Trial Review

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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.
Scientific title
Efficacy of a Psychoeducation Intervention for Symptom Reduction in Women with Borderline Personality Disorder Traits in the Perinatal Period
Secondary ID [1] 310138 0
Nil
Universal Trial Number (UTN)
Trial acronym
PBPDI
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Perinatal Borderline Personality Disorder Traits 330698 0
Condition category
Condition code
Mental Health 327530 327530 0 0
Psychosis and personality disorders
Reproductive Health and Childbirth 327773 327773 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 326533 0
Early detection / Screening
Intervention code [2] 326534 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 335390 0
Score on the Zanarini Rating Scale for Borderline Personality Disorder.
Timepoint [1] 335390 0
Baseline (pre-intervention), and six weeks postpartum.
Secondary outcome [1] 424260 0
Score on the Edinburgh Postnatal Depression Scale.
Timepoint [1] 424260 0
Baseline (pre-intervention), and six weeks postpartum.
Secondary outcome [2] 425893 0
A composite secondary outcome of medical conditions, obstetric complications, and procedures performed as measured by SA Health Pregnancy Outcome Record.
Timepoint [2] 425893 0
6 weeks postpartum.
Secondary outcome [3] 425894 0
A composite secondary outcome of labour including onset, induction, augmentation, and complications as measured by SA Health Pregnancy Outcome Record.
Timepoint [3] 425894 0
6 weeks postpartum.
Secondary outcome [4] 425895 0
A composite secondary outcome of infant measures including gestational age, birthweight, Apgar score, and congenial anomalies as measured by SA Health Pregnancy Outcome Record.
Timepoint [4] 425895 0
6 weeks postpartum.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by Qualtrics software.
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
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
1/07/2026
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
165
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 25194 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [2] 25195 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 40865 0
5006 - North Adelaide
Recruitment postcode(s) [2] 40864 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 314298 0
Charities/Societies/Foundations
Name [1] 314298 0
Breakthrough Mental Health Research Foundation
Country [1] 314298 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Rd, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 316242 0
None
Name [1] 316242 0
Nil
Address [1] 316242 0
Nil
Country [1] 316242 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313412 0
SA Department for Health and Wellbeing Human Research Ethics Committee
Ethics committee address [1] 313412 0
Citi Centre Building, 11 Hindmarsh Square, Adelaide SA 5000
Ethics committee country [1] 313412 0
Australia
Date submitted for ethics approval [1] 313412 0
24/06/2022
Approval date [1] 313412 0
Ethics approval number [1] 313412 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128066 0
Prof Tracey Wade
Address 128066 0
Flinders University
College of Education, Psychology and Social Work
Sturt Rd, Bedford Park SA 5042
Country 128066 0
Australia
Phone 128066 0
+61 8 8201 3911
Fax 128066 0
Email 128066 0
tracey.wade@flinders.edu.au
Contact person for public queries
Name 128067 0
Ms Alexandra May
Address 128067 0
Flinders University
College of Education, Psychology and Social Work
Sturt Rd, Bedford Park SA 5042
Country 128067 0
Australia
Phone 128067 0
+61 0423937434
Fax 128067 0
Email 128067 0
may0160@flinders.edu.au
Contact person for scientific queries
Name 128068 0
Prof Tracey Wade
Address 128068 0
Flinders University
College of Education, Psychology and Social Work
Sturt Rd, Bedford Park SA 5042
Country 128068 0
Australia
Phone 128068 0
+61 8 8201 3911
Fax 128068 0
Email 128068 0
tracey.wade@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD not relevant to research as congregate outcomes are solely required.


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.