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

Sponsor

Rush University Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02404194

Collaborator

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

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Clinical High Risk for Psychosis	Behavioral: Targeted Cognitive Training Behavioral: Computer Games	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

Sep 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Targeted Cognitive Training 40 hours of computerized cognitive training	Behavioral: Targeted Cognitive Training 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
Placebo Comparator: Computer Games 40 hours of computer games	Behavioral: Computer Games 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.

Arm

Intervention/Treatment

Experimental: Targeted Cognitive Training

40 hours of computerized cognitive training

Behavioral: Targeted Cognitive Training

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

Placebo Comparator: Computer Games

40 hours of computer games

Behavioral: Computer Games

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 30 Years

Sexes Eligible for Study:

All

Accepts 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