Negative symptoms, which include the loss of motivation, social withdrawal and reduced emotional expression are prominent in youth at clinical high risk (CHR) for psychosis. These negative symptoms lead to significant functional impairment and enduring disability in these youth. At present, there are no established treatments for negative symptoms. Recent evidence from independent studies, however, suggests two promising novel treatment approaches for negative symptoms, transcranial direct current stimulation (tDCS), and computerized remediation strategies. The primary aim of this study is to evaluate if tDCS combined with a virtual reality-based computerized remediation (VR) is effective for treating negative symptoms in CHR youth, thereby mitigating the enduring functional disability these symptoms cause.
Negative symptoms, which include amotivation, social withdrawal and diminished emotional expression are prominent in youth at clinical high risk (CHR) for psychosis. Negative symptoms lead to significant functional impairment and enduring disability in these youth regardless of subsequent conversion to psychosis. At present, there are no established treatments for negative symptoms. Recent evidence from independent studies, however, suggests two promising novel treatment approaches for negative symptoms, transcranial direct current stimulation (tDCS), and computerized remediation strategies, both of which have revealed significant therapeutic effects on negative symptoms in schizophrenia (SZ). tDCS involves delivery of a low intensity continuous electrical field to the frontal cortex. tDCS is very safe and well tolerated, and is currently being investigated as a treatment for several psychiatric disorders. tDCS is also Health Canada approved for the treatment of major depressive disorder. The primary aim of this randomized controlled trial is to evaluate if tDCS combined with a virtual reality-based computerized remediation (VR), administered three times per week for four weeks, is effective for treating negative symptoms in CHR youth, thereby mitigating the enduring functional disability these symptoms cause.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
22
Active anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks.
Active computerized treatment with a virtual reality-based motivation training program, administered for 60 minutes, three times per week for four weeks.
Sham anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks.
Sham computerized training in a virtual reality-based environment, administered for 60 minutes, three times per week for four weeks.
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
RECRUITINGScale of Prodromal Symptoms - Negative Subscale (SOPS-Neg)
Time frame: 8 weeks
Scale of Prodromal Symptoms - Positive Subscale (SOPS-Pos)
Time frame: 8 weeks
Global Function: Role scale
Time frame: 8 weeks
Global Function: Social scale
Time frame: 8 weeks
Beck Scale for Suicidal Ideation (BSS)
Time frame: 4 weeks
Calgary Depression Scale for Schizophrenia
Time frame: 4 weeks
MATRICS Consensus Cognitive Battery (MCCB)
Time frame: 4 weeks
Relationships Across Domains (RAD)
Time frame: 4 weeks
Reading the Mind in the Eyes Task (RMET)
Time frame: 4 weeks
The Awareness of Social Inferences Test (TASIT)
Time frame: 4 weeks
Emotion Recognition - 40 (ER-40)
Time frame: 4 weeks
Interpersonal Reactivity Index (IRI)
Time frame: 4 weeks
Simulator Sickness Questionnaire (SSQ)
Time frame: 4 weeks
Functional Brain Imaging
Change in regional brain activity measured with functional MRI
Time frame: 4 weeks
Structural Brain Imaging
Changes in brain structure (e.g., white matter tract integrity) measure with structural MRI
Time frame: 4 weeks
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