Evaluation of a multiprofessional intervention to reduce childbirth-related posttraumatic stress

ISRCTN	ISRCTN44616568
DOI	https://doi.org/10.1186/ISRCTN44616568
Sponsors	Mid Sweden University, Dalarna University, Örebro University, Uppsala University, Linköping University
Funders	Forskningsrådet för hälsa, arbetsliv och välfärd, Mittuniversitetet

Submission date: 06/07/2026
Registration date: 07/07/2026
Last edited: 19/08/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Elisabet Rondung
Principal investigator, Public, Scientific

Mid Sweden University
Department of Education, Psychology and Social Work
Kunskapens väg 1
Östersund
83125
Sweden

ORCID ID	0000-0001-5109-106X
Phone	+46 10 142 89 72
Email	elisabet.rondung@miun.se

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Treatment
Scientific title	ReWrite Birth RCT: Evaluating a multiprofessional intervention including childbirth review and written exposure therapy compared with childbirth review only and waitlist control for reducing childbirth-related posttraumatic stress
Study acronym	ReWrite Birth RCT
Study objectives	The aim of the ReWrite Birth RCT is to test the efficacy of a multi-professional intervention, combining a midwife-led childbirth review (CR) and a psychological intervention built on written exposure therapy (WET), to reduce symptoms of post-traumatic stress and secondary outcomes following a traumatic childbirth experience. 1. Our primary objective is to assess the efficacy of the multiprofessional intervention (CR + WET) in comparison with a waitlist control condition. 2. As a secondary objective we wish to evaluate the relative effect of the different intervention components by comparing (1) CR+WET vs CR only, (2) CR only vs waitlist control, and (3) the symptom change over time in the CR+WLC condition. 3. A third object is to describe the participants’ experiences of the two intervention components.
Ethics approval(s)	Approved 11/03/2026, Swedish Ethical Review Authority (Etikprövningsmyndigheten) (Drottninggatan 7, Uppsala, 75237, Sweden; +46 10 475 08 00; registrator@etikprovning.se), ref: 2026-01010-01
Health condition(s) or problem(s) studied	Childbirth-related posttraumatic stress
Intervention	The multiprofessional intervention used in this trial is built on two components. In the current trial, all interventions will be delivered via online video calls. However, they are designed in a way that would also make them suitable for delivery in a face-to-face format. The first intervention component is a patient-led childbirth review (CR), in which participants meet with a midwife for approximately 90 minutes to discuss their childbirth experience. After a short introduction, the participant is encouraged to share her experience of giving birth in her own way, with the midwife supporting and validating along the way. As a second step, the participant is given an opportunity to ask any questions she might have about the course of labour and birth or her experiences when giving birth. If she wishes, she can also ask questions relating to the medical birth record. The midwife is there to explain without defending medical decisions. In the third part of the session, the midwife and participant explore whether the woman takes any strengthening or positive experiences from childbirth. Before ending the session, the midwife asks how the woman experienced talking about these issues in this way, and they summarise the discussion together. This summary is documented in the study/intervention portal. If the participant is randomised to receive both intervention components, this summary will be accessible to the psychologist who conducts the second intervention component. The second intervention component is a structured psychological intervention, built on Written Exposure Therapy (WET; Sloan & Marx, 2025). This is a highly manualised exposure-based trauma intervention in 5 sessions. In the first session (60 minutes), the psychologist offers psychoeducation about CB-PTSD symptoms and introduces the intervention rationale along with general writing guidelines. Following this, the participant writes about her traumatic childbirth experience for 30 minutes according to session-specific writing instructions. Afterwards, the psychologist and participant talk about the experience of writing, and the written narrative is photographed and sent to the psychologist. Some more psychoeducation about the possibility of a temporary symptom increase and brief instructions on how to handle trauma-related symptoms in the upcoming week ends the session. Sessions 2-4 (45 minutes each) are structured in a similar way, starting with a brief check-in and feedback on last week’s writing, before the new writing instructions are provided. The participant writes about the childbirth-related trauma for 30 minutes, the experience of writing is discussed, narratives are shared with the psychologist, and the session is ended by a reminder of how to handle trauma-related experiences in the coming week. The last session (45 minutes) follows a similar structure, except focusing more on a general summary and evaluation at the end of the session. In the ReWrite Birth RCT, original WET reading instructions (for the therapist) and writing instructions (for the participant) are translated into Swedish and slightly adapted to the target group, e.g., by