Trial from ANZCTR


Trial ID ACTRN12609000563268
Trial Status: Registered
Date Submitted: 9/07/2009
Date Registered: 9/07/2009
Prospectively registered

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Public title Internet-based treatment of generalized anxiety disorder (the Worry program): A randomized controlled study exploring the role of a clinician.
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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.
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UTN
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Trial acronym GAD RCT2
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Health condition(s) or problem(s) studied:
Mental Health 237203 0
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Condition category: Condition code:
Mental Health Anxiety
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Descriptions 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.
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Intervention Code:
Treatment: Other 236904 0
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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.
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Control group Active
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Primary Outcome: Symptoms of GAD are measured by the Generalized Anxiety Disorder - 7 Item (GAD-7) questionnaire. 238332 0
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Timepoint: Administered at application, pre-treatment, post-treatment, and at 3-months post-treatment. 238332 0
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Primary Outcome: Symptoms of GAD are also measured by the Penn State Worry Questionnaire (PSWQ). 238333 0
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Timepoint: Administered at pre-treatment, post-treatment, and at 3-months post-treatment. 238333 0
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Secondary Outcome: Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9). 244738 0
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Timepoint: Administered at application, pre-treatment, post-treatment, and at 3-months post-treatment 244738 0
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Secondary Outcome: Psychological distress is measured by the Kessler-10 (K-10). 244739 0
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Timepoint: Administered at application, pre-treatment, post-treatment, and at 3-months post-treatment 244739 0
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Secondary Outcome: Disability is measured by the Sheehan Disability Scale. 244740 0
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Timepoint: Administered at application, pre-treatment, post-treatment, and at 3-months post-treatment 244740 0
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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
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Minimum age 18 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? Yes
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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
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the 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.
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Describe the 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.
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 7/09/2009
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 120
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Actual sample size
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Recruitment status Closed: follow-up continuing
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Recruitment in Australia

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Recruitment outside Australia

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Funding Source: University 237301 0
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Name: School of Psychiatry, University of New South Wales at St Vincent's Hospital 237301 0
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Address: 299 Forbes Street Darlinghurst NSW2010 237301 0
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Country: Australia 237301 0
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Primary Sponsor University
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Name: School of Psychiatry, University of New South Wales at St Vincent's Hospital
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Address: 299 Forbes Street Darlinghurst NSW2010
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Country: Australia
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Secondary Sponsor: None 236785 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: 239398 0
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Approval Date: 239398 0
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Submitted Date: 16/06/2009 239398 0
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HREC: 239398 0
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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.
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Trial website www.virtualclinic.org.au
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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.
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Dr Nickolai Titov
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Address: 299 Forbes Street Darlinghurst NSW2010
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Tel: 612 8382 1726
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Fax: 612 8382 1721
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Email: nickt@unsw.edu.au
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Contact person for scientific queries
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Name: Dr Nickolai Titov
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Address: 299 Forbes Street Darlinghurst NSW2010
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Contact person responsible for updating information
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Name: Dr Nickolai Titov
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Address: 299 Forbes Street Darlinghurst NSW2010
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Tel: 612 8382 1726
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