The Efficacy of Computerized Cognitive Remediation Therapy for Chronic Schizophrenia
Study Details
Study Description
Brief Summary
The study group received antipsychotic drugs combined with Computerized Cognitive Remediation Therapy (CCRT) for 4 times/week for 45 minutes each time. The control group only received antipsychotic drugs. For a total of 12 weeks. Brain Derived Neurotrophic Factor (BDNF) and Tropomyosin-related kinase B (Trk B) genes in peripheral blood were detected in both groups before and after treatment. Clinical symptoms and executive function assessment were performed in both groups before and after treatment. The relevance of genes and their effects on downstream protein expression levels led to a molecular genetic mechanism for the efficacy of Computerized Cognitive Remediation Therapy (CCRT) .
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Among the cognitive disorders of chronic schizophrenia, the most reported is the executive dysfunction of the prefrontal lobe. There is increasing evidence that Computerized Cognitive Remediation Therapy (CCRT) has a significant improvement in the implementation of schizophrenia, but the specific mechanism is unknown. Therefore, this study plans to select 154 patients with chronic schizophrenia who were hospitalized for a long time. They were randomly divided into two groups. The study group received antipsychotic drugs combined with Computerized Cognitive Remediation Therapy (CCRT) for 4 times/week for 45 minutes each time. The control group only received antipsychotic drugs. For a total of 12 weeks. brain-derived neurotrophic factor (BDNF) and tyrosine receptor kinase B(TRK-B) genes in peripheral blood were detected in both groups before and after treatment. Clinical symptoms and executive function assessment were performed in both groups before and after treatment. The relevance of genes and their effects on downstream protein expression levels led to a molecular genetic mechanism for the efficacy of Computerized Cognitive Remediation Therapy (CCRT).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Cognitive Remediation Therapy The study group received antipsychotic drugs Clozapine combined with Computerized Cognitive Remediation Therapy for 4 times/week for 45 minutes each time. For a total of 12 weeks. Clozapine, dosage, dosage form, and frequency :300~600 mg/d; po; duration: 12 week. |
Other: Cognitive Remediation Therapy
Through computer information technology, using error-free, procedural learning, speech enhancement and a series of targeted computer programmatic cognitive correction tasks, patients can gradually improve problem solving and information processing capabilities, thereby improving their recognition function.
Other Names:
Drug: Clozapine
the course of disease is more than 2 years, the condition is stable for more than one month
Other Names:
|
| Placebo Comparator: Clozapine Clozapine, dosage, dosage form, and frequency :300~600 mg/d; po; duration: 12 week. |
Drug: Clozapine
the course of disease is more than 2 years, the condition is stable for more than one month
Other Names:
|
Outcome Measures
Primary Outcome Measures
- The score of Positive and Negative Syndrome Scale (PANSS) [the baseline]
The score of Positive and Negative Syndrome Scale (PANSS) ranges from 19-133 and will be administered to assess the effectiveness of treatment. Do higher values represent a worse outcome. The subscales are summed to compute a total score.
- The score of Positive and Negative Syndrome Scale (PANSS) [the end of 12 week]
The score of Positive and Negative Syndrome Scale (PANSS) ranges from 19-133 and will be administered to assess the effectiveness of treatment. Do higher values represent a worse outcome.The subscales are summed to compute a total score.
- The concentration of Brain Derived Neurotrophic Factor (BDNF) used to assess the effectiveness of treatment [the baseline]
The Concentration of Brain Derived Neurotrophic Factor (BDNF) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.
- The concentration of Brain Derived Neurotrophic Factor (BDNF) used to assess the effectiveness of treatment [the end of 12 week]
The Concentration of Brain Derived Neurotrophic Factor (BDNF) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.
Secondary Outcome Measures
- The concentration of tyrosine receptor kinase B(TRK-B) used to assess the effectiveness of treatment [the baseline]
The Concentration of tyrosine receptor kinase B(TRK-B) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.
- The concentration of tyrosine receptor kinase B(TRK-B) used to assess the effectiveness of treatment [the end of 12 week]
The Concentration of tyrosine receptor kinase B(TRK-B) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18-45 years old, Han nationality, male or female;
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Comply with the American Diagnostic Criteria for Mental Disorder (DSM-V) diagnostic criteria for "schizophrenia";
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The course of the disease and continued treatment with antipsychotic drugs for > 2 years, stable for at least one month;
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Positive NegativeSyndrome Scale (PANSS) < 70 points;
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intelligence quotient (IQ)>80;
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Cultural, social and educational backgrounds are sufficient to understand informed consent and research content.
Exclusion Criteria:
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Concomitant diagnosis in addition to Diagnostic and Statistical Manual of Mental Disorders-V other than schizophrenia;
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Central nervous system organic diseases;
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There are alcohol or other substances dependent or abused in the past two months, causing significant social and cognitive impairment;
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In the past year, there have been major life events such as widowhood;
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Those who have serious suicide attempts (the third item of the (Hamilton Depression Scale-17,HAMD-17) scale "suicide" ≥ 3 points);
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The current patient's severe unstable physical disease;
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pregnant women and lactating women;
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Those who have received modified electroconvulsive therapy (MECT) and repetitive Transcranial Magnetic Stimulation (rTMS) treatment in the past month;
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Those who have been ineffective for more than 3 months of systemic psychotherapy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Huangpu District Mental Health Center | Shanghai | Shanghai | China | 20000 |
Sponsors and Collaborators
- Shanghai Mental Health Center
Investigators
- Study Director: tao shen, professor, Shanghai Huangpu District Health and Wellness Committee
Study Documents (Full-Text)
More Information
Publications
None provided.- HKQ201813