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Trial registered on ANZCTR
Registration number
ACTRN12614000124639
Ethics application status
Approved
Date submitted
28/01/2014
Date registered
3/02/2014
Date last updated
28/10/2021
Date data sharing statement initially provided
28/10/2021
Date results information initially provided
28/10/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
A Trial of Self-Guided Internet-Delivered Education for Adults of an Arabic speaking background With Symptoms of Anxiety or Depression
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Scientific title
A open trial of self-guided internet delivered education course for Arabs with symptoms of depression and anxiety evaluating the treatment efficacy of a culturally-adapted course.
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Secondary ID [1]
283989
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anxiety
291020
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Depression
291021
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Condition category
Condition code
Mental Health
291364
291364
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0
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Anxiety
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Mental Health
291365
291365
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0
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will be assigned to one group: 1) a culturally-adapted treatment group. All participants will have at least mild symptoms of anxiety and/or depression (i.e. have a score or greater than 4 on the PHQ-9 and GAD-7 questionnaires). All participants will complete 5 lessons of Internet based treatment about management of symptoms of anxiety and depression. One lesson will be completed every 7 to 10 days. Each lesson will take about 15 minutes to complete. Participants will also have access to summaries of each lesson, and will read anonymous stories about other people with anxiety and depression, taking a further 20 minutes per summary. Online monitoring will occur to monitor lessons completed and treatment adherence. When each participant clicks through all the slides of each lesson the computer will log the time spent on the lesson and the time/date when the lesson was completed.
All Participants will have access to the culturally-adapted Wellbeing intervention Course that involves the same overall structure as the non-adapted version. However the adaptation will involve the following: (a) using Arabic names; (b) presenting main themes that may be relevant to the Arabic speaking community in the case studies and stories (c) use of key words written in English and Arabic throughout the Course; (d) inclusion of content that reflects that some find their relationship with God is important for wellbeing; and (e) finally the inclusion of an additional optional resource (i.e., Religion/Spiirtuality and Wellbeing) that includes culturally and religious accepted practices. In all other respects the Courses are identical.
All participants will also receive automatic email reminders. The duration of the reminder emails expected to be 2-3 minutes per week. The duration of the program is 8 weeks, and participants will be contacted at 3 months and 12 months post program and asked to complete follow-up questionnaires. Outcome questionnaires will be administered at application, pre-treatment, post-treatment, 3-months and 12-months follow-up. These will take about 20-30 minutes to complete. The treatment materials are based on previous internet-based programs, which apply cognitive behavioural techniques.
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Intervention code [1]
288675
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Treatment: Other
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Intervention code [2]
288700
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Behaviour
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Comparator / control treatment
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression.
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Assessment method [1]
291360
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Timepoint [1]
291360
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Administered at pre-treatment, mid-treatment (on completion of Lesson 3, after 4 weeks of treatment), post-treatment, and at 3-months and 12-months post-treatment
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Primary outcome [2]
291363
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Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.
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Assessment method [2]
291363
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Timepoint [2]
291363
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Administered at pre-treatment, mid-treatment (on completion of Lesson 3; after 4 weeks of treatment), post-treatment, at 3-months and 12-months post-treatment
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Secondary outcome [1]
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Kessler 10-Item (K-10), which measures symptoms of psychological distress.
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Assessment method [1]
306594
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Timepoint [1]
306594
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Administered at pre-treatment, post-treatment, at 3-months and 12-months post-treatment
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Secondary outcome [2]
306595
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Sheehan Disability Scale (SDS), which is a measure of disability or functional impairment
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Assessment method [2]
306595
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Timepoint [2]
306595
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Administered at pre-treatment, post-treatment, at 3-months and 12-months post-treatment
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Secondary outcome [3]
306596
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The Things You Do Questionnaire, which measures frequency of adaptive behaviours performed by a participant in the previous week
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Assessment method [3]
306596
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Timepoint [3]
306596
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Administered at pre-treatment, post-treatment, at 3-months and 12-months post-treatment
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Secondary outcome [4]
306597
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Multigroup Ethnic Identity Measure -Revised (MEIM-R), which measures the strength of association to ethnic identity
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Assessment method [4]
306597
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Timepoint [4]
306597
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Administered at pretreatment only
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Secondary outcome [5]
306598
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Stephenson Multigroup Acculturation Scale (SMAS), which measures levels of acculturation.
