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

Occurrence and Influencing Factors of Cognitive Impairment in Elderly Patients With Schizophrenia and the Application Effect of Acceptance and Commitment Therapy Nursing Model

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

Study Overview

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Huzhou, China, 313000
        • Huzhou third people's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
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 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cognitive Function
Time Frame: Baseline to 6 weeks post-intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological Flexibility (AAQ-II)
Time Frame: Baseline to 6 weeks.
Scores on the Acceptance and Action Questionnaire-II (7 items, Likert scale 1-7). Lower scores indicate greater flexibility.
Baseline to 6 weeks.
Self-Efficacy (GSES)
Time Frame: Baseline to 6 weeks.
General Self-Efficacy Scale (10 items, scores 10-40). Higher scores reflect stronger self-efficacy.
Baseline to 6 weeks.
Family Functioning (FACES II-CV)
Time Frame: Baseline to 6 weeks.
Family Adaptability and Cohesion Evaluation Scale (cohesion + adaptability subscales). Higher scores indicate healthier family dynamics.
Baseline to 6 weeks.
Stigma Reduction (SSMI-C)
Time Frame: Baseline to 6 weeks.
Stigma Scale for Mental Illness (28 items). Lower scores on Discrimination/Illness Concealment subscales indicate reduced stigma.
Baseline to 6 weeks.
Quality of Life (SQLS)
Time Frame: Baseline to 6 weeks.
Schizophrenia Quality of Life Scale (30 items). Lower scores indicate better QoL in psychosocial, motivation, and symptom domains.
Baseline to 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ying Xu, Huzhou third people's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2023

Primary Completion (Actual)

January 5, 2024

Study Completion (Actual)

September 19, 2024

Study Registration Dates

First Submitted

April 22, 2025

First Submitted That Met QC Criteria

April 22, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

June 24, 2025

Last Update Submitted That Met QC Criteria

June 18, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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