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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 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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anxiety

Depression

Condition category

Condition code

Mental Health

Anxiety

Mental Health

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]

Treatment: Other

Intervention code [2]

Behaviour

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression.

Timepoint [1]

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]

Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.

Timepoint [2]

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]

Kessler 10-Item (K-10), which measures symptoms of psychological distress.

Timepoint [1]

Administered at pre-treatment, post-treatment, at 3-months and 12-months post-treatment

Secondary outcome [2]

Sheehan Disability Scale (SDS), which is a measure of disability or functional impairment

Timepoint [2]

Administered at pre-treatment, post-treatment, at 3-months and 12-months post-treatment

Secondary outcome [3]

The Things You Do Questionnaire, which measures frequency of adaptive behaviours performed by a participant in the previous week

Timepoint [3]

Administered at pre-treatment, post-treatment, at 3-months and 12-months post-treatment

Secondary outcome [4]

Multigroup Ethnic Identity Measure -Revised (MEIM-R), which measures the strength of association to ethnic identity

Timepoint [4]

Administered at pretreatment only

Secondary outcome [5]

Stephenson Multigroup Acculturation Scale (SMAS), which measures levels of acculturation.

Timepoint [5]

Administered at pretreatment only

Secondary outcome [6]

Transcultural Acculturation Scale, which measures level of acculturation.

Timepoint [6]

Administered in pretreatment only

Secondary outcome [7]

Intervention satisfaction measures, which measures satisfaction with intervention, using a Likert Scale survey designed specifically for this study.

Timepoint [7]

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?

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

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Macquarie University

Address [1]

eCentreClinic, The Centre For Emotional Health (CEH), Department of Psychology, Macquarie University, NSW, 2109, Australia.

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Associate Professor Nick Titov

Address [1]

Department of Psychology, Macquarie University, NSW, 2109, Australia.

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Dr Luke Johnston

Address [2]

Department of Psychology, Macquarie University, NSW, 2109, Australia.

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Mr Rony Kayrouz

Address [3]

Department of Psychology, Macquarie University, NSW, 2109, Australia.

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Mr Matthew Terides

Address [4]

Department of Psychology, Macquarie University, NSW 2109, Australia

Country [4]

Australia

Other collaborator category [5]

Individual

Name [5]

Dr Vincent Fogliati

Address [5]

Department of Psychology, Macquarie University, NSW 2109, Australia

Country [5]

Australia

Other collaborator category [6]

Individual

Name [6]

Dr. Milena Gandy

Address [6]

Department of Psychology, Macquarie University, NSW 2109, Australia

Country [6]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Macquarie University, Human Research Ethics Committee

Ethics committee address [1]

Human Research Ethics Committee
Level 3, Research Hub, Building C5C, Macquarie University, NSW, 2109

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/11/2013

Approval date [1]

17/01/2014

Ethics approval number [1]

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

Mr Rony Kayrouz

Address

eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.

Country

Australia

Phone

+61 2 9850 9643

Fax

+61 2 9850 8062

rony.kayrouz@students.mq.edu.au

Contact person for public queries

Name

Blake F. Dear

Address

eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.

Country

Australia

Phone

+61 2 9850 9979

Fax

+61 2 9850 8062

blake.dear@mq.edu.au

Contact person for scientific queries

Name

Blake F. Dear

Address

eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109.

Country

Australia

Phone

+61 2 9850 9979

Fax

+61 2 9850 8062

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

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
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
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

N.B. These documents automatically identified may not have been verified by the study sponsor.

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