Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Schizophrenia

Treatments: Behavioral: Computer games; Behavioral: Neuroadaptive cognitive training

Study type: Interventional

Funder types: Other

Identifiers

NCT00694889

06TAF-972

Details and patient eligibility

About

The aim of this study is to investigate the efficacy of neuroscience-guided computerized cognitive training exercises on the remediation of cognitive deficits and symptoms associated with recent-onset schizophrenia and to examine the influence of subject characteristics, brain structure and function, and pharmacotherapy on the response to remediation.

Full description

Participation in this study will last approximately 12 months and will involve individuals with recent-onset 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 will then be assigned randomly to receive treatment with either computerized neuroadaptive cognitive training or commercially available computer games. Participants will be asked to complete 60-minute sessions of their assigned treatments 5 days per week for 8 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 8 weeks of treatment will focus on targeted cognitive training (TCT). Participants assigned to practice computer games will play standard commercially available games, with no targeted response.

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.

Enrollment: 144 patients

Sex: All

Ages: 12 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder
• 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

• Any neurological disorder
• History of psychoactive substance abuse in the past 6 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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144 participants in 3 patient groups

1

Active Comparator group

Description:

Participants will use commercially available computer games.

Treatment:

Behavioral: Computer games

2

Experimental group

Description:

Participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation.

Treatment:

Behavioral: Neuroadaptive cognitive training

3

Active Comparator group

Description:

Healthy participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation.

Treatment:

Behavioral: Neuroadaptive cognitive training