Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001329752
Ethics application status
Approved
Date submitted
28/11/2013
Date registered
3/12/2013
Date last updated
22/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
An open trial of a guided internet-delivered cognitive behavioural therapy intervention to determine the benefits of the Wellbeing Course for Arab Australians with symptoms of anxiety and depression
Scientific title
An open trial of a guided internet-delivered cognitive behavioural therapy intervention to determine the benefits of the Wellbeing Course for Arab Australians with symptoms of anxiety and depression
Secondary ID [1] 283659 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 290610 0
Depression 290639 0
Condition category
Condition code
Mental Health 291000 291000 0 0
Depression
Mental Health 291001 291001 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this open trial participants will receive access to an 8 week internet-delivered education course, the Wellbeing Course (Arabic speaking background), which teaches participants how to manage symptoms of anxiety and low mood. All participants will have at least mild symptoms of depression or anxiety (PHQ-9 or GAD-7 total score of >4).

The Wellbeing Course comprises 5 online lessons, which describe evidence-based cognitive behavioural and interpersonal therapy strategies for managing cognitive, behavioural, and physical symptoms of anxiety and low mood. One lesson will be completed every 7 to 10 days. Each lesson will take about 15 minutes to read. Participants will also have access to summaries of each lesson, and will read anonymous stories about other people with anxiety, taking a further 20 minutes per week. All participants will also receive 10-20 automatic emails to promote adherence and engagement, and brief weekly (<10minutes week) supportive telephone calls from a experienced counsellor.

Study questionnaires will be administered at application, pre-intervention, post-intervention, and at 3-months post-intervention. These will take about 20-30 minutes to complete.

Strategy used to monitor adherence to the intervention is online monitoring of lessons completed (i.e., completion is logged online once the participant clicks through all the slides of the lesson).
Intervention code [1] 288361 0
Treatment: Other
Intervention code [2] 288378 0
Behaviour
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290983 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [1] 290983 0
Administered at pre-intervention, prior to each Lesson in the course, post-intervention, and at 3-months post-intervention
Secondary outcome [1] 305742 0
Symptoms of anxiety are measured by the Generalised Anxiety Disorder 7 Item Scale (GAD-7).
Timepoint [1] 305742 0
Administered at pre-intervention, prior to each Lesson in the course, post-intervention, and at 3-months post-intervention
Secondary outcome [2] 305743 0
Symptoms of psychological distress are measured by the Kessler-10 Item (K-10)
Timepoint [2] 305743 0
Administered at pre-intervention, post-intervention, and at 3-months post-intervention
Secondary outcome [3] 305744 0
Levels of impairment in functioning are measured by the Sheehan Disability Scale (SDS)
Timepoint [3] 305744 0
Administered at pre-intervention, post-intervention, and at 3-months post-intervention
Secondary outcome [4] 305745 0
Frequency of adaptive behaviours are measured by the Things You Do Questionnaire (TYDQ)
Timepoint [4] 305745 0
Administered at pre-intervention, post-intervention, and at 3-months post-intervention

Eligibility
Key inclusion criteria
1) Resident of Australia,
(2) Of Arabic ancestry,
(3) 18-70 years of age,
(4) English reading ability level at year 9 equivalence or above.
(5) Not currently participating in CBT for target symptoms,
(6) A score above 4 on the GAD-7 (indicating at least mild anxiety) or above 4 on the PHQ-9 (indicating at least mild depression),
(7) Provides informed consent,
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Very severe depression (i.e. score > 22 on PHQ-9)
(2) Suicidal intention or plan (determined on interview)
(3) Principal problem not anxiety or depression
(4) acute psychosis

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)
Details about the study will be circulated to participants who expressed interest in future research from a previous online survey, the research clinic website and Facebook accounts of the eCentreClinic, www.ecentreclinic.org, using an article in an Arabic newspaper, to over 100 organisations providing services to Arab Australians, to over 100 Arabic speaking health providers, and to spiritual leaders of an Arabic speaking background in Australia. Those interested will provide Informed Consent and will complete an application which will consist of questionnaires of symptoms of depression and anxiety, the Patient Health Questionnaire-9 Item and Generalised Anxiety Disorder-7 item questionnaires, respectively. Applicants with scores too high on these questionnaires will not be eligible but will be referred to other services by the eCentreClinic staff, while eligible applicants will be asked to provide demographic details. Participants who meet eligibility criteria will be given access codes to begin the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2013
Actual
4/03/2013
Date of last participant enrolment
Anticipated
10/06/2013
Actual
16/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 288343 0
University
Name [1] 288343 0
eCentreClinic, Centre for Emotional Health, Department of Psychology, Macquarie University
Country [1] 288343 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
eCentreClinic, Centre for Emotional Health, Department of Psychology, Macquarie University Address: C3A 724
North Ryde
NSW2109
Country
Australia
Secondary sponsor category [1] 287055 0
None
Name [1] 287055 0
Address [1] 287055 0
Country [1] 287055 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290230 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 290230 0
Ethics committee country [1] 290230 0
Australia
Date submitted for ethics approval [1] 290230 0
07/08/2012
Approval date [1] 290230 0
29/08/2012
Ethics approval number [1] 290230 0
5201200603

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

Contacts
Principal investigator
Name 44586 0
A/Prof Nickolai Titov
Address 44586 0
C3A 724 Macquarie University North Ryde NSW 2109
Country 44586 0
Australia
Phone 44586 0
+61 2 98509901
Fax 44586 0
Email 44586 0
[email protected]
Contact person for public queries
Name 44587 0
Nickolai Titov
Address 44587 0
C3A 724 Macquarie University North Ryde NSW 2109
Country 44587 0
Australia
Phone 44587 0
+61 2 98509901
Fax 44587 0
Email 44587 0
[email protected]
Contact person for scientific queries
Name 44588 0
Nickolai Titov
Address 44588 0
C3A 724 Macquarie University North Ryde NSW 2109
Country 44588 0
Australia
Phone 44588 0
+61 2 98509901
Fax 44588 0
Email 44588 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.