Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000460505p
Ethics application status
Submitted, not yet approved
Date submitted
26/03/2024
Date registered
15/04/2024
Date last updated
15/04/2024
Date data sharing statement initially provided
15/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Supporting Mothers in Regional NSW: A Telehealth Intervention for Birth Trauma
Scientific title
Supporting Mothers in Regional NSW: A Narrative-Informed Group Based Telehealth Intervention for Birth Trauma
Secondary ID [1] 311793 0
Nil known
Universal Trial Number (UTN)
U1111-1305-9340
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-traumatic stress disorder 333298 0
Adjustment disorder 333299 0
Post-natal depression 333300 0
Post-natal anxiety 333301 0
Condition category
Condition code
Mental Health 329985 329985 0 0
Depression
Mental Health 329986 329986 0 0
Anxiety
Mental Health 329987 329987 0 0
Other mental health disorders
Reproductive Health and Childbirth 329988 329988 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of six psychotherapy sessions based on the trauma narrative recovery model developed by Lane and Lane (2018). The six-session model comprises psychological treatment that is Narrative-Informed and therapist-guided psychotherapy inclusive of interactive activities covering key themed modules of loss of agency, grief, feelings of self-blame, shame, anger, feelings of powerlessness, fragmentation and integration of memories, that are associated with trauma. The intervention will be delivered by a registered Clinical Psychologist, via telehealth, in group format, once per week for six weeks, and each of the six treatment sessions will last between 60 to 90 minutes each. Groups are expected to be between 4 and 8 participants. An attendance and adherence record will be kept to quantify the number of sessions attended for each participant.
Intervention code [1] 328239 0
Treatment: Other
Comparator / control treatment
The control group are those allocated to a wait list during the same observation period as the intervention. There will be no restrictions on outside care for the waitlist control group. Once the study concludes, the wait list control will receive the full intervention.
Control group
Active

Outcomes
Primary outcome [1] 337752 0
Scores on a measure of birth trauma at the end of treatment.
Timepoint [1] 337752 0
Baseline and end of treatment at 6 weeks.
Secondary outcome [1] 433139 0
Scores on a measure of post-natal depression at the end of treatment.
Timepoint [1] 433139 0
Baseline and end of treatment at 6 weeks.
Secondary outcome [2] 433343 0
Scores on a measure of postpartum anxiety at the end of treatment.
Timepoint [2] 433343 0
Baseline and end of treatment at 6 weeks.

Eligibility
Key inclusion criteria
Women residing in the Hunter New England Local Health District, up to 6 months postpartum, aged 18 years and above, Australian resident, proficient in English, and who subjectively report having had a traumatic birth experience with their most recent birth. Women should have also had a live birth with a gestation of at least 34+ completed weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women residing outside of the Hunter New England Local Health District will be excluded, as will women who are nulliparous, pregnant or more than 6 months postpartum, under 18 years of age, not an Australian resident, not proficient in English, and who do not subjectively report having had a traumatic birth experience with their most recent birth. Women will also be excluded if their most recent delivery involved a still birth or a live birth with a gestation of under 34 weeks. Women who endorse item 10 on the Edinburgh Postnatal Depression Scale (an item about suicidal ideation), or who have a total score of more than 13 will also be excluded from the study and appropriate referrals will be made to Perinatal and Infant Mental Health Services (PIMHS). Women with serious mental health concerns that impinge on their ability to provide informed consent (e.g., have an intense mood or psychotic episode associated with bipolar disorder or schizophrenia) will be excluded from the study (and appropriate referrals made where relevant).

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 involves contacting the holder of the allocation schedule who is "off-site" .
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generated in permutated blocks alternating in block sizes of 4 and 6
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants will be randomised at enrolment using a random sequence in permutated blocks alternating in block size of 4 and 6. Those allocated to the intervention group will receive the intervention within 4 weeks from the date of revealing allocation, with the intervention delivered over the next 6 weeks, Thus the period of revealing allocation to completing the intervention is 10 weeks.

Those allocated to the control group will receive usual care from the date of enrolment and over a period of 10 weeks. After completion of the final assessment measure the control group will receive the intervention, and thus are classified as a waitlist control group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will be based on intention to treat principles. Analyses will model the effect of group allocation and time utilising the general linear model (ANOVA), assuming a < 0.05 between intervention and wait-list control denotes significance for the continuous outcomes (City Birth Trauma Scale, Edinburgh Postnatal Depression Scale, Postpartum Specific Anxiety Scale). As a feasibility and acceptability study, testing proof of principle, our analyses will provide an estimate of change data and effect sizes to inform a larger trial in the future.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2024
Actual
Date of last participant enrolment
Anticipated
30/11/2024
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 42272 0
2350 - Armidale

Funding & Sponsors
Funding source category [1] 316126 0
Charities/Societies/Foundations
Name [1] 316126 0
The Peregrine Centre
Country [1] 316126 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Peregrine Centre
Address
Country
Australia
Secondary sponsor category [1] 318317 0
None
Name [1] 318317 0
Address [1] 318317 0
Country [1] 318317 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314956 0
University of New England Human Research Ethics Committee
Ethics committee address [1] 314956 0
http://www.une.edu.au/research/res-services/rdi/ethics/hre/human-research-ethics-committee
Ethics committee country [1] 314956 0
Australia
Date submitted for ethics approval [1] 314956 0
03/04/2024
Approval date [1] 314956 0
Ethics approval number [1] 314956 0

Summary
Brief summary
For most women, childbirth is a significant life event that can be associated with a range of emotional responses, from joy and relief for some, but trauma and distress for others. A traumatic childbirth experience, sometimes referred to as ‘birth trauma’ lead to poor mental health outcomes in postpartum women, severely impacting mother-infant attachment, child development, and overall mental health of the family unit. The current project will be the first intervention for postpartum mothers with recent traumatic birth experiences, to decrease serious and persistent mental health concerns. This project will assess the feasibility and acceptability of a highly innovative telehealth group-based early intervention for this vulnerable population group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133242 0
Dr Cassandra Sundaraja
Address 133242 0
School of Psychology, Elm Ave, The University of New England, Armidale NSW 2351
Country 133242 0
Australia
Phone 133242 0
+61267735165
Fax 133242 0
Email 133242 0
csundar2@une.edu.au
Contact person for public queries
Name 133243 0
Cassandra Sundaraja
Address 133243 0
School of Psychology, Elm Ave, The University of New England, Armidale NSW 2351
Country 133243 0
Australia
Phone 133243 0
+61267735165
Fax 133243 0
Email 133243 0
csundar2@une.edu.au
Contact person for scientific queries
Name 133244 0
Dr Phillip J Tully
Address 133244 0
School of Psychology, Elm Ave, The University of New England, Armidale NSW 2351
Country 133244 0
Australia
Phone 133244 0
+61267735028
Fax 133244 0
Email 133244 0
ptully2@une.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?
Baseline and end of treatment data for quantitative data as specified in the primary and secondary outcomes.
When will data be available (start and end dates)?
The data will be available from December 2025 with no restriction on the data availability end date.
Available to whom?
Reasonable requests for collaborative investigations
Available for what types of analyses?
Available for individual participant data meta-analyses involving the investigators
How or where can data be obtained?
By contacting the Principal Investigator Dr Cassandra Sundaraja csundar2@une.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.