Clinical trial NCT02098408: Effects of Neurocognitive and Social Cognitive Remediation in Patients at Ultra-High Risk of Psychosis
Official title: A Randomised Clinical Trial Examining Cognitive Remediation Plus Standard Treatment Versus Standard Treatment in Participants at Ultra-High Risk of Psychosis. - Effect on Cognitive Functioning, Functional Outcome and Symptomatology.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients at Ultra-high Risk of Psychosis
Keywords: Ultra-high risk psychosis
Schizophrenia prodrome
Cognitive remediation
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS
name: Copenhagen Trial Unit, Center for Clinical Intervention Research
First posted: 2014-03-28
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cognitive deficits are known to be a core feature of schizophrenia and seem to become manifest in the prodromal or Ultra-High Risk (UHR) state of psychosis. The cognitive deficits are known to pose a critical barrier to functional recovery. Hence it is of vital importance to find intervention strategies that can alleviate these cognitive deficits and consequently improve daily functioning, and quality of life, as well as the prognosis for UHR-patients. The investigators will examine whether:

* Cognitive remediation therapy will be superior to standard treatment in improving cognitive functioning in UHR- patients (null hypothesis: No difference between the two groups).
* Cognitive remediation therapy will be superior to standard treatment in improving psychosocial functioning and clinical symptoms in UHR-patients (null hypothesis: No difference between the two groups).


Eligibility criteria: Inclusion Criteria:

* Age 18-40 yrs.
* Fulfill criteria for being at Ultra-High Risk of psychosis (defined by one or more of the following):

  * Vulnerability (Trait and State Risk Factor) Group: Individuals with a combination of a trait risk factor (schizotypal personality disorder or a family history of psychotic disorder in a first degree relative) and a significant deterioration in functioning, or sustained low functioning during the past year.
  * Attenuated Psychotic Symptoms (APS) Group: Individuals with sub-threshold (intensity or frequency) positive psychotic symptoms. The symptoms must have been present during the past year.
  * Brief Limited Intermittent Psychotic Symptoms Group (BLIPS): Individuals with a recent history of frank psychotic symptoms that resolved spontaneously (without antipsychotic medication) within one week. The symptoms must have been present during the past year.
* Provided informed consent.

Exclusion Criteria:

* Past history of a treated or untreated psychotic episode of one week's duration or longer
* Psychiatric symptoms that are explained by a physical illness with psychotropic effect or acute intoxication (e.g., cannabis use).
* Diagnosis of a serious developmental disorder, e.g,. Asperger's syndrome
* Currently receiving treatment with metylphenidate.
* Rejects providing informed consent.

Primary outcomes:
measure: Brief Assessment of Cognition in Schizophrenia (BACS)
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Personal and Social Performance Scale (PSP)
timeFrame: 6 and 12 months
measure: Brief Psychiatric Rating Scale Expanded Version (BPRS-E)
timeFrame: 6 and 12 months
measure: Scale for the Assessment of Negative Symptoms (SANS)
timeFrame: 6 and 12 months
measure: The Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: 6 and 12 months
Other outcomes:
measure: Schizophrenia Prediction/Proneness Instrument - Adult Version (SPI-A)
timeFrame: 6 and 12 months
measure: Behaviour Rating Inventory of Executive Function -Adult Version (BRIEF-A)
timeFrame: 6 and 12 months
measure: Global Functioning: Social and Role Scales
timeFrame: 6 and 12 months
measure: Quality Of Life Scale (QOLS).
timeFrame: 6 and 12 months
measure: Comprehensive Assessment of At-Risk Mental States (CAARMS)
timeFrame: 6 and 12 months
measure: The Awareness of Social Inference Test (TASIT)
timeFrame: 6 and 12 months
measure: Emotion Recognition Task (ERT)
timeFrame: 6 and 12 months
measure: Social Responsiveness Scale (SRS)
timeFrame: 6 and 12 months
measure: Social Cognition Screening Questionnaire (SCSQ)
timeFrame: 6 and 12 months
measure: Adverse events
timeFrame: 6 and 12 months
measure: The High-Risk Social Challenge (HiSoC) Task
timeFrame: 6 and 12 months
Locations:
city: Copenhagen
country: Denmark
facility: Mental Health Centre Copenhagen
Study officials:
affiliation: Mental Health Services in the Capital Region, Denmark
name: Merete Nordentoft, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Mental Health Services in the Capital Region, Denmark
name: Louise B Glenthøj, MsC
role: STUDY_DIRECTOR
References:
citation: Kristensen TD, Ebdrup BH, Hjorthoj C, Mandl RCW, Raghava JM, Jepsen JRM, Fagerlund B, Glenthoj LB, Wenneberg C, Krakauer K, Pantelis C, Glenthoj BY, Nordentoft M. No Effects of Cognitive Remediation on Cerebral White Matter in Individuals at Ultra-High Risk for Psychosis-A Randomized Clinical Trial. Front Psychiatry. 2020 Aug 28;11:873. doi: 10.3389/fpsyt.2020.00873. eCollection 2020.
citation: Glenthoj LB, Mariegaard LS, Fagerlund B, Jepsen JRM, Kristensen TD, Wenneberg C, Krakauer K, Medalia A, Roberts DL, Hjorthoj C, Nordentoft M. 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. Schizophr Res. 2020 Oct;224:151-158. doi: 10.1016/j.schres.2020.08.016. Epub 2020 Aug 29.
citation: Wenneberg C, Nordentoft M, Rostrup E, Glenthoj LB, Bojesen KB, Fagerlund B, Hjorthoj C, Krakauer K, Kristensen TD, Schwartz C, Edden RAE, Broberg BV, Glenthoj BY. Cerebral Glutamate and Gamma-Aminobutyric Acid Levels in Individuals at Ultra-high Risk for Psychosis and the Association With Clinical Symptoms and Cognition. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Jun;5(6):569-579. doi: 10.1016/j.bpsc.2019.12.005. Epub 2019 Dec 19.
citation: Glenthoj LB, Fagerlund B, Randers L, Hjorthoj CR, Wenneberg C, Krakauer K, Vosgerau A, Gluud C, Medalia A, Roberts DL, Nordentoft M. 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. Trials. 2015 Jan 27;16:25. doi: 10.1186/s13063-014-0542-8.