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Trial registered on ANZCTR


Registration number
ACTRN12624000750583
Ethics application status
Approved
Date submitted
13/05/2024
Date registered
17/06/2024
Date last updated
21/07/2024
Date data sharing statement initially provided
17/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of an online ultra-brief treatment for perinatal depression and anxiety
Scientific title
A randomised controlled trial evaluating the efficacy of an online ultra-brief treatment for perinatal depression and anxiety
Secondary ID [1] 312132 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a follow up to ACTRN12623001074684.

Health condition
Health condition(s) or problem(s) studied:
Perinatal anxiety 333772 0
Perinatal depression 333773 0
Condition category
Condition code
Mental Health 330447 330447 0 0
Anxiety
Mental Health 330448 330448 0 0
Depression
Reproductive Health and Childbirth 330516 330516 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment consists of a single online lesson which provides psychoeducation about the nature of perinatal anxiety and depression, recommendations for self-management of symptoms, and one week of optional contact with a clinician from 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 and are accessed via the eCentreClinic website. Adherence will be monitored by tracking the number of times a participant has viewed or downloaded each document.

The psychologist will contact participants to arrange a telephone call within a week of this lesson being released. Participants will be able to speak over the phone with the psychologist within a week of the participant viewing the lesson (i.e., this contact is not limited to the week that the treatment becomes available to accommodate participant availability). There is no time limit to this telephone consult or private messages, although it is expected that phone consults will be 20-30 minutes long. The purpose of contact is to answer any questions participants may have about the lesson and support them to implement the skills. Additional contact outside this week will be made if participants indicate that they are at risk of suicide/ self-harm or are experiencing technical difficulties.
Intervention code [1] 328567 0
Treatment: Other
Comparator / control treatment
The waitlist control will receive access to treatment after an 8-week waiting period. Participants' depression and anxiety symptoms will be monitored by psychologists during this time, and participants are able to contact the eCentreClinic at any time if required.
Control group
Active

Outcomes
Primary outcome [1] 338210 0
Depression
Timepoint [1] 338210 0
Week 1, Week 3, Week 5, Week 9 (primary timepoint), Week 13, and Week 17 post-baseline.
Primary outcome [2] 338211 0
Anxiety
Timepoint [2] 338211 0
Week 1, Week 3, Week 5, Week 9 (primary timepoint), Week 13, and Week 17 post-baseline.
Secondary outcome [1] 434993 0
Depression
Timepoint [1] 434993 0
Week 1, Week 3, Week 5, Week 9, Week 13, and Week 17 post-baseline.

Eligibility
Key inclusion criteria
(a) Australian woman or person assigned female at birth,
(b) Are aged 18 years or older,
(c) In the perinatal period (defined as pregnancy to 1-year post-partum), and
(d) Experiencing symptoms of depression or anxiety.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Actively suicidal or unable to keep themselves safe,
(b) Significant risk of harm to others,
(c) Living outside of Australia, and
(d) 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
29/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316488 0
Charities/Societies/Foundations
Name [1] 316488 0
Liptember Foundation
Country [1] 316488 0
Australia
Funding source category [2] 316491 0
University
Name [2] 316491 0
Macquarie University
Country [2] 316491 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 318665 0
None
Name [1] 318665 0
Address [1] 318665 0
Country [1] 318665 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315286 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 315286 0
Ethics committee country [1] 315286 0
Australia
Date submitted for ethics approval [1] 315286 0
12/05/2024
Approval date [1] 315286 0
27/06/2024
Ethics approval number [1] 315286 0

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

Contacts
Principal investigator
Name 134226 0
Dr Madelyne Bisby
Address 134226 0
Macquarie University, 16 University Avenue, Macquarie Park, NSW, 2109
Country 134226 0
Australia
Phone 134226 0
+61 2 98508724
Fax 134226 0
Email 134226 0
madelyne.bisby@mq.edu.au
Contact person for public queries
Name 134227 0
Madelyne Bisby
Address 134227 0
Macquarie University, 16 University Avenue, Macquarie Park, NSW, 2109
Country 134227 0
Australia
Phone 134227 0
+61 2 98508724
Fax 134227 0
Email 134227 0
madelyne.bisby@mq.edu.au
Contact person for scientific queries
Name 134228 0
Madelyne Bisby
Address 134228 0
Macquarie University, 16 University Avenue, Macquarie Park, NSW, 2109
Country 134228 0
Australia
Phone 134228 0
+61 2 98508724
Fax 134228 0
Email 134228 0
madelyne.bisby@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Any non-identifiable data necessary to verify the outcomes reported in any published reports by the research team.
When will data be available (start and end dates)?
Data will be made after any original reports have been published. There will be no end date to the availability.
Available to whom?
Researchers working with the approval and under the governance of a Human Research Ethics Committee.
Available for what types of analyses?
Any analyses required to verify the outcomes reported in published reports.
How or where can data be obtained?
Data will be made available following formal request to the chief investigator using a mechanism that is satisfactory for the Macquarie University Human Research Ethics Committee (providing governance for the current research) and any other Human Research Ethics Committee's involved. Data can be obtained by e-mailing the principal investigator (madelyne.bisby@mq.edu.au)


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.