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

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Status

Completed

Conditions

Clinical High Risk for Psychosis

Treatments

Behavioral: Computer Games
Behavioral: Targeted Cognitive Training

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02404194
R01MH105246 (U.S. NIH Grant/Contract)
MH105246

Details and patient eligibility

About

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.

Enrollment

139 patients

Sex

All

Ages

15 to 30 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

139 participants in 2 patient groups, including a placebo group

Targeted Cognitive Training
Experimental group
Description:
40 hours of computerized cognitive training
Treatment:
Behavioral: Targeted Cognitive Training
Computer Games
Placebo Comparator group
Description:
40 hours of computer games
Treatment:
Behavioral: Computer Games

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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