Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia
NCT ID: NCT00694889
Last Updated: 2016-05-16
Study Results
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Basic Information
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COMPLETED
PHASE1/PHASE2
144 participants
INTERVENTIONAL
2007-08-31
2015-02-28
Brief Summary
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Detailed Description
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Participants will repeat baseline assessments after the computer training and Month 6 of follow-up. The EEG and MRI will be repeated only at post training assessment visit. There will be a blood draw at Week 2 of treatment as well. After the Month 6 assessment, participants in the control condition will be offered an opportunity to complete an additional 8 weeks of computer training with different modules.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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1
Participants will use commercially available computer games.
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.
2
Participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation.
Neuroadaptive cognitive training
Neuroadaptive cognitive training includes cognitive remediation exercises that participants will practice 1 hour per day, 5 days per week, for 8 weeks. The exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal targets. The treatment will focus on TCT.
3
Healthy participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation.
Neuroadaptive cognitive training
Neuroadaptive cognitive training includes cognitive remediation exercises that participants will practice 1 hour per day, 5 days per week, for 8 weeks. The exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal targets. The treatment will focus on TCT.
Interventions
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Neuroadaptive cognitive training
Neuroadaptive cognitive training includes cognitive remediation exercises that participants will practice 1 hour per day, 5 days per week, for 8 weeks. The exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal targets. The treatment will focus on TCT.
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.
Eligibility Criteria
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Inclusion Criteria
* First psychotic episode within the last 3 years
* Good general physical health
* Age between 12-35
* Is fluent and proficient in the English language
* Achieved clinical stability (e.g., outpatient status for at least 3 months before study entry; on stable doses of medication for at least 1 month before study entry
* Minors must have parental/legal guardian consent to participate
Exclusion Criteria
* History of psychoactive substance abuse in the past 6 months
12 Years
35 Years
ALL
No
Sponsors
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Stanley Medical Research Institute
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Sophia Vinogradov, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco; San Francisco VA Medical Center; NCIRE - The Veterans Health Research Institute
Rachel Loewy, PhD
Role: STUDY_DIRECTOR
University of California, San Francisco
Cameron Carter, MD
Role: STUDY_DIRECTOR
University of California, Davis
Locations
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University of California, Davis
Sacramento, California, United States
University of California, San Francisco
San Francisco, California, United States
Countries
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References
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Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.
Puig O, Fisher M, Loewy R, Miley K, Ramsay IS, Carter CS, Ragland JD, Niendam T, Vinogradov S. Early- Versus Adult-Onset Schizophrenia as a Predictor of Response to Neuroscience-Informed Cognitive Training. J Clin Psychiatry. 2020 Mar 3;81(2):18m12369. doi: 10.4088/JCP.18m12369.
Roach BJ, Ford JM, Biagianti B, Hamilton HK, Ramsay IS, Fisher M, Loewy R, Vinogradov S, Mathalon DH. Efference copy/corollary discharge function and targeted cognitive training in patients with schizophrenia. Int J Psychophysiol. 2019 Nov;145:91-98. doi: 10.1016/j.ijpsycho.2018.12.015. Epub 2018 Dec 29.
Biagianti B, Roach BJ, Fisher M, Loewy R, Ford JM, Vinogradov S, Mathalon DH. Trait aspects of auditory mismatch negativity predict response to auditory training in individuals with early illness schizophrenia. Neuropsychiatr Electrophysiol. 2017;3:2. doi: 10.1186/s40810-017-0024-9. Epub 2017 Jun 9.
Biagianti B, Fisher M, Neilands TB, Loewy R, Vinogradov S. Engagement with the auditory processing system during targeted auditory cognitive training mediates changes in cognitive outcomes in individuals with schizophrenia. Neuropsychology. 2016 Nov;30(8):998-1008. doi: 10.1037/neu0000311. Epub 2016 Sep 12.
Panizzutti R, Hamilton SP, Vinogradov S. Genetic correlate of cognitive training response in schizophrenia. Neuropharmacology. 2013 Jan;64(1):264-7. doi: 10.1016/j.neuropharm.2012.07.048. Epub 2012 Aug 7.
Other Identifiers
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06TAF-972
Identifier Type: -
Identifier Source: org_study_id
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