Effectiveness of Traditional Chinese Metacognitive Training (MCT) in Patients With Schizophrenia, Depression, or Bipolar Disorder Attending a Psychiatric Day Hospital in Taiwan

NCT07051746 | Completed

• 1 other identifier: 202506037RIN
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

  Baseline and Week 5 (within 1 week after completing the final MCT session)

• Change in SRG-PSP Total Score

  Baseline and Week 5 (within 1 week after completing the final MCT session)

• Change in sf-ADLS Total Score

  Baseline and Week 5 (within 1 week after completing the final MCT session)

• Participant Satisfaction with Metacognitive Training (MCT) Program

  Week 5 (within 1 week after completing the final MCT session)

Study Arms (1)

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.

Behavioral: Metacognitive Training (MCT), Traditional Chinese version

Interventions

Metacognitive Training (MCT), Traditional Chinese version BEHAVIORAL

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.

Metacognitive Training Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ZI-YU LIN: lead

Study Sites (1)

National Taiwan University Hospital, Department of Psychiatry, General Psychiatry Day Hospital

Taipei, Taiwan Province, 100, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia; Depressive Disorder, Major; Bipolar Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Depressive Disorder; Mood Disorders; Bipolar and Related Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: October 3, 2025
• Primary Completion: November 19, 2025
• Study Completion: November 26, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

TW (1)