Occurrence and Influencing Factors of Cognitive Impairment in Elderly Patients With Schizophrenia and

NCT ID: NCT06949657

Last Updated: 2025-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-13

Study Completion Date

2024-09-19

Brief Summary

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ACT combined with stratified intervention improved cognitive function and quality of life in elderly schizophrenia patients by enhancing psychological flexibility and family support.

Detailed Description

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This study analyzes factors influencing cognitive impairment and evaluates the efficacy of a stratified intervention combining Acceptance and Commitment Therapy (ACT) with these factors to improve cognitive function and quality of life. A total of 149 elderly patients with schizophrenia were enrolled, split into cognitive impairment (n = 86) and non-cognitive impairment (n = 63) groups. A combined case-control and randomized controlled trial design was employed. Logistic regression was used to identify independent risk factors. Cognitive impairment patients were randomly assigned to either the conventional treatment group (n = 39) or the ACT group (n = 39) for a 6-week intervention. Evaluation instruments included the AAQ-II (psychological flexibility), GSES (self-efficacy), FACES II-CV (family functioning), SSMI-C (internalized stigma), and SQLS (quality of life).

Conditions

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Schizophrenia Disorders Cognitive Impairment Acceptance and Commitment Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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the conventional treatment group

Patients received conventional mental health education once weekly for 6 weeks, covering schizophrenia symptoms, treatment, and prognosis. Standard nursing care and antipsychotic medications (e.g., olanzapine, quetiapine) were maintained without additional psychological interventions.

Group Type OTHER

the conventional treatment group

Intervention Type OTHER

Patients received conventional mental health education once weekly for 6 weeks, covering schizophrenia symptoms, treatment, and prognosis. Standard nursing care and antipsychotic medications (e.g., olanzapine, quetiapine) were maintained without additional psychological interventions.

the ACT group

Patients received ACT-based nursing interventions tailored to risk factors (e.g., age ≥70, long disease duration), including:

ACT modules: Acceptance, cognitive defusion, mindfulness, values clarification, and committed action.

Adjunct strategies: Family therapy, Tai Chi, and crisis planning. Frequency: Daily practice + 1-2 group sessions/week for 6 weeks. Goal: Enhance psychological flexibility, reduce stigma, and improve cognitive function.

Group Type OTHER

the ACT group

Intervention Type OTHER

Patients received ACT-based nursing interventions tailored to risk factors (e.g., age ≥70, long disease duration), including:

ACT modules: Acceptance, cognitive defusion, mindfulness, values clarification, and committed action.

Adjunct strategies: Family therapy, Tai Chi, and crisis planning. Frequency: Daily practice + 1-2 group sessions/week for 6 weeks. Goal: Enhance psychological flexibility, reduce stigma, and improve cognitive function.

Interventions

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the conventional treatment group

Patients received conventional mental health education once weekly for 6 weeks, covering schizophrenia symptoms, treatment, and prognosis. Standard nursing care and antipsychotic medications (e.g., olanzapine, quetiapine) were maintained without additional psychological interventions.

Intervention Type OTHER

the ACT group

Patients received ACT-based nursing interventions tailored to risk factors (e.g., age ≥70, long disease duration), including:

ACT modules: Acceptance, cognitive defusion, mindfulness, values clarification, and committed action.

Adjunct strategies: Family therapy, Tai Chi, and crisis planning. Frequency: Daily practice + 1-2 group sessions/week for 6 weeks. Goal: Enhance psychological flexibility, reduce stigma, and improve cognitive function.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* (1)Meets the diagnostic criteria for schizophrenia as defined in the International Classification of Diseases, Tenth Revision (ICD-10);
* (2) age \> 60 years;
* (3)possesses at least a primary school education, enabling independent completion of all questionnaires;
* (4) has been taking antipsychotic medication continuously and regularly for at least one year during the enrollment period, with current symptoms and disease status stabilized in the maintenance phase;
* (5)informed consent obtained from the patient or their family/guardian.

Exclusion Criteria

* (1) Coexisting organic mental disorders, affective disorders, or similar conditions;
* (2) coexisting physical illnesses that may affect cognitive function, such as hepatic or renal dysfunction;
* (3) alcohol dependence or dependence on psychoactive substances;
* (4) receipt of electroconvulsive therapy within the past three months.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third People's Hospital, Huzhou City, Zhejiang Province, China

OTHER

Sponsor Role lead

Responsible Party

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Ying Xu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ying Xu

Role: PRINCIPAL_INVESTIGATOR

Huzhou Third People's Hospital

Locations

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Huzhou Third People's Hospital

Huzhou, , China

Site Status

Countries

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China

Other Identifiers

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No. 2025-130

Identifier Type: -

Identifier Source: org_study_id

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