Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001074684
Ethics application status
Approved
Date submitted
18/09/2023
Date registered
9/10/2023
Date last updated
14/06/2024
Date data sharing statement initially provided
9/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Development and evaluation of an ultra-brief online treatment for women with perinatal depression or anxiety
Scientific title
Development and evaluation of the efficacy of an ultra-brief online treatment for symptoms of perinatal depression or anxiety
Secondary ID [1] 310618 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perinatal depression 331498 0
Perinatal anxiety 331499 0
Condition category
Condition code
Reproductive Health and Childbirth 328321 328321 0 0
Other reproductive health and childbirth disorders
Mental Health 328235 328235 0 0
Depression
Mental Health 328234 328234 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single group trial; therefore, all participants will receive access to treatment.

The treatment itself 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. 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] 327021 0
Treatment: Other
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336101 0
Anxiety
Timepoint [1] 336101 0
Baseline (i.e., Week 1), Week 3 and Week 5 (primary timepoint) post-baseline
Primary outcome [2] 336100 0
Depression
Timepoint [2] 336100 0
Baseline (i.e., Week 1), Week 3 and Week 5 (primary timepoint) post-baseline
Secondary outcome [1] 426835 0
Depression
Timepoint [1] 426835 0
Baseline (i.e., Week 1), Week 3 and Week 5 post-baseline

Eligibility
Key inclusion criteria
(a) Australian woman
(b) Aged 18-years or over
(c) In the perinatal period (pregnant to 12m postpartum)
(d) experiencing depression or anxiety symptoms
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Imminently suicidal or unable to keep themselves safe
(b) Not living in Australia
(c) Unable to read and understand English
(d) Displaying significant risk of harming others

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Generalized estimating equations will be used to examine change in depression and anxiety over time. Multiple imputation will be used to handle missing data consistent with intent-to-treat.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/12/2023
Actual
14/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
27
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314834 0
Charities/Societies/Foundations
Name [1] 314834 0
Liptember Foundation
Country [1] 314834 0
Australia
Funding source category [2] 314835 0
University
Name [2] 314835 0
Macquarie University
Country [2] 314835 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
16 University Avenue, Macquarie Park, NSW, 2109
Country
Australia
Secondary sponsor category [1] 316824 0
None
Name [1] 316824 0
None
Address [1] 316824 0
None
Country [1] 316824 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313836 0
Macquarie Unviersity Human Research Ethics Committee
Ethics committee address [1] 313836 0
Ethics committee country [1] 313836 0
Australia
Date submitted for ethics approval [1] 313836 0
11/09/2023
Approval date [1] 313836 0
29/11/2023
Ethics approval number [1] 313836 0

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

Contacts
Principal investigator
Name 129502 0
Dr Madelyne Bisby
Address 129502 0
Macquarie University, 16 University Avenue, Macquarie Park, NSW, 2109
Country 129502 0
Australia
Phone 129502 0
+61 298508724
Fax 129502 0
Email 129502 0
[email protected]
Contact person for public queries
Name 129503 0
Madelyne Bisby
Address 129503 0
Macquarie University, 16 University Avenue, Macquarie Park, NSW, 2109
Country 129503 0
Australia
Phone 129503 0
+61 298508724
Fax 129503 0
Email 129503 0
[email protected]
Contact person for scientific queries
Name 129504 0
Madelyne Bisby
Address 129504 0
Macquarie University, 16 University Avenue, Macquarie Park, NSW, 2109
Country 129504 0
Australia
Phone 129504 0
+61 298508724
Fax 129504 0
Email 129504 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 working with the approval and under the governance of a Human Research Ethics Committee.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Any non-identifiable data necessary to verify the outcomes reported in any published reports by the research team.

What types of analyses could be done with individual participant data?
• Any analyses required to verify the outcomes reported in published reports.

When can requests for individual participant data be made (start and end dates)?
From:
Data will be made after any original reports have been published. There will be no end date to the availability.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• 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 ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


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.