Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000414819
Ethics application status
Approved
Date submitted
22/03/2012
Date registered
13/04/2012
Date last updated
25/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Clinical Research Unit for Anxiety and Depression (CRUfAD) Schools Program for the Prevention of Adolescent Anxiety and Depression - A Randomised Controlled Trial
Scientific title
A Randomised Controlled Trial of Two School Based Internet-Delivered Cognitive Behavioural Therapy Programs for Adolescent Anxiety and Depression
Secondary ID [1] 280074 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
CRUfADschools Program for Anxiety and Depression
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 285982 0
Generalised Anxiety Disorder 285983 0
Condition category
Condition code
Mental Health 286172 286172 0 0
Depression
Mental Health 286173 286173 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CRUfAD Schools: Overcoming Anxiety and Combating Depression is an online universal prevention program delivered as part of the Personal Development, Health and Physical Education (PDHPE) Syllabus for New South Wales.
Participants will receive access to the CRUfADschool’s anxiety and depression course as an internet Cognitive Behaviour Therapy (iCBT) program. This iCBT program is based on the efficacy of the CRUfAD Schools model in stress, alcohol and cannabis in three earlier based interventions (Van Vilet & Andrews, 2009), (Newton, Andrews, Teesson, & Vogl, 2009; Newton, Teesson, Vogl, & Andrews, 2010; Vogl et al., 2009). The Overcoming Anxiety program consist of six lessons and summaries and the Combating Depression program contains seven lessons.
Both represent best practice principles used in Cognitive Behaviour Therapy (CBT) for depression and anxiety including skill acquisition, psychoeducation, and management of psychological symptoms, cognitive symptoms, behaviour and additional skills specific to each disorder. The program was delivered once a week over a total of six weeks. The lessons run for 40 minutes using blended (online and classroom) teaching techniques.
The first is a 15-20 minute online module. Students are instructed to log onto the program and individually undertake the self-directed program. Students complete quizzes and follow a cartoon storyline of teenagers experiencing and solving real life problems with anxiety and depression. As participants progress through each lesson they complete quizzes and a lesson summary activity sheet. The second half of the lesson, students return to a class discussion. Using the downloadable teacher’s manual, teachers are instructed to hand out a set of activities and resources to reinforce the information learnt in the previous lesson. Teachers in the intervention group required minimal training. The control schools received PDHPE classes as usual.
Intervention code [1] 284396 0
Prevention
Intervention code [2] 284399 0
Behaviour
Intervention code [3] 284400 0
Treatment: Other
Comparator / control treatment
Standard treatment was used. Participants attended their regular personal development and health lessons (PDHPE) under the supervision of their regular class teacher.
Control group
Active

Outcomes
Primary outcome [1] 286645 0
Symptoms and severity of depression is measured by the short-form Patient Health Questionnaire-5 (PHQ-5).
Timepoint [1] 286645 0
Administered at pre-treatment and post-treatment
Primary outcome [2] 286646 0
Generalised Anxiety Disorder is measured by the Generalized Anxiety Disorder - 7 Item (GAD-7) questionnaire.
Timepoint [2] 286646 0
Administered at pre-treatment and post-treatment
Secondary outcome [1] 296370 0
Psychological distress as measured by the Kessler Psychological Distress Scale 6 Item (K-6).
Timepoint [1] 296370 0
Administered at pre-treatment and post-treatment
Secondary outcome [2] 296371 0
Knowledge questionnaire for depression and anxiety as a test of knowledge gained
Name of questionnaire: N/A
Timepoint [2] 296371 0
Administered at pre-treatment and post-treatment

Eligibility
Key inclusion criteria
Students currently enrolled in year 9-10 of high school (14-16 years old) who provide self and parental consent. Schools: Catholic and Independent high schools.
Minimum age
14 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
Randomisation occurred at the level of school (not at the individual student). Schools were invited to participate in the condition to which they had been allocated as determined by a random allocation schedule. The condition to which schools were allocated was not concealed from the schools. However, students were not informed about the use of a CONTROL versus INTERVENTION to ensure this did not bias responding.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation process was completed by an independent researcher, who developed a simple randomisation schedule for schools using a coin tossing procedure.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/07/2008
Actual
28/07/2008
Date of last participant enrolment
Anticipated
Actual
28/07/2009
Date of last data collection
Anticipated
Actual
31/12/2009
Sample size
Target
976
Accrual to date
Final
976
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 5069 0
2031
Recruitment postcode(s) [2] 5070 0
2069
Recruitment postcode(s) [3] 5071 0
2024
Recruitment postcode(s) [4] 5072 0
2444
Recruitment postcode(s) [5] 5073 0
2602
Recruitment postcode(s) [6] 5074 0
2800
Recruitment postcode(s) [7] 5075 0
2582
Recruitment postcode(s) [8] 5076 0
2155
Recruitment postcode(s) [9] 5077 0
2076
Recruitment postcode(s) [10] 5078 0
2029
Recruitment postcode(s) [11] 5079 0
2154
Recruitment postcode(s) [12] 5080 0
2099

Funding & Sponsors
Funding source category [1] 284836 0
Government body
Name [1] 284836 0
Australian Government Department of Health and Ageing
Country [1] 284836 0
Australia
Primary sponsor type
Hospital
Name
The Clinical Unit of Anxiety and Depression (CRUfAD), St Vincent's Hospital, Sydney
Address
Level 4, The O'Brien Centre
St Vincent's Hospital
394-404 Victoria Street
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 283714 0
None
Name [1] 283714 0
Address [1] 283714 0
Country [1] 283714 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286826 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 286826 0
Ethics committee country [1] 286826 0
Australia
Date submitted for ethics approval [1] 286826 0
Approval date [1] 286826 0
11/03/2008
Ethics approval number [1] 286826 0
08001

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

Contacts
Principal investigator
Name 33865 0
Prof Gavin Andrews
Address 33865 0
Level 4, The O'Brien Centre St Vincent's Hospital 394-404 Victoria Street Darlinghurst NSW 2010
Country 33865 0
Australia
Phone 33865 0
+612 8382 1405
Fax 33865 0
Email 33865 0
[email protected]
Contact person for public queries
Name 17112 0
Gavin Andrews
Address 17112 0
Level 4, The O'Brien Centre
St Vincent's Hospital
394-404 Victoria Street
Darlinghurst NSW 2010
Country 17112 0
Australia
Phone 17112 0
+61 02 8382 1400
Fax 17112 0
+61 02 8382 1402
Email 17112 0
[email protected]
Contact person for scientific queries
Name 8040 0
Gavin Andrews
Address 8040 0
Level 4, The O'Brien Centre
St Vincent's Hospital
394-404 Victoria Street
Darlinghurst NSW 2010
Country 8040 0
Australia
Phone 8040 0
+61 02 8382 1400
Fax 8040 0
+61 02 8382 1402
Email 8040 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.