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

NCT06949657 | Terminated

• 1 other identifier: No. 2025-130
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia Disorders; Cognitive Impairment; Acceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Cognitive Function

  Improvement in global cognitive function assessed via the Montreal Cognitive Assessment (MoCA), focusing on memory, attention, and executive function. Higher scores indicate better cognition (range: 0-30).

  Baseline to 6 weeks post-intervention

Secondary Outcomes (5)

• Psychological Flexibility (AAQ-II)

  Baseline to 6 weeks.

• Self-Efficacy (GSES)

  Baseline to 6 weeks.

• Family Functioning (FACES II-CV)

  Baseline to 6 weeks.

• Stigma Reduction (SSMI-C)

  Baseline to 6 weeks.

• Quality of Life (SQLS)

  Baseline to 6 weeks.

Study Arms (2)

the conventional treatment group

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.

Other: the conventional treatment group

the ACT group

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.

Other: the ACT group

Interventions

the conventional treatment group 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 conventional treatment group

the ACT group 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.

the ACT group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Third People's Hospital, Huzhou City, Zhejiang Province, China: lead

Study Sites (1)

Huzhou Third People's Hospital

Huzhou, 313000, China

Location

MeSH Terms

Conditions

Schizophrenia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Study Officials

• Ying Xu

  Huzhou Third People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: October 13, 2023
• Primary Completion: January 5, 2024
• Study Completion: September 19, 2024
• Last Updated: June 24, 2025

Record last verified: 2024-04

Locations

CN (1)