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

NCT ID: NCT02404194

Last Updated: 2022-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2021-02-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Targeted Cognitive Training

40 hours of computerized cognitive training

Group Type: EXPERIMENTAL

Targeted Cognitive Training

Intervention Type: 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.

Computer Games

40 hours of computer games

Group Type: PLACEBO_COMPARATOR

Computer Games

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Posit Science

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Christine Hooker

Professor, Department of Psychiatry and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christine I Hooker, PhD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center, Dept of Psychiatry & Behavioral Sciences

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

Related Links

http://scholar.harvard.edu/chooker/home

Website for Dr. Hooker's Laboratory

Other Identifiers

R01MH105246

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MH105246

Identifier Type: -

Identifier Source: org_study_id