Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000704998
Ethics application status
Approved
Date submitted
6/07/2011
Date registered
8/07/2011
Date last updated
8/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of "Anxiety Online": A public online mental health service
Scientific title
Evaluation of clinical severity and psychological distress following use of Anxiety Online: A virtual psychology clinic for adults with anxiety disorders or subclinical symptoms
Secondary ID [1] 252939 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety disorders 258470 0
Condition category
Condition code
Mental Health 258636 258636 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Online treatment programs for each of the anxiety disorders: Generalised Anxiety Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Post Traumatic Stress Disorder and Social Anxiety Disorder. Participants choose whether to do an online program on their own or with email assistance from a psychologist. Programs are based on cognitive behaviour therapy techniques and contain 12 multi-media enriched modules with homework exercises designed to be completed over 12 weeks. It is anticipated that participants will spent about 40 minutes a week reading through the online module and completing associated offline exercises.
Intervention code [1] 257476 0
Treatment: Other
Intervention code [2] 266921 0
Behaviour
Comparator / control treatment
No control group is being used. Participants are given treatment options based on their completion of a comprehensive online assessment (e-PASS). Comparisons are being made for fully automated self-help and therapist versions of each of the anxiety disorder treatment programs. The therapist-assisted version involves receiving an email from a psychologist or provisional psychologist under supervision each week over the 12 week treatment period.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259491 0
Anxiety disorders (Generalised Anxiety Disorder, Obsessive-Compulsive Disorder, Panic Disorder with or without agoraphobia, Post Traumatic Stress Disorder, Social Anxiety Disorder) clinical severity ratings, as measured by online assessment (e-PASS) based on DSM-IV criteria and currently undergoing validity testing
Timepoint [1] 259491 0
Pre-program, post-program (week 12) then annually from 1-year post-program through to 5-years post-program
Primary outcome [2] 269144 0
Psychological distress, as measured by the Kessler-6
Timepoint [2] 269144 0
Pre-program, post-program (week 12) then annually from 1-year post-program through to 5-years post-program
Secondary outcome [1] 266077 0
depression, as measured by online assessment (e-PASS) based on DSM-IV criteria and currently undergoing validity testing
Timepoint [1] 266077 0
Pre-program, post-program (week 12) then annually from 1-year post-program through to 5-years post-program
Secondary outcome [2] 266078 0
eating disorders (anorexia nervosa, bulimia nervosa, binge eating disorder), as measured by online assessment (e-PASS) based on DSM-IV criteria and currently undergoing validity testing
Timepoint [2] 266078 0
Pre-program, post-program (week 12) then annually from 1-year post-program through to 5-years post-program
Secondary outcome [3] 266079 0
Somatoform disorders (somatisation, body dysmorphic disorder), as measured by online assessment (e-PASS) based on DSM-IV criteria and currently undergoing validity testing
Timepoint [3] 266079 0
Pre-program, post-program (week 12) then annually from 1-year post-program through to 5-years post-program
Secondary outcome [4] 266080 0
pathological gambling, as measured by online assessment (e-PASS) based on DSM-IV criteria and currently undergoing validity testing
Timepoint [4] 266080 0
Pre-program, post-program (week 12) then annually from 1-year post-program through to 5-years post-program
Secondary outcome [5] 266081 0
Sleeping disorders (insomnia, hypersomnia), as measured by online assessment (e-PASS) based on DSM-IV criteria and currently undergoing validity testing
Timepoint [5] 266081 0
Pre-program, post-program (week 12) then annually from 1-year post-program through to 5-years post-program
Secondary outcome [6] 266082 0
dependence disorders (alcohol dependence and substance dependence), as measured by online assessment (e-PASS) based on DSM-IV criteria and currently undergoing validity testing
Timepoint [6] 266082 0
Pre-program, post-program (week 12) then annually from 1-year post-program through to 5-years post-program
Secondary outcome [7] 279019 0
Quality of life rating, as measured by Likert-type scale within an online assessment
Timepoint [7] 279019 0
Pre-program, post-program (week 12) then annually from 1-year post-program through to 5-years post-program
Secondary outcome [8] 279020 0
Confidence in managing mental health, as measured by a Likert-type scale within an online assessment
Timepoint [8] 279020 0
Pre-program, post-program (week 12) then annually from 1-year post-program through to 5-years post-program
Secondary outcome [9] 279021 0
Likert scale-based questions (largely self-developed) are used to measure treatment satisfaction and self-perceived improvement, as well as open-ended questions regarding the best and worst aspects of the program and how the program could be improved.
Timepoint [9] 279021 0
Post-program (week 12)
Secondary outcome [10] 279022 0
Client's perceptions of the helpfulness of their relationship with their therapist - as measured by the Working Alliance Questionnaire
Timepoint [10] 279022 0
Post-program (week 12) for those consumers accessing therapist-assisted programs
Secondary outcome [11] 279023 0
Number of mental health disorder diagnoses, as measured by the number of diagnoses on a person's online assessment (e-PASS report)
Timepoint [11] 279023 0
Pre-program, post-program (week 12) than annually from 1-year post-program through to 5-years post-program

Eligibility
Key inclusion criteria
18 years or older
For the therapist-assisted programs, Australian resident (people residing outside of Australia can only undertake the fully automated self-help programs)
Internet access
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18
No internet access
For the therapist-assisted programs (but not the fully automated self-help programs), not an Australian resident

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants receive different online treatment programs depending on their e-PASS results and personal choice as to which online program to complete. They complete programs at different time points as registration is open continuously.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257928 0
Government body
Name [1] 257928 0
Department of Health and Ageing
Country [1] 257928 0
Australia
Primary sponsor type
University
Name
National eTherapy Centre and BPsyC eTherapy Research Unit, Swinburne University
Address
Mail H29, PO Box 218, Hawthorn, VIC, 3122
Country
Australia
Secondary sponsor category [1] 257119 0
None
Name [1] 257119 0
Address [1] 257119 0
Country [1] 257119 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259940 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 259940 0
Ethics committee country [1] 259940 0
Australia
Date submitted for ethics approval [1] 259940 0
05/10/2009
Approval date [1] 259940 0
30/10/2009
Ethics approval number [1] 259940 0
2009/261

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31821 0
Address 31821 0
Country 31821 0
Phone 31821 0
Fax 31821 0
Email 31821 0
Contact person for public queries
Name 15068 0
A/Prof Britt Klein
Address 15068 0
BPsyC eTherapy Research Unit and National eTherapy Centre, Faculty of Life and Social Sciences, Swinburne University of Technology, Mail H29, PO Box 218, Hawthorn, VIC, 3122
Country 15068 0
Australia
Phone 15068 0
+61 3 9214 8851
Fax 15068 0
Email 15068 0
[email protected]
Contact person for scientific queries
Name 5996 0
A/Prof Britt Klein
Address 5996 0
BPsyC eTherapy Research Unit and National eTherapy Centre, Faculty of Life and Social Sciences, Swinburne University of Technology, Mail H29, PO Box 218, Hawthorn, VIC, 3122
Country 5996 0
Australia
Phone 5996 0
+61 3 9214 8851
Fax 5996 0
Email 5996 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.