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

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ClinicalTrials.gov Identifier: NCT02098408
Recruitment Status : Recruiting
First Posted : March 28, 2014
Last Update Posted : March 18, 2016
Sponsor:
Collaborators:
Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS
Copenhagen Trial Unit, Center for Clinical Intervention Research
Information provided by (Responsible Party):
Mental Health Services in the Capital Region, Denmark

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).

Condition or disease Intervention/treatment Phase
Patients at Ultra-high Risk of Psychosis Behavioral: Cognitive remediation Behavioral: Standard treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2014
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Standard treatment + cognitive remediation
The cognitive remediation therapy targets neurocognition as well as social cognition.
Behavioral: Cognitive remediation

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.

Other Names:
  • Neuropsychological & Educational Approach to Remediation (NEAR) using software from Scientific Brain Training Pro (SBT) and Posit Science.
  • Social Cognition and Interaction Training (SCIT)

Behavioral: Standard treatment
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.

Active Comparator: Standard treatment
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
Behavioral: Standard treatment
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 Measures :
  1. Brief Assessment of Cognition in Schizophrenia (BACS) [ Time Frame: 6 and 12 months ]
    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 :
  1. Personal and Social Performance Scale (PSP) [ Time Frame: 6 and 12 months ]
  2. Brief Psychiatric Rating Scale Expanded Version (BPRS-E) [ Time Frame: 6 and 12 months ]
  3. Scale for the Assessment of Negative Symptoms (SANS) [ Time Frame: 6 and 12 months ]
  4. The Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 6 and 12 months ]

Other Outcome Measures:
  1. Schizophrenia Prediction/Proneness Instrument - Adult Version (SPI-A) [ Time Frame: 6 and 12 months ]
  2. Behaviour Rating Inventory of Executive Function -Adult Version (BRIEF-A) [ Time Frame: 6 and 12 months ]
  3. Global Functioning: Social and Role Scales [ Time Frame: 6 and 12 months ]
  4. Quality Of Life Scale (QOLS). [ Time Frame: 6 and 12 months ]
  5. Comprehensive Assessment of At-Risk Mental States (CAARMS) [ Time Frame: 6 and 12 months ]
  6. The Awareness of Social Inference Test (TASIT) [ Time Frame: 6 and 12 months ]
  7. Emotion Recognition Task (ERT) [ Time Frame: 6 and 12 months ]
    Emotion Recognition Task from CANTAB

  8. Social Responsiveness Scale (SRS) [ Time Frame: 6 and 12 months ]
  9. Social Cognition Screening Questionnaire (SCSQ) [ Time Frame: 6 and 12 months ]
  10. Adverse events [ Time Frame: 6 and 12 months ]
    Number of participants with adverse events

  11. The High-Risk Social Challenge (HiSoC) Task [ Time Frame: 6 and 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098408


Contacts
Contact: Louise B Glenthøj, MSc, PhDstud louise.birkedal.glenthoej@regionh.dk
Contact: Merete Nordentoft, Prof merete.nordentoft@dadlnet.dk

Locations
Denmark
Mental Health Centre Copenhagen Recruiting
Copenhagen, Denmark, 2400
Principal Investigator: Merete Nordentoft, Professor         
Sub-Investigator: Louise B Glenthøj, PhD Student         
Sponsors and Collaborators
Mental Health Services in the Capital Region, Denmark
Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS
Copenhagen Trial Unit, Center for Clinical Intervention Research
Investigators
Principal Investigator: Merete Nordentoft, Professor Mental Health Centre Copenhagen
Study Director: Louise B Glenthøj, MsC Mental Health Centre Copenhagen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mental Health Services in the Capital Region, Denmark
ClinicalTrials.gov Identifier: NCT02098408     History of Changes
Other Study ID Numbers: H-6-2013-015
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: March 18, 2016
Last Verified: March 2016

Keywords provided by Mental Health Services in the Capital Region, Denmark:
Ultra-high risk psychosis
Schizophrenia prodrome
Cognitive remediation

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders