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
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
Trial website
Trial related presentations / publications
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
[email protected]
Contact person for public queries
Name 12977 0
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
[email protected]
Contact person for scientific queries
Name 3905 0
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
[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.