Schizophrenia DisordersNCT06949657
Occurrence and Influencing Factors of Cognitive Impairment in Elderly Patients With Schizophrenia and
A study testing the conventional treatment group and the ACT group in people with Schizophrenia Disorders and Cognitive Impairment, run by Third People's Hospital, Huzhou City, Zhejiang Province, China at 1 site in China.
Trial summary
ACT combined with stratified intervention improved cognitive function and quality of life in elderly schizophrenia patients by enhancing psychological flexibility and family support. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Schizophrenia Disorders, Cognitive Impairment, Acceptance and Commitment Therapy
- What is being tested?
- the conventional treatment group and the ACT group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2023to 19 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
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
ACT combined with stratified intervention improved cognitive function and quality of life in elderly schizophrenia patients by enhancing psychological flexibility and family support.
Read the 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).
- Being tested
- the conventional treatment group, the ACT group
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the conventional treatment groupOther
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: the ACT group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 6 weeks post-intervention
Secondary outcomes (5)
Psychological Flexibility (AAQ-II)
Scores on the Acceptance and Action Questionnaire-II (7 items, Likert scale 1-7). Lower scores indicate greater flexibility.
Measured: Baseline to 6 weeks.
Self-Efficacy (GSES)
General Self-Efficacy Scale (10 items, scores 10-40). Higher scores reflect stronger self-efficacy.
Measured: Baseline to 6 weeks.
Family Functioning (FACES II-CV)
Family Adaptability and Cohesion Evaluation Scale (cohesion + adaptability subscales). Higher scores indicate healthier family dynamics.
Measured: Baseline to 6 weeks.
Stigma Reduction (SSMI-C)
Stigma Scale for Mental Illness (28 items). Lower scores on Discrimination/Illness Concealment subscales indicate reduced stigma.
Measured: Baseline to 6 weeks.
Quality of Life (SQLS)
Schizophrenia Quality of Life Scale (30 items). Lower scores indicate better QoL in psychosocial, motivation, and symptom domains.
Measured: Baseline to 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start13 Oct 2023
- Primary completion5 Jan 2024
- Study completion19 Sep 2024
Why it stopped: the sponsor has determined that access to the full dataset is no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third People's Hospital, Huzhou City, Zhejiang Province, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Xu, Third People's Hospital, Huzhou City, Zhejiang Province, China
- Investigators
- Ying Xu, Principal investigator, Huzhou Third People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949657
- Sponsor's protocol ID
- No. 2025-130
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06949657
- Acronym / sponsor ID
- No. 2025-130
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the sponsor has determined that access to the full dataset is no longer available
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Third People's Hospital, Huzhou City, Zhejiang Province, ChinaUniversity, hospital or other
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the conventional treatment group | Other | Other: the conventional treatment groupPatients 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 | Other | Other: the ACT groupPatients 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (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.
Key exclusion criteria (4 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the conventional treatment groupPatients 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 groupPatients 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 |
Primary outcome
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).
5 secondary outcomes
Psychological Flexibility (AAQ-II)
Time frame: Baseline to 6 weeks.
Self-Efficacy (GSES)
Time frame: Baseline to 6 weeks.
Family Functioning (FACES II-CV)
Time frame: Baseline to 6 weeks.
Stigma Reduction (SSMI-C)
Time frame: Baseline to 6 weeks.
Quality of Life (SQLS)
Time frame: Baseline to 6 weeks.
Results and safety
The study was stopped early (reason given: the sponsor has determined that access to the full dataset is no longer available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Xu principal investigator
Huzhou Third People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the conventional treatment group and the ACT group in people with Schizophrenia Disorders and Cognitive Impairment, run by Third People's Hospital, Huzhou City, Zhejiang Province, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: the sponsor has determined that access to the full dataset is no longer available). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Function (time frame: Baseline to 6 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.