Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001103055
Ethics application status
Approved
Date submitted
15/12/2010
Date registered
16/12/2010
Date last updated
9/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of two implementation methods of the e-couch Anxiety and Worry program in an adolescent school-based population.
Scientific title
Comparison of implementation methods and the effect of the e-couch Anxiety and Worry program on generalised anxiety disorder in an adolescent school-based population.
Secondary ID [1] 253301 0
N/A
Universal Trial Number (UTN)
Trial acronym
Y-Worri Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Generalised anxiety disorder 258830 0
Social anxiety disorder 258831 0
Depression 258832 0
Panic disorder 258833 0
Condition category
Condition code
Mental Health 258971 258971 0 0
Depression
Mental Health 258970 258970 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The e-couch Anxiety and Worry program is available online at www.ecouch.anu.edu.au. This program is designed to prevent and reduce symptoms of generalised anxiety and includes information and exercises on psychoeducation, cognitive behavioural therapy, relaxation and physical activity. Schools randomised to the intervention conditions will receive the e-couch Anxiety and Worry program during one class period (50-60 minutes) a week for 6 weeks. The program will be modulated, so as to deliver one section of the program each week. Classroom teachers and headspace education officers will be provided with a trial implementation guide.
Intervention code [1] 257748 0
Prevention
Intervention code [2] 257749 0
Treatment: Other
Comparator / control treatment
Wait-list control (usual classes). The wait-list control condition will be offered the e-couch Anxiety and Worry program at the conclusion of the trial (after the 12-month follow-up questionnaire).
Control group
Active

Outcomes
Primary outcome [1] 259826 0
Mean GAD-7 score (Generalised Anxiety Disorder).
Timepoint [1] 259826 0
Pre-intervention, post-intervention, 6- and 12-month follow-up.
Primary outcome [2] 259825 0
Mean Spence Children's Anxiety Scale (SCAS) score.
Timepoint [2] 259825 0
Pre-intervention, post-intervention, 6- and 12-month follow-up.
Secondary outcome [1] 268651 0
Mean Centre for Epidemiological Studies Depression (CES-D) scale score.
Timepoint [1] 268651 0
Pre-intervention, post-intervention, 6- and 12-month follow-up.
Secondary outcome [2] 268653 0
Mean Childhood Anxiety Sensitivity Index (CASI) score.
Timepoint [2] 268653 0
Pre-intervention, post-intervention, 6- and 12-month follow-up.
Secondary outcome [3] 268652 0
Mean Social Anxiety Scale for Adolescents (SAS-A) score.
Timepoint [3] 268652 0
Pre-intervention, post-intervention, 6- and 12-month follow-up.
Secondary outcome [4] 268654 0
Mean Warwick-Edinburgh Mental Well-being Scale score.
Timepoint [4] 268654 0
Pre-intervention, post-intervention, 6- and 12-month follow-up.

Eligibility
Key inclusion criteria
Male and female adolescents aged betwen 14 and 17 years attending secondary school (Years 9-11).
Minimum age
14 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria. Universal trial.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Individual schools will be approached, with the approval of relevant Education Departments, to participate in the trial. Schools will be randomly allocated to one of the two intervention conditions or to the wait-list control condition by an independent statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation according to school, using a computerised randomisation table.
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
12/04/2011
Actual
25/08/2011
Date of last participant enrolment
Anticipated
Actual
8/06/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
1767
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258216 0
Charities/Societies/Foundations
Name [1] 258216 0
Headspace: Australia's National Youth Mental Health Foundation
Country [1] 258216 0
Australia
Funding source category [2] 258215 0
Charities/Societies/Foundations
Name [2] 258215 0
Vincent Fairfax Family Foundation
Country [2] 258215 0
Australia
Funding source category [3] 258217 0
University
Name [3] 258217 0
Brain and Mind Research Institute, University of Sydney
Country [3] 258217 0
Australia
Primary sponsor type
University
Name
The Australian National University
Address
Acton, Canberra, ACT 0200
Country
Australia
Secondary sponsor category [1] 257386 0
None
Name [1] 257386 0
Address [1] 257386 0
Country [1] 257386 0
Other collaborator category [1] 251739 0
Charities/Societies/Foundations
Name [1] 251739 0
Headspace: Australia's National Youth Mental Health Foundation
Address [1] 251739 0
PO Box 473, North Melbourne, Vic 3051
Country [1] 251739 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260201 0
The Australian National University Human Research Ethics Committee
Ethics committee address [1] 260201 0
Ethics committee country [1] 260201 0
Australia
Date submitted for ethics approval [1] 260201 0
Approval date [1] 260201 0
04/11/2010
Ethics approval number [1] 260201 0
2010/550

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

Contacts
Principal investigator
Name 32018 0
Dr Alison Calear
Address 32018 0
Building 63 Eggleston Road The Australian National University Canberra, ACT 0200
Country 32018 0
Australia
Phone 32018 0
+61 2 6125 8406
Fax 32018 0
Email 32018 0
Alison.Calear@anu.edu.au
Contact person for public queries
Name 15265 0
Dr Alison Calear
Address 15265 0
Building 63
Eggleston Road
The Australian National University
Canberra, ACT 0200
Country 15265 0
Australia
Phone 15265 0
+61 2 6125 8406
Fax 15265 0
+61 2 6125 0733
Email 15265 0
Alison.Calear@anu.edu.au
Contact person for scientific queries
Name 6193 0
Dr Alison Calear
Address 6193 0
Building 63
Eggleston Road
The Australian National University
Canberra, ACT 0200
Country 6193 0
Australia
Phone 6193 0
+61 2 6125 8406
Fax 6193 0
+61 2 6125 0733
Email 6193 0
Alison.Calear@anu.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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.