Today is 2020-07-05

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

注册号:

Registration number:

ChiCTR2000032618 

最近更新日期:

Date of Last Refreshed on:

2020-05-04 

注册时间:

Date of Registration:

2020-05-04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

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

Public title:

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

注册题目简写:

 

English Acronym:

iCBT for GAD 

研究课题的正式科学名称:

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

Scientific title:

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

研究课题代号(代码):

Study subject ID:

2018.603 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

NG YIK YING 

研究负责人:

LEUNG WING LEUNG PATRICK 

Applicant:

NG YIK YING 

Study leader:

LEUNG WING LEUNG PATRICK 

申请注册联系人电话:

Applicant telephone:

+852 96724151 

研究负责人电话:

Study leader's telephone:

+852 39436502 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

+852 26035019 

申请注册联系人电子邮件:

Applicant E-mail:

nyy229@ha.org.hk 

研究负责人电子邮件:

Study leader's E-mail:

pleung@cuhk.edu.hk 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

Dept of CP, IRS, Tseung Kwan O Hospital, Hong Kong SAR, China 

研究负责人通讯地址:

Rm 356, Sino Building, The Chinese University of Hong Kong, Hong Kong SAR, China 

Applicant address:

Dept of CP, IRS, Tseung Kwan O Hospital, Hong Kong SAR, China 

Study leader's address:

Rm 356, Sino Building, The Chinese University of Hong Kong, Hong Kong SAR, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

香港中文大學 

Applicant's institution:

The Chinese University of Hong Kong 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2018.603 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會 

Name of the ethic committee:

Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-04-16 

伦理委员会联系人:

Ms Envy Lee (Secretary) 

Contact Name of the ethic committee:

Ms Envy Lee (Secretary) 

伦理委员会联系地址:

中國香港特別行政區新界沙田銀城街威爾士親王醫院呂志和臨床醫學大樓八樓 

Contact Address of the ethic committee:

8/F, Lui Chee Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong SAR, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+852 35053935 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

crec@cuhk.edu.hk 

研究实施负责(组长)单位:

Nil, student study 

Primary sponsor:

Nil, student study 

研究实施负责(组长)单位地址:

Nil, student study 

Primary sponsor's address:

Nil, student study 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

Nil, student study 

Source(s) of funding:

Nil, student study 

研究疾病:

廣泛性焦慮障礙 

Target disease:

Generalized Anxiety Disorder 

研究疾病代码:

 

Target disease code:

 

研究类型:

治疗研究 

Study type:

Treatment study 

研究所处阶段:

I期临床试验 

Study phase:

研究目的:

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. 

Objectives of Study:

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. 

药物成份或治疗方案详述:

