- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04916483
Exploring the Effectiveness of Group Cognitive Stimulation Therapy in People With Schizophrenia.
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.
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Chia-Chi Chang, MSN
- Telefonnummer: 3317 886-3-211-8999
- E-mail: ccchang@mail.cgust.edu.tw
Undersøgelse Kontakt Backup
- Navn: Chiu-Yueh Yang, PhD
- Telefonnummer: 7388 886-2-2826
- E-mail: cyyang3@ym.edu.tw
Studiesteder
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Taipei City, Taiwan
- Rekruttering
- National Yang-Ming Jiaotong University
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Kontakt:
- Yang Chiu Yueh, PhD
- Telefonnummer: 02-28267388
- E-mail: cyyang3@ym.edu.tw
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Exploring the effectiveness of GCST in people with schizophrenia.
The experimental group will receive a total of 14 sessions, twice a week group cognitive stimulation therapy for 7 weeks.
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The experimental group will receive totally 7 weeks,14 sessions, twice a week, and 60 minute group cognitive stimulation therapy (GCST).
Andre navne:
The control group maintains the unit routine treatment.
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Ingen indgriben: Control group
The control group maintains the usual care.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Montreal Cognitive Assessment, MoCA
Tidsramme: baseline
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Cognitive function test
|
baseline
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Taiwanese Version of Frontal Assessment Battery, TFAB
Tidsramme: baseline
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Cognitive function test
|
baseline
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Wechsler Memory Scale-Third Edition, WMS-III
Tidsramme: baseline
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Cognitive function test
|
baseline
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Beck Depression Inventory II, BDI-II
Tidsramme: baseline
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Depressive symptoms test
|
baseline
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Social Function Scales-Taiwanese version, SFST
Tidsramme: baseline
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Social Function test
|
baseline
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WHOQOL-BREF
Tidsramme: baseline
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quality of life test
|
baseline
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Montreal Cognitive Assessment, MoCA
Tidsramme: 7th weeks
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Cognitive function test
|
7th weeks
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Taiwanese Version of Frontal Assessment Battery, TFAB
Tidsramme: 7th weeks
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Cognitive function test
|
7th weeks
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Wechsler Memory Scale-Third Edition, WMS-III
Tidsramme: 7th weeks
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Cognitive function test
|
7th weeks
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Beck Depression Inventory II, BDI-II
Tidsramme: 7th weeks
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Depressive symptoms test
|
7th weeks
|
Social Function Scales-Taiwanese version, SFST
Tidsramme: 7th weeks
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Social Function test
|
7th weeks
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WHOQOL-BREF
Tidsramme: 7th weeks
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quality of life test
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7th weeks
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Montreal Cognitive Assessment, MoCA
Tidsramme: 20th week
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Cognitive function test
|
20th week
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Taiwanese Version of Frontal Assessment Battery, TFAB
Tidsramme: 20th week
|
Cognitive function test
|
20th week
|
Wechsler Memory Scale-Third Edition, WMS-III
Tidsramme: 20th week
|
Wechsler Memory Scale-Third Edition, WMS-III
|
20th week
|
Beck Depression Inventory II, BDI-II
Tidsramme: 20th week
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Depressive symptoms test
|
20th week
|
Social Function Scales-Taiwanese version, SFST
Tidsramme: 20th week
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Social Function test
|
20th week
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WHOQOL-BREF
Tidsramme: 20th week
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quality of life test
|
20th week
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Chiu-Yueh Yang, PhD, National Yang-Ming Jiaotong University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB1081209-04
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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