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【ChiCTR2200061863】Effects of mindfulness-based cognitive therapy for adults with post-traumatic stress disorder symptoms in primary care: a randomised controlled trial

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基本信息

登记号

ChiCTR2200061863

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2022-07-05

临床申请受理号

靶点

适应症

Post-traumatic stress disorder symptoms

试验通俗题目

Effects of mindfulness-based cognitive therapy for adults with post-traumatic stress disorder symptoms in primary care: a randomised controlled trial

试验专业题目

Effects of mindfulness-based cognitive therapy for adults with post-traumatic stress disorder symptoms in primary care: a randomised controlled trial

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临床试验信息

试验目的

1. To evaluate the effectiveness of mindfulness-based cognitive therapy in reducing PTSD symptoms among adults when compared to a psychoeducation group. 2. To evaluate the effectiveness of mindfulness-based cognitive therapy in reducing depressive and anxiety symptoms among adults with PTSD symptoms when compared to a psychoeducation group. 3. To explore whether improved attentional control, reduced avoidance and reduced ruminative thoughts are potential mediators of the intervention and outcomes for PTSD symptoms among adults in Hong Kong.

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试验类型

病例对照研究

试验分期

Ⅰ期

随机化

The method of sampling will be a stratified randomization based on gender and psychiatric medication use to achieve demographic balance between the two arms. The randomisation sequence will be generated by an experienced independent statistician using computer-generated random results.

盲法

Not stated

试验项目经费来源

General Research Fund

试验范围

目标入组人数

实际入组人数

第一例入组时间

2021-03-11

试验终止时间

2025-06-13

是否属于一致性

入选标准

1. Aged 18 years or above; 2. Score 33 or above in the Post-traumatic Stress Disorder Checklist (PCL-5) of the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition, which is the cut-off score used in previous research to indicate significant PTSD symptoms 44; 3. Presence of PTSD symptoms for more than 1 month; 4. If taking psychiatric medications, must have been on a stable dosage for at least three months.；

排除标准

1. Inability to communicate and understand Chinese; 2. Possession of physical illness with moderate to severe disability or mental illness (e.g., suicidal ideation, schizophrenia, psychosis, and substance abuse); 3. Previous participation in a structured mindfulness-based training programme.；

研究者信息

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试验机构

香港中文大學

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