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

Not Applicable

Completed

• Conditions: Patients at Ultra-high Risk of Psychosis
• Interventions: Behavioral: Cognitive remediation; Behavioral: Standard treatment

• Registration Number: NCT02098408
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-24
• Study First Posted: 2014-03-28
• Primary Completion: 2019-02
• Study Completion: 2019-02
• Status Verified: 2019-03
• Last Update Submitted: 2019-09-13
• Last Update Posted: 2019-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard treatment + cognitive remediation	Cognitive remediation	The cognitive remediation therapy targets neurocognition as well as social cognition.
Standard treatment	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
Standard treatment + cognitive remediation	Standard treatment	The cognitive remediation therapy targets neurocognition as well as social cognition.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Mental Health Centre Copenhagen; 🇩🇰 Copenhagen, Denmark