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Trial registered on ANZCTR


Registration number
ACTRN12610000242022
Ethics application status
Approved
Date submitted
18/02/2010
Date registered
23/03/2010
Date last updated
2/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Internet-based treatment of generalized anxiety disorder, and/or social phobia, and/or panic disorder (the Anxiety 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), and/or social phobia and/or panic disorder vs. self-guided Internet-based treatment for GAD and/or social phobia and/or panic disorder vs. a waitlist control condition on severity of symptoms of anxiety.
Secondary ID [1] 1427 0
Nil.
Universal Trial Number (UTN)
Trial acronym
The Anxiety Program RCT2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social phobia (an anxiety disorder) 256849 0
Panic disorder (with or without Agoraphobia) (both anxiety disorders) 256850 0
Generalised Anxiety Disorder (an anxiety disorder) 256851 0
Condition category
Condition code
Mental Health 256997 256997 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of three groups: Group 1) Treatment with self-guided Internet based treatment for GAD and/or social phobia, and/or panic disorder, or; Group 2) Treatment with clinician-assisted Internet based treatment for GAD and/or social phobia, and/or panic disorder, or; Group 3) Waitlist control. All participants will meet Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for GAD and/or social phobia, and/or panic disorder. All group 1 and group 2 participants will complete 8 lessons of Internet based treatment about the management of anxiety symptoms. 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, and will receive weekly reminder emails. Group 2 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. 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] 256043 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 2.
Control group
Active

Outcomes
Primary outcome [1] 257887 0
Anxiety is measured by the Mini International Neuropsychiatric Interview
Timepoint [1] 257887 0
Administered at pre-treatment, and at 3-months post-treatment
Primary outcome [2] 257888 0
Anxiety is measured by the Depression, Anxiety, Stress Scale -21 item (DASS-21)
Timepoint [2] 257888 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Primary outcome [3] 257889 0
Anxiety is measured by the Generalised Anxiety Disorder Assessment (GAD-7)
Timepoint [3] 257889 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [1] 263341 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9
Timepoint [1] 263341 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [2] 263342 0
Neuroticism is measured by using the NEO-Five Factor Inventory (NEO-FFI) Neuroticism scale
Timepoint [2] 263342 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [3] 263343 0
Disability is measured by the Sheehan Disability Scale
Timepoint [3] 263343 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [4] 263363 0
Generalised Anxiety Disorder is measured using the Penn State Worry Questionnaire
Timepoint [4] 263363 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [5] 263364 0
Panic disorder is measured using the Agoraphobic Cognitions Questionnaire
Timepoint [5] 263364 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [6] 263365 0
Panic disorder is measured using the Panic Disorder Severity Scale - Self Rated
Timepoint [6] 263365 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [7] 263366 0
Social phobia is measured by the Social Phobia Scale
Timepoint [7] 263366 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [8] 263367 0
Social phobia is measured by the Social Interaction Anxiety Scale
Timepoint [8] 263367 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment

Eligibility
Key inclusion criteria
Meet DSM-IV criteria for social phobia and/or panic disorder (with or without agoraphobia) and/or GAD - Internet access + printer access. - Australian citizen- Males and females.
Minimum age
18 Years
Maximum age
No limit
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 - Current use of benzodiazepines or beta-blockers

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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/03/2010
Actual
22/03/2010
Date of last participant enrolment
Anticipated
Actual
22/05/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256546 0
University
Name [1] 256546 0
School of Psychiatry, University of New South Wales at St Vincent's Hospital
Country [1] 256546 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] 255846 0
None
Name [1] 255846 0
Address [1] 255846 0
Country [1] 255846 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293955 0
St Vincent's Hospital HREC
Ethics committee address [1] 293955 0
390 Victoria Street
Darlinghurst
NSW 2010
Ethics committee country [1] 293955 0
Australia
Date submitted for ethics approval [1] 293955 0
01/12/2009
Approval date [1] 293955 0
22/01/2010
Ethics approval number [1] 293955 0
Unkown

Summary
Brief summary
Our previous research into Internet based treatment programs have been shown to be effective (e.g the Worry Program for the treatment of generalised anxiety disorder (ACTRN12609000563268). These programs informed the creation of a program for treating GAD, and/or social phobia, and/or panic disorder (the Anxiety Program). Our preliminary research indicated tenative support that the Anxiety Program (ACTRN12609000501246) was effective at helping people to learn to manage their symptoms of anxiety.

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

We expect that people completing the Anxiety 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
Andrews, G. and N. Titov, Alternate models of care. Treating people you never see: Internet-based treatment of the internalizing mental disorders. Australian Health Review, submitted.Titov, N., et al., The Shyness Program: Longer Term Benefits, Cost-Effectiveness, and Acceptability. Australian & New Zealand Journal of Psychiatry, 2009. 43(1): p. 36-44. - Titov, N., G. Andrews, and P.M. McEvoy, Key components in low intensity interventions for anxiety. Oxford Guide, submitted - Titov, N. and G. Andrews, Email and brief internet based mental health interventions. Oxford Guide, submitted. - Titov, N. and G. Andrews, Monitoring social phobia outcomes with the GAD7 Journal of Anxiety Disorders, submitted. - Titov, N., Shyness 4. British Journal of Psychiatry, submitted. - Titov, N., et al., Brief Internet Treatment for Social Phobia reduces Comorbidity Australian and New Zealand Journal of Psychiatry in press. - Titov N, Andrews G, Schwencke G: Shyness 2: Treating social phobia online: replication and extension. Australian and New Zealand Journal of Psychiatry 2008 42(7):595-605. - Titov N, Andrews G, Schwencke G, Drobny J, Einstein D: Shyness 1: Distance treatment for social over the Internet. A randomized controlled trial. Australian & New Zealand Journal of Psychiatry 2008; 42(7):585-594. - Titov N, Andrews G, Choi I, Schwencke G, Mahoney A: Shyness 3: An RCT of guided vs unguided internet based CBT for social phobia. Australian & New Zealand Journal of Psychiatry 2008; 42(12):1030-1040. - Titov N: Status of computerized cognitive behavioural therapy for adults. Australian & New Zealand Journal of Psychiatry 2007; 41(2):95-114. - Wims E, Titov N, Andrews G: The Climate Panic program: an open trial of Internet-based treatment for panic disorder. Electronic Journal of Applied Psychology 2008; 4(2)
Public notes

Contacts
Principal investigator
Name 30860 0
Prof Nick Titov
Address 30860 0
Department of Psychology
Macquarie University
NSW 2109
Country 30860 0
Australia
Phone 30860 0
61 2 9850 9901
Fax 30860 0
Email 30860 0
[email protected]
Contact person for public queries
Name 14107 0
Dr Nickolai Titov
Address 14107 0
299 Forbes Street
Darlinghurst
NSW2010
Country 14107 0
Australia
Phone 14107 0
612 8382 1726
Fax 14107 0
612 8382 1721
Email 14107 0
[email protected]
Contact person for scientific queries
Name 5035 0
Dr Nickolai Titov
Address 5035 0
299 Forbes Street
Darlinghurst
NSW2010
Country 5035 0
Australia
Phone 5035 0
612 8382 1726
Fax 5035 0
612 8382 1721
Email 5035 0
[email protected]

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