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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
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Scientific title
Development and evaluation of the efficacy of an ultra-brief online treatment for symptoms of perinatal depression or anxiety
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Secondary ID [1]
310618
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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:
Perinatal depression
331498
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Perinatal anxiety
331499
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Condition category
Condition code
Mental Health
328234
328234
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0
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Anxiety
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Mental Health
328235
328235
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0
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Depression
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Reproductive Health and Childbirth
328321
328321
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0
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Other reproductive health and childbirth disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
327021
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Treatment: Other
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Comparator / control treatment
NA
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Depression
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Assessment method [1]
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Edinburgh Postnatal Depression Scale
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Timepoint [1]
336100
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Baseline (i.e., Week 1), Week 3 and Week 5 (primary timepoint) post-baseline
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Primary outcome [2]
336101
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Anxiety
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Assessment method [2]
336101
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Generalized Anxiety Disorder 7 item (GAD7)
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Timepoint [2]
336101
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Baseline (i.e., Week 1), Week 3 and Week 5 (primary timepoint) post-baseline
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Secondary outcome [1]
426835
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Depression
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Assessment method [1]
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Patient Health Questionnaire 9 item
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Timepoint [1]
426835
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Baseline (i.e., Week 1), Week 3 and Week 5 post-baseline
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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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
Single group
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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
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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
4/12/2023
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Actual
14/03/2024
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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
40
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Accrual to date
27
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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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Funding & Sponsors
Funding source category [1]
314834
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Charities/Societies/Foundations
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Name [1]
314834
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Liptember Foundation
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Address [1]
314834
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PO BOX 2317, Ringwood North, VIC, 3134
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Country [1]
314834
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Australia
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Funding source category [2]
314835
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University
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Name [2]
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Macquarie University
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Address [2]
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16 University Avenue, Macquarie Park, NSW, 2109
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Country [2]
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Australia
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Primary sponsor type
University
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Name
Macquarie University
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Address
16 University Avenue, Macquarie Park, 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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None
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Address [1]
316824
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None
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Country [1]
316824
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313836
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Macquarie Unviersity Human Research Ethics Committee
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Ethics committee address [1]
313836
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Balaclava Road, Macquarie Park, NSW, 2109
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Ethics committee country [1]
313836
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Australia
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Date submitted for ethics approval [1]
313836
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11/09/2023
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Approval date [1]
313836
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29/11/2023
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Ethics approval number [1]
313836
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Summary
Brief summary
This trial will evaluate a highly accessible and ultra-brief online psychological treatment for women with perinatal depression or anxiety. The treatment involves online materials and optional support from a psychologist. We will evaluate how helpful the treatment has been 2 weeks and then 4 weeks after baseline. All participants will complete questionnaires at baseline, Week 3, and Week 5. We hypothesise that the treatment will lead to reductions in depression and anxiety.
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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
129502
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Dr Madelyne Bisby
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Address
129502
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Macquarie University, 16 University Avenue, Macquarie Park, NSW, 2109
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Country
129502
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Australia
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Phone
129502
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+61 298508724
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Fax
129502
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Email
129502
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[email protected]
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Contact person for public queries
Name
129503
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Dr Madelyne Bisby
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Address
129503
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Macquarie University, 16 University Avenue, Macquarie Park, NSW, 2109
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Country
129503
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Australia
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Phone
129503
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+61 298508724
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Fax
129503
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Email
129503
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[email protected]
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Contact person for scientific queries
Name
129504
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Dr Madelyne Bisby
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Address
129504
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Macquarie University, 16 University Avenue, Macquarie Park, NSW, 2109
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Country
129504
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Australia
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Phone
129504
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+61 298508724
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Fax
129504
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Email
129504
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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)?
Yes
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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.
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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.
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Available to whom?
Researchers working with the approval and under the governance of a Human Research Ethics Committee.
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Available for what types of analyses?
Any analyses required to verify the outcomes reported in published reports.
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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 (
[email protected]
)
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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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