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Sponsored by: |
National Institute of Mental Health (NIMH) |
Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00655239 |
This study will evaluate the effectiveness of intensive computerized cognitive training in preventing the onset of psychotic disorder and improving adaptive functioning in adolescents at high risk of schizophrenia.
Condition | Intervention | Phase |
Schizophrenia |
Behavioral: Neuroadaptive cognitive training Behavioral: Computer games |
Phase I Phase II |
MedlinePlus related topics: | Psychotic Disorders Schizophrenia |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Neuroscience-Guided Cognitive Remediation in Adolescents at Risk for Psychosis |
Estimated Enrollment: | 100 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | March 2013 |
Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Participants will use commercially available computer games.
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Behavioral: Computer games
The control treatment involves commercially available computer games that participants will practice 1 hour per day, 5 days per week, for 16 weeks.
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2: Experimental
Participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation.
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Behavioral: Neuroadaptive cognitive training
Neuroadaptive cognitive training includes cognitive remediation exercises that participants will practice 1 hour per day, 5 days per week, for 16 weeks. The exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal and visuospatial targets. The first 8 weeks of treatment will focus on TCT and the second 8 weeks will focus on visuospatial training.
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3: Active Comparator
Healthy participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation.
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Behavioral: Neuroadaptive cognitive training
Neuroadaptive cognitive training includes cognitive remediation exercises that participants will practice 1 hour per day, 5 days per week, for 16 weeks. The exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal and visuospatial targets. The first 8 weeks of treatment will focus on TCT and the second 8 weeks will focus on visuospatial training.
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Schizophrenia is a severe mental disorder that is marked by significant disruption in a person's thought and emotional processes, frequently involving psychotic features. Identifying behavioral changes and symptoms that indicate the beginning stages of schizophrenia is important for early intervention and prevention of a full psychotic episode. These initial symptoms, known as the prodromal symptoms of psychosis, may include odd behaviors, increased social withdrawal, difficulty concentrating, inappropriate emotional responses, suspicion of others, and dramatic sleep and appetite changes. Common treatments for adolescents demonstrating prodromal symptoms include forms of psychotherapy, nutritional training, and low doses of medication. As a form of psychotherapy, neuroadaptive cognitive training exercises delivered on a computer may be the most effective means of remediating the thinking difficulties of adolescents who are experiencing prodromal symptoms and are at risk for developing a first psychotic episode. This study will evaluate the effectiveness of intensive computerized neuroadaptive cognitive training exercises in preventing the onset of psychotic disorder and improving adaptive functioning in adolescents at high risk of schizophrenia.
Participation in this study will last 6 months and will involve both healthy participants and participants at high risk of schizophrenia. All participants will undergo baseline assessments that will include an interview, written tests, blood draws, and electroencephalogram (EEG) and magnetic resonance imaging (MRI) scans. Participants at high risk of schizophrenia will then be assigned randomly to receive treatment with either computerized neuroadaptive cognitive training or commercially available computer games. Healthy participants will receive treatment with computerized neuroadaptive cognitive training only. All participants will be asked to complete 60-minute sessions of their assigned treatments 5 days per week for 16 weeks. For participants receiving cognitive training, exercises will focus on improving speed and accuracy in the perception of and response to verbal and visuospatial targets. The first 8 weeks of treatment will focus on targeted cognitive training (TCT) and the second 8 weeks will focus on visuospatial training. Participants assigned to practice computer games will play standard, commercially available games, with no targeted response.
Participants will repeat baseline assessments at Weeks 8 and 16 of treatment and Month 6 of follow-up. The EEG and MRI will be repeated only at the Week 16 assessment visit. There will be a blood draw at Week 2 of treatment as well. After the Month 6 assessment, participants will be offered an opportunity to complete an additional 8 to 16 weeks of computer training with different modules.
Ages Eligible for Study: | 16 Years to 25 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Linda May, PhD, MFT | 415-476-7278 | lmay@lppi.ucsf.edu |
United States, California | |||||
University of California, San Francisco | Recruiting | ||||
San Francisco, California, United States, 94591 | |||||
Contact: Linda May, PhD, MFT 415-476-7278 lmay@lppi.ucsf.edu | |||||
Contact: Rachel Loewy, PhD 415-476-7659 rloewy@lppi.ucsf.edu | |||||
Principal Investigator: Rachel Loewy, PhD | |||||
University of California, Davis | Recruiting | ||||
Davis, California, United States, 95817 | |||||
Contact: Keur Moua, BA 916-734-0512 keur.moua@ucdmc.ucdavis.edu | |||||
Principal Investigator: Cameron Carter, MD |
Principal Investigator: | Sophia Vinogradov, MD | University of California, San Francisco; San Francisco VA Medical Center; NCIRE - The Veterans Health Research Institute |
Study Director: | Rachel Loewy, PhD | University of California, San Francisco |
Study Director: | Cameron Carter, MD | University of California, Davis |
Responsible Party: | University of California, San Francisco ( Sophia Vinogradov, MD, Professor of Psychiatry ) |
Study ID Numbers: | R01 MH081051, DDTR B2-NDS |
First Received: | April 7, 2008 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00655239 |
Health Authority: | United States: Federal Government |
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