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Assessment method [5]
306598
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Timepoint [5]
306598
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Administered at pretreatment only
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Secondary outcome [6]
306599
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Transcultural Acculturation Scale, which measures level of acculturation.
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Assessment method [6]
306599
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Timepoint [6]
306599
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Administered in pretreatment only
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Secondary outcome [7]
306600
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Intervention satisfaction measures, which measures satisfaction with intervention, using a Likert Scale survey designed specifically for this study.
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Assessment method [7]
306600
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Timepoint [7]
306600
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Administered at post-treatment, 3-months and 12-months post-treatment
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Eligibility
Key inclusion criteria
(1) Adults of Arabic Ancestry
(2) Ability to read and understand English at a basic level (i.e., read a local newspaper)
(2) 18+ years of age,
(3) Not currently participating in CBT for target symptoms,
(4) A score above 4 on the GAD-7 and above 4 on the PHQ-9 (indicating at least mild anxiety or depression),
(5) Provides informed consent,
(6) Reliable internet access
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1) Severe depression (i.e. score > 22 on PHQ-9), suicidal intention or plan
(2) Principal problem not anxiety or low mood/depression
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants of an Arabic speaking background from any where in the world apply online via the clinic's website (www.ecentreclinic.org.au). Successful applications are allocated to one group (i.e. culturally adapted version of Wellbeing Course).
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As open trial, no randomisation sequence required
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The multiple regression analysis of examining whether acculturation and cultural identity levels predicted treatment outcome was not conducted.
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data analysis is complete
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
10/02/2014
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Actual
30/06/2014
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Date of last participant enrolment
Anticipated
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Actual
2/03/2015
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Date of last data collection
Anticipated
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Actual
2/08/2015
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Sample size
Target
150
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Accrual to date
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Final
36
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
288616
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University
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Name [1]
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Macquarie University
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Address [1]
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eCentreClinic, The Centre For Emotional Health (CEH), Department of Psychology, Macquarie University, NSW, 2109, Australia.
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Country [1]
288616
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Australia
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Primary sponsor type
University
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Name
Macquarie University
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Address
eCentreClinic, The Centre For Emotional Health (CEH), Department of Psychology, Macquarie University, NSW, 2109, Australia.
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Country
Australia
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Secondary sponsor category [1]
287326
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None
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Name [1]
287326
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Address [1]
287326
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Country [1]
287326
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Other collaborator category [1]
277784
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Individual
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Name [1]
277784
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Associate Professor Nick Titov
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Address [1]
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Department of Psychology, Macquarie University, NSW, 2109, Australia.
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Country [1]
277784
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Australia
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Other collaborator category [2]
277785
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Individual
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Name [2]
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Dr Luke Johnston
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Address [2]
277785
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Department of Psychology, Macquarie University, NSW, 2109, Australia.
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Country [2]
277785
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Australia
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Other collaborator category [3]
277786
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Individual
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Name [3]
277786
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Mr Rony Kayrouz
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Address [3]
277786
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Department of Psychology, Macquarie University, NSW, 2109, Australia.
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Country [3]
277786
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Australia
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Other collaborator category [4]
277787
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Individual
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Name [4]
277787
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Mr Matthew Terides
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Address [4]
277787
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Department of Psychology, Macquarie University, NSW 2109, Australia
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Country [4]
277787
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Australia
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Other collaborator category [5]
277788
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Individual
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Name [5]
277788
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Dr Vincent Fogliati
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Address [5]
277788
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Department of Psychology, Macquarie University, NSW 2109, Australia
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Country [5]
277788
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Australia
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Other collaborator category [6]
277789
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Individual
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Name [6]
277789
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Dr. Milena Gandy
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Address [6]
277789
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Department of Psychology, Macquarie University, NSW 2109, Australia
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Country [6]
277789
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
290476
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Macquarie University, Human Research Ethics Committee
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Ethics committee address [1]
290476
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Human Research Ethics Committee
Level 3, Research Hub, Building C5C, Macquarie University, NSW, 2109
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Ethics committee country [1]
290476
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Australia
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Date submitted for ethics approval [1]
290476
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02/11/2013
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Approval date [1]
290476
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17/01/2014
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Ethics approval number [1]
290476
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5201300657
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Summary
Brief summary
This project builds on an earlier project and seeks to examine the efficacy and acceptability of the Wellbeing Course for Arabs. We expect overall the Course that symptoms of anxiety and depression will improve in the culturally-adapted group. However, we expect that the participants who are more acculturated will do better in the culturally adapted version of the Wellbeing Course.
