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

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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

首次公示信息日的期

2012-10-26

临床申请受理号

靶点

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

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申请人名称

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联系人邮箱

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联系人邮编

联系人通讯地址

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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

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试验类型

随机平行对照

试验分期

Ⅳ期

随机化

Random

盲法

试验项目经费来源

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

试验范围

目标入组人数

实际入组人数

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

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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

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研究负责人邮编

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