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

Primary Purpose

Cognitive Therapy

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
group cognitive stimulation therapy
usual care
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Therapy focused on measuring cognitive stimulation therapy, depressive symptoms, schizophrenia, social function, quality of life

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Yang-Ming Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exploring the effectiveness of GCST in people with schizophrenia.

Control group

Arm Description

The experimental group will receive a total of 14 sessions, twice a week group cognitive stimulation therapy for 7 weeks.

The control group maintains the usual care.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 9, 2020
Last Updated
June 1, 2021
Sponsor
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT04916483
Brief Title
Exploring the Effectiveness of Group Cognitive Stimulation Therapy in People With Schizophrenia.
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Therapy
Keywords
cognitive stimulation therapy, depressive symptoms, schizophrenia, social function, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were divided into experimental group and control group through block randomization
Masking
Care ProviderOutcomes Assessor
Masking Description
The questionnaire is distributed and applied by another researcher (non-investigator)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exploring the effectiveness of GCST in people with schizophrenia.
Arm Type
Experimental
Arm Description
The experimental group will receive a total of 14 sessions, twice a week group cognitive stimulation therapy for 7 weeks.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group maintains the usual care.
Intervention Type
Other
Intervention Name(s)
group cognitive stimulation therapy
Other Intervention Name(s)
GCST
Intervention Description
The experimental group will receive totally 7 weeks,14 sessions, twice a week, and 60 minute group cognitive stimulation therapy (GCST).
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
The control group maintains the unit routine treatment.
Primary Outcome Measure Information:
Title
Montreal Cognitive Assessment, MoCA
Description
Cognitive function test
Time Frame
baseline
Title
Taiwanese Version of Frontal Assessment Battery, TFAB
Description
Cognitive function test
Time Frame
baseline
Title
Wechsler Memory Scale-Third Edition, WMS-III
Description
Cognitive function test
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Beck Depression Inventory II, BDI-II
Description
Depressive symptoms test
Time Frame
baseline
Title
Social Function Scales-Taiwanese version, SFST
Description
Social Function test
Time Frame
baseline
Title
WHOQOL-BREF
Description
quality of life test
Time Frame
baseline
Other Pre-specified Outcome Measures:
Title
Montreal Cognitive Assessment, MoCA
Description
Cognitive function test
Time Frame
7th weeks
Title
Taiwanese Version of Frontal Assessment Battery, TFAB
Description
Cognitive function test
Time Frame
7th weeks
Title
Wechsler Memory Scale-Third Edition, WMS-III
Description
Cognitive function test
Time Frame
7th weeks
Title
Beck Depression Inventory II, BDI-II
Description
Depressive symptoms test
Time Frame
7th weeks
Title
Social Function Scales-Taiwanese version, SFST
Description
Social Function test
Time Frame
7th weeks
Title
WHOQOL-BREF
Description
quality of life test
Time Frame
7th weeks
Title
Montreal Cognitive Assessment, MoCA
Description
Cognitive function test
Time Frame
20th week
Title
Taiwanese Version of Frontal Assessment Battery, TFAB
Description
Cognitive function test
Time Frame
20th week
Title
Wechsler Memory Scale-Third Edition, WMS-III
Description
Wechsler Memory Scale-Third Edition, WMS-III
Time Frame
20th week
Title
Beck Depression Inventory II, BDI-II
Description
Depressive symptoms test
Time Frame
20th week
Title
Social Function Scales-Taiwanese version, SFST
Description
Social Function test
Time Frame
20th week
Title
WHOQOL-BREF
Description
quality of life test
Time Frame
20th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chia-Chi Chang, MSN
Phone
886-3-211-8999
Ext
3317
Email
ccchang@mail.cgust.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Chiu-Yueh Yang, PhD
Phone
886-2-2826
Ext
7388
Email
cyyang3@ym.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiu-Yueh Yang, PhD
Organizational Affiliation
National Yang-Ming Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Yang-Ming Jiaotong University
City
Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Chiu Yueh, PhD
Phone
02-28267388
Email
cyyang3@ym.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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