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

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ClinicalTrials.gov Identifier: NCT02404194
Recruitment Status : Recruiting
First Posted : March 31, 2015
Last Update Posted : March 31, 2015
Information provided by (Responsible Party):

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
Clinical High Risk for Psychosis Behavioral: Targeted Cognitive Training Behavioral: Computer Games

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2015
Estimated Primary Completion Date : September 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 :
  1. Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery [ Time Frame: Change in cognition from baseline (pre-intervention) to 10 weeks (post-intervention) ]
    Behavioral assessment of cognition

Secondary Outcome Measures :
  1. Global Function: Social and Role Scales [ Time Frame: Change in functioning from baseline (pre-intervention) to 10 weeks (post-intervention) ]
    Behavioral assessment of daily functioning

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404194

Contact: David Dodell-Feder, M.A. 559-904-4431 braintrainingstudy@gmail.com

United States, Massachusetts
Harvard University Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: David Dodell-Feder, M.A.    559-904-4431    braintrainingstudy@gmail.com   
Principal Investigator: Christine I Hooker, Ph.D.         
Sponsors and Collaborators
Harvard University
Harvard Medical School
Beth Israel Deaconess Medical Center
National Institute of Mental Health (NIMH)
National Alliance for Research on Schizophrenia and Depression
Principal Investigator: Christine I Hooker, Ph.D. Associate Professor
More Information

Additional Information:
Responsible Party: Christine I. Hooker, Associate Professor of Psychology, Harvard University
ClinicalTrials.gov Identifier: NCT02404194     History of Changes
Other Study ID Numbers: MH105246
R01MH105246 ( U.S. NIH Grant/Contract )
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015

Keywords provided by Christine I. Hooker, Harvard University:
at risk
attenuated psychosis syndrome

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders