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

Sponsor

Mental Health Services in the Capital Region, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT02098408

Collaborator

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

146

Enrollment

Location

Arms

59.1

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Patients at Ultra-high Risk of Psychosis	Behavioral: Cognitive remediation Behavioral: Standard treatment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

146 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.

Actual Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Feb 1, 2019

Actual Study Completion Date :

Feb 1, 2019

Arms and Interventions

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.

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

Behavioral: Standard treatment

Outcome Measures

Primary Outcome Measures

Brief Assessment of Cognition in Schizophrenia (BACS) [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

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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mental Health Centre Copenhagen	Copenhagen		Denmark	2400

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