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Trial website
www.ecentreclinic.org
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Trial related presentations / publications
- Kayrouz, R., Titov, N., Dear, B. F., Johnston, L., Terides, M., Fogliatti, V., & Gandy, M. (submitted). An open trial of guided iCBT intervention to determine the benefits of the Wellbeing Course for Arab Australians with symptoms of anxiety and depression. Transcultural Psychiatry.
- Johnston, L., Titov, N., Andrews, G., Dear, B. F., & Spence, J. (submitted). Comorbidity and internet-delivered transdiagnostic cognitive behavioural therapy for anxiety disorders. Cognitive Behaviour Therapy.
- Dear, B. F., Titov, N., Schwencke, G., Andews, G., Johnston, L., Craske, M. G., & McEvoy, P. (2011). An open trial of a brief transdiagnostic treatment for anxiety and depression. Behaviour Research and Therapy, 49, 830-837.
- Johnston, L., Titov, N., Andrews, G., Spence, J., & Dear, B.F. (2011). A RCT of a transdiagnostic internet-delivered treatment for three anxiety disorders: Examination of support roles and disorder-specific outcomes. PLoS ONE 6(11): e28079.
- Titov N., Dear B.F., Schwencke G., Andrews G., Johnston L., Craske M., & McEvoy, P. (2011). Transdiagnostic Internet treatment of anxiety and depression: A randomised controlled trial. Behaviour Research and Therapy, 49, 441-452.
- Titov, N., Andrews, G., Johnston, L., Robinson, E., & Spence, J. (2010). Transdiagnostic Internet treatment for anxiety disorders: A randomized controlled trial. Behaviour Research and Therapy, 48, 890-899.
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Public notes
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Contacts
Principal investigator
Name
45870
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Mr Rony Kayrouz
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Address
45870
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eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
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Country
45870
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Australia
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Phone
45870
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+61 2 9850 9643
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Fax
45870
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+61 2 9850 8062
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Email
45870
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[email protected]
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Contact person for public queries
Name
45871
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Dr Blake F. Dear
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Address
45871
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eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
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Country
45871
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Australia
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Phone
45871
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+61 2 9850 9979
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Fax
45871
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+61 2 9850 8062
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Email
45871
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[email protected]
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Contact person for scientific queries
Name
45872
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Dr Blake F. Dear
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Address
45872
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eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
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Country
45872
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Australia
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Phone
45872
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+61 2 9850 9979
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Fax
45872
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+61 2 9850 8062
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Email
45872
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Group means, SDs and effect sizes
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When will data be available (start and end dates)?
no end date
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Available to whom?
Access will be provided to researchers, subject to a formal written request, the generation of a methodologically sound research protocol, the establishment of appropriate data governance, and the approval of an independent and recognised Human Research Ethics Committee.
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Available for what types of analyses?
Data is available for a generalised estimation equation (GEE) modelling technique which examine changes in the symptom measures over time. GEE emphasizes the modelling of change in an average group effect over time while accounting for within-subject variance with the specification of a working correlation structure.
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How or where can data be obtained?
Macquarie University Shared One drive
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Kayrouz, R., Dear, B. F., Karin, E., Gandy, M., Fo...
[
More Details
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Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Facebook as an effective recruitment strategy for mental health research of hard to reach populations.
2016
https://dx.doi.org/10.1016/j.invent.2016.01.001
Embase
A pilot study of self-guided internet-delivered cognitive behavioural therapy for anxiety and depression among Arabs.
2016
https://dx.doi.org/10.1016/j.invent.2015.10.005
N.B. These documents automatically identified may not have been verified by the study sponsor.
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