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

NCT02404194 | Completed DMC

• 2 other identifiers: MH105246R01MH105246
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical High Risk for Psychosis

Keywords

schizophrenia; psychosis; at risk; prodrome; attenuated psychosis syndrome

Outcome Measures

Primary Outcomes (1)

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

  Behavioral assessment of cognition

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

Secondary Outcomes (1)

• Global Function: Social and Role Scales

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

Study Arms (2)

Targeted Cognitive Training

EXPERIMENTAL

40 hours of computerized cognitive training

Behavioral: Targeted Cognitive Training

Computer Games

PLACEBO COMPARATOR

40 hours of computer games

Behavioral: Computer Games

Interventions

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.

Also known as: Posit Science

Targeted Cognitive Training

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.

Computer Games

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• Harvard Medical School (HMS and HSDM): collaborator
• Beth Israel Deaconess Medical Center: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Links

• Website for Dr. Hooker's Laboratory

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Christine I Hooker, PhD

  Rush University Medical Center, Dept of Psychiatry & Behavioral Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 31, 2015
• Study Start: March 1, 2015
• Primary Completion: November 23, 2020
• Study Completion: February 15, 2021
• Last Updated: December 2, 2022

Record last verified: 2022-12

Locations

US (1)