Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000136202
Ethics application status
Approved
Date submitted
10/02/2009
Date registered
2/03/2009
Date last updated
3/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Internet-based education for generalized anxiety disorder (the Worry Program): A randomized controlled trial.
Scientific title
A randomized controlled trial comparing clinician-assisted Internet based education for generalized anxiety disorder (GAD) vs. a waitlist control condition on severity of symptoms of GAD.
Secondary ID [1] 288068 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Generalized anxiety disorder (GAD) 4302 0
Condition category
Condition code
Mental Health 4534 4534 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of two groups: 1) Clinician-assisted Internet based education for GAD, or; 2) Wait-list control. All participants will meet Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for GAD. All education group participants will complete 6 lessons of Internet based education about management of symptoms of GAD. One lesson will be completed every 7 to 10 days. Each lesson will take about 15 minutes to complete. Education group participants will also have access to summaries of each lesson, will contribute to an online forum moderated by a clinical psychologist, and will receive weekly emails from the clinical psychologist. The duration of the program is 8 weeks, but participants will be contacted 3 months post program and asked to complete follow-up questionnaires. Study questionnaires will be administered at application, pre-education, post-education, and at 3-months post-education. These will take about 20 minutes to complete. The educational materials are based on cognitive behavioural techniques.
Intervention code [1] 4031 0
Other interventions
Comparator / control treatment
Waitlist control group. These participants remain on the waitlist until the treatment group has completed their treatment (8 weeks). At that time (8 weeks) the waitlist group will receive treatment.
Control group
Active

Outcomes
Primary outcome [1] 5412 0
GAD is measured by the GAD-7 questionnaire.
Timepoint [1] 5412 0
Administered at application, pre-education, post-education, and at 3-months post-education.
Primary outcome [2] 5413 0
GAD is measured by the Penn State Worry Questionnaire questionnaire.
Timepoint [2] 5413 0
Administered at pre-education, post-education, and at 3-months post-education.
Secondary outcome [1] 9104 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [1] 9104 0
Administered at application, pre-education, post-education, and at 3-months post-education.
Secondary outcome [2] 9105 0
Psychological distress is measured by the Kessler-10 (K-10)
Timepoint [2] 9105 0
Administered at pre-education, post-education, and at 3-months post-education.
Secondary outcome [3] 9106 0
Disability is measured by the Sheehan Disability Scale.
Timepoint [3] 9106 0
Administered at application, pre-education, post-education, and at 3-months post-education.

Eligibility
Key inclusion criteria
Meet Diagnostic and Statistical Manual of the American Psychiatric Association-4th Edition (DSM-IV) criteria for GAD - Internet access + printer access. - Australian citizen- Males and females
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current substance abuse/dependence- Psychotic disorder- Current or planned psychological treatment during study duration- Change in medications during last 1 month or intended change during study duration

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants apply on line, followed by a telephone interview to confirm diagnosis via structured diagnostic interview (MINI 5.0.0). Participants will be randomized using a list generated prior to the study. Allocation concealment will occur by contacting the holder of the allocation schedule who is off-site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation list will be generated prior to the study using computer software.
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
16/03/2009
Actual
16/03/2009
Date of last participant enrolment
Anticipated
16/05/2009
Actual
16/05/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4478 0
University
Name [1] 4478 0
School of Psychiatry, University of New South Wales at St Vincent's Hospital
Country [1] 4478 0
Australia
Primary sponsor type
University
Name
School of Psychiatry, University of New South Wales at St Vincent's Hospital
Address
299 Forbes Street Darlinghurst NSW2010
Country
Australia
Secondary sponsor category [1] 4037 0
None
Name [1] 4037 0
Address [1] 4037 0
Country [1] 4037 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6539 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 6539 0
Ethics committee country [1] 6539 0
Australia
Date submitted for ethics approval [1] 6539 0
Approval date [1] 6539 0
29/08/2008
Ethics approval number [1] 6539 0
08232

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29268 0
Prof Nick Titov
Address 29268 0
Department of Psychology
Macquarie University
NSW 2109
Country 29268 0
Australia
Phone 29268 0
61 2 9850 9901
Fax 29268 0
Email 29268 0
[email protected]
Contact person for public queries
Name 12515 0
Dr Nickolai Titov
Address 12515 0
C/- Clinical Research Unit for Anxiety Disorders (CRUfAD) UNSW 299 Forbes Street Darlinghurst NSW 2010
Country 12515 0
Australia
Phone 12515 0
+61 2 83821732
Fax 12515 0
Email 12515 0
[email protected]
Contact person for scientific queries
Name 3443 0
Dr Nickolai Titov
Address 3443 0
C/- Clinical Research Unit for Anxiety Disorders (CRUfAD) UNSW 299 Forbes Street Darlinghurst NSW 2010
Country 3443 0
Australia
Phone 3443 0
+61 2 83821732
Fax 3443 0
Email 3443 0
[email protected]

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
No additional documents have been identified.