Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000261415
Ethics application status
Approved
Date submitted
28/03/2025
Date registered
9/04/2025
Date last updated
9/04/2025
Date data sharing statement initially provided
9/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the efficacy of a self-guided ultra-brief digital treatment for depression and anxiety
Scientific title
Examining the efficacy of a self-guided ultra-brief digital treatment for depression and anxiety in adults
Secondary ID [1] 314066 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a follow up to (1) ACTRN12621001617853 and (2) ACTRN12623001075673

Health condition
Health condition(s) or problem(s) studied:
Anxiety 336812 0
Depression 336811 0
Condition category
Condition code
Mental Health 333306 333306 0 0
Anxiety
Mental Health 333305 333305 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A two arm randomised controlled trial. Participants will be randomised to treatment or a waitlist control group.

The treatment itself consists of a single online lesson which provides psychoeducation about the nature of anxiety and depression and recommendations for self-management of symptoms. The lesson has been designed specifically for this program of research by the eCentreClinic. This intervention will also include practice exercises, illustrative case examples, and an additional resource on managing worry and problem solving. It is expected that participants will take 60 minutes to read the lesson, read the practice exercises and resource, and read the case stories. Additional skills practice is at the discretion of the participant. The materials consist of PDF and static powerpoint slides (i.e., no video or audio). Adherence will be measured by tracking the number of times a participant views or downloads each document.

The treatment is being delivered in a self-guided format. Contact will be made if participants indicate that they are at risk of suicide/ self-harm or are experiencing technical difficulties.
Intervention code [1] 330643 0
Treatment: Other
Comparator / control treatment
The waitlist control will receive access to treatment after a 9-week waiting period. Participants' depression and anxiety symptoms will be monitored by psychologists during this time based on self-report questionnaires (completed monthly)
Control group
Active

Outcomes
Primary outcome [1] 340886 0
Anxiety
Timepoint [1] 340886 0
Baseline, Week 5, Week 9 (primary), Week 17 post-baseline
Primary outcome [2] 340885 0
Depression
Timepoint [2] 340885 0
Baseline, Week 5, Week 9 (primary), Week 17 post-baseline
Secondary outcome [1] 445345 0
Therapeutic realisations
Timepoint [1] 445345 0
Baseline, Week 5, Week 9, Week 17 post-baseline
Secondary outcome [2] 445344 0
Insight into psychological difficulties
Timepoint [2] 445344 0
Baseline, Week 5, Week 9, Week 17 post-baseline
Secondary outcome [3] 445346 0
Frequency of daily actions
Timepoint [3] 445346 0
Baseline, Week 5, Week 9, Week 17 post-baseline

Eligibility
Key inclusion criteria
(a) Australian resident
(b) Are aged 18 years or older
(c) Experiencing depression or anxiety symptoms
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Actively suicidal or unable to keep themselves safe
(b) Living outside of Australia
(c) 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)
Allocation concealment is ensured by having a blacked out column in an Excel sheet which is only visible after the assessment has been conducted. In other words, the psychologist who completes the phone assessment will not know the group allocation until after the assessment has been completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised 1:1 to two groups. Randomisation will occur using a computer-generated randomisation sequence (using www.random.org) by an independent researcher not involved in the recruitment of participants. This sequence will be generated prior to enrolment of the first participant, which ensures that the research team are unable to affect group allocation.
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
Generalized estimating equations will be used to examine change in depressive and anxiety symptoms over time according to group allocation. Multiple imputation will be used to handle missing data, consistent with intent-to-treat.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318573 0
University
Name [1] 318573 0
Macquarie University
Country [1] 318573 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 320972 0
None
Name [1] 320972 0
Address [1] 320972 0
Country [1] 320972 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317173 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 317173 0
Ethics committee country [1] 317173 0
Australia
Date submitted for ethics approval [1] 317173 0
Approval date [1] 317173 0
13/03/2025
Ethics approval number [1] 317173 0

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

Contacts
Principal investigator
Name 140242 0
Dr Madelyne Bisby
Address 140242 0
Australian Hearing Hub, 16 University Avenue, Macquarie University, NSW, 2109
Country 140242 0
Australia
Phone 140242 0
+61 2 98508724
Fax 140242 0
Email 140242 0
[email protected]
Contact person for public queries
Name 140243 0
Madelyne Bisby
Address 140243 0
Australian Hearing Hub, 16 University Avenue, Macquarie University, NSW, 2109
Country 140243 0
Australia
Phone 140243 0
+61 2 98508724
Fax 140243 0
Email 140243 0
[email protected]
Contact person for scientific queries
Name 140244 0
Madelyne Bisby
Address 140244 0
Australian Hearing Hub, 16 University Avenue, Macquarie University, NSW, 2109
Country 140244 0
Australia
Phone 140244 0
+61 2 98508724
Fax 140244 0
Email 140244 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Dr Madelyne Bisby ([email protected])

Are there extra considerations when requesting access to individual participant data?
Yes: Will depend on institutional policies around data sharing



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.