replacing general examples with examples relevant to childbirth-related trauma. Before the first WET session, the participant will meet with her psychologist once for a planning and scheduling session. This session does not include any active WET components but aims to build rapport, introduce the link to the CR intervention, establish the start and end points of the trauma narrative to be used in the writing sessions, agree on a safety plan (if indicated), and address practical issues (e.g., scheduling meetings, solving childcare arrangements during the sessions, troubleshooting technical issues, etc.). In the trial, participants will be randomised to one of three conditions (1:1:1) using random permuted blocks of 6, 9 and 12 participants to ensure balance in sample size across the groups. One group will receive the complete multiprofessional intervention combining CR and WET, one group will receive the CR component only, and one group will be a waitlist control condition (WLC). Participants in the WLC condition will be offered the interventions in a stepped care approach after the 6-month follow-up. All WLC participants will first be offered CR and can continue with WET if they wish. Reference: Sloan, D. M. & Marx, B. P. (2025). Written Exposure Therapy for PTSD: A Brief Treatment Approach for Mental Health Professionals, Second Edition. Washington, DC: American Psychological Association.
Intervention type	Behavioural
Primary outcome measure(s)	Symptoms of childbirth‑related post‑traumatic stress measured using The City Birth Trauma Scale (City BiTS) at post-intervention (approximately 10 weeks after intervention start, or the equivalent time point for the WLC condition)
Key secondary outcome measure(s)	Symptoms of childbirth‑related post‑traumatic stress measured using the City Birth Trauma Scale (City BiTS) at mid-intervention (3-7 days after CR and before WET, or the equivalent time point for the WLC condition), 6-month follow-up (6 months after intervention start, or the equivalent time point for the WLC condition), and 9-month follow-up (9 months after intervention start, or the equivalent time point for the WLC condition) Symptoms of post traumatic stress (for sensitivity analysis) measured using the PTSD Checklist for DSM 5 (PCL 5) at post-intervention and 9-month follow-up Symptoms of postpartum depression measured using the Edinburgh Postnatal Depression Scale (EPDS) at mid-intervention, post-intervention, 6-month follow-up, and 9-month follow-up Fear of childbirth measured using the Fear of Birth Scale (FOBS) at mid-intervention, post-intervention, 6-month follow-up, and 9-month follow-up Fear of childbirth measured using the Fear of Childbirth Questionnaire (FCQ) at post-intervention and 9-month follow-up Quality of life measured using items 1 and 2 from WHOQOL-BREF at mid-intervention, post-intervention, 6-month follow-up, and 9-month follow-up Well-being measured using the World Health Organization-Five Well-Being Index (WHO-5) at mid-intervention, post-intervention, 6-month follow-up, and 9-month follow-up Symptoms indicating complex PTSD measured using the subscale ‘Disturbances in Self-Organisation’ in the International Trauma Questionnaire (ITQ) at post-intervention and 9-month follow-up Parental self-efficacy measured using the Karitane Parenting Confidence Scale (KPCS) at post-intervention and 6-month follow-up Positive parent behaviours measured using the Comprehensive Early Childhood Parenting Questionnaire (CEQPAQ), subdomains Activities and Affection at 6-month follow-up Parent-infant bonding measured using the Postpartum Bonding Questionnaire (PBQ) at post-intervention and 6-month follow-up Acceptability of interventions measured using the Theoretical Framework of Acceptability Questionnaire (TFA) at post-intervention for the CR+WET group and CR only group, and 9- month follow-up for the waitlist group Treatment satisfaction and negative effects measured using single items at post-intervention for the CR+WET group and CR only group, and 9- month follow-up for the waitlist group
Completion date	11/02/2028

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	50 Years
Sex	Female
Target sample size at registration	120
Key inclusion criteria	1. Age 18 or above 2. Self-reported traumatic experience during (or immediately after) the labour and birth of one’s most recent baby 3. 3 to 12 months have elapsed since the birth 4. Symptom score ≥14 on the City Birth Trauma Scale 5. Being able to read and write by hand in Swedish
Key exclusion criteria	1. Pregnant at inclusion 2. Having experienced neonatal or perinatal mortality in the last labour and birth 3. Posttraumatic stress symptoms are primarily related to another traumatic experience 4. Severe mental health or social problems 5. Currently receiving other professional support for the traumatic birth experience or related mental health problems 6. Previous completion of WET or other manualised exposure-based intervention targeting the index childbirth trauma
Date of first enrolment	13/08/2026
Date of final enrolment	07/05/2027

Locations

Countries of recruitment

Sweden

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

19/08/2026: The Date of first enrolment was changed from 07/08/2026 to 13/08/2026.
06/07/2026: Study’s existence confirmed by the Swedish Ethical Review Authority (Etikprövningsmyndigheten), Sweden.