【ChiCTR2000032618】Treatment of generalized anxiety disorder: A randomized controlled trial of an internet self-help program with minimal non-therapist support

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基本信息

登记号

ChiCTR2000032618

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

2020-05-04

临床申请受理号

靶点

适应症

廣泛性焦慮障礙

试验通俗题目

Treatment of generalized anxiety disorder: A randomized controlled trial of an internet self-help program with minimal non-therapist support

试验专业题目

Treatment of generalized anxiety disorder: A randomized controlled trial of an internet self-help program with minimal non-therapist support

申办单位信息

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联系人邮编

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临床试验信息

试验目的

The current study aims to 1) evaluate an internet-based CBT self-help program with minimal non-therapist support for people suffering from generalized anxiety disorder, 2) to examine the acceptability and satisfaction of the internet-based CBT self-help program.

试验分类

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试验类型

随机平行对照

试验分期

Ⅰ期

随机化

after subject recruitment, screening clinician would obtained the participants randomization information by asking the research assistant the SPSS-generated random numbers to determine which group the participants would be randomized into, either the treatment or control group.

盲法

Both subjects and the PI will not be blinded to the assigned intervention. The outcome assessors are the subjects themselves, and therefore will also not be blinded. Data analyst will be blinded during data analysis.

试验项目经费来源

Nil, student study

试验范围

目标入组人数

实际入组人数

第一例入组时间

2020-04-28

试验终止时间

2020-12-31

是否属于一致性

入选标准

Participants would be recruited via 1) non-governmental organizations and community centers that serve clients with chronic mental conditions and 2) a website introducing the research. Subjects may apply online to join the research treatment program by following a link or be contacted via phone for subject recruitment. Potential subjects would be invited to complete the screening questionnaires PHQ-9 and GAD-7 and provide basic demographic details. Inclusion criteria include the following: - Passed cutoff scores of GAD7: > 10 - Age 18-65 years; - Can understand Cantonese; - Secondary 5 educated and can comprehend written Chinese; - is willing to complete internet-based self-help CBT-based program either immediately or 10 weeks after subject recruitment.；

排除标准

Subjects will be excluded if he / she meets the following criteria: - has no regular access to a computer and the internet; - has moderately severe to severe symptoms of depression (total score > 14 on PHQ-9); - is presented with active suicidal ideation (score of >2 for question 9 on PHQ-9); - is suffering from psychiatric or medical comorbidities that were potentially life-threatening (i.e. psychosis, suicidal ideations, terminal medical illnesses); - is presented with conditions that are expected to severely limit patients participation / adherence to treatment (such as psychosis, current substance misuse, dementia); - If psychotropic medications are taken for anxiety or other mood symptoms, participants should have been on stable doses for at least 2 months.；

研究者信息

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试验机构

Nil, student study

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