Clinical trial NCT02404194: 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
Overall status: COMPLETED
Phase: NA
Conditions: Clinical High Risk for Psychosis
Keywords: schizophrenia
psychosis
at risk
prodrome
attenuated psychosis syndrome
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
name: Beth Israel Deaconess Medical Center
name: National Institute of Mental Health (NIMH)
First posted: 2015-03-31
Enrollment: 139
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
timeFrame: Change in cognition from baseline (pre-intervention) to 10 weeks (post-intervention)
Secondary outcomes:
measure: Global Function: Social and Role Scales
timeFrame: Change in functioning from baseline (pre-intervention) to 10 weeks (post-intervention)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center, Dept of Psychiatry & Behavioral Sciences
name: Christine I Hooker, PhD
role: PRINCIPAL_INVESTIGATOR
References: