Cognitive TherapyNCT04916483
Exploring the Effectiveness of Group Cognitive Stimulation Therapy in People With Schizophrenia.
A study testing group cognitive stimulation therapy in people with Cognitive Therapy, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
Background: Cognitive dysfunction is the core defect of schizophrenia, which seriously affects the emotional, social functions and quality of life in people with schizophrenia. Objective: The purpose of this study is to explore the efficacy of group cognitive stimulation therapy in cognitive function, depressive… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Cognitive Therapy
- What is being tested?
- group cognitive stimulation therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jan 2021to 31 Dec 2021
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People who according the DSM-5 diagnosis of schizophrenia spectrum and have been sick for more than two years.
- Age between 20 and 65 years old.
- There are currently rules for receiving antipsychotics treatment.
- Regardless of whether you take antidepressants or not.
- Can communicate clearly in Mandarin and Taiwanese.
- Those with a score of 10-25 on the Montreal Cognitive Assessment Scale (MoCA).
- Those who are willing to participate in this study and complete the subject consent form.
Who cannot join
- According to DSM-5 criteria, suspected bipolar disorder, anxiety disorder, obsessive- compulsive disorder, cognitive impairment, substance use disorders, and other unthinking disorders are exclusion.
- Have been in or out of the acute ward within three months and currently have suicidal attempts or violence.
- Those who are receiving individual or group cognitive behavior therapy.
- People with intellectual disabilities.
- Those who are unable to conduct research due to visual or hearing impairment.
- People who are accepting other clinical trials.
- Those who have no intention to participate in this study or are unable to complete the subject's consent form.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Yang-Ming Jiaotong University
Taipei
Yang Chiu Yueh, PhD, 02-28267388, cyyang3@ym.edu.tw
About this study
Official title: Exploring the Effectiveness of Group Cognitive Stimulation Therapy on Cognitive Function, Depressive Symptoms, Social Function and Quality of Life in People With Schizophrenia: A Randomized Controlled Trial
Background: Cognitive dysfunction is the core defect of schizophrenia, which seriously affects the emotional, social functions and quality of life in people with schizophrenia.
Objective: The purpose of this study is to explore the efficacy of group cognitive stimulation therapy in cognitive function, depressive symptoms, social function, and quality of life in people with Schizophrenia.
Read more
Research method:This study used a single-blind randomized controlled trial design. Participants's Montreal Cognitive Assessment Scale (MoCA) score between 10-25 points are include. Chronic rehabilitation wards were randomly assigned to the experimental group and the conventional treatment group using blocking. The experimental group (EG) (n = 45) is receive 7 weeks, twice a week, 60 minutes each time of group cognitive stimulation therapy(GCST), the control group (CG) (n = 45) maintain usual care.
Expected results: GCST can improve cognitive function, depressive symptoms, social function and quality of life in people with schizophrenia.
Read the detailed description
Background: Cognitive dysfunction is the core defect of schizophrenia, which seriously affects the emotional and social functions of patients. Group cognitive stimulation therapy has been supported by research abroad to improve cognition and mood. Domestically, this group of people with schizophrenia will also face the above symptoms. Therefore, non-pharmacological therapy is among mental health personnel It is worth paying attention to and developing in the process of providing medical services.
Objective: The purpose of this study explores the efficacy of group cognitive stimulation therapy in cognitive function, depressive symptoms, social function and quality of life in people with Schizophrenia.
Research method: This study used a single-blind randomized controlled trial design to reduce it to people with schizophrenia.This study used a single-blind randomized controlled trial design. Participants's Montreal Cognitive Assessment Scale (MoCA) score between 10-25 points are include. Chronic rehabilitation wards were randomly assigned to the EG and the CG using blocking. The EG receive 7 weeks, twice a week, 60 minutes each time of GCST, the CG maintain usual care. Both groups use the Montreal Cognitive Assessment Scale (MoCA), the Taiwanese Version of Frontal Assessment Battery (TFAB), the Beck Depression Inventory II (Beck Depression Inventory II, BDI-II), and Social Function Scales-Taiwanese version(SFST) and WHOQOL-BREF is use as an evaluation tool to measure the results at the baseline, T1 (7th weeks) and T2 (20th weeks). The research results were filed and statistically analyzed with IBM SPSS 20.0 software package. Descriptive statistics were used for general demographic variables and primary , secondary outcome: mean, SD, range, percentage. The difference between the two groups of benchmark values was analyzed with t-test or χ2, independent-t test, pair-t, and GEE.
Expected results: GCST can improve cognitive function, depressive symptoms, social function and quality of life in people with schizophrenia.
- Conditions
- Cognitive Therapy
- Being tested
- group cognitive stimulation therapy, usual care
- Keywords
- cognitive stimulation therapy, depressive symptoms, schizophrenia, social function, quality of life
- Medical subject headings
- Depression, Schizophrenia, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group cognitive stimulation therapyOther
Also called GCST
The experimental group will receive totally 7 weeks,14 sessions, twice a week, and 60 minute group cognitive stimulation therapy (GCST).
usual careOther
The control group maintains the unit routine treatment.
| Study group | Role | What they receive |
|---|---|---|
| Exploring the effectiveness of GCST in people with schizophrenia. | Experimental | The experimental group will receive a total of 14 sessions, twice a week group cognitive stimulation therapy for 7 weeks. Receives: Other: group cognitive stimulation therapy; Other: usual care |
| Control group | No intervention | The control group maintains the usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment, MoCA
Cognitive function test
Measured: baseline
Taiwanese Version of Frontal Assessment Battery, TFAB
Cognitive function test
Measured: baseline
Wechsler Memory Scale-Third Edition, WMS-III
Cognitive function test
Measured: baseline
Secondary outcomes (3)
Beck Depression Inventory II, BDI-II
Depressive symptoms test
Measured: baseline
Social Function Scales-Taiwanese version, SFST
Social Function test
Measured: baseline
WHOQOL-BREF
quality of life test
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start15 Jan 2021
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive TherapyStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were divided into experimental group and control group through block randomization
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiu-Yueh Yang, National Yang Ming Chiao Tung University
- Investigators
- Chiu-Yueh Yang, PhD, Principal investigator, National Yang-Ming Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916483
- Sponsor's protocol ID
- IRB1081209-04
- Status last verified
- Jun 2021
- First submitted
- 9 Apr 2020
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effectiveness of Group Cognitive Stimulation Therapy on Cognitive Function, Depressive Symptoms, Social Function and Quality of Life in People With Schizophrenia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04916483
- Acronym / sponsor ID
- IRB1081209-04
- Conditions
- Cognitive Therapy
- Keywords
- cognitive stimulation therapy, depressive symptoms, schizophrenia, social function, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 7 Jun 2021 (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.
Background: Cognitive dysfunction is the core defect of schizophrenia, which seriously affects the emotional, social functions and quality of life in people with schizophrenia.
Objective: The purpose of this study is to explore the efficacy of group cognitive stimulation therapy in cognitive function, depressive symptoms, social function, and quality of life in people with Schizophrenia.
Research method:This study used a single-blind randomized controlled trial design. Participants's Montreal Cognitive Assessment Scale (MoCA) score between 10-25 points are include. Chronic rehabilitation wards were randomly assigned to the experimental group and the conventional treatment group using blocking. The experimental group (EG) (n = 45) is receive 7 weeks, twice a week, 60 minutes each time of group cognitive stimulation therapy(GCST), the control group (CG) (n = 45) maintain usual care.
Expected results: GCST can improve cognitive function, depressive symptoms, social function and quality of life in people with schizophrenia.
Detailed description
Background: Cognitive dysfunction is the core defect of schizophrenia, which seriously affects the emotional and social functions of patients. Group cognitive stimulation therapy has been supported by research abroad to improve cognition and mood. Domestically, this group of people with schizophrenia will also face the above symptoms. Therefore, non-pharmacological therapy is among mental health personnel It is worth paying attention to and developing in the process of providing medical services.
Objective: The purpose of this study explores the efficacy of group cognitive stimulation therapy in cognitive function, depressive symptoms, social function and quality of life in people with Schizophrenia.
Research method: This study used a single-blind randomized controlled trial design to reduce it to people with schizophrenia.This study used a single-blind randomized controlled trial design. Participants's Montreal Cognitive Assessment Scale (MoCA) score between 10-25 points are include. Chronic rehabilitation wards were randomly assigned to the EG and the CG using blocking. The EG receive 7 weeks, twice a week, 60 minutes each time of GCST, the CG maintain usual care. Both groups use the Montreal Cognitive Assessment Scale (MoCA), the Taiwanese Version of Frontal Assessment Battery (TFAB), the Beck Depression Inventory II (Beck Depression Inventory II, BDI-II), and Social Function Scales-Taiwanese version(SFST) and WHOQOL-BREF is use as an evaluation tool to measure the results at the baseline, T1 (7th weeks) and T2 (20th weeks). The research results were filed and statistically analyzed with IBM SPSS 20.0 software package. Descriptive statistics were used for general demographic variables and primary , secondary outcome: mean, SD, range, percentage. The difference between the two groups of benchmark values was analyzed with t-test or χ2, independent-t test, pair-t, and GEE.
Expected results: GCST can improve cognitive function, depressive symptoms, social function and quality of life in people with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were divided into experimental group and control group through block randomization
| Arm | Type | Receives |
|---|---|---|
| Exploring the effectiveness of GCST in people with schizophrenia. | Experimental | Other: group cognitive stimulation therapy, Other: usual careThe experimental group will receive a total of 14 sessions, twice a week group cognitive stimulation therapy for 7 weeks. |
| Control group | No intervention | –The control group maintains the usual care. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- People who according the DSM-5 diagnosis of schizophrenia spectrum and have been sick for more than two years.
- Age between 20 and 65 years old.
- There are currently rules for receiving antipsychotics treatment.
- Regardless of whether you take antidepressants or not.
- Can communicate clearly in Mandarin and Taiwanese.
Key exclusion criteria (7 listed)
- According to DSM-5 criteria, suspected bipolar disorder, anxiety disorder, obsessive- compulsive disorder, cognitive impairment, substance use disorders, and other unthinking disorders are exclusion.
- Have been in or out of the acute ward within three months and currently have suicidal attempts or violence.
- Those who are receiving individual or group cognitive behavior therapy.
- People with intellectual disabilities.
- Those who are unable to conduct research due to visual or hearing impairment.
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 |
|---|---|---|
| group cognitive stimulation therapyAlso: GCSTThe experimental group will receive totally 7 weeks,14 sessions, twice a week, and 60 minute group cognitive stimulation therapy (GCST). | Other | Exploring the effectiveness of GCST in people with schizophrenia. |
| usual careThe control group maintains the unit routine treatment. | Other | Exploring the effectiveness of GCST in people with schizophrenia. |
Primary outcome
Montreal Cognitive Assessment, MoCA
Time frame: baseline
Cognitive function test
Taiwanese Version of Frontal Assessment Battery, TFAB
Time frame: baseline
Cognitive function test
Wechsler Memory Scale-Third Edition, WMS-III
Time frame: baseline
Cognitive function test
3 secondary outcomes
Beck Depression Inventory II, BDI-II
Time frame: baseline
Social Function Scales-Taiwanese version, SFST
Time frame: baseline
WHOQOL-BREF
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Chiu-Yueh Yang, PhD principal investigator
National Yang-Ming Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group cognitive stimulation therapy in people with Cognitive Therapy, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 Jun 2021. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-Chi Chang, MSN (886-3-211-8999 ext. 3317, ccchang@mail.cgust.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment, MoCA (time frame: baseline). The study lists 3 primary outcomes in all. 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 7 Jun 2021.