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

NCT ID: NCT04916483

Last Updated: 2021-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cognitive Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants were divided into experimental group and control group through block randomization
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
The questionnaire is distributed and applied by another researcher (non-investigator)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

group cognitive stimulation therapy

Intervention Type OTHER

The experimental group will receive totally 7 weeks,14 sessions, twice a week, and 60 minute group cognitive stimulation therapy (GCST).

usual care

Intervention Type OTHER

The control group maintains the unit routine treatment.

Control group

The control group maintains the usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

group cognitive stimulation therapy

The experimental group will receive totally 7 weeks,14 sessions, twice a week, and 60 minute group cognitive stimulation therapy (GCST).

Intervention Type OTHER

usual care

The control group maintains the unit routine treatment.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

GCST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Yang Ming Chiao Tung University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chiu-Yueh Yang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chiu-Yueh Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

National Yang-Ming Jiaotong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Yang-Ming Jiaotong University

Taipei, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chia-Chi Chang, MSN

Role: CONTACT

886-3-211-8999 ext. 3317

Chiu-Yueh Yang, PhD

Role: CONTACT

886-2-2826 ext. 7388

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yang Chiu Yueh, PhD

Role: primary

02-28267388

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB1081209-04

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Peer-led Psycho-education for Schizophrenia
NCT03246932 ACTIVE_NOT_RECRUITING NA