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Effects of Neurocognitive and Social Cognitive Remediation in Patients at Ultra-High Risk of Psychosis (FOCUS)

Primary Purpose

Patients at Ultra-high Risk of Psychosis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cognitive remediation
Standard treatment
Sponsored by
Mental Health Services in the Capital Region, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients at Ultra-high Risk of Psychosis focused on measuring Ultra-high risk psychosis, Schizophrenia prodrome, Cognitive remediation

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mental Health Centre Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Standard treatment + cognitive remediation

Standard treatment

Arm Description

The cognitive remediation therapy targets neurocognition as well as social cognition.

Patients allocated to the control condition are free to choose whatever standard treatment they are offered by the clinicians managing their treatment. Usually standard treatment consists of regular contact to health professionals in the in- and outpatient facilities in Copenhagen, Denmark, and encompass different kinds of supportive counselling

Outcomes

Primary Outcome Measures

Brief Assessment of Cognition in Schizophrenia (BACS)
BACS will be used to assess changes in cognition at the cessation of treatment at (6 months) and 12 months post baseline.

Secondary Outcome Measures

Personal and Social Performance Scale (PSP)
Brief Psychiatric Rating Scale Expanded Version (BPRS-E)
Scale for the Assessment of Negative Symptoms (SANS)
The Montgomery-Åsberg Depression Rating Scale (MADRS)

Full Information

First Posted
March 18, 2014
Last Updated
September 13, 2019
Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, Copenhagen Trial Unit, Center for Clinical Intervention Research
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1. Study Identification

Unique Protocol Identification Number
NCT02098408
Brief Title
Effects of Neurocognitive and Social Cognitive Remediation in Patients at Ultra-High Risk of Psychosis
Acronym
FOCUS
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, Copenhagen Trial Unit, Center for Clinical Intervention Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients at Ultra-high Risk of Psychosis
Keywords
Ultra-high risk psychosis, Schizophrenia prodrome, Cognitive remediation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard treatment + cognitive remediation
Arm Type
Experimental
Arm Description
The cognitive remediation therapy targets neurocognition as well as social cognition.
Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
Patients allocated to the control condition are free to choose whatever standard treatment they are offered by the clinicians managing their treatment. Usually standard treatment consists of regular contact to health professionals in the in- and outpatient facilities in Copenhagen, Denmark, and encompass different kinds of supportive counselling
Intervention Type
Behavioral
Intervention Name(s)
Cognitive remediation
Other Intervention Name(s)
Neuropsychological & Educational Approach to Remediation (NEAR) using software from Scientific Brain Training Pro (SBT) and Posit Science., Social Cognition and Interaction Training (SCIT)
Intervention Description
Neurocognition will be trained using the NEAR model (Medalia et al. 2003), whereas the training of social cognitive skills will be by use of the SCIT manual (Social Cognition and Interaction Training) developed by Roberts et al. 2014. The intervention consists of 24 group sessions taking place once a week (two hours) and additional neurocognitive training at home. Furthermore, there will be a total of 12 individual sessions aiming at bridging the cognitive training to the everyday functioning of the patients.
Intervention Type
Behavioral
Intervention Name(s)
Standard treatment
Intervention Description
Patients allocated to the control condition are free to choose whatever standard treatment they are offered by the clinicians managing their treatment. Usually standard treatment consists of regular contact to health professionals in the in- and outpatient facilities in Copenhagen, Denmark, and encompass different kinds of supportive counselling.
Primary Outcome Measure Information:
Title
Brief Assessment of Cognition in Schizophrenia (BACS)
Description
BACS will be used to assess changes in cognition at the cessation of treatment at (6 months) and 12 months post baseline.
Time Frame
6 and 12 months
Secondary Outcome Measure Information:
Title
Personal and Social Performance Scale (PSP)
Time Frame
6 and 12 months
Title
Brief Psychiatric Rating Scale Expanded Version (BPRS-E)
Time Frame
6 and 12 months
Title
Scale for the Assessment of Negative Symptoms (SANS)
Time Frame
6 and 12 months
Title
The Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame
6 and 12 months
Other Pre-specified Outcome Measures:
Title
Schizophrenia Prediction/Proneness Instrument - Adult Version (SPI-A)
Time Frame
6 and 12 months
Title
Behaviour Rating Inventory of Executive Function -Adult Version (BRIEF-A)
Time Frame
6 and 12 months
Title
Global Functioning: Social and Role Scales
Time Frame
6 and 12 months
Title
Quality Of Life Scale (QOLS).
Time Frame
6 and 12 months
Title
Comprehensive Assessment of At-Risk Mental States (CAARMS)
Time Frame
6 and 12 months
Title
The Awareness of Social Inference Test (TASIT)
Time Frame
6 and 12 months
Title
Emotion Recognition Task (ERT)
Description
Emotion Recognition Task from CANTAB
Time Frame
6 and 12 months
Title
Social Responsiveness Scale (SRS)
Time Frame
6 and 12 months
Title
Social Cognition Screening Questionnaire (SCSQ)
Time Frame
6 and 12 months
Title
Adverse events
Description
Number of participants with adverse events
Time Frame
6 and 12 months
Title
The High-Risk Social Challenge (HiSoC) Task
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merete Nordentoft, Professor
Organizational Affiliation
Mental Health Centre Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Louise B Glenthøj, MsC
Organizational Affiliation
Mental Health Centre Copenhagen
Official's Role
Study Director
Facility Information:
Facility Name
Mental Health Centre Copenhagen
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
33005161
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.
Results Reference
derived
PubMed Identifier
32873460
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.
Results Reference
derived
PubMed Identifier
32008981
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.
Results Reference
derived
PubMed Identifier
25623736
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.
Results Reference
derived

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Effects of Neurocognitive and Social Cognitive Remediation in Patients at Ultra-High Risk of Psychosis

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