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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
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Scientific title
Assessing the health literacy of people accessing digital mental health treatment for depression and/or anxiety
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Secondary ID [1]
305487
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depression
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Anxiety
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Condition category
Condition code
Mental Health
321385
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0
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Depression
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Mental Health
321386
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
321887
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Behaviour
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Intervention code [2]
322042
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Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Symptoms of depression assessed using the Patient Health Questionnaire-9 (PHQ-9)
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Assessment method [1]
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Timepoint [1]
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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).
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Primary outcome [2]
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Symptoms of anxiety assessed using the Generalised Anxiety Disorder 7 items (GAD-7).
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Assessment method [2]
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Timepoint [2]
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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).
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Primary outcome [3]
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Changes in health literacy assessed using the Health Literacy Questionnaire (HLQ)
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Assessment method [3]
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Timepoint [3]
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Difference scores between at application and at post-treatment (9 weeks after starting the Wellbeing Course).
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Secondary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Pre-treatment; i.e., AFTER the decision to enrol in/start the Course has been made.
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
(a) Significant self-reported suicidal risk
(b) Unable to read and understand English
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
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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.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
- Descriptive analyses;
- Correlational analyses;
- Binomial logistic regressions;
- Hierarchical multiple regressions;
- Generalised estimating equation modelling;
- T-tests, chi-square tests.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/12/2021
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
24171
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Country [2]
24172
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Canada
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State/province [2]
24172
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Country [3]
24175
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United Kingdom
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State/province [3]
24175
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Country [4]
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United States of America
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State/province [4]
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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eCentre Clinic, Macquarie University
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Address [1]
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Level 2, Siemens Building, Level 2/160 Herring Rd, Macquarie University NSW 2109
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Country [1]
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Australia
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Primary sponsor type
University
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Name
eCentre Clinic, Macquarie University
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Address
Level 2, Siemens Building, Level 2/160 Herring Rd, Macquarie University NSW 2109
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
310883
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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Macquarie University Human Research Ethics Committee (Medical Sciences)
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Ethics committee address [1]
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Research Hub, Building C5C East, Macquarie University NSW 2109
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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01/10/2021
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Approval date [1]
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Ethics approval number [1]
309584
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Summary
Brief summary
This study seeks to explore the health-related beliefs, motivations, skills and support needs of people who access online psychological treatment for depression and/or anxiety, and how these influence whether and how people engage with and respond to treatment. There is already a lot of research to support the safety, acceptability, and effectiveness of online psychological treatments for adults with depression and/or anxiety. Now, we wish to build our understanding about how different people may engage with and respond to treatment differently, so that we can develop practical strategies and supports to help people engage in way that best suits their needs and priorities. To do this, we will recruit adults both in Australia and overseas with depression and/or anxiety and if eligible, randomly allocate them to receive treatment either straightaway or after an 8-week delay (waitlist control). We will ask participants to complete questionnaires when they apply for treatment, before starting treatment, mid-way through treatment, and after finishing treatment. Australian participants who enrol in treatment will also be asked to participate in an optional interview asking about their views and experience of deciding to take-up online psychological treatment. It is expected that participants reporting lower health literacy levels in their application will have higher levels of depression and anxiety at all time-points (before, during, and after treatment), and will be less likely to take-up and complete treatment.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Alana Fisher
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Address
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eCentre Clinic, Level 2, Siemens Building, Level 2/160 Herring Rd, Macquarie University NSW 2109
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Country
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Australia
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Phone
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+61404629858
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Fax
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N/A
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Email
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[email protected]
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Contact person for public queries
Name
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Alana Fisher
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Address
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eCentre Clinic, Level 2, Siemens Building, Level 2/160 Herring Rd, Macquarie University NSW 2109
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Country
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Australia
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Phone
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+61404629858
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Fax
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N/A
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Email
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[email protected]
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Contact person for scientific queries
Name
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Alana Fisher
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Address
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eCentre Clinic, Level 2, Siemens Building, Level 2/160 Herring Rd, Macquarie University NSW 2109
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Country
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Australia
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Phone
114676
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+61404629858
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Fax
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N/A
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Email
114676
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Not within application for ethics approval.
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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.
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