Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000951954
Ethics application status
Approved
Date submitted
25/08/2011
Date registered
5/09/2011
Date last updated
5/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Sino-Swiss Internet-based intervention for Posttraumatic Stress Disorder project
Scientific title
The effect of an internet-based intervention on symptoms of Posttraumatic Stress Disorder in Chinese trauma survivors
Secondary ID [1] 262920 0
Nil
Universal Trial Number (UTN)
U1111-1123-8904
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder 270648 0
Condition category
Condition code
Mental Health 270821 270821 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Internet-based intervention is to be used with a multimodal program “My trauma recovery”, which provides education information about Posttraumatic Stress Disorder and helps users to increase their coping skills and self-efficacy through interactive exercises with feedbacks. The intervention lasts four weeks. Participants are required to use the program at least three times per week with a minimum usage time of 30 minutes per time. The program will provide all participants’ usage information, including login and logout time, time spent on each module and so on.
Intervention code [1] 269275 0
Behaviour
Intervention code [2] 269312 0
Treatment: Other
Comparator / control treatment
The scientific goal is to conduct a comprehensive randomized-controlled trial of internet-based treatment of PTSD for Chinese patients. Half of the sample will be randomly allocated to a group starting treatment immediately (after satisfying the intake criteria) and which lasts for four weeks. The second half of the sample will serve as a waiting list control group, starting treatment after a waiting period of, at minimum, four weeks.
Control group
Active

Outcomes
Primary outcome [1] 279514 0
Symptoms of Posttraumatic Stress Disorder as assessed by Posttraumatic Diagnostic Scale (PDS)
Timepoint [1] 279514 0
Before the intervention, at the end of intervention, and 3 months following the completion of intervention
Secondary outcome [1] 287777 0
Social functional impairment as assessed by Functional Impairment questionnaire
Timepoint [1] 287777 0
Before the intervention, at the end of intervention, and 3 months following the completion of intervention

Eligibility
Key inclusion criteria
Trauma events: experienced at least one trauma event (e.g., death or threat to life, assault, or humiliation) during the past five years;
Trauma Timing: 3 months - 5 years;
Trauma symptoms screening: at least 4 symptoms using Trauma Screening Questionnaire
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age: younger than 18 years;
Competency of Chinese language: bad reading and aural comprehension;
Internet access time: less than 360 minutes in four weeks;
Acute psychosis screening: clinical rating using Psychosescreening;
Substance abuse and intoxication screening: clinical rating using The CAGE Questionnaire

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants make first the trauma symptoms screening by telephone. Those who pass the screening procedure are then allocated to the intervention group or the waiting group by randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table containing number 1 to 90 created by computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 3811 0
China
State/province [1] 3811 0

Funding & Sponsors
Funding source category [1] 269740 0
Government body
Name [1] 269740 0
Sino-Swiss Science and Technology Cooperation
Country [1] 269740 0
Switzerland
Primary sponsor type
Government body
Name
Sino-Swiss Science and Technology Cooperation
Address
International Institutional Affairs (IIA)
ETH Zurich, HG F 11
Raemistrasse 101
CH-8092 Zurich
Country
Switzerland
Secondary sponsor category [1] 268781 0
University
Name [1] 268781 0
University of Zurich
Address [1] 268781 0
Department of Psychopathology & Clinical Intervention University of Zurich
Binzmuehlestr. 14/17
CH-8050 Zurich
Country [1] 268781 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271702 0
Research ethics board in School of Psychology, Beijing Normal University
Ethics committee address [1] 271702 0
No. 19, XinJieKouWai St., HaiDian District, Beijing 100875, China
Ethics committee country [1] 271702 0
China
Date submitted for ethics approval [1] 271702 0
10/09/2011
Approval date [1] 271702 0
28/10/2011
Ethics approval number [1] 271702 0

Summary
Brief summary
The aim of this project is to develop, implement and evaluate a self-sustained virtual out-door clinic for traumatized patients (http://mandarin.mytraumarecovery.com). The virtual treatment center for posttraumatic stress disorder (PTSD) applies the multimodal program “My trauma recovery” as the main technological tool. Its modules focus on social support, cognitive restructuring (“self talk”), relaxation, coping, trigger recognition, and recognition of the need for further professional help. It contains various technological advantages, such as progress charts and interactive tools.
The scientific goal is to conduct a comprehensive randomized-controlled trial of internet-based treatment of PTSD for Chinese patients. Half of the sample will be randomly allocated to a group starting treatment immediately (after satisfying the intake criteria) which lasts for four weeks. The second half of the sample will serve as a wait list control group, starting treatment after a waiting period of, at minimum, four weeks. Follow-up assessments will be conducted at the end of treatment and 3 months following the completion of treatment. It is expected that the Internet-based intervention reduce significantly participants’ distress of Posttraumatic Stress Disorder.
Trial website
http://mandarin.mytraumarecovery.com
Trial related presentations / publications
Wang, Z., Tang, S., Wang, J. & Maercker, A. (2012). Foundations and future application of internet-based interventions for PTSD in PR China. International Journal of Electronic Healthcare, 7(1), 19-35.
Wang, Z., Wang, J. & Maercker, A. (submitted). Traumatized users’ adherence to Internet-based interventions in an randomized controlled trial. Journal of Mental Health.
Wang, Z., Wang, J. & Maercker, A. (in preparation). Chinese My Trauma Recovery: An Internet randomized controlled trial for traumatized persons.
Public notes

Contacts
Principal investigator
Name 33077 0
Address 33077 0
Country 33077 0
Phone 33077 0
Fax 33077 0
Email 33077 0
Contact person for public queries
Name 16324 0
Zhiyun WANG
Address 16324 0
School of Law, Tsinghua University,
No. 30, Shuangqing Road, HaiDian District, Beijing 100086, China
Country 16324 0
China
Phone 16324 0
+86 158 1012 0837
Fax 16324 0
Email 16324 0
z.wang@psychologie.uzh.ch
Contact person for scientific queries
Name 7252 0
Andreas MAERCKER
Address 7252 0
Department of Psychopathology & Clinical Intervention,
University of Zurich,
Binzmuehlestr. 14/17,
CH-8050 Zurich
Country 7252 0
Switzerland
Phone 7252 0
+41 (0)44 635 73 10
Fax 7252 0
+41 (0)44 635 73 19
Email 7252 0
maercker@psychologie.uzh.ch

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseChinese My Trauma Recovery, a Web-based intervention for traumatized persons in two parallel samples: randomized controlled trial.2013https://dx.doi.org/10.2196/jmir.2690
N.B. These documents automatically identified may not have been verified by the study sponsor.