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Trial registered on ANZCTR

Registration number

ACTRN12626001293358

Ethics application status

Approved

Date submitted

18/09/2026

Date registered

28/10/2026

Date last updated

28/10/2026

Date data sharing statement initially provided

28/10/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

Mental Health Begins at Birth: Exploring the Impact of Psychological Treatment on Parent-Infant Relationships and Child Mental Health in Mothers Experiencing Childbirth-Related Posttraumatic Stress Disorder

Scientific title

Mental Health Begins at Birth: Exploring the Impact of Imagery Rescripting and Relaxation Training on Dyadic Synchrony and Child Mental Health Trajectories in Mothers experiencing Childbirth-Related Posttraumatic Stress Disorder

Additional trial identifiers [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

Infant mental health

Childbirth-related post traumatic stress disorder

Condition category

Condition code

Mental Health

Other mental health disorders

Reproductive Health and Childbirth

Childbirth and postnatal care

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

Imagery Rescripting is a psychological intervention that focuses on memories of the childbirth experience. During treatment, participants are guided to recall and describe aspects of the memory, including their thoughts, feelings, and sensory experiences. With support from the psychologist, participants identify unmet emotional needs associated with the experience and imagine alternative outcomes that incorporate elements such as safety, support, and control. The aim of the intervention is to reduce distress associated with the memory, promote more adaptive interpretations of the experience, alleviate symptoms of post-traumatic stress, and improve mother-infant relationship.

The intervention will be delivered by a psychologist, either online via Zoom teleconferencing platform (https://zoom.us/) or face to face at the University of Sydney Psychology Clinic. There will be 4 x 1 hour individual sessions over 4 weeks. However, scheduling will be kept flexible to ensure the mother can meet the infant’s needs (e.g., feeding, sleeping).

Intervention code [1]

Treatment: Other

Description of the comparator or control

Relaxation Training is a psychological intervention that teaches skills to manage distress and physiological arousal associated with childbirth-related trauma. Participants receive psychoeducation about the effects of trauma on emotional and physiological responses, Guided by a psychologist, participants learn and practise a range of relaxation strategies, such as progressive muscle relaxation, mental relaxation exercises, and guided imagery. The aim of the intervention is to reduce emotional distress and physical tension, improve emotional regulation, and provide participants with practical coping skills that can be applied in everyday life.

The intervention will be delivered by a psychologist, either online via Zoom teleconferencing platform (https://zoom.us/) or face to face at the University of Sydney Psychology Clinic. There will be 4 x 1 hour individual sessions over 4 weeks. However, scheduling will be kept flexible to ensure the mother can meet the infant’s needs (e.g., feeding, sleeping).

Control group

Active

Outcomes

Primary outcome [1]

Observed dyadic synchrony between mother and infant

Timepoint [1]

Pre-treatment assessment (Week 0), Post-treatment assessment (Week 5), 6-month follow-up (week 29)

Secondary outcome [1]

PTSD diagnosis

Timepoint [1]

Pre-treatment assessment (Week 0), Post-treatment assessment (Week 5), 6-month follow-up (week 29)

Secondary outcome [2]

Maternal childbirth-related PTSD symptoms

Timepoint [2]

Pre-treatment assessment (Week 0), Post-treatment assessment (Week 5), 6-month follow-up (week 29)

Secondary outcome [3]

Infant communication development

Timepoint [3]

Pre-treatment assessment (Week 0), 6-month follow-up (week 29)

Secondary outcome [4]

Infant social development

Timepoint [4]

Pre-treatment assessment (Week 0), 6-month follow-up (week 29)

Secondary outcome [5]

Maternal anxiety

Timepoint [5]

Pre-treatment assessment (Week 0), Post-treatment assessment (Week 5), 6-month follow-up (week 29)

Secondary outcome [6]

Maternal depression

Timepoint [6]

Pre-treatment assessment (Week 0), Post-treatment assessment (Week 5), 6-month follow-up (week 29)

Secondary outcome [7]

Maternal post-traumatic cognitions

Timepoint [7]

Pre-treatment assessment (Week 0), Post-treatment assessment (Week 5), 6-month follow-up (week 29)

Secondary outcome [8]

Maternal trait dissociation

Timepoint [8]

Pre-treatment assessment (Week 0), Post-treatment assessment (Week 5), 6-month follow-up (week 29)

Secondary outcome [9]

Maternal inflated parental responsibility appraisals

Timepoint [9]

Pre-treatment assessment (Week 0), Post-treatment assessment (Week 5), 6-month follow-up (week 29)

Secondary outcome [10]

Maternal safety behaviours

Timepoint [10]

Pre-treatment assessment (Week 0), Post-treatment assessment (Week 5), 6-month follow-up (week 29)

Secondary outcome [11]

Maternal sleep quality

Timepoint [11]

Pre-treatment assessment (Week 0), Post-treatment assessment (Week 5), 6-month follow-up (week 29)

Secondary outcome [12]

Therapeutic Alliance

Timepoint [12]

Post-treatment assessment (Week 5),

Secondary outcome [13]

Participant Satisfaction

Timepoint [13]

Post-treatment assessment (Week 5)

Secondary outcome [14]

Self-reported mother-infant bonding

Timepoint [14]

Pre-treatment assessment (Week 0), Post-treatment assessment (Week 5), 6-month follow-up (week 29)

Secondary outcome [15]

Characteristics of childbirth memories

Timepoint [15]

Pre-treatment assessment (Week 0), Post-treatment assessment (Week 5), 6-month follow-up (week 29)

