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PTSD (Childbirth-Related)NCT07246356

Feasibility and Efficacy of GTEP for Birth Trauma

A study testing Group Traumatic Episode Protocol (GTEP) in people with PTSD (Childbirth-Related) and Psychological Wellbeing, run by University of Birmingham at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
What is being tested?
Group Traumatic Episode Protocol (GTEP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited Kingdom
Study dates
19 Jun 2025to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Grace E Rodgers, Study Chief Investigator contact

+44 7817937825

gxr327@student.bham.ac.uk

Rachel Strachan, Study Principal Investigator contact

rachel.strachan1@nhs.net

United Kingdom1 site, 1 recruiting
  • Black Country Healthcare NHS Foundation Trust

    Wolverhampton, WV4 5HN

    Julie Fletcher, Research and Innovation, +44 01902 446724, bchft.researchandinnovation@nhs.net

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
Group Traumatic Episode Protocol (GTEP)
Keywords
GTEP, Group EMDR, Birth trauma, Psychological wellbeing, Perinatal, Parent infant bonding
Medical subject headings
Stress Disorders, Post-Traumatic, Birth Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group Traumatic Episode Protocol (GTEP)Behavioural

    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.

Study groups in NCT07246356
Study groupRoleWhat they receive
GTEPExperimentalParticipants will receive the GTEP intervention, delivered online.
Receives: Behavioral: Group Traumatic Episode Protocol (GTEP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PTSD Checklist for DSM-5 (PCL-5)

    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.

    Measured: From enrolment to post-treatment follow-up session, from baseline up to 24 weeks.

Secondary outcomes (6)
  1. City Birth Trauma Scale (CiBTS)

    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.

    Measured: From enrolment through to post-intervention follow-up, from baseline up to 24 weeks.

  2. Clinical Outcomes in Routine Evaluation 10 (CORE-10)

    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.

    Measured: From enrolment through to post-intervention follow-up session, from baseline up to 24 weeks.

  3. Parental Bonding Questionnaire (PBQ)

    To measure levels of parent-infant bonding. Scores can range from 0-125, with higher scores indicating greater bonding difficulties.

    Measured: From enrolment through to post-intervention follow-up session, from baseline up to 24 weeks.

  4. Acceptability of Intervention Measure (AIM)

    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.

    Measured: Participants - from session 2 to post-treatment follow up session, up to 24 weeks. Facilitators - up to 12 weeks post-intervention

  5. Feasibility of Intervention Measure (FIM)

    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.

    Measured: Participants - From session 2 to post-treatment follow up session, up to 24 weeks. Facilitators - up to 12 weeks post-intervention.

  6. Intervention Appropriateness Measure (IAM)

    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.

    Measured: Participants - From session 2 to post-treatment follow up session, up to 24 weeks. Facilitators - up to 12 weeks post-intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2025
  2. Study start19 Jun 2025
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07246356
Sponsor's protocol ID
RG_24-029
Other IDs
341922
Status last verified
Jul 2025
First submitted
25 Jul 2025
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ertan D, Hingray C, Burlacu E, Sterle A, El-Hage W. Post-traumatic stress disorder following childbirth. BMC Psychiatry. 2021 Mar 16;21(1):155. doi: 10.1186/s12888-021-03158-6.

    PubMed 33726703
  • Kjerulff KH, Attanasio LB, Sznajder KK, Brubaker LH. A prospective cohort study of post-traumatic stress disorder and maternal-infant bonding after first childbirth. J Psychosom Res. 2021 May;144:110424. doi: 10.1016/j.jpsychores.2021.110424. Epub 2021 Mar 17.

    PubMed 33756149
  • Yurtsever A, Konuk E, Akyuz T, Zat Z, Tukel F, Cetinkaya M, Savran C, Shapiro E. An Eye Movement Desensitization and Reprocessing (EMDR) Group Intervention for Syrian Refugees With Post-traumatic Stress Symptoms: Results of a Randomized Controlled Trial. Front Psychol. 2018 Jun 12;9:493. doi: 10.3389/fpsyg.2018.00493. eCollection 2018.

    PubMed 29946275
  • Roberts, A. K. P. (2018). The effects of the EMDR group traumatic episode protocol with cancer survivors. Journal of EMDR Practice and Research, 12(3), 105-117. https://doi.org/10.1891/1933-3196.12.3.105

  • Tsouvelas, G., Chondrokouki, M., Nikolaidis, G., & Shapiro, E. (2019). A vicarious trauma preventive approach. The Group Traumatic Episode Protocol EMDR and workplace affect in professionals who work with child abuse and neglect. 2, 130-138. https://doi.org/10.26386/obrela.v2i3.123

  • Farrell D, Moran J, Zat Z, Miller PW, Knibbs L, Papanikolopoulos P, Prattos T, McGowan I, McLaughlin D, Barron I, Matthess C, Kiernan MD. Group early intervention eye movement desensitization and reprocessing therapy as a video-conference psychotherapy with frontline/emergency workers in response to the COVID-19 pandemic in the treatment of post-traumatic stress disorder and moral injury-An RCT study. Front Psychol. 2023 Mar 23;14:1129912. doi: 10.3389/fpsyg.2023.1129912. eCollection 2023.

    PubMed 37063579
  • Pink, J., Ghomi, M., Smart, T., & Richardson, T. (2022). Effects of EMDR Group Traumatic Episode Protocol on Burnout Within IAPT Healthcare Professionals: A Feasibility and Acceptability Study. Journal of EMDR Practice and Research, 16(4), 215-227. https://doi.org/10.1891/EMDR-2022-0029

  • Barkham, M., Bewick, B., Mullin, T., Gilbody, S., Connell, J., Cahill, J., Mellor-Clark, J., Richards, D., Unsworth, G., & Evans, C. (2013). The CORE-10: A short measure of psychological distress for routine use in the psychological therapies. Counselling and Psychotherapy Research, 13, 3-13. https://doi.org/10.1080/14733145.2012.729069

  • Brockington, I. F., Oates, J., George, S., Turner, D., Vostanis, P., Sullivan, M., Loh, C., & Murdoch, C. (2001). A Screening Questionnaire for mother-infant bonding disorders. Archives of Women's Mental Health, 3(4), 133-140. https://doi.org/10.1007/s007370170010

  • Ayers S, Wright DB, Thornton A. Development of a Measure of Postpartum PTSD: The City Birth Trauma Scale. Front Psychiatry. 2018 Sep 18;9:409. doi: 10.3389/fpsyt.2018.00409. eCollection 2018.

    PubMed 30279664
  • Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.

    PubMed 26606250
  • Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

    PubMed 28851459
  • Shapiro, E (2013). "The EMDR Group Traumatic Episode Protocol." Presentation to the EMDR Turkey Conference, Istanbul, Turkey.

  • Shapiro, E., & Laub, B. (2008). Early EMDR Intervention (EEI): A Summary, a Theoretical Model, and the Recent Traumatic Episode Protocol (R-TEP). Journal of EMDR Practice and Research, 2(2), 79-96. https://doi.org/10.1891/1933-3196.2.2.79

Questions about this trial

What is this clinical trial studying?

A study testing Group Traumatic Episode Protocol (GTEP) in people with PTSD (Childbirth-Related) and Psychological Wellbeing, run by University of Birmingham at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Grace E Rodgers, Study Chief Investigator (+44 7817937825, gxr327@student.bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PTSD Checklist for DSM-5 (PCL-5) (time frame: From enrolment to post-treatment follow-up session, from baseline up to 24 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07246356, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

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