The treatment protocol of low intensity cognitive behavioral therapy (LICBT) for generalized anxiety disorder (GAD) The treatment content is based on the Worry Program which includes cognitive therapy, challenging beliefs about worry and other core beliefs, graded exposure, and relapse prevention. Two formats with identical treatment materials will be designed, which will be 1) in written form as a workbook and as electronic materials that participants can read online. There are 6 sessions in total. Participants are advised to complete one session every 7 to 10 days. All 6 sessions should be completed within 10 weeks. After subject recruitment, subjects will be invited to complete a batch of primary and secondary outcome measures before the treatment starts. Upon completing all the baseline measures and screening assessment, the participants would be randomized into either waitlist group or treatment group. For treatment group, all participants should have access to a computer with an internet connection. It is at best if they can print out training instructions, thought records, and other exercise materials. They should communicate with the research assistant if they have difficulties in producing the printouts. Written form of materials will be mailed to them if necessary. A research assistant will be responsible for monitoring of participants adherence and maintaining contact with the participants, under the supervision of a clinical psychologist. All participants receive an email on introduction of treatment content, guideline on use of electronic materials, guideline of formation of treatment goals and a recommended timetable for working through the materials. Participants are invited to fill out Penn State Worry Questionnaire (PSWQ) and Generalized Anxiety Disorder 7-item Scale (GAD-7)’ for each session. They would be invited to answer questions on risk assessment for management of risk along treatment trajectory. The research assistant would inform the clinical psychologist for possible risk of participants and the latter would decide if the participants should receive more intensive risk management and if exit from the self-help intervention is necessary. In each session, participants are given instructions on how they can review their homework of last session and new homework will be assigned. Treatment goal will be revisited and they would be invited to track and review their treatment goal. For knowledge checking, each module would end with an interactive multiple-choice quiz. If they are unsuccessful they receive immediate automatic feedback on what specific questions they fail and what the correct answer is, together with an explanation on why that is the correct response. As a form of unguided self-help treatment, neither the research assistant nor the clinical psychologist would answer questions related specifically to the treatment content of CBT. When participants raise questions about life difficulties, the research assistant can suggest areas of the website or written materials to explore, but does not engage in a discussion of the life problem with them and does not assist them in the therapeutic use of the website or provide clinical advice. To enhance treatment compliance, there would be weekly reminders one day before the session module begins via email (or phone call / text messages) and another reminder would be sent if subjects have not completed a module within 7 days of first notification. There would also be automatic emails that reinforce their progress, congratulated them on the completion of lessons. Emails (or phone call / text messages) for validation of effort upon completing homework would be sent within 24 hours after the homework is submitted at the end of each session. Reminders for non-adherence to homework will be sent if the subjects fail to hand in the homework. Technical, procedural and non-clinical questions, such as login problems, difficulty locating session materials he / she needs and functionality of the website, will be answered timely (within 24 hours). For the waitlist control group, they will complete all the post-treatment measures within ten weeks. The participant would subsequently be offered the treatment program upon completing of the measures. 

Description for medicine or protocol of treatment in detail:

The treatment protocol of low intensity cognitive behavioral therapy (LICBT) for generalized anxiety disorder (GAD) The treatment content is based on the Worry Program which includes cognitive therapy, challenging beliefs about worry and other core beliefs, graded exposure, and relapse prevention. Two formats with identical treatment materials will be designed, which will be 1) in written form as a workbook and as electronic materials that participants can read online. There are 6 sessions in total. Participants are advised to complete one session every 7 to 10 days. All 6 sessions should be completed within 10 weeks. After subject recruitment, subjects will be invited to complete a batch of primary and secondary outcome measures before the treatment starts. Upon completing all the baseline measures and screening assessment, the participants would be randomized into either waitlist group or treatment group. For treatment group, all participants should have access to a computer with an internet connection. It is at best if they can print out training instructions, thought records, and other exercise materials. They should communicate with the research assistant if they have difficulties in producing the printouts. Written form of materials will be mailed to them if necessary. A research assistant will be responsible for monitoring of participants adherence and maintaining contact with the participants, under the supervision of a clinical psychologist. All participants receive an email on introduction of treatment content, guideline on use of electronic materials, guideline of formation of treatment goals and a recommended timetable for working through the materials. Participants are invited to fill out Penn State Worry Questionnaire (PSWQ) and Generalized Anxiety Disorder 7-item Scale (GAD-7) for each session. They would be invited to answer questions on risk assessment for management of risk along treatment trajectory. The research assistant would inform the clinical psychologist for possible risk of participants and the latter would decide if the participants should receive more intensive risk management and if exit from the self-help intervention is necessary. In each session, participants are given instructions on how they can review their homework of last session and new homework will be assigned. Treatment goal will be revisited and they would be invited to track and review their treatment goal. For knowledge checking, each module would end with an interactive multiple-choice quiz. If they are unsuccessful they receive immediate automatic feedback on what specific questions they fail and what the correct answer is, together with an explanation on why that is the correct response. As a form of unguided self-help treatment, neither the research assistant nor the clinical psychologist would answer questions related specifically to the treatment content of CBT. When participants raise questions about life difficulties, the research assistant can suggest areas of the website or written materials to explore, but does not engage in a discussion of the life problem with them and does not assist them in the therapeutic use of the website or provide clinical advice. To enhance treatment compliance, there would be weekly reminders one day before the session module begins via email (or phone call / text messages) and another reminder would be sent if subjects have not completed a module within 7 days of first notification. There would also be automatic emails that reinforce their progress, congratulated them on the completion of lessons. Emails (or phone call / text messages) for validation of effort upon completing homework would be sent within 24 hours after the homework is submitted at the end of each session. Reminders for non-adherence to homework will be sent if the subjects fail to hand in the homework. Technical, procedural and non-clinical questions, such as login problems, difficulty locating session materials he / she needs and functionality of the website, will be answered timely (within 24 hours). For the waitlist control group, they will complete all the post-treatment measures within ten weeks. The participant would subsequently be offered the treatment program upon completing of the measures. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

