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    【ChiCTR-TRC-12002623】HealthyLiving – an Internet-based mental health program

    基本信息
    登记号

    ChiCTR-TRC-12002623

    试验状态

    尚未开始

    药物名称

    /

    药物类型

    /

    规范名称

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    首次公示信息日的期

    2012-10-26

    临床申请受理号

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    靶点

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    适应症

    Mental health

    试验通俗题目

    HealthyLiving – an Internet-based mental health program

    试验专业题目

    Internet-based mindfulness programme for the promotion of public mental health: Randomised 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

    Mindfuliving, a mindfulness program The program teaches participants to cultivate mindfulness (paying attention nonjudgmentally to the present moment) by using various exercises that are adapted from the Mindfulness-based Stress Reduction Program (MBSR), and Mindfulness-based Cognitive Therapy (MBCT) for 8 weeks; comparative treatments: Wiseliving, a psychoeducation program The program focuses on enhancing mental health literacy through the provision of basic facts and information about mental health. Contents of this program are based on MacDonald and O’Hara’s ‘10 elements of mental health promotion and demotion’, which is adopted by the UK and Victorian government as a reference for formulating mental health policies. The primary outcomes: Well-being: The WHO 5-item Well-Being Index (WBI) will be used to measure overall psychological well-being at pre-test, each week before browsing the program, post-test and 3-month follow-up. Besides, the following aspects will be assessed at pre-test, post-test and 3-month follow-up. Mental health: Participants will complete the 18-item Mental Health Inventory (MHI) to assess their mental health. Domains of mental health measured include anxiety, depression, behavioural control and positive affect. Life satisfaction: Life satisfaction will be assessed by the 5-item Satisfaction with Life Scale (LS). Pain: Average level of pain will be measured by the Visual Analogue Scale-Pain (VAS-P). Participants are asked to rate their average daily pain on a line from 0 (no pain) to 100 (very severe pain). Energy: Average level of energy will be measured by VAS-Energy (VAS-E). Participants are asked to rate their average daily energy level on a 100mm long line from 0 (no energy) to 100 (a lot of energy). Sleep: The 4-item sleep disturbance subscale of the Medical Outcomes Study Sleep Measure (MOS-Sleep) will be used to assess how well participants sleep without tapping into other sleep-related medical conditions. The secondary outcomes: Mindfulness: The shortened 20-item version of Five Facets Mindfulness Questionnaire (FFMQ) is administered in the study to examine the changes in the mindfulness. It will be measured at pre-test, week 3, week 5, week 7 of the program, post-test and 3-month follow-up. General self-efficacy: The 10-item General Self-efficacy Scale (GSES) will be used to measure participants’ perceived self-efficacy to cope with stressful situations or problems. It will be measured at pre-test, week 3, week 5, week 7 of the program. Users’ expected creditability of the program: At pre-test, the participants will be asked to complete the 6-item Credibility/Expectancy Questionnaire (CEQ), which aims to examine if expectancies or perception of treatment credibility are related to outcomes. Users’ satisfaction: The 8-item Client Satisfaction Questionnaire (CSQ) will be used to measure participants’ attitude towards and satisfaction with the internet-based interventions at post-test.

    试验分类
    试验类型

    随机平行对照

    试验分期

    Ⅳ期

    随机化

    Random

    盲法

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    试验项目经费来源

    Health and Health Services Research Fund, Food and Health Bureau, HKSAR Government

    试验范围

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    目标入组人数

    63

    实际入组人数

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    第一例入组时间

    2014-12-01

    试验终止时间

    2014-03-01

    是否属于一致性

    /

    入选标准

    (1) At least 18 of age; (2) Read and understand Chinese; (3) Computer literate; (4) Have consistent access to the internet.；

    排除标准

    (1) Severe to extremely severe depression or anxiety scores on the DASS-21 based on the cut-off scores recommended by the DASS21; (2) Scoring 1-3 on items 16, 21 or 28 of Mental Health Inventory (MHI-38) indicating possible suicidal ideation; (3) Currently receiving professional mental health services; (4) Currently taking psychotropic medication.；

    研究者信息
    研究负责人姓名
    试验机构

    Prof. Winnie Wing Sze MAK, Department of Psychology, 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

    Prof. Winnie Wing Sze MAK, Department of Psychology, The Chinese University of Hong Kong的其他临床试验

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    The Chinese University of Hong Kong的其他临床试验

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