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Trial registered on ANZCTR


Registration number
ACTRN12621001554853p
Ethics application status
Submitted, not yet approved
Date submitted
7/10/2021
Date registered
15/11/2021
Date last updated
15/11/2021
Date data sharing statement initially provided
15/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the health literacy of people accessing digital mental health treatment for depression and/or anxiety
Scientific title
Assessing the health literacy of people accessing digital mental health treatment for depression and/or anxiety
Secondary ID [1] 305487 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 323870 0
Anxiety 323871 0
Condition category
Condition code
Mental Health 321385 321385 0 0
Depression
Mental Health 321386 321386 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Wellbeing Course is a self-guided internet-delivered psychological treatment, based on cognitive behaviour therapy principles. It consists of:
(a) 5 online lessons provided over 8 weeks.
(b) A homework summary with assignments for each lesson
(c) Additional written resources that can be downloaded and which include information about other important skills, such as assertiveness and communication skills and techniques for managing sleep difficulties.
(d) Case Stories based on previous participants, which they can follow throughout the Course.
The online course and additional written resources have been developed and previously evaluated by the eCentre Clinic for their efficacy and safety. In terms of time commitment, each lesson is expected to take approximately 15 minutes with a further 20 minutes to read accompanying case stories and other supplementary materials. All the lesson materials are in a written, slide deck-style format using a combination of text and visuals (images/diagrams etc). It will be at the discretion of participants how long they spend on each lesson, and they can access multiple times. Website analytics (e.g., login frequency, time spent per login) is also available to monitor adherence to the intervention. In terms of lesson content, it comprises the following:
Lesson 1 - Education about the prevalence, symptoms and treatment of depression and anxiety including an explanation of the functional relationship between symptoms. Vignettes describing impact of symptoms. Normalising difficulties during recovery. Assertive communication skills.
Lesson 2 - Basic principles of cognitive therapy, including strategies for monitoring and challenging thoughts. Strategies for shifting attention. Worry time.
Lesson 3 - Instructions about controlling physical symptoms including de-arousal strategies and scheduling activities. The importance of lifestyle factors. Managing symptoms of
panic. Maintaining healthy interpersonal boundaries.
Lesson 4 - Education and guidelines about behavioural activation. Education about guidelines about practising graded exposure. Education and guidelines for acting “as if”. Structured problem solving.
Lesson 5 - Information about relapse prevention and constructing relapse prevention plans.
Intervention code [1] 321887 0
Behaviour
Intervention code [2] 322042 0
Treatment: Other
Comparator / control treatment
Waitlist control; participants randomised to this group will receive access to the Intervention (Wellbeing Course) when the active treatment group has finished.
Control group
Active

Outcomes
Primary outcome [1] 329157 0
Symptoms of depression assessed using the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [1] 329157 0
At application, prior to starting the Course (i.e., pre-treatment), midway through the Course (i.e., week 5), and 9 weeks after starting the Course (i.e., post-treatment; primary endpoint).
Primary outcome [2] 329354 0
Symptoms of anxiety assessed using the Generalised Anxiety Disorder 7 items (GAD-7).
Timepoint [2] 329354 0
At application, prior to starting the Course (i.e., pre-treatment), midway through the Course (i.e., week 5), and 9 weeks after starting the Course (i.e., post-treatment; primary endpoint).
Primary outcome [3] 329355 0
Changes in health literacy assessed using the Health Literacy Questionnaire (HLQ)
Timepoint [3] 329355 0
Difference scores between at application and at post-treatment (9 weeks after starting the Wellbeing Course).
Secondary outcome [1] 401680 0
Views and experience of deciding to take-up online psychological treatment using a purpose-designed, semi-structured interview guide based on the Ottawa decision-support Framework.
Timepoint [1] 401680 0
Pre-treatment; i.e., AFTER the decision to enrol in/start the Course has been made.

Eligibility
Key inclusion criteria
(a) Aged 18 years and older
(b) Internet and computer access for the duration of the study
(c) Current self-reported difficulties with anxiety and/or depression
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Significant self-reported suicidal risk
(b) Unable to read and understand English

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent website, www.random.org, will be used to generate a list of randomly generated numbers corresponding to the two groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
- Descriptive analyses;
- Correlational analyses;
- Binomial logistic regressions;
- Hierarchical multiple regressions;
- Generalised estimating equation modelling;
- T-tests, chi-square tests.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24171 0
New Zealand
State/province [1] 24171 0
Country [2] 24172 0
Canada
State/province [2] 24172 0
Country [3] 24175 0
United Kingdom
State/province [3] 24175 0
Country [4] 24176 0
United States of America
State/province [4] 24176 0

Funding & Sponsors
Funding source category [1] 309845 0
University
Name [1] 309845 0
eCentre Clinic, Macquarie University
Country [1] 309845 0
Australia
Primary sponsor type
University
Name
eCentre Clinic, Macquarie University
Address
Level 2, Siemens Building, Level 2/160 Herring Rd, Macquarie University NSW 2109
Country
Australia
Secondary sponsor category [1] 310883 0
None
Name [1] 310883 0
Address [1] 310883 0
Country [1] 310883 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309584 0
Macquarie University Human Research Ethics Committee (Medical Sciences)
Ethics committee address [1] 309584 0
Ethics committee country [1] 309584 0
Australia
Date submitted for ethics approval [1] 309584 0
01/10/2021
Approval date [1] 309584 0
Ethics approval number [1] 309584 0

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

Contacts
Principal investigator
Name 114674 0
Dr Alana Fisher
Address 114674 0
eCentre Clinic, Level 2, Siemens Building, Level 2/160 Herring Rd, Macquarie University NSW 2109
Country 114674 0
Australia
Phone 114674 0
+61404629858
Fax 114674 0
N/A
Email 114674 0
alana.fisher@mq.edu.au
Contact person for public queries
Name 114675 0
Alana Fisher
Address 114675 0
eCentre Clinic, Level 2, Siemens Building, Level 2/160 Herring Rd, Macquarie University NSW 2109
Country 114675 0
Australia
Phone 114675 0
+61404629858
Fax 114675 0
N/A
Email 114675 0
alana.fisher@mq.edu.au
Contact person for scientific queries
Name 114676 0
Alana Fisher
Address 114676 0
eCentre Clinic, Level 2, Siemens Building, Level 2/160 Herring Rd, Macquarie University NSW 2109
Country 114676 0
Australia
Phone 114676 0
+61404629858
Fax 114676 0
N/A
Email 114676 0
alana.fisher@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not within application for ethics approval.


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.