Effectiveness of Metacognitive Training on Symptoms and Cognitive Biases in Taiwanese Individuals With Mental Disorders: A One-Group Pretest-Posttest Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in PROMIS Depression 4a T-score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Metacognitive Training Group
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.
干预措施: Metacognitive Training (MCT), Traditional Chinese version (Behavioral)
结局指标
主要结局
Change in PROMIS Depression 4a T-score
时间窗: 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
时间窗: 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 MCL-DACOBS Total Score
时间窗: 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.
Change in PROMIS Anxiety 4a T-score
时间窗: 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.
次要结局
- Change in Neuro-QoL Cognitive Function Short Form 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))
- 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))
研究者
ZI-YU LIN
Principal Investigator
National Taiwan University