Targeted Cognitive Training in Clinical High Risk (CHR) for Psychosis

Not Applicable

Completed

• Conditions: Clinical High Risk for Psychosis
• Interventions: Behavioral: Computer Games; Behavioral: Targeted Cognitive Training

• Registration Number: NCT02404194
• Lead Sponsor: Rush University Medical Center

Brief Summary

This project is a randomized-controlled trial to test the efficacy of computer-based targeted cognitive training (TCT) versus a placebo intervention of commercial computer games in adolescent/young adults at clinical high risk (CHR) for psychosis. TCT is designed to optimize learning-induced neuroplasticity in vulnerable neurocognitive systems. A main aim is to test the hypothesis that this neuroscience-guided TCT intervention will improve neural function, and that these neural improvements will improve cognition and functional outcome. CHR participants will be randomly assigned to 40 hours of TCT or placebo computer games completed within 10 weeks. TCT consists of 20 hours of training in cognition, including processing speed, memory, attention, and cognitive control followed by 20 hours of training in social cognition including affect recognition and theory of mind. Neuroimaging, cognition, social cognition, clinical symptoms, and functional status will be assessed at baseline, after 20 hours/5 weeks of cognitive training (mid-intervention), and after 20 hours/5 weeks of social-cognitive training (post-intervention). Cognition, social cognition, symptoms, and functioning will also be assessed at a 9 month follow-up (i.e. 9 months after intervention completion). We predict that TCT will lead to improvements in neurocognitive function and functional status. The results of this study will provide important information about a benign, non-pharmacological intervention for improving cognition and functional outcome in CHR individuals.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-16
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-31
• Primary Completion: 2020-11-23
• Study Completion: 2021-02-15
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-01
• Last Update Posted: 2022-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

• English speaking
• One or more psychosis-risk syndromes as defined by the Structured Interview for Psychosis-Risk Syndromes (SIPS)

Exclusion Criteria

• Intelligence Quotient (IQ) < 70
• Major medical illness or neurological disorder
• Lifetime history of Axis I psychotic disorder and/or clear evidence that psychosis-risk syndrome is due to non-schizophrenia-spectrum Axis I or Axis II disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computer Games	Computer Games	40 hours of computer games
Targeted Cognitive Training	Targeted Cognitive Training	40 hours of computerized cognitive training

Primary Outcome Measures

Name	Time	Method
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery	Change in cognition from baseline (pre-intervention) to 10 weeks (post-intervention)	Behavioral assessment of cognition

Secondary Outcome Measures

Name	Time	Method
Global Function: Social and Role Scales	Change in functioning from baseline (pre-intervention) to 10 weeks (post-intervention)	Behavioral assessment of daily functioning

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States