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.

Mental Health Services in the Capital Region, Denmark1 site in 1 country146 target enrollmentMarch 2014

ConditionsPatients at Ultra-high Risk of Psychosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Patients at Ultra-high Risk of Psychosis
Sponsor: Mental Health Services in the Capital Region, Denmark
Enrollment: 146
Locations: 1
Primary Endpoint: Brief Assessment of Cognition in Schizophrenia (BACS)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 2014

End Date

February 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mental Health Services in the Capital Region, Denmark

Responsible Party

Sponsor

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.