The Efficacy of Computerized Cognitive Remediation Therapy for Chronic Schizophrenia

NCT ID: NCT03772951

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-10
• Study Completion Date: 2021-03-31

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).

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Cognitive Remediation Therapy

Intervention Type: OTHER

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.

Clozapine

Intervention Type: DRUG

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

Clozapine

Clozapine, dosage, dosage form, and frequency :300\~600 mg/d; po; duration: 12 week.

Group Type: PLACEBO_COMPARATOR

Clozapine

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: OTHER

Clozapine

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

Intervention Type: DRUG

Other Intervention Names

CCRT; CLZ

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

tao shen, professor

Role: STUDY_DIRECTOR

Shanghai Huangpu District Health and Wellness Committee

Locations

Huangpu District Mental Health Center

Shanghai, Shanghai Municipality, China

Countries

China

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

HKQ201813

Identifier Type: -

Identifier Source: org_study_id