Trial registered on ANZCTR


Trial ID
ACTRN12609000563268
Ethics application status
Approved
Date submitted
9/07/2009
Date registered
9/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Internet-based treatment of generalized anxiety disorder (the Worry program): A randomized controlled study exploring the role of a clinician.
Scientific title
A randomized controlled trial comparing clinician-assisted Internet based treatment for generalized anxiety disorder (GAD) vs. self-guided Internet-based treatment for GAD vs. a waitlist control condition on severity of symptoms of generalized anxiety disorder.
Secondary ID [1] 288062 0
Nil
Universal Trial Number (UTN)
Trial acronym
GAD RCT2

Health condition
Health condition(s) or problem(s) studied:
Mental Health 237203 0
Condition category
Condition code
Mental Health 237522 237522 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of three groups: 1) Treatment with clinician-assisted Internet based treatment for GAD, or; 2) Treatment with self-guided Internet based treatment for GAD, or; 3) Waitlist control. All participants will meet Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for GAD. All group 1 and group 2 participants will complete 6 lessons of Internet based treatment about the management of symptoms of GAD. One lesson will be completed every 7 to 14 days. Each lesson will take about 15 minutes to complete. Group 1 participants will have access to summaries of each lesson, will contribute to an online forum moderated by a clinical psychologist or psychiatrist, and will receive weekly reminder emails. Group 2 participants will have access to summaries of each lesson, and will receive weekly reminder emails. The duration of the program is up to 10 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-treatment, post-treatment, and at 3-month post-treatment. These will take about 20 minutes to complete. The treatment materials are based on cognitive behavioural techniques.
Intervention code [1] 236904 0
Treatment: Other
Comparator / control treatment
Waitlist control group. These participants remain on the waitlist until the treatment groups have completed their treatment (10 weeks). At that time (10 weeks) the waitlist group will receive the same treatment as Treatment Group 1.
Control group
Active

Outcomes
Primary outcome [1] 238332 0
Symptoms of GAD are measured by the Generalized Anxiety Disorder - 7 Item (GAD-7) questionnaire.
Timepoint [1] 238332 0
Administered at application, pre-treatment, post-treatment, and at 3-months post-treatment.
Primary outcome [2] 238333 0
Symptoms of GAD are also measured by the Penn State Worry Questionnaire (PSWQ).
Timepoint [2] 238333 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment.
Secondary outcome [1] 244738 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9).
Timepoint [1] 244738 0
Administered at application, pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [2] 244739 0
Psychological distress is measured by the Kessler-10 (K-10).
Timepoint [2] 244739 0
Administered at application, pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [3] 244740 0
Disability is measured by the Sheehan Disability Scale.
Timepoint [3] 244740 0
Administered at application, pre-treatment, post-treatment, and at 3-months post-treatment

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
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
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
Treatment
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 the Mini-International Neuropsychiatric Interview (MINI 5.0.0), a structured diagnostic interview. 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy

Recruitment
Anticipated date of first participant enrolment
7/09/2009
Actual date of first participant enrolment
7/09/2009
Anticipated date last participant enrolled
Actual date last participant enrolled
1/12/2009
Anticipated date of last data collection
Actual date of last data collection
Target sample size
120
Actual sample size
150
Recruitment status
Completed
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237301 0
University
Name [1] 237301 0
School of Psychiatry, University of New South Wales at St Vincent's Hospital
Address [1] 237301 0
299 Forbes Street Darlinghurst NSW2010
Country [1] 237301 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] 236785 0
None
Name [1] 236785 0
Address [1] 236785 0
Country [1] 236785 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239398 0
Ethics committee address [1] 239398 0
Ethics committee country [1] 239398 0
Date submitted for ethics approval [1] 239398 0
16/06/2009
Approval date [1] 239398 0
01/09/2009
Ethics approval number [1] 239398 0

Summary
Brief summary
Our previous research indicates that the Worry Program, an Internet-based treatment program for people with GAD, is effective at helping people to learn to manage their symptoms of GAD.

The study described here aims to find out whether therapist support is required for people to successfully complete the Worry Program.

We expect that people completing the Worry Program without therapist support will still benefit, but not as much as those receiving the usual levels of therapist support.
Trial website
www.virtualclinic.org.au
Trial related presentations / publications
Titov N, Andrews G, Robinson E, Schwencke E, Johnston L, Solley K, Choi I. Clinician-assisted Internet-based treatment is effective for generalized anxiety disorder: A randomized controlled trial. In press. Aust N Z J Psychiatry.
Public notes

Contacts
Principal investigator
Name 29874 0
Prof Nick Titov
Address 29874 0
Department of Psychology
Macquarie University
NSW 2109
Country 29874 0
Australia
Phone 29874 0
61 2 9850 9979
Fax 29874 0
Email 29874 0
nick.titov@mq.edu.au
Contact person for public queries
Name 13121 0
Prof Dr Nickolai Titov
Address 13121 0
299 Forbes Street
Darlinghurst
NSW2010
Country 13121 0
Australia
Phone 13121 0
612 8382 1726
Fax 13121 0
612 8382 1721
Email 13121 0
nickt@unsw.edu.au
Contact person for scientific queries
Name 4049 0
Prof Dr Nickolai Titov
Address 4049 0
299 Forbes Street
Darlinghurst
NSW2010
Country 4049 0
Australia
Phone 4049 0
612 8382 1726
Fax 4049 0
612 8382 1721
Email 4049 0
nickt@unsw.edu.au