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The Efficacy of Computerized Cognitive Remediation Therapy for Chronic Schizophrenia

The Efficacy for Execution Function and Genetic Mechanism of Computerized Cognitive Remediation Therapy for Chronic Schizophrenia

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03772951
Enrollment
154
Registered
2018-12-12
Start date
2019-01-10
Completion date
2021-03-31
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

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) .

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).

Interventions

OTHERCognitive 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.

DRUGClozapine

the course of disease is more than 2 years, the condition is stable for more than one month

Sponsors

Shanghai Mental Health Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

1. Age 18-45 years old, Han nationality, male or female; 2. Comply with the American Diagnostic Criteria for Mental Disorder (DSM-V) diagnostic criteria for schizophrenia; 3. The course of the disease and continued treatment with antipsychotic drugs for \> 2 years, stable for at least one month; 4. Positive NegativeSyndrome Scale (PANSS) \< 70 points; 5. intelligence quotient (IQ)\>80; 6. Cultural, social and educational backgrounds are sufficient to understand informed consent and research content.

Exclusion criteria

1. Concomitant diagnosis in addition to Diagnostic and Statistical Manual of Mental Disorders-V other than schizophrenia; 2. Central nervous system organic diseases; 3. There are alcohol or other substances dependent or abused in the past two months, causing significant social and cognitive impairment; 4. In the past year, there have been major life events such as widowhood; 5. Those who have serious suicide attempts (the third item of the (Hamilton Depression Scale-17,HAMD-17) scale suicide ≥ 3 points); 6. The current patient's severe unstable physical disease; 7. pregnant women and lactating women; 8. Those who have received modified electroconvulsive therapy (MECT) and repetitive Transcranial Magnetic Stimulation (rTMS) treatment in the past month; 9. Those who have been ineffective for more than 3 months of systemic psychotherapy.

Design outcomes

Primary

MeasureTime frameDescription
The score of Positive and Negative Syndrome Scale (PANSS)the baselineThe 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 treatmentthe baselineThe Concentration of Brain Derived Neurotrophic Factor (BDNF) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.

Secondary

MeasureTime frameDescription
The concentration of tyrosine receptor kinase B(TRK-B) used to assess the effectiveness of treatmentthe baselineThe Concentration of tyrosine receptor kinase B(TRK-B) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026