Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000832875
Ethics application status
Approved
Date submitted
28/07/2012
Date registered
7/08/2012
Date last updated
4/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A trial to determine the benefits of the Wellbeing Course for consumers of the Mental Health Association, NSW, with symptoms of anxiety
Scientific title
An open trial of guided internet-delivered cognitive behavioural therapy education to determine the benefits of the Wellbeing Course for consumers of the Mental Health Association with symptoms of anxiety
Secondary ID [1] 280915 0
Nil
Universal Trial Number (UTN)
Trial acronym
MHA Open Trial 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 286996 0
Condition category
Condition code
Mental Health 287329 287329 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, which teaches participants how to manage symptoms of anxiety and low mood. All participants will have at least mild symptoms of anxiety (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 Registered Psychologist from the Mental Health Association.

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.
Intervention code [1] 285351 0
Treatment: Other
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287601 0
Symptoms of anxiety are measured by the Generalised Anxiety Disorder 7 Item Scale (GAD-7).
Timepoint [1] 287601 0
Administered at pre-intervention, prior to each Lesson in the course, post-intervention, and at 3-months post-intervention
Secondary outcome [1] 298511 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [1] 298511 0
Administered at pre-intervention, prior to each Lesson in the course, post-intervention, and at 3-months post-intervention
Secondary outcome [2] 298512 0
Symptoms of psychological distress are measured by the Kessler-10 Item (K-10)
Timepoint [2] 298512 0
Administered at pre-intervention, post-intervention, and at 3-months post-intervention
Secondary outcome [3] 298513 0
Frequency of adaptive behaviours are measured by the Things You Do Questionnaire (TYDQ)
Timepoint [3] 298513 0
Administered at pre-intervention, post-intervention, and at 3-months post-intervention

Eligibility
Key inclusion criteria
(1) Resident of Australia
(2) 18+ years of age
(3) not currently participating in CBT for anxiety symptoms
(4) a score above 4 on the GAD-7 (indicating at least mild anxiety)
(5) provides informed consent
(6) access to a computer, printer, and internet
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 ideation or plan (based on interview)
(2) suicidal intention or plan
(3) principal problem not anxiety
(4) principal problem are symptoms of OCD
(5) acute psychosis

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consumers aged 18+ years who telephone the 1300 794 992 Mental Health Association (MHA), NSW, INC, Anxiety Support line, will be informed about the aims of the study, and invited to apply. Those interest will be provided with more information and then sent an informed consent form, and asked to complete and return this. Those who complete the form will be telephoned by a Psychologist from the MHA who will provide more details, and administer the Patient Health Questionnaire-9 Item and Generalised Anxiety Disorder-7 item questionnaires. Applicants with scores too high or too low on these questionnaires will be excluded and will be referred to other services, while eligible applicants will be asked to provide demographic details and contact details for their GP.
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
8/08/2012
Actual
23/07/2012
Date of last participant enrolment
Anticipated
25/08/2012
Actual
13/08/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285699 0
University
Name [1] 285699 0
eCentreClinic, Centre for Emotional Health, Department of Psychology, Macquarie University
Country [1] 285699 0
Australia
Primary sponsor type
University
Name
eCentreClinic, Centre for Emotional Health, Department of Psychology, Macquarie University
Address
C3A 724
Macquarie University
North Ryde
NSW2109
Country
Australia
Secondary sponsor category [1] 284527 0
None
Name [1] 284527 0
Address [1] 284527 0
Country [1] 284527 0
Other collaborator category [1] 276977 0
Charities/Societies/Foundations
Name [1] 276977 0
Mental Health Association, NSW, Inc
Address [1] 276977 0
Mental Health Association NSW
501/80 William Street, East Sydney
NSW2011
Country [1] 276977 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287696 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 287696 0
Ethics committee country [1] 287696 0
Australia
Date submitted for ethics approval [1] 287696 0
Approval date [1] 287696 0
15/06/2012
Ethics approval number [1] 287696 0
5201200348

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

Contacts
Principal investigator
Name 34487 0
A/Prof Nickolai Titov
Address 34487 0
C3A 724 Macquarie University North Ryde NSW 2109
Country 34487 0
Australia
Phone 34487 0
+61 2 98509901
Fax 34487 0
Email 34487 0
[email protected]
Contact person for public queries
Name 17734 0
Nickolai Titov
Address 17734 0
C3A 724
Macquarie University
North Ryde
NSW 2109
Country 17734 0
Australia
Phone 17734 0
+61298509901
Fax 17734 0
Email 17734 0
[email protected]
Contact person for scientific queries
Name 8662 0
Nickolai Titov
Address 8662 0
C3A 724
Macquarie University
North Ryde
NSW 2109
Country 8662 0
Australia
Phone 8662 0
+61298509901
Fax 8662 0
Email 8662 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.