Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000094370
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
18/12/2025
Date registered
Help: Date registered
23/01/2026
Date last updated
Help: Date last updated
23/01/2026
Date data sharing statement initially provided
Help: Data sharing statement date
23/01/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of an online ultra-brief treatment for depression or anxiety
Scientific title
Digital ultra-brief treatment for adults with depression or anxiety: a randomised controlled trial examining the effect of a diagnostic interview
Additional trial identifiers [1] 316190 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records
This study is a follow up to (1) ACTRN12621001617853, (2) ACTRN12623001075673 and (3) ACTRN12625000261415

Health condition
Health condition(s) studied:
Depression 340179 0
Anxiety 340180 0
Condition category
Condition code
Mental Health 336373 336373 0 0
Depression
Mental Health 336374 336374 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants are randomized to one of four groups:

1. Immediate treatment with diagnostic interview

2. Immediate treatment without diagnostic interview

3. Waitlist control with diagnostic interview

4. Waitlist control without diagnostic interview

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:
a) practice exercises (a PDF document that participants can complete for their own information, to assist them to apply the information from the Course to their own situation)
b) a resource that provides case examples of how the skills from the Course can be utilised
c) additional resource on managing worry and problem solving that provides information about worry, some strategies to manage worry and a step by step problem solving exercise that can be completed by participants.

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.

Participants will also have the option of support from a psychologist as they work through the treatment – specifically, for one week after accessing the online lesson. Participants will have a month to access the lesson and work through the content.

The diagnostic interview is a 15-20 series of questions (QuickSCID-5) based on the DSM5 criteria for depression and anxiety disorders. Participants will be blinded as to whether or not they will receive a diagnostic interview.
Intervention code [1] 332812 0
Treatment: Other
Description of the comparator or control
The waitlist control groups 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).

The no interview group will receive an administrative phone call prior to treatment which does not include the diagnostic interview QuickSCID-5.
Control group
Active

Outcomes
Primary outcome [1] 343891 0
Depression
Timepoint [1] 343891 0
Baseline, Week 5, Week 9, Week 13, Week 17 post-baseline
Primary outcome [2] 343892 0
Anxiety
Timepoint [2] 343892 0
Baseline, Week 5, Week 9, Week 13, Week 17 post-baseline
Secondary outcome [1] 456033 0
Insight into psychological difficulties
Timepoint [1] 456033 0
Baseline, Week 5, Week 9, Week 13 and Week 17 post-baseline.
Secondary outcome [2] 456034 0
Therapeutic realisations
Timepoint [2] 456034 0
Week 5, Week 13, Week 9, Week 13, and Week 17 post-baseline
Secondary outcome [3] 456035 0
Frequency of daily actions
Timepoint [3] 456035 0
Baseline, Week 5, Week 9, Week 13, and Week 17 post-baseline
Secondary outcome [4] 456036 0
Ongoing practice
Timepoint [4] 456036 0
Week 5, Week, 9, Week 13, and Week 17 post-baseline

Eligibility
Key inclusion criteria
(a) Australian resident
(b) Are aged 18 years or older, and
(c) Screen positive for a depression or anxiety disorder on the Psychiatric Diagnostic Screening Questionnaire (i.e., Major Depression, Panic Disorder, Agoraphobia, Social Anxiety Disorder, or Generalised Anxiety Disorder).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
(a) Actively suicidal or unable to keep themselves safe,
(b) Living outside of Australia, or
(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 administrative section of the assessment has been conducted. Then, the psychologist will unblind the allocation sequence and either complete the diagnostic interview section or not.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised 1:1:1:1 to one of the four 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. The randomisation 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will be carried out using conservative intention-to-treat principles to provide unbiased estimates in the case of missing data. Under the assumption that data will not be missing at random (Karin et al., 2021), multiple imputation will be used to account for missing cases. Generalized Estimating Equations will be used to analyse the change in outcome measures across time according to group (treatment vs. control, interview vs. no interview).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2026
Actual
Date of last participant enrolment
Anticipated
1/09/2027
Actual
Date of last data collection
Anticipated
1/02/2028
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 320788 0
University
Name [1] 320788 0
Macquarie University
Country [1] 320788 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 323450 0
None
Name [1] 323450 0
Address [1] 323450 0
Country [1] 323450 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319320 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 319320 0
Ethics committee country [1] 319320 0
Australia
Date submitted for ethics approval [1] 319320 0
07/11/2025
Approval date [1] 319320 0
16/12/2025
Ethics approval number [1] 319320 0

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

Contacts
Principal investigator
Name 146966 0
Dr Madelyne Bisby
Address 146966 0
Australian Hearing Hub, 16 University Avenue, Macquarie University, NSW, 2109
Country 146966 0
Australia
Phone 146966 0
+61 2 98508724
Fax 146966 0
Email 146966 0
[email protected]
Contact person for public queries
Name 146967 0
Madelyne Bisby
Address 146967 0
Australian Hearing Hub, 16 University Avenue, Macquarie University, NSW, 2109
Country 146967 0
Australia
Phone 146967 0
+61 2 98508724
Fax 146967 0
Email 146967 0
[email protected]
Contact person for scientific queries
Name 146968 0
Madelyne Bisby
Address 146968 0
Australian Hearing Hub, 16 University Avenue, Macquarie University, NSW, 2109
Country 146968 0
Australia
Phone 146968 0
+61 2 98508724
Fax 146968 0
Email 146968 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 approval by an ethics committee
• 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.