Trial Review

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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
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.
Secondary ID [1] 283989 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 291020 0
Depression 291021 0
Condition category
Condition code
Mental Health 291364 291364 0 0
Anxiety
Mental Health 291365 291365 0 0
Depression

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 288675 0
Treatment: Other
Intervention code [2] 288700 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291360 0
Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression.
Timepoint [1] 291360 0
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
Primary outcome [2] 291363 0
Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.
Timepoint [2] 291363 0
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
Secondary outcome [1] 306594 0
Kessler 10-Item (K-10), which measures symptoms of psychological distress.
Timepoint [1] 306594 0
Administered at pre-treatment, post-treatment, at 3-months and 12-months post-treatment
Secondary outcome [2] 306595 0
Sheehan Disability Scale (SDS), which is a measure of disability or functional impairment
Timepoint [2] 306595 0
Administered at pre-treatment, post-treatment, at 3-months and 12-months post-treatment
Secondary outcome [3] 306596 0
The Things You Do Questionnaire, which measures frequency of adaptive behaviours performed by a participant in the previous week
Timepoint [3] 306596 0
Administered at pre-treatment, post-treatment, at 3-months and 12-months post-treatment
Secondary outcome [4] 306597 0
Multigroup Ethnic Identity Measure -Revised (MEIM-R), which measures the strength of association to ethnic identity
Timepoint [4] 306597 0
Administered at pretreatment only
Secondary outcome [5] 306598 0
Stephenson Multigroup Acculturation Scale (SMAS), which measures levels of acculturation.
Timepoint [5] 306598 0
Administered at pretreatment only
Secondary outcome [6] 306599 0
Transcultural Acculturation Scale, which measures level of acculturation.
Timepoint [6] 306599 0
Administered in pretreatment only
Secondary outcome [7] 306600 0
Intervention satisfaction measures, which measures satisfaction with intervention, using a Likert Scale survey designed specifically for this study.
Timepoint [7] 306600 0
Administered at post-treatment, 3-months and 12-months post-treatment

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As open trial, no randomisation sequence required
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The multiple regression analysis of examining whether acculturation and cultural identity levels predicted treatment outcome was not conducted.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
10/02/2014
Actual
30/06/2014
Date of last participant enrolment
Anticipated
Actual
2/03/2015
Date of last data collection
Anticipated
Actual
2/08/2015
Sample size
Target
150
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 288616 0
University
Name [1] 288616 0
Macquarie University
Country [1] 288616 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
eCentreClinic, The Centre For Emotional Health (CEH), Department of Psychology, Macquarie University, NSW, 2109, Australia.
Country
Australia
Secondary sponsor category [1] 287326 0
None
Name [1] 287326 0
Address [1] 287326 0
Country [1] 287326 0
Other collaborator category [1] 277784 0
Individual
Name [1] 277784 0
Associate Professor Nick Titov
Address [1] 277784 0
Department of Psychology, Macquarie University, NSW, 2109, Australia.
Country [1] 277784 0
Australia
Other collaborator category [2] 277785 0
Individual
Name [2] 277785 0
Dr Luke Johnston
Address [2] 277785 0
Department of Psychology, Macquarie University, NSW, 2109, Australia.
Country [2] 277785 0
Australia
Other collaborator category [3] 277786 0
Individual
Name [3] 277786 0
Mr Rony Kayrouz
Address [3] 277786 0
Department of Psychology, Macquarie University, NSW, 2109, Australia.
Country [3] 277786 0
Australia
Other collaborator category [4] 277787 0
Individual
Name [4] 277787 0
Mr Matthew Terides
Address [4] 277787 0
Department of Psychology, Macquarie University, NSW 2109, Australia
Country [4] 277787 0
Australia
Other collaborator category [5] 277788 0
Individual
Name [5] 277788 0
Dr Vincent Fogliati
Address [5] 277788 0
Department of Psychology, Macquarie University, NSW 2109, Australia
Country [5] 277788 0
Australia
Other collaborator category [6] 277789 0
Individual
Name [6] 277789 0
Dr. Milena Gandy
Address [6] 277789 0
Department of Psychology, Macquarie University, NSW 2109, Australia
Country [6] 277789 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290476 0
Macquarie University, Human Research Ethics Committee
Ethics committee address [1] 290476 0
Human Research Ethics Committee
Level 3, Research Hub, Building C5C, Macquarie University, NSW, 2109
Ethics committee country [1] 290476 0
Australia
Date submitted for ethics approval [1] 290476 0
02/11/2013
Approval date [1] 290476 0
17/01/2014
Ethics approval number [1] 290476 0
5201300657

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.
Trial website
www.ecentreclinic.org
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.
Public notes

Contacts
Principal investigator
Name 45870 0
Mr Rony Kayrouz
Address 45870 0
eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
Country 45870 0
Australia
Phone 45870 0
+61 2 9850 9643
Fax 45870 0
+61 2 9850 8062
Email 45870 0
rony.kayrouz@students.mq.edu.au
Contact person for public queries
Name 45871 0
Dr Blake F. Dear
Address 45871 0
eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
Country 45871 0
Australia
Phone 45871 0
+61 2 9850 9979
Fax 45871 0
+61 2 9850 8062
Email 45871 0
blake.dear@mq.edu.au
Contact person for scientific queries
Name 45872 0
Dr Blake F. Dear
Address 45872 0
eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.
Country 45872 0
Australia
Phone 45872 0
+61 2 9850 9979
Fax 45872 0
+61 2 9850 8062
Email 45872 0
blake.dear@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Group means, SDs and effect sizes
When will data be available (start and end dates)?
no end date
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.
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.
How or where can data be obtained?
Macquarie University Shared One drive


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Kayrouz, R., Dear, B. F., Karin, E., Gandy, M., Fo... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFacebook as an effective recruitment strategy for mental health research of hard to reach populations.2016https://dx.doi.org/10.1016/j.invent.2016.01.001
EmbaseA pilot study of self-guided internet-delivered cognitive behavioural therapy for anxiety and depression among Arabs.2016https://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.