- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06949657
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Huzhou, China, 313000
- Huzhou third people's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Investigators
- Principal Investigator: Ying Xu, Huzhou third people's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- No. 2025-130
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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