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Trial registered on ANZCTR
Registration number
ACTRN12623000945628p
Ethics application status
Submitted, not yet approved
Date submitted
16/07/2023
Date registered
1/09/2023
Date last updated
1/09/2023
Date data sharing statement initially provided
1/09/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Psychoeducation Intervention for Perinatal Borderline Personality Disorder Traits.
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Scientific title
Efficacy of a Psychoeducation Intervention for Symptom Reduction in Women with Borderline Personality Disorder Traits in the Perinatal Period
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Secondary ID [1]
310138
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Nil
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Universal Trial Number (UTN)
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Trial acronym
PBPDI
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Linked study record
Not applicable
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Health condition
Health condition(s) or problem(s) studied:
Perinatal Borderline Personality Disorder Traits
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Condition category
Condition code
Mental Health
327530
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0
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Psychosis and personality disorders
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Reproductive Health and Childbirth
327773
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0
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Antenatal care
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants allocated to the intervention group will be sent a link via email or SMS to participate in an online psychoeducation program via Qualtrics within one week of completing screening questionnaires. Modelled on Mother Infant Dialectical Behaviour Therapy (MI-DBT; Sved Williams et al., 2018), the brief digital psychoeducation intervention will take approximately thirty minutes to complete, presented as written information. The psychoeducation will address how past trauma can lead to emotional dysregulation (Blankley et al., 2015; Pare-Miron et al., 2016), and list appropriate parenting practices such as infant soothing skills (Geerling et al., 2019; Sved Williams et al., 2018), strategies for emotional regulation, behaviour awareness (Eyden et al., 2016), mother-infant dyadic interaction, empathy, and sensitivity (Newman & Stevenson, 2005; Newman et al., 2007). Post completion, the intervention group will receive a brief 5-question multiple choice quiz to ensure that content was actively received. Participants will have the option of downloading the psychoeducation, and will be sent two email reminders of content to ensure memory retention, approximately one week and one month after.
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Intervention code [1]
326533
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Early detection / Screening
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Intervention code [2]
326534
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Treatment: Other
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Comparator / control treatment
Participants in the control group will be sent a link via email or SMS with newsletter content derived from the Centre of Perinatal Excellence, offering general information about parenting and mental health. Comparable to the intervention group, completion will take approximately thirty minutes to complete, occurring once only.
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Control group
Active
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Outcomes
Primary outcome [1]
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Score on the Zanarini Rating Scale for Borderline Personality Disorder.
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Assessment method [1]
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Timepoint [1]
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Baseline (pre-intervention), and six weeks postpartum.
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Secondary outcome [1]
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Score on the Edinburgh Postnatal Depression Scale.
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Assessment method [1]
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Timepoint [1]
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Baseline (pre-intervention), and six weeks postpartum.
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Secondary outcome [2]
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A composite secondary outcome of medical conditions, obstetric complications, and procedures performed as measured by SA Health Pregnancy Outcome Record.
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Assessment method [2]
425893
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Timepoint [2]
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6 weeks postpartum.
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Secondary outcome [3]
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A composite secondary outcome of labour including onset, induction, augmentation, and complications as measured by SA Health Pregnancy Outcome Record.
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Assessment method [3]
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Timepoint [3]
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6 weeks postpartum.
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Secondary outcome [4]
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A composite secondary outcome of infant measures including gestational age, birthweight, Apgar score, and congenial anomalies as measured by SA Health Pregnancy Outcome Record.
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Assessment method [4]
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Timepoint [4]
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6 weeks postpartum.
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Eligibility
Key inclusion criteria
• Pregnant women less than 37 weeks gestation with traits of Borderline Personality Disorder (BPD) (as indicated by a high score on the Zanarini Rating Scale for BPD)
• Reside in South Australia (SA)
• English speaking
• Valid mobile phone number and/or email address
• Aged eighteen years or over
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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
• Pregnant women greater than 37 weeks gestation without traits of Borderline Personality Disorder (BPD) (as indicated by a low score on the Zanarini Rating Scale for BPD)
• Reside in South Australia (SA)
• English speaking
• Valid mobile phone number and/or email address
• Aged over eighteen years
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by Qualtrics software.
