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Status unknownNCT04916483Updated Jun 7, 2021

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

An interventional study of group cognitive stimulation therapy and usual care in Cognitive Therapy, sponsored by National Yang Ming Chiao Tung University. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-06-07.

Sponsored by National Yang Ming Chiao Tung University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Cognitive Therapy

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Keywords

  • cognitive stimulation therapy
  • depressive symptoms
  • schizophrenia
  • social function
  • quality of life
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's planned enrollment of 90 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

National Yang Ming Chiao Tung University is the lead sponsor of 201 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    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.

    Other: group cognitive stimulation therapy · Other: usual care

  • No intervention
    Control group

    The control group maintains the usual care.

Interventions

  • Othergroup cognitive stimulation therapy

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

    Also known as: GCST

  • Otherusual care

    The control group maintains the unit routine treatment.

06

What researchers measure

Primary outcomes

  1. Montreal Cognitive Assessment, MoCA

    Cognitive function test

    Time frame: baseline

  2. Taiwanese Version of Frontal Assessment Battery, TFAB

    Cognitive function test

    Time frame: baseline

  3. Wechsler Memory Scale-Third Edition, WMS-III

    Cognitive function test

    Time frame: baseline

Secondary outcomes

  1. Beck Depression Inventory II, BDI-II

    Depressive symptoms test

    Time frame: baseline

  2. Social Function Scales-Taiwanese version, SFST

    Social Function test

    Time frame: baseline

  3. WHOQOL-BREF

    quality of life test

    Time frame: baseline

Other outcomes

  1. Montreal Cognitive Assessment, MoCA

    Cognitive function test

    Time frame: 7th weeks

  2. Taiwanese Version of Frontal Assessment Battery, TFAB

    Cognitive function test

    Time frame: 7th weeks

  3. Wechsler Memory Scale-Third Edition, WMS-III

    Cognitive function test

    Time frame: 7th weeks

  4. Beck Depression Inventory II, BDI-II

    Depressive symptoms test

    Time frame: 7th weeks

  5. Social Function Scales-Taiwanese version, SFST

    Social Function test

    Time frame: 7th weeks

  6. WHOQOL-BREF

    quality of life test

    Time frame: 7th weeks

  7. Montreal Cognitive Assessment, MoCA

    Cognitive function test

    Time frame: 20th week

  8. Taiwanese Version of Frontal Assessment Battery, TFAB

    Cognitive function test

    Time frame: 20th week

  9. Wechsler Memory Scale-Third Edition, WMS-III

    Wechsler Memory Scale-Third Edition, WMS-III

    Time frame: 20th week

  10. Beck Depression Inventory II, BDI-II

    Depressive symptoms test

    Time frame: 20th week

  11. Social Function Scales-Taiwanese version, SFST

    Social Function test

    Time frame: 20th week

  12. WHOQOL-BREF

    quality of life test

    Time frame: 20th week

07

Study locations

1 of 1 sites recruiting
  • National Yang-Ming Jiaotong University
    Taipei City, Taiwan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04916483
Lead sponsor
National Yang Ming Chiao Tung University
Responsible party
Chiu-Yueh Yang (Professor, National Yang Ming Chiao Tung University) — Principal investigator
First posted
Jun 7, 2021
Start date
Jan 15, 2021
Primary completion
Aug 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Jun 7, 2021

Study contacts

Chia-Chi Chang, MSN
Contact
ccchang@mail.cgust.edu.tw
886-3-211-8999 ext. 3317
Chiu-Yueh Yang, PhD
Contact
cyyang3@ym.edu.tw
886-2-2826 ext. 7388
Chiu-Yueh Yang, PhD
principal investigator · National Yang-Ming Jiaotong University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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