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

Clinical High Risk for Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02404194
• Other study ID #: MH105246
• Secondary ID: R01MH105246
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: February 15, 2021

Study information

• Verified date: December 2022
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: February 15, 2021
• Est. primary completion date: November 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinical High Risk for Psychosis
• Mental Disorders
• Psychotic Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Rush University Medical Center	Beth Israel Deaconess Medical Center, Harvard Medical School (HMS and HSDM), National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Global Function: Social and Role Scales	Behavioral assessment of daily functioning	Change in functioning from baseline (pre-intervention) to 10 weeks (post-intervention)

External Links

•   Website for Dr. Hooker's Laboratory