Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000501246
Ethics application status
Approved
Date submitted
11/06/2009
Date registered
23/06/2009
Date last updated
25/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Anxiety Program: A randomized controlled trial of internet based education for Anxiety
Scientific title
A randomized controlled trial of Internet based education for anxiety comparing immediate education vs. delayed education on anxiety symptoms.
Secondary ID [1] 290021 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social phobia (an anxiety disorder) 236972 0
Panic disorder (with or without Agoraphobia) (both anxiety disorders) 236973 0
Generalised Anxiety Disorder (an anxiety disorder) 236974 0
Condition category
Condition code
Mental Health 237318 237318 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of two groups: 1) an immediate education group, or; 2) a delayed education group AKA waitlist control group(beginnning the program 9 weeks after the immediate education group begin). All participants will meet Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for social phobia and/or panic disorder (with or without agoraphobia) and/or generalised anxiety disorder (GAD). All participants will complete 6 lessons of Internet based education about management of symptoms of anxiety. One lesson will be completed every 7 to 10 days. Each lesson will take about 15 minutes to complete. Participants will also have access to summaries of each lesson, and will read anonymous stories about other people with anxiety, taking a further 20 minutes per summary. All participants will also receive automatic email and weekly reminder phone calls by a research assistant, and have access to a research team-moderated online forum discussing content of the program. The duration of the reminder emails/phone calls and contribution to the forum is expected to be 5-10 minutes. The duration of the program is 9 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 20-30 minutes to complete. The educational materials are based on the Shyness, Panic and Worry Programs, which apply cognitive behavioural techniques.
Intervention code [1] 236744 0
Other interventions
Comparator / control treatment
The delayed education group (beginnning the program 9 weeks after the immediate education group begin)". this is a wait-list control group, .
Control group
Active

Outcomes
Primary outcome [1] 238132 0
Anxiety is measured by the Mini International Neuropsychiatric Interview
Timepoint [1] 238132 0
Administered at pre-education, post-education, and at 3-months post-education.
Primary outcome [2] 238133 0
Anxiety is measured by the Beck Anxiety Inventory
Timepoint [2] 238133 0
Administered at pre-education, post-education, and at 3-months post-education.
Primary outcome [3] 238134 0
Social phobia is measured by the Social Phobia Scale
Timepoint [3] 238134 0
Administered at pre-education, post-education, and at 3-months post-education.
Primary outcome [4] 238135 0
Social phobia is measured by the Social Interaction Anxiety Scale
Timepoint [4] 238135 0
Administered at pre-education, post-education, and at 3-months post-education.
Primary outcome [5] 238136 0
Panic disorder is measured using the Body Vigilance Scale
Timepoint [5] 238136 0
Administered at pre-education, post-education, and at 3-months post-education.
Primary outcome [6] 238137 0
Panic disorder is measured using the Agoraphobic Cognitions Questionnaire
Timepoint [6] 238137 0
Administered at pre-education, post-education, and at 3-months post-education.
Primary outcome [7] 238138 0
Generalised Anxiety Disorder is measured using the Generalised Anxiety Disorder Assessment (GAD-7)
Timepoint [7] 238138 0
Administered at pre-education, post-education, and at 3-months post-education.
Primary outcome [8] 238139 0
Neuroticism is measured by using the NEO-Five Factor Inventory (NEO-FFI) Neuroticism scale
Timepoint [8] 238139 0
Administered at pre-education, post-education, and at 3-months post-education.
Secondary outcome [1] 242340 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [1] 242340 0
Administered at pre-education, post-education, and at 3-months post-education.
Secondary outcome [2] 242341 0
Disability is measured by the Sheehan Disability Scale
Timepoint [2] 242341 0
Administered at pre-education, post-education, and at 3-months post-education.
Secondary outcome [3] 242342 0
Disability is measured by the World Health Organisation Disability Assessment Schedule II (WHODAS-II)
Timepoint [3] 242342 0
Administered at pre-education, post-education, and at 3-months post-education.

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
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
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
23/06/2009
Actual
30/07/2009
Date of last participant enrolment
Anticipated
Actual
31/12/2009
Date of last data collection
Anticipated
Actual
1/06/2010
Sample size
Target
80
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237139 0
University
Name [1] 237139 0
School of Psychiatry, University of New South Wales at St Vincent's Hospital
Country [1] 237139 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] 4630 0
Other
Name [1] 4630 0
New South Wales Institute of Psychiatry
Address [1] 4630 0
Cumberland Hospital Campus
5 Fleet Street
North Parramatta
NSW 2151
Country [1] 4630 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239232 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 239232 0
UNSW Kensington Campus NSW 2052
Ethics committee country [1] 239232 0
Australia
Date submitted for ethics approval [1] 239232 0
03/02/2009
Approval date [1] 239232 0
17/02/2009
Ethics approval number [1] 239232 0
09029

Summary
Brief summary
This project is part of a research program examining the efficacy of Internet based education and treatment programs for people with commmon mental disorders. This project examines the effectiveness of an education program for people with social phobia and/or panic disorder (with or without agoraphobia) and/or GAD. We expect that people in either immediate or delayed education groups to report similar benefit following the active component of their program.
Trial website
www.virtualclinic.org.au
Trial related presentations / publications
The publication that relates to this trail is
Titov N, Andrews G, Johnston L, Robinson E, Spence J: Transdiagnostic Internet treatment for anxiety disorders. A randomized controlled trial. Behavior Research and Therapy. 2010, 48(9):890-899.
Public notes

Contacts
Principal investigator
Name 29730 0
Prof Gavin Andrews
Address 29730 0
St Vincent's Hospital
Darlinghurst
2010 NSW
Country 29730 0
Australia
Phone 29730 0
+612 8382 1400
Fax 29730 0
Email 29730 0
gavina@unsw.edu.au
Contact person for public queries
Name 12977 0
Prof Prof. Gavin Andrews
Address 12977 0
C/- Clinical Research Unit for Anxiety Disorders (CRUfAD) UNSW 299 Forbes Street Darlinghurst NSW 2010
Country 12977 0
Australia
Phone 12977 0
+61 2 83821726
Fax 12977 0
Email 12977 0
gavina@unsw.edu.au
Contact person for scientific queries
Name 3905 0
Prof Prof. Gavin Andrews
Address 3905 0
C/- Clinical Research Unit for Anxiety Disorders (CRUfAD) UNSW 299 Forbes Street Darlinghurst NSW 2010
Country 3905 0
Australia
Phone 3905 0
+61 2 83821726
Fax 3905 0
Email 3905 0
gavina@unsw.edu.au

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
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Documents added automatically
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