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    【ChiCTR2200062460】Online integrated mindfulness-meaning programme for depression and anxiety during COVID-19: A pilot randomized controlled trial

    基本信息
    登记号

    ChiCTR2200062460

    试验状态

    尚未开始

    药物名称

    /

    药物类型

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    规范名称

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    首次公示信息日的期

    2022-08-08

    临床申请受理号

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    靶点

    /

    适应症

    Mild-moderate depression and anxiety

    试验通俗题目

    Online integrated mindfulness-meaning programme for depression and anxiety during COVID-19: A pilot randomized controlled trial

    试验专业题目

    Online integrated mindfulness-meaning programme for depression and anxiety during COVID-19: A pilot randomized controlled trial

    申办单位信息
    申请人联系人
    申请人名称
    联系人邮箱
    联系人邮编

    联系人通讯地址
    临床试验信息
    试验目的

    The primary objective is to: 1. Evaluate the feasibility and acceptability of the online IMMP by measuring recruitment feasibility, intervention adherence, dropout, participants self-rated satisfaction/engagement/ perceived difficulty/helpfulness of the IMMP intervention, and adverse events. The secondary objectives are to provide: 2. Preliminary efficacy of IMMP on depression and anxiety, negative and positive affect, meaning in life, and mindfulness, to provide useful sample size calculation reference for future full RCTs. 3. Qualitative feedbacks on the IMMP for improvement.

    试验分类
    试验类型

    随机平行对照

    试验分期

    探索性研究/预试验

    随机化

    Stratified block randomization using a block of 8 will be applied to enhance the balance of age, gender, and depression/anxiety severity level between groups. The randomization procedure will be conducted by an independent statistician using computer program.

    盲法

    Due to the nature of the intervention, it is impossible to blind participants, but the investigators and persons who conduct the statistical analyses will be blinded to treatment allocation.

    试验项目经费来源

    Health and Medical Research Fund, Food and Health Bureau, HKSAR

    试验范围

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    目标入组人数

    40

    实际入组人数

    /

    第一例入组时间

    2022-08-26

    试验终止时间

    2023-07-25

    是否属于一致性

    /

    入选标准

    1) Adults aged 18 or above in Hong Kong; 2) With PHQ-9 and/or GAD-7 scores at 5-14 which suggested mild to moderate depression and/or anxiety levels; 3) No regular practice of mindfulness meditation; and 4) Willing to complete the 8 weekly online interventions.；

    排除标准

    1) Suicidal ideation, plans or behaviours, as they may need more intensive clinical care; 2) Cannot understand Chinese as the programmes will be conducted in Chinese; 3) No WhatsApp account as the intervention will be sent through WhatsApp - a popular instant messenger in Hong Kong; and 4) Other conditions rendering them incapable of following in the 8-week online interventions (e.g., vision and hearing problems).；

    研究者信息
    研究负责人姓名
    试验机构

    JC School of Public Health and Primary Care, The Chinese University of Hong Kong

    研究负责人电话
    研究负责人邮箱
    研究负责人邮编

    /

    联系人通讯地址

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