Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000408088
Ethics application status
Approved
Date submitted
18/05/2010
Date registered
21/05/2010
Date last updated
15/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot trial of the e-couch Anxiety and Worry program in an adolescent school-based population.
Scientific title
Effect of the e-couch Anxiety and Worry program on generalised anxiety disorder in an adolescent school-based population.
Secondary ID [1] 251792 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Generalised anxiety disorder 257391 0
Social anxiety disorder 257392 0
Depression 257393 0
Panic disorder 257394 0
Condition category
Condition code
Mental Health 257537 257537 0 0
Anxiety
Mental Health 257538 257538 0 0
Depression

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. Classes randomised to the intervention condition will deliver the e-couch Anxiety & Worry program during one class period (50-60 minutes) a week for 6 weeks. Students will be provided with a step-by-step guide for the program each week, which will provide information on the components of the program to be completed each week. Classroom teachers will go through this guide with students prior to completion.
Intervention code [1] 256500 0
Prevention
Intervention code [2] 256528 0
Treatment: Other
Comparator / control treatment
Wait-list control (usual classes). The wait-list control condition will be offered the e-couch Anxiety & Worry program at the conclusion of the trial (after the 3-month follow-up questionnaire).
Control group
Active

Outcomes
Primary outcome [1] 258449 0
Mean GAD-7 (Generalised Anxiety Disorder) score.
Timepoint [1] 258449 0
Pre-intervention, post-intervention and 3-month follow-up.
Primary outcome [2] 258450 0
Mean Spence Children's Anxiety Scale (SCAS) score.
Timepoint [2] 258450 0
Pre-intervention, post-intervention and 3-month follow-up.
Secondary outcome [1] 264240 0
Mean Center for Epidemiological Studies Depression (CES-D) scale score.
Timepoint [1] 264240 0
Pre-intervention, post-intervention and 3-month follow-up.
Secondary outcome [2] 264241 0
Mean Social Anxiety Scale for Adolescents (SAS-A) score.
Timepoint [2] 264241 0
Pre-intervention, post-intervention and 3-month follow-up.
Secondary outcome [3] 264242 0
Mean Childhood Anxiety Sensitivity Index (CASI) score.
Timepoint [3] 264242 0
Pre-intervention, post-intervention and 3-month follow-up.

Eligibility
Key inclusion criteria
Male and female adolescents aged between 14 and 18 years attending secondary school.
Minimum age
14 Years
Maximum age
18 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)
Classes within schools were randomly allocated to the intervention or wait-list control conditon 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
13/05/2010
Actual
13/05/2010
Date of last participant enrolment
Anticipated
Actual
13/05/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
225
Recruitment in Australia
Recruitment state(s)
ACT,SA
Recruitment postcode(s) [1] 2897 0
2612
Recruitment postcode(s) [2] 2898 0
5072
Recruitment postcode(s) [3] 2899 0
5290

Funding & Sponsors
Funding source category [1] 256987 0
Government body
Name [1] 256987 0
ACT Health and Medical Research Council
Country [1] 256987 0
Australia
Primary sponsor type
University
Name
The Australian National University
Address
Acton, Canberra, ACT 0200
Country
Australia
Secondary sponsor category [1] 256251 0
None
Name [1] 256251 0
Address [1] 256251 0
Country [1] 256251 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258997 0
The Australian National University Human Research Ethics Committee
Ethics committee address [1] 258997 0
Ethics committee country [1] 258997 0
Australia
Date submitted for ethics approval [1] 258997 0
Approval date [1] 258997 0
16/02/2010
Ethics approval number [1] 258997 0
2010/001

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

Contacts
Principal investigator
Name 31177 0
Dr Alison Calear
Address 31177 0
63 Eggleston Road, The Australian National Univesity, ACT 2601
Country 31177 0
Australia
Phone 31177 0
+61 2 6125 8406
Fax 31177 0
Email 31177 0
Alison.Calear@anu.edu.au
Contact person for public queries
Name 14424 0
Dr Alison Calear
Address 14424 0
63 Eggleston Road, The Australian National Univesity, ACT 2601
Country 14424 0
Australia
Phone 14424 0
+61 2 6125 8406
Fax 14424 0
Email 14424 0
Alison.Calear@anu.edu.au
Contact person for scientific queries
Name 5352 0
Dr Alison Calear
Address 5352 0
63 Eggleston Road, The Australian National Univesity, ACT 2601
Country 5352 0
Australia
Phone 5352 0
+61 2 6125 8406
Fax 5352 0
Email 5352 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.