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

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基本信息

登记号

ChiCTR2200062460

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2022-08-08

临床申请受理号

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

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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

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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

目标入组人数

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

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试验机构

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

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