Secondary outcome [16]

Observed maternal responsiveness

Timepoint [16]

Pre-treatment assessment (Week 0), Post-treatment assessment (Week 5), 6-month follow-up (week 29)

Secondary outcome [17]

Observed infant engagement

Timepoint [17]

Pre-treatment assessment (Week 0), Post-treatment assessment (Week 5), 6-month follow-up (week 29)

Secondary outcome [18]

Daily Memory Ratings

Timepoint [18]

Digital daily diary will be completed for seven consecutive days at pre-treatment (7 days before Session 1), mid-treatment (7 days following Session 2), and post-treatment (7 days after the final treatment session)

Secondary outcome [19]

PTSD Symptom Tracking

Timepoint [19]

At each treatment session

Secondary outcome [20]

Imagery ratings

Timepoint [20]

At each treatment session

Secondary outcome [21]

Memory meaning ratings

Timepoint [21]

All treatment sessions

Eligibility

Key inclusion criteria

1) Mother meets diagnostic criteria for PTSD, or subthreshold posttraumatic stress symptoms (PTSS) related to childbirth
2) Mother 18 years or older
3) Mother have an infant aged 4-6 months (this range may be extended to 3-9 months if necessary) [NB. adjusted age if baby was premature]
4) If mother is taking psychotropic medication, she agrees to maintain stable medication type/dosage where possible
5). Dyad not engaged in concurrent psychological treatment
6) Living in Australia
7) Fluent in English

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Healthy volunteers

Key exclusion criteria

(1) the mother is assessed by clinician judgement as being at significant risk of harm to themselves or others, including active suicidal ideation indicated by a 'high' risk rating on the suicide screen of the DIAMOND (Tolin et al., 2022);
(2) The mother is experiencing active psychotic symptoms, as assessed by clinician judgement using the Psychosis Screening Questionnaire (Bebbington & Nayani, 1995).
(3) the mother has an intellectual disability or significant cognitive impairment (estimated IQ < 70); (4) The dyad is experiencing circumstances that affect safe study participation or require alternative clinical care;
(5) the dyad does not have regular access to the internet and a device with a camera;
(6) the dyad is currently involved in legal proceedings related to birth experience
(7) the infant is from a multiple birth (e.g., twins or triplets);
(8) the infant has a significant neurological or developmental condition (e.g., cerebral palsy).

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)

After eligibility has been confirmed and pre-treatment diagnostic assessment completed participants will be randomised to imagery rescripting or relaxation training using a secure central randomisation system.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer-generated random sequence.
Permuted block randomisation sequence: Block size = 2, N = 100 participants, 2 conditions (ImR / Relaxation).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size calculations were informed by a recent meta-analysis of imagery rescripting across psychological disorders (Kroener et al., 2023), which reported a large treatment effect (Hedges' g = 1.09, 95% CI 0.64–1.59). To provide a conservative estimate and account for the use of an active treatment condition, the lower bound of the confidence interval (g = 0.64) was used for power calculations. Using GPower, a total sample of 79 participants was required to achieve 80% power to detect a treatment effect at a two-sided significance level of 0.05. Allowing for an anticipated attrition rate of 20%, the target recruitment sample was increased to 100 mother–infant dyads.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

2/11/2026

Actual

Date of last participant enrolment

Anticipated

1/05/2028

Actual

Date of last data collection

Anticipated

3/11/2028

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment postcode(s) [1]

2050 - Camperdown

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian Rotary Health

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Sydney Human Research Ethics Committee

Ethics committee address [1]

https://www.sydney.edu.au/research/research-integrity-and-ethics.html

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

22/05/2026

Ethics approval number [1]

2025/HE001604

Summary

Brief summary

Some women experience post-traumatic stress disorder (PTSD) after a difficult or traumatic childbirth. These experiences can affect their emotional wellbeing and may make it harder to feel connected with and respond to their baby in everyday interactions. Early parent–infant relationships are important for a child’s social, emotional, and mental health development. This study aims to compare two brief psychological treatments for mothers experiencing post-traumatic stress symptoms following childbirth. The two treatments are imagery rescripting, a therapy that helps people process and change the meaning of distressing memories, and relaxation training, which teaches skills to reduce stress and promote relaxation. The study will examine whether either treatment can improve mothers' wellbeing and strengthen their relationship and interactions with their infant. Around 100 mothers and their infants will take part. Mothers who have symptoms of childbirth-related PTSD will be randomly assigned to receive either four sessions of imagery rescripting or four sessions of relaxation training. Researchers will assess whether the treatments help improve mother–infant bonding and interaction, reduce PTSD, anxiety, and depression symptoms, and support positive infant development. The findings may help identify effective ways to support mothers recovering from birth trauma and promote healthy early relationships between mothers and their babies.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Alice Norton

Address

Mallett St Building F M02F, The University of Sydney, NSW, 2006

Country

Australia

Phone

+61 2 9351 0988

Fax

[email protected]

Contact person for public queries

Name

Dr Emily Wilson

Address

Mallett St Building F M02F, The University of Sydney, NSW, 2006

Country

Australia

Phone

+61 2 9114 4343

Fax

[email protected]

Contact person for scientific queries

Name

Dr Emily Wilson

Address

Mallett St Building F M02F, The University of Sydney, NSW, 2006

Country

Australia

Phone

+61 2 9114 4343

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: No. Individual participant data will not be shared. Study findings will be reported only in aggregate form, with all data fully de-identified to protect participant confidentiality and privacy.

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.

Trial Review

Documents added manually

Documents added automatically