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Completed

NCT Number: NCT02404194

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

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.

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Key information

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Targeted Cognitive Training

Behavioral

Targeted Cognitive Training is performed on the computer through Posit Science. Games are modern and engaging modifications of classic neuropsychological tests, such as set-shifting games modeled on the Wisconsin Card Sort Test, and cognitive control games modeled on Stroop-like interference tasks. Games will target two sets of skills: Targeted cognitive skills include: processing speed, memory, attention, flexibility/cognitive-control, and problem-solving. After 20 hours of training on these skills, participants will complete 20 hours of training on core social cognitive skills, including facial affect recognition, gaze direction perception, and face identity recognition, and theory of mind.

Other names: Posit Science

Computer games

Behavioral

The comparison intervention consists of 40 hours of commercially available and cognitively non-specific computer games. These computer games - such as checkers, solitaire, crossword puzzles - are entertaining and engaging but do not target specific neurocognitive skills.

Primary outcomes

  1. Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery

    Time frame: Change in cognition from baseline (pre-intervention) to 10 weeks (post-intervention)

    Behavioral assessment of cognition

Secondary outcomes

  1. Global Function: Social and Role Scales

    Time frame: Change in functioning from baseline (pre-intervention) to 10 weeks (post-intervention)

    Behavioral assessment of daily functioning

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Harvard Medical School (HMS and HSDM)
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Optimizing Cognitive Training to Improve Functional Outcome in Clinical High Risk (CHR)

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Mar 31, 2015
Registry last updated
Dec 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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