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. 

Inclusion criteria

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. 

Exclusion criteria:

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. 

研究实施时间:

Study execute time:

From2020-04-28To 2020-12-31 

干预措施:

Interventions:

组别:

Experimental group

样本量:

57

Group:

Experimental group

Sample size:

干预措施:

internet self-help program

干预措施代码:

Intervention:

internet self-help program

Intervention code:

组别:

Control group

样本量:

57

Group:

Control group

Sample size:

干预措施:

waitlist, to receive same internet self-help program 10 weeks after subject recruitment

干预措施代码:

Intervention:

waitlist, to receive same internet self-help program 10 weeks after subject recruitment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國 

省(直辖市):

香港特別行政區 

市(区县):

 

Country:

China 

Province:

Hong Kong SAR 

City:

 

单位(医院):

香港中文大學 

单位级别:

大學 

Institution
hospital:

The Chinese University of Hong Kong  

Level of the institution:

University 

测量指标:

Outcomes:

指标中文名:

Generalized Anxiety Disorder 7-item Scale (GAD-7)

指标类型:

主要指标 

Outcome:

Generalized Anxiety Disorder 7-item Scale (GAD-7)

Type:

Primary indicator 

测量时间点:

each of the six sessions

测量方法:

self-reported questionnaires

Measure time point of outcome:

each of the six sessions

Measure method:

self-reported questionnaires

指标中文名:

Penn State Worry Questionnaire (PSWQ)

指标类型:

主要指标 

Outcome:

Penn State Worry Questionnaire (PSWQ)

Type:

Primary indicator 

测量时间点:

each of the six sessions

测量方法:

self-reported questionnaires

Measure time point of outcome:

each of the six sessions

Measure method:

self-reported questionnaires

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

No

组织:

No

Sample Name:

N/A

Tissue:

N/A

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

N/A

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

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.

Randomization Procedure (please state who generates the random number sequence and by what method):

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.

Blinding:

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.

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

IPD (including metadata and protocol) will be registered with the Chinese Clinical Trial Registry (www.chictr.org.cn) and be made available 6 months after the completion of the study.

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

IPD (including metadata and protocol) will be registered with the Chinese Clinical Trial Registry (www.chictr.org.cn) and be made available 6 months after the completion of the study.

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

Data will be collected through Google Document. Data from Google Document will be exported into Excel spreadsheets and stored locally in the principal investigator's computer. SPSS data file will be created with both the metadata and raw data imported from Excel spreadsheets. SPSS data file(s) will be stored locally in the principal investigator's computer. Password-protected backups (with subjects number and without identifiable confidential information) will be made weekly and stored digitally online.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Data will be collected through Google Document. Data from Google Document will be exported into Excel spreadsheets and stored locally in the principal investigator's computer. SPSS data file will be created with both the metadata and raw data imported from Excel spreadsheets. SPSS data file(s) will be stored locally in the principal investigator's computer. Password-protected backups (with subjects number and without identifiable confidential information) will be made weekly and stored digitally online.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-05-04
return list