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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS + Active VR | Experimental | Active tDCS over the left DLPFC (30 minutes) combined with active VR motivation training (60 minutes), administered 3 times per week for 4 weeks. |
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| Sham tDCS + Sham VR | Sham Comparator | Sham tDCS over the left DLPFC (30 minutes) combined with sham VR motivation training (60 minutes), administered 3 times per week for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active tDCS | Device | Active anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Scale of Prodromal Symptoms - Negative Subscale (SOPS-Neg) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Scale of Prodromal Symptoms - Positive Subscale (SOPS-Pos) | 8 weeks | |
| Global Function: Role scale | 8 weeks | |
| Global Function: Social scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| George Foussias, MD PhD FRCPC | Contact | 416-535-8501 | 34390 | george.foussias@camh.ca |
| Jessica D'Arcey | Contact | 416-535-8501 | 32578 | jessica.darcey@camh.ca |
| Name | Affiliation | Role |
|---|---|---|
| George Foussias, MD PhD FRCPC | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Addiction and Mental Health | Recruiting | Toronto | Ontario | M5T 1R8 | Canada |
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| Label | URL |
|---|---|
| The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world. | View source |
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| Active VR Motivation Training | Behavioral | Active computerized treatment with a virtual reality-based motivation training program, administered for 60 minutes, three times per week for four weeks. |
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| Sham tDCS | Device | Sham anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks. |
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| Sham VR Motivation Training | Behavioral | Sham computerized training in a virtual reality-based environment, administered for 60 minutes, three times per week for four weeks. |
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| 8 weeks |
| Beck Scale for Suicidal Ideation (BSS) | 4 weeks |
| Calgary Depression Scale for Schizophrenia | 4 weeks |
| MATRICS Consensus Cognitive Battery (MCCB) | 4 weeks |
| Relationships Across Domains (RAD) | 4 weeks |
| Reading the Mind in the Eyes Task (RMET) | 4 weeks |
| The Awareness of Social Inferences Test (TASIT) | 4 weeks |
| Emotion Recognition - 40 (ER-40) | 4 weeks |
| Interpersonal Reactivity Index (IRI) | 4 weeks |
| Simulator Sickness Questionnaire (SSQ) | 4 weeks |
| Functional Brain Imaging | Change in regional brain activity measured with functional MRI | 4 weeks |
| Structural Brain Imaging | Changes in brain structure (e.g., white matter tract integrity) measure with structural MRI | 4 weeks |