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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
Parallel
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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
To examine comparative outcomes on our primary outcome measure, we will use linear mixed modelling. It yields unbiased estimates of intervention effects under the assumption that data are missing at random (MAR; Han & Guo, 2014). An unstructured covariance matrix will be assumed. All analyses will be adjusted for baseline observations (i.e., the first assessment during pregnancy) to ensure that outcomes resulted from intervention-related influences and not measurement error or baseline score differences, and therefore significant between group results as well as significant interactions between time and group were both of interest. This will result in a 2 (group: intervention, informational control) x 2 (time: pre-intervention, post-intervention) repeated measures design, and a priori Bonferroni corrections will be used to examine comparisons between the groups. Between group Cohen’s d effect sizes will be calculated, where 0.2 = small; 0.5 = moderate, and 0.8 = large differences (Cohen, 1992). All models will also be examined for interactions with the following variables: SES (bottom and top 50th percentile), and high and low levels of depression.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/07/2024
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Actual
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Date of last participant enrolment
Anticipated
1/07/2026
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Actual
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Date of last data collection
Anticipated
1/09/2026
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Actual
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Sample size
Target
165
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment hospital [2]
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Womens and Childrens Hospital - North Adelaide
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Recruitment postcode(s) [1]
40864
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5112 - Elizabeth Vale
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Recruitment postcode(s) [2]
40865
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5006 - North Adelaide
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Breakthrough Mental Health Research Foundation
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Address [1]
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Level 6/121 King William St, Adelaide SA 5000
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Flinders University
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Address
Sturt Rd, Bedford Park SA 5042
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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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Nil
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Address [1]
316242
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Nil
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Country [1]
316242
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
313412
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SA Department for Health and Wellbeing Human Research Ethics Committee
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Ethics committee address [1]
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Citi Centre Building, 11 Hindmarsh Square, Adelaide SA 5000
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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24/06/2022
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Approval date [1]
313412
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Ethics approval number [1]
313412
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Summary
Brief summary
The perinatal period, encompassing pregnancy and the first year postpartum, is a time of immense change where women are faced with new challenges, stress, and high emotions (Chlebowski, 2013; Newman et al., 2007). Previous coping strategies may prove inadequate when faced with sleep deprivation, a crying infant, physical pain, role transformation, and relationship stress (Geerling et al., 2019; Sved Williams & Apter, 2017; Wilson & Donachie, 2018). Women with personality vulnerability may become emotionally unstable (Sved Williams et al., 2018; Yelland et al., 2015), and existing symptoms of borderline personality disorder (BPD) may be exacerbated (Dunn et al., 2020). The National Health and Medical Research Council (2012) guidelines recommend that women with BPD who are pregnant, have infants or young children “should be provided with interventions designed to support parenting skills and attachment relationships”. As dysregulation (Apter at al., 2017) and neurobiological disturbances (Newman et al., 2011) can occur in infants of mothers with BPD by three months of age, early intervention is imperative. We will evaluate the impact of the provision of psychoeducation material in pregnant women with BPD/BPD traits compared to general information about parenting and mental health. It is hypothesised that emotional regulation, obstetric/birth outcomes, postnatal maternal behaviours will be less compromised for women who have completed psychoeducation compared to women who have completed general information about parenting and mental health.
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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
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Prof Tracey Wade
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Address
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Flinders University
College of Education, Psychology and Social Work
Sturt Rd, Bedford Park SA 5042
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Country
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Australia
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Phone
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+61 8 8201 3911
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Alexandra May
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Address
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Flinders University
College of Education, Psychology and Social Work
Sturt Rd, Bedford Park SA 5042
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Country
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Australia
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Phone
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+61 0423937434
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Tracey Wade
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Address
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Flinders University
College of Education, Psychology and Social Work
Sturt Rd, Bedford Park SA 5042
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Country
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Australia
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Phone
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+61 8 8201 3911
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Fax
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Email
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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)?
No
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No/undecided IPD sharing reason/comment
IPD not relevant to research as congregate outcomes are solely required.
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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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