Clinical trial NCT06949657: Occurrence and Influencing Factors of Cognitive Impairment in Elderly Patients With Schizophrenia and
Official title: Occurrence and Influencing Factors of Cognitive Impairment in Elderly Patients With Schizophrenia and the Application Effect of Acceptance and Commitment Therapy Nursing Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia Disorders
Cognitive Impairment
Acceptance and Commitment Therapy
Lead sponsor: Third People's Hospital, Huzhou City, Zhejiang Province, China
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 78
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Cognitive Function
timeFrame: Baseline to 6 weeks post-intervention
Secondary outcomes:
measure: Psychological Flexibility (AAQ-II)
timeFrame: Baseline to 6 weeks.
measure: Self-Efficacy (GSES)
timeFrame: Baseline to 6 weeks.
measure: Family Functioning (FACES II-CV)
timeFrame: Baseline to 6 weeks.
measure: Stigma Reduction (SSMI-C)
timeFrame: Baseline to 6 weeks.
measure: Quality of Life (SQLS)
timeFrame: Baseline to 6 weeks.
Other outcomes:
Locations:
city: Huzhou
country: China
facility: Huzhou Third People's Hospital
Study officials:
affiliation: Huzhou Third People's Hospital
name: Ying Xu
role: PRINCIPAL_INVESTIGATOR
References: