Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Exploring the Effectiveness of Group Cognitive Stimulation Therapy in People With Schizophrenia.

1. juni 2021 opdateret af: Chiu-Yueh Yang, National Yang Ming University

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

Rekruttering

Betingelser

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

Interventionel

Tilmelding (Forventet)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

      • Taipei City, Taiwan
        • Rekruttering
        • National Yang-Ming Jiaotong University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. People who according the DSM-5 diagnosis of schizophrenia spectrum and have been sick for more than two years.
  2. Age between 20 and 65 years old.
  3. There are currently rules for receiving antipsychotics treatment.
  4. Regardless of whether you take antidepressants or not.
  5. Can communicate clearly in Mandarin and Taiwanese.
  6. Those with a score of 10-25 on the Montreal Cognitive Assessment Scale (MoCA).
  7. Those who are willing to participate in this study and complete the subject consent form.

Exclusion Criteria:

  1. According to DSM-5 criteria, suspected bipolar disorder, anxiety disorder, obsessive- compulsive disorder, cognitive impairment, substance use disorders, and other unthinking disorders are exclusion.
  2. Have been in or out of the acute ward within three months and currently have suicidal attempts or violence.
  3. Those who are receiving individual or group cognitive behavior therapy.
  4. People with intellectual disabilities.
  5. Those who are unable to conduct research due to visual or hearing impairment.
  6. People who are accepting other clinical trials.
  7. Those who have no intention to participate in this study or are unable to complete the subject's consent form.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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.
The experimental group will receive totally 7 weeks,14 sessions, twice a week, and 60 minute group cognitive stimulation therapy (GCST).
Andre navne:
  • GCST
The control group maintains the unit routine treatment.
Ingen indgriben: Control group
The control group maintains the usual care.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Montreal Cognitive Assessment, MoCA
Tidsramme: baseline
Cognitive function test
baseline
Taiwanese Version of Frontal Assessment Battery, TFAB
Tidsramme: baseline
Cognitive function test
baseline
Wechsler Memory Scale-Third Edition, WMS-III
Tidsramme: baseline
Cognitive function test
baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Beck Depression Inventory II, BDI-II
Tidsramme: baseline
Depressive symptoms test
baseline
Social Function Scales-Taiwanese version, SFST
Tidsramme: baseline
Social Function test
baseline
WHOQOL-BREF
Tidsramme: baseline
quality of life test
baseline

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Montreal Cognitive Assessment, MoCA
Tidsramme: 7th weeks
Cognitive function test
7th weeks
Taiwanese Version of Frontal Assessment Battery, TFAB
Tidsramme: 7th weeks
Cognitive function test
7th weeks
Wechsler Memory Scale-Third Edition, WMS-III
Tidsramme: 7th weeks
Cognitive function test
7th weeks
Beck Depression Inventory II, BDI-II
Tidsramme: 7th weeks
Depressive symptoms test
7th weeks
Social Function Scales-Taiwanese version, SFST
Tidsramme: 7th weeks
Social Function test
7th weeks
WHOQOL-BREF
Tidsramme: 7th weeks
quality of life test
7th weeks
Montreal Cognitive Assessment, MoCA
Tidsramme: 20th week
Cognitive function test
20th week
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
Depressive symptoms test
20th week
Social Function Scales-Taiwanese version, SFST
Tidsramme: 20th week
Social Function test
20th week
WHOQOL-BREF
Tidsramme: 20th week
quality of life test
20th week

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Chiu-Yueh Yang, PhD, National Yang-Ming Jiaotong University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. januar 2021

Primær færdiggørelse (Forventet)

31. august 2021

Studieafslutning (Forventet)

31. december 2021

Datoer for studieregistrering

Først indsendt

9. april 2020

Først indsendt, der opfyldte QC-kriterier

1. juni 2021

Først opslået (Faktiske)

7. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2021

Sidst verificeret

1. juni 2021

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kognitiv terapi

Kliniske forsøg med group cognitive stimulation therapy

3
Abonner