Feasibility and Efficacy of GTEP for Birth Trauma

February 18, 2026 updated by: University of Birmingham

A Study to Explore the Feasibility and Efficacy of Group Traumatic Episode Protocol (GTEP) for Reducing Trauma Symptoms Following a Traumatic Birthing Experience

This clinical study aims to evaluate the feasibility and initial efficacy of Group Traumatic Episode Protocol (GTEP) for reducing trauma symptoms (measured by the PCL-5 and City BiTS) for individuals following a traumatic birthing experience. A secondary aim is to evaluate the efficacy of GTEP in improving parental wellbeing (measured through the CORE-10) and parent-infant bonding (measured through the PBQ) following a traumatic birthing experience.

Participants (those who have experienced a traumatic birthing experience) will complete the GTEP intervention, delivered online. They will be asked to complete outcome measures and give feedback on their experience of the group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

It is estimated that up to 15.7% of individuals will experience some trauma symptoms following childbirth, with 4-6% developing Post-Traumatic Stress Disorder. Research has found there to be an increased risk of postpartum depression, postpartum psychosis and anxiety following a complicated or traumatic childbirth, along with reduced parent-infant bonding at 1, 6 and 12-months postpartum. Group Traumatic Episode Protocol (GTEP) is a version of Eye Movement Desensitization and Reprocessing (EMDR) to be used in group settings. There is a growing evidence base for the efficacy of GTEP in other populations and it has been found to reduce trauma symptoms in a refugee population, adult cancer patients and healthcare professionals . However, there is no research to date exploring the feasibility and efficacy of GTEP for trauma symptoms related to birth.

This study aims to evaluate the feasibility and efficacy of GTEP for reducing trauma symptoms (measured by the PCL-5 and City BiTS) for individuals following a traumatic birthing experience. Feasibility / acceptability will be evaluated using structured measures, along with open-ended qualitative questions. The facilitators of the group will also be administered these measures and asked for qualitative feedback about their experience of facilitating the group.

A secondary aim is to evaluate the efficacy of GTEP in improving parental wellbeing (measured through the CORE-10) and parent-infant bonding (measured through the PBQ) following a traumatic birthing experience

The GTEP Intervention (for use in this study):

The intervention will involve a total of 8 sessions:

  • Session 1: a home visit to gain consent, determine full eligibility and complete outcome measures.
  • Sessions 2 - 7: 6 online GTEP sessions, conducted via Zoom, which will happen weekly. Each session will last approximately 90 minutes.
  • Session 8: A post-group follow-up, either face-to-face or over the telephone, to discuss experiences of the group, discuss any onward referrals (as required), complete final outcome measures.

Study Design:

This study will use a pre-post design, with outcome measure questionnaires (CORE-10, City BiTS, PBQ) completed at two time points (before and after the GTEP intervention). In addition, the primary outcome measure of the PCL-5, will be administered at 8 time points (i.e., during the pre-intervention home visit, before sessions 2, 3, 4, 5, 6 and 7 and during the post-intervention follow-up).

A study feasibility measure will also be administered to evaluate the feasibility of the intervention for this population. This will be administered to both client participants and the group facilitators, where appropriate. Qualitative feedback will also be gathered.

A further qualitative component will also be utilised. In order to gather more feedback from facilitators of G-TEP, stakeholders / professionals from around the country who have used, or are considering using G-TEP, with individuals who have experienced birth trauma will be recruited to complete an online questionnaire. These participants will be recruited via social media adverts. They need to be UK-based to be eligible to take part. Consent forms and PIS will be sent via email and once these have been returned, a link to an online questionnaire (via MS Forms) will be sent.

Participants:

Participants will be recruited via the Black Country Perinatal Mental Health Service (BCPMHS) who are self-reporting trauma symptoms related to a traumatic birthing experience within the last 18 months.

Data Analysis:

Data will be analysed at the University of Birmingham. Quantitative data analysis will include a pre-and-post-intervention comparison scores at both an individual (using a Reliable Change Index) and a group level (using either a bootstrapped paired samples t-test or a matched-pairs Wilcoxon). Descriptive statistics will also be used where appropriate.

Qualitative analysis may be conducted related to the feasibility questions outlined above.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged between 18-65 years.
  • Currently under the Black Country Perinatal Mental Health Service
  • Experiencing self-reported trauma symptoms related to a birthing experience within the last 18 months (this includes the birth itself, the postnatal hospital stay, and/or any neonatal admissions).
  • Access to technology (e.g., laptop, internet connection) to be able to access the online group.
  • Access to a confidential space within their home, and childcare for their baby/any other existing children.
  • Proficient levels of English Language to engage with the group.
  • Ability to engage in group therapy based on clinical presentation.
  • Capacity to consent to engage in the GTEP group and research study.

Exclusion Criteria:

  • Women/birthing people whose baby is no longer under their care.
  • Severe and enduring mental health presentations (i.e., diagnosis of bipolar, psychosis and/or schizophrenia.
  • Significant sensory impairment (e.g., needing a British Sign Language interpreter).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GTEP
Participants will receive the GTEP intervention, delivered online.
Behavioral: Group Traumatic Episode Protocol (GTEP)

GTEP is a group version of the Recent Traumatic Episode Protocol (R-TEP), a form of EMDR.

