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

September 13, 2019 updated by: Mental Health Services in the Capital Region, Denmark

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Mental Health Centre Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Personal and Social Performance Scale (PSP)
Time Frame: 6 and 12 months
6 and 12 months
Brief Psychiatric Rating Scale Expanded Version (BPRS-E)
Time Frame: 6 and 12 months
6 and 12 months
Scale for the Assessment of Negative Symptoms (SANS)
Time Frame: 6 and 12 months
6 and 12 months
The Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: 6 and 12 months
6 and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Schizophrenia Prediction/Proneness Instrument - Adult Version (SPI-A)
Time Frame: 6 and 12 months
6 and 12 months
Behaviour Rating Inventory of Executive Function -Adult Version (BRIEF-A)
Time Frame: 6 and 12 months
6 and 12 months
Global Functioning: Social and Role Scales
Time Frame: 6 and 12 months
6 and 12 months
Quality Of Life Scale (QOLS).
Time Frame: 6 and 12 months
6 and 12 months
Comprehensive Assessment of At-Risk Mental States (CAARMS)
Time Frame: 6 and 12 months
6 and 12 months
The Awareness of Social Inference Test (TASIT)
Time Frame: 6 and 12 months
6 and 12 months
Emotion Recognition Task (ERT)
Time Frame: 6 and 12 months
Emotion Recognition Task from CANTAB
6 and 12 months
Social Responsiveness Scale (SRS)
Time Frame: 6 and 12 months
6 and 12 months
Social Cognition Screening Questionnaire (SCSQ)
Time Frame: 6 and 12 months
6 and 12 months
Adverse events
Time Frame: 6 and 12 months
Number of participants with adverse events
6 and 12 months
The High-Risk Social Challenge (HiSoC) Task
Time Frame: 6 and 12 months
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mental Health Services in the Capital Region, Denmark

Collaborators

Copenhagen Trial Unit, Center for Clinical Intervention Research
Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS

Investigators

  • Principal Investigator: Merete Nordentoft, Professor, Mental Health Centre Copenhagen
  • Study Director: Louise B Glenthøj, MsC, Mental Health Centre Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (Estimate)

March 28, 2014

Study Record Updates

Last Update Posted (Actual)

September 16, 2019

Last Update Submitted That Met QC Criteria

September 13, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-6-2013-015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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