SchizophreniaNCT07051746
Effectiveness of Traditional Chinese Metacognitive Training (MCT) in Patients With Schizophrenia, Depression, or Bipolar Disorder Attending a Psychiatric Day Hospital in Taiwan
A study testing Metacognitive Training (MCT), Traditional Chinese version in people with Schizophrenia and Major Depressive Disorder, run by ZI-YU LIN at 1 site in Taiwan.
Trial summary
Schizophrenia is characterized by positive symptoms such as delusions and hallucinations, which significantly impact daily functioning. While antipsychotics are the primary treatment, many patients exhibit resistance or intolerance. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Schizophrenia, Major Depressive Disorder, Bipolar Disorder
- What is being tested?
- Metacognitive Training (MCT), Traditional Chinese version
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Oct 2025to 26 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 75 years.
- Diagnosed with schizophrenia, major depressive disorder, or bipolar disorder based on DSM-5 criteria by a psychiatrist.
- Currently enrolled in a psychiatric day hospital.
- Judged by an occupational therapist as capable of understanding written/spoken Mandarin and completing Chinese-language questionnaires.
- No changes in psychiatric medication within the past month.
Who cannot join
- History of severe hearing or visual impairments.
- Severe psychiatric symptoms or attention deficits that would prevent full participation in a 60-minute session, as judged by the therapist.
- Presence of inappropriate social behaviors such as aggression, sexual harassment, or antisocial behavior.
- Ongoing major life crises or recent traumatic events.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital, Department of Psychiatry, General Psychiatry Day Hospital
Taipei, Taiwan Province, 100
About this study
Official title: Effectiveness of Metacognitive Training on Symptoms and Cognitive Biases in Taiwanese Individuals With Mental Disorders: A One-Group Pretest-Posttest Study
Schizophrenia is characterized by positive symptoms such as delusions and hallucinations, which significantly impact daily functioning. While antipsychotics are the primary treatment, many patients exhibit resistance or intolerance. Metacognitive Training (MCT) has shown promise in addressing cognitive biases related to positive symptoms, offering potential benefits as an adjunct to pharmacological treatment. Additionally, cognitive biases are prevalent in other psychiatric disorders, such as bipolar disorder and major depression, and are closely related to the onset and persistence of emotional symptoms. Preliminary studies have supported the effectiveness of MCT in reducing depressive symptoms and related biases. However, its effects in Taiwan remain unexplored. Therefore, this study aims to examine the effectiveness of the Traditional Chinese version of MCT for individuals with schizophrenia in Taiwan.
This study adopts a one-group pretest-posttest design, recruiting 26 participants to undergo an 8-session MCT group intervention over four weeks. Assessments include the Chinese versions of the Psychotic Symptom Rating Scales (C-PSYRATS), the Traditional Chinese version of the PROMIS Depression and Anxiety Short Forms (4a v1.0), the Modified Davos Assessment of Cognitive Biases Scale (MCL-DACOBS), the Self-reported Graphic Personal and Social Performance Scale (SRG-PSP), Self-Reported Activities of Daily Living Scale, third version (sf-ADLS), and Neuro-QoL Item Bank v2.0 - Cognitive Function- Short Form. Participant satisfaction is also collected. Statistical analyses will utilize non-parametric Wilcoxon Signed-Rank Test and Cohen's d for effect size calculations.
Despite limitations such as a single-group design and recruitment from one hospital, this study is the first to examine MCT's applicability in Taiwanese clinical settings. Expected outcomes include improvements in positive symptoms, depressive and anxiety symptoms, cognitive biases, cognitive functioning, daily living skills, and social functioning. Future research should validate these findings through randomized controlled trials across multiple sites.
- Conditions
- Schizophrenia, Major Depressive Disorder, Bipolar Disorder
- Being tested
- Metacognitive Training (MCT), Traditional Chinese version
- Medical subject headings
- Schizophrenia, Depressive Disorder, Major, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive Training (MCT), Traditional Chinese versionBehavioural
The intervention is a culturally adapted version of Metacognitive Training (MCT) for psychiatric populations in Taiwan. The program consists of 8 group sessions over 4 weeks. Each session includes psychoeducation, cognitive exercises, and group discussion to help participants recognize and reduce cognitive biases.
| Study group | Role | What they receive |
|---|---|---|
| Metacognitive Training Group | Experimental | Participants in this arm will receive group-based Metacognitive Training (MCT), the Traditional Chinese version adapted for the Taiwanese population. The intervention consists of 8 sessions delivered twice weekly over 4 weeks. Each session focuses on cognitive biases commonly associated with psychotic and affective disorders, including jumping to conclusions, attribution biases, and social cognitive deficits, etc. Receives: Behavioral: Metacognitive Training (MCT), Traditional Chinese version |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PROMIS Depression 4a T-score
PROMIS Depression 4a v1.0 (Traditional Chinese version) is a 4-item patient-reported outcome scale. Items are rated 1-5 and converted into T-scores; higher T-scores indicate greater depression severity.
Measured: Baseline and Week 5 (within 1 week after completing the final MCT session)
Change in C-PSYRATS Total Score
The Chinese version of the Psychotic Symptom Rating Scales (C-PSYRATS) includes 17 items measuring severity of delusions and auditory hallucinations. Each item is rated 0-4, with higher scores indicating more severe symptoms.
Measured: Baseline and Week 5 (within 1 week after completing the final MCT session)
Change in PROMIS Anxiety 4a T-score
PROMIS Anxiety 4a v1.0 (Traditional Chinese version) is a 4-item patient-reported scale. Items are rated 1-5 and converted into T-scores; higher T-scores reflect higher anxiety severity.
Measured: Baseline and Week 5 (within 1 week after completing the final MCT session)
Change in MCL-DACOBS Total Score
The Modified Chinese version of the Davos Assessment of Cognitive Biases Scale (MCL-DACOBS) includes 42 items across cognitive biases, limitations, and avoidance. Each item is rated on a 7-point scale; higher scores indicate greater cognitive distortions.
Measured: Baseline and Week 5 (within 1 week after completing the final MCT session)
Secondary outcomes (4)
Change in Neuro-QoL Cognitive Function Short Form Score
The Neuro-QoL Cognitive Function Short Form (Traditional Chinese version) contains 8 self-report items. Each is rated on a 1-5 scale, with higher scores indicating better perceived cognitive function.
Measured: Baseline and Week 5 (within 1 week after completing the final MCT session)
Change in SRG-PSP Total Score
The Self-Reported Graphic version of the Personal and Social Performance Scale (SRG-PSP) assesses role performance, interpersonal relationships, self-care, and disruptive behaviors. Each domain is rated 1-3; higher scores in most domains reflect better function.
Measured: Baseline and Week 5 (within 1 week after completing the final MCT session)
Change in sf-ADLS Total Score
The Self-Reported Activities of Daily Living Scale, 3rd edition (sf-ADLS), includes 14 items rated 1-3. Higher total scores indicate greater independence in daily life.
Measured: Baseline and Week 5 (within 1 week after completing the final MCT session)
Participant Satisfaction with Metacognitive Training (MCT) Program
A 4-item self-reported questionnaire developed by the investigator to assess participants' satisfaction with the MCT program. Each item is rated on a 4-point scale: 1 = Very Dissatisfied, 2 = Dissatisfied, 3 = Satisfied, 4 = Very Satisfied. The questionnaire evaluates perceived helpfulness, understanding, utility, and overall satisfaction. Higher scores indicate greater satisfaction.
Measured: Week 5 (within 1 week after completing the final MCT session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start3 Oct 2025
- Primary completion19 Nov 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZI-YU LIN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ZI-YU LIN, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051746
- Sponsor's protocol ID
- 202506037RIN
- Status last verified
- Dec 2025
- First submitted
- 26 Jun 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Metacognitive Training on Symptoms and Cognitive Biases in Taiwanese Individuals With Mental Disorders: A One-Group Pretest-Posttest Study
- ClinicalTrials.gov ID
- NCT07051746
- Acronym / sponsor ID
- 202506037RIN
- Conditions
- Schizophrenia, Major Depressive Disorder, Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- ZI-YU LINUniversity, hospital or other
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Schizophrenia is characterized by positive symptoms such as delusions and hallucinations, which significantly impact daily functioning. While antipsychotics are the primary treatment, many patients exhibit resistance or intolerance. Metacognitive Training (MCT) has shown promise in addressing cognitive biases related to positive symptoms, offering potential benefits as an adjunct to pharmacological treatment. Additionally, cognitive biases are prevalent in other psychiatric disorders, such as bipolar disorder and major depression, and are closely related to the onset and persistence of emotional symptoms. Preliminary studies have supported the effectiveness of MCT in reducing depressive symptoms and related biases. However, its effects in Taiwan remain unexplored. Therefore, this study aims to examine the effectiveness of the Traditional Chinese version of MCT for individuals with schizophrenia in Taiwan.
