Targeted Cognitive Training in Clinical High Risk (CHR) for Psychosis
Primary Purpose
Clinical High Risk for Psychosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Targeted Cognitive Training
Computer Games
Sponsored by
About this trial
This is an interventional treatment trial for Clinical High Risk for Psychosis focused on measuring schizophrenia, psychosis, at risk, prodrome, attenuated psychosis syndrome
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
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Targeted Cognitive Training
Computer Games
Arm Description
40 hours of computerized cognitive training
40 hours of computer games
Outcomes
Primary Outcome Measures
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
Behavioral assessment of cognition
Secondary Outcome Measures
Global Function: Social and Role Scales
Behavioral assessment of daily functioning
Full Information
NCT ID
NCT02404194
First Posted
March 16, 2015
Last Updated
December 1, 2022
Sponsor
Rush University Medical Center
Collaborators
Harvard Medical School (HMS and HSDM), Beth Israel Deaconess Medical Center, National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT02404194
Brief Title
Targeted Cognitive Training in Clinical High Risk (CHR) for Psychosis
Official Title
Optimizing Cognitive Training to Improve Functional Outcome in Clinical High Risk (CHR)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
November 23, 2020 (Actual)
Study Completion Date
February 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
Collaborators
Harvard Medical School (HMS and HSDM), Beth Israel Deaconess Medical Center, National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical High Risk for Psychosis
Keywords
schizophrenia, psychosis, at risk, prodrome, attenuated psychosis syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Targeted Cognitive Training
Arm Type
Experimental
Arm Description
40 hours of computerized cognitive training
Arm Title
Computer Games
Arm Type
Placebo Comparator
Arm Description
40 hours of computer games
Intervention Type
Behavioral
Intervention Name(s)
Targeted Cognitive Training
Other Intervention Name(s)
Posit Science
Intervention Description
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
Intervention Name(s)
Computer Games
Intervention Description
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 Outcome Measure Information:
Title
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
Description
Behavioral assessment of cognition
Time Frame
Change in cognition from baseline (pre-intervention) to 10 weeks (post-intervention)
Secondary Outcome Measure Information:
Title
Global Function: Social and Role Scales
Description
Behavioral assessment of daily functioning
Time Frame
Change in functioning from baseline (pre-intervention) to 10 weeks (post-intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine I Hooker, PhD
Organizational Affiliation
Rush University Medical Center, Dept of Psychiatry & Behavioral Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Links:
URL
http://scholar.harvard.edu/chooker/home
Description
Website for Dr. Hooker's Laboratory
Learn more about this trial
Targeted Cognitive Training in Clinical High Risk (CHR) for Psychosis
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