The GTEP intervention will involve 2 sessions focusing on preparation (e.g., through grounding and emotional regulation) followed by 4 processing sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD Checklist for DSM-5 (PCL-5)
Time Frame: From enrolment to post-treatment follow-up session, from baseline up to 24 weeks.
PCL-5 questionnaire to measure any changes in trauma symptoms. Scores can range between 0-80. The cut-off score for indicating probable PTSD is 31-33.
From enrolment to post-treatment follow-up session, from baseline up to 24 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
City Birth Trauma Scale (CiBTS)
Time Frame: From enrolment through to post-intervention follow-up, from baseline up to 24 weeks.
To measure trauma symptoms related directly to the childbirth experience. Scores on this measure range from 0-60, with higher scores indicating greater likelihood of trauma symptoms related to a childbirth experience.
From enrolment through to post-intervention follow-up, from baseline up to 24 weeks.
Clinical Outcomes in Routine Evaluation 10 (CORE-10)
Time Frame: From enrolment through to post-intervention follow-up session, from baseline up to 24 weeks.
A measure of psychological wellbeing. Scores range from 0-40, with higher scores indicating higher levels of distress. A score of 11 or above is generally considered clinically significant.
From enrolment through to post-intervention follow-up session, from baseline up to 24 weeks.
Parental Bonding Questionnaire (PBQ)
Time Frame: From enrolment through to post-intervention follow-up session, from baseline up to 24 weeks.
To measure levels of parent-infant bonding. Scores can range from 0-125, with higher scores indicating greater bonding difficulties.
From enrolment through to post-intervention follow-up session, from baseline up to 24 weeks.
Acceptability of Intervention Measure (AIM)
Time Frame: Participants - from session 2 to post-treatment follow up session, up to 24 weeks. Facilitators - up to 12 weeks post-intervention

These measured are used to help evaluate the feasibility and acceptability of the GTEP intervention. These questions will be asked at the beginning of each session from T2 - T8. Questionnaires have been based on these measures but adapted for this specific population. Scores can range from 13-70, with higher scores indicating greater acceptability / feasibility.

These will be asked of both participants and facilitators.
Participants - from session 2 to post-treatment follow up session, up to 24 weeks. Facilitators - up to 12 weeks post-intervention
Feasibility of Intervention Measure (FIM)
Time Frame: Participants - From session 2 to post-treatment follow up session, up to 24 weeks. Facilitators - up to 12 weeks post-intervention.

This measure is used to help evaluate the feasibility of the G-TEP intervention. Questionnaires have been based on these measures but adapted for this specific population. Scores can range from 13-70, with higher scores indicating greater acceptability / feasibility. These questions will be asked at the beginning of each session from T2 - T8.

These will be asked of both facilitators and participants.
Participants - From session 2 to post-treatment follow up session, up to 24 weeks. Facilitators - up to 12 weeks post-intervention.
Intervention Appropriateness Measure (IAM)
Time Frame: Participants - From session 2 to post-treatment follow up session, up to 24 weeks. Facilitators - up to 12 weeks post-intervention.

This measure is used to help evaluate the appropriateness of the G-TEP intervention for this population group. These questions will be asked at the beginning of each session from T2 - T8. Questionnaires have been based on these measures but adapted for this specific population. Scores can range from 13-70, with higher scores indicating greater acceptability / feasibility.

These will be asked of both participants and facilitators.
Participants - From session 2 to post-treatment follow up session, up to 24 weeks. Facilitators - up to 12 weeks post-intervention.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
G-TEP Participant Survey
Time Frame: Up to 12 weeks post-intervention.
A qualitative survey to be given to participants at the end of the G-TEP intervention to gather feedback on their experiences of G-TEP. Questions are based around elements they found helpful / less helpful, online vs in-person group, barriers to engagement, suggestions for improvement.
Up to 12 weeks post-intervention.
G-TEP facilitator survey
Time Frame: Up to 12 weeks post-intervention.
Online questionnaire to be completed by facilitators of G-TEP within the BCPMHS service. Questions are based around their experiences of running G-TEP, any deviations from the protocol, things that worked well, barriers to engagement.
Up to 12 weeks post-intervention.
G-TEP Stakeholder questionnaire
Time Frame: Throughout study completion, an average of 6 months.
Questionnaire to be given to stakeholders / professionals from within the G-TEP community, asking about their experiences of either running a G-TEP group or considering running a G-TEP group. Online questionnaire via MS Forms.
Throughout study completion, an average of 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Birmingham

Collaborators

Black Country Healthcare NHS Foundation Trust

Investigators

  • Principal Investigator: Rachel Strachan, Study Principal Investigator, Black Country Healthcare NHS Foundation Trust
  • Study Chair: Alice Welham, Study Co-Investigator, University of Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

July 25, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG_24-029
  • 341922 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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