Personal and Social Performance Scale, Brief Psychiatric Rating Scale-Expanded Version, Scale for the Assessment of Negative Symptoms, and the Montgomery-Åsberg Depression Rating Scale. DISCUSSION: This is the first trial to evaluate the effects of neurocognitive and social cognitive remediation in UHR patients. The FOCUS trial results will provide evidence on the effect of targeted and comprehensive cognitive rehabilitation on cognition, daily living, and symptomatology as well as long-term outcome in preventing transition to psychosis in UHR patients.
trial registrationClinicalTrials.gov NCT 02098408 . Date of registration 18 March 2014.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.