This study adopts a one-group pretest-posttest design, recruiting 26 participants to undergo an 8-session MCT group intervention over four weeks. Assessments include the Chinese versions of the Psychotic Symptom Rating Scales (C-PSYRATS), the Traditional Chinese version of the PROMIS Depression and Anxiety Short Forms (4a v1.0), the Modified Davos Assessment of Cognitive Biases Scale (MCL-DACOBS), the Self-reported Graphic Personal and Social Performance Scale (SRG-PSP), Self-Reported Activities of Daily Living Scale, third version (sf-ADLS), and Neuro-QoL Item Bank v2.0 - Cognitive Function- Short Form. Participant satisfaction is also collected. Statistical analyses will utilize non-parametric Wilcoxon Signed-Rank Test and Cohen's d for effect size calculations.
Despite limitations such as a single-group design and recruitment from one hospital, this study is the first to examine MCT's applicability in Taiwanese clinical settings. Expected outcomes include improvements in positive symptoms, depressive and anxiety symptoms, cognitive biases, cognitive functioning, daily living skills, and social functioning. Future research should validate these findings through randomized controlled trials across multiple sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metacognitive Training Group | Experimental | Behavioral: Metacognitive Training (MCT), Traditional Chinese versionParticipants in this arm will receive group-based Metacognitive Training (MCT), the Traditional Chinese version adapted for the Taiwanese population. The intervention consists of 8 sessions delivered twice weekly over 4 weeks. Each session focuses on cognitive biases commonly associated with psychotic and affective disorders, including jumping to conclusions, attribution biases, and social cognitive deficits, etc. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 75 years.
- Diagnosed with schizophrenia, major depressive disorder, or bipolar disorder based on DSM-5 criteria by a psychiatrist.
- Currently enrolled in a psychiatric day hospital.
- Judged by an occupational therapist as capable of understanding written/spoken Mandarin and completing Chinese-language questionnaires.
- No changes in psychiatric medication within the past month.
Key exclusion criteria (4 listed)
- History of severe hearing or visual impairments.
- Severe psychiatric symptoms or attention deficits that would prevent full participation in a 60-minute session, as judged by the therapist.
- Presence of inappropriate social behaviors such as aggression, sexual harassment, or antisocial behavior.
- Ongoing major life crises or recent traumatic events.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive Training (MCT), Traditional Chinese versionThe intervention is a culturally adapted version of Metacognitive Training (MCT) for psychiatric populations in Taiwan. The program consists of 8 group sessions over 4 weeks. Each session includes psychoeducation, cognitive exercises, and group discussion to help participants recognize and reduce cognitive biases. | Behavioural | Metacognitive Training Group |
Primary outcome
Change in PROMIS Depression 4a T-score
Time frame: Baseline and Week 5 (within 1 week after completing the final MCT session)
PROMIS Depression 4a v1.0 (Traditional Chinese version) is a 4-item patient-reported outcome scale. Items are rated 1-5 and converted into T-scores; higher T-scores indicate greater depression severity.
Change in C-PSYRATS Total Score
Time frame: Baseline and Week 5 (within 1 week after completing the final MCT session)
The Chinese version of the Psychotic Symptom Rating Scales (C-PSYRATS) includes 17 items measuring severity of delusions and auditory hallucinations. Each item is rated 0-4, with higher scores indicating more severe symptoms.
Change in PROMIS Anxiety 4a T-score
Time frame: Baseline and Week 5 (within 1 week after completing the final MCT session)
PROMIS Anxiety 4a v1.0 (Traditional Chinese version) is a 4-item patient-reported scale. Items are rated 1-5 and converted into T-scores; higher T-scores reflect higher anxiety severity.
Change in MCL-DACOBS Total Score
Time frame: Baseline and Week 5 (within 1 week after completing the final MCT session)
The Modified Chinese version of the Davos Assessment of Cognitive Biases Scale (MCL-DACOBS) includes 42 items across cognitive biases, limitations, and avoidance. Each item is rated on a 7-point scale; higher scores indicate greater cognitive distortions.
4 secondary outcomes
Change in Neuro-QoL Cognitive Function Short Form Score
Time frame: Baseline and Week 5 (within 1 week after completing the final MCT session)
Change in SRG-PSP Total Score
Time frame: Baseline and Week 5 (within 1 week after completing the final MCT session)
Change in sf-ADLS Total Score
Time frame: Baseline and Week 5 (within 1 week after completing the final MCT session)
Participant Satisfaction with Metacognitive Training (MCT) Program
Time frame: Week 5 (within 1 week after completing the final MCT session)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
Schizophrenia Spectrum Disorders, Psychotic Affective Disorders
RecruitingObservational study
Tau Biomarkers in Late-onset Psychosis (LOP)
Late Onset Schizophrenia, Delusional Disorder (Late Onset)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Training (MCT), Traditional Chinese version in people with Schizophrenia and Major Depressive Disorder, run by ZI-YU LIN at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PROMIS Depression 4a T-score (time frame: Baseline and Week 5 (within 1 week after completing the final MCT session)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.