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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
Universal Trial Number (UTN)
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
Mental Health 286173 286173 0 0

Study type
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
Intervention code [2] 284399 0
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

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

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria

Study design
Purpose of the study
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
Other design features
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5071 0
Recruitment postcode(s) [2] 5078 0
Recruitment postcode(s) [3] 5069 0
Recruitment postcode(s) [4] 5070 0
Recruitment postcode(s) [5] 5077 0
Recruitment postcode(s) [6] 5080 0
Recruitment postcode(s) [7] 5079 0
Recruitment postcode(s) [8] 5076 0
Recruitment postcode(s) [9] 5072 0
Recruitment postcode(s) [10] 5075 0
Recruitment postcode(s) [11] 5073 0
Recruitment postcode(s) [12] 5074 0

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
Primary sponsor type
The Clinical Unit of Anxiety and Depression (CRUfAD), St Vincent's Hospital, Sydney
Level 4, The O'Brien Centre
St Vincent's Hospital
394-404 Victoria Street
Darlinghurst NSW 2010
Secondary sponsor category [1] 283714 0
Name [1] 283714 0
Address [1] 283714 0
Country [1] 283714 0

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 286826 0
Approval date [1] 286826 0
Ethics approval number [1] 286826 0

Brief summary
The aim is to assess the feasibility and efficacy of an evidence-based internet anxiety and depression prevention program for year 9-10 of high school. Currently, evidence-based programs do exist, but are largely not implemented in schools due to implementation (e.g., limited resources and teacher training) and dissemination failure. The aim of developing CRUfAD Schools: Alcohol Module is to overcome such concerns by developing a online intervention which would have the advantage of providing complete, consistent and flexible delivery on every occasion, without demanding excess teacher’s time, resources and training. CRUfAD Schools: Overcoming Anxiety and Combating Depression would also have the potential advantage of being an interactive program which would allow high-risk populations, who often do not seek help, to seek help with relative anonymity and confidentiality.
Trial website
Trial related presentations / publications
Wong N, Kady L, Mewton L, Sunderland M, Andrews G. Preventing anxiety and depression in adolescents: A randomised controlled trial of two school based Internet-delivered cognitive behavioural therapy programmes. Internet Interventions 1(2):90-94 Apr 2014 DOI
Public notes

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
Phone 33865 0
+612 8382 1405
Fax 33865 0
Email 33865 0
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
Phone 17112 0
+61 02 8382 1400
Fax 17112 0
+61 02 8382 1402
Email 17112 0
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
Phone 8040 0
+61 02 8382 1400
Fax 8040 0
+61 02 8382 1402
Email 8040 0

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.