ClinicalTrials.gg
RecruitingNCT07246356Updated Feb 19, 2026

Feasibility and Efficacy of GTEP for Birth Trauma

An interventional study of Group Traumatic Episode Protocol (GTEP) in PTSD (Childbirth-Related), Psychological Wellbeing and Bonding, sponsored by University of Birmingham. Recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-19.

Sponsored by University of Birmingham · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Jun 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • PTSD (Childbirth-Related)
  • Psychological Wellbeing
  • Bonding

Keywords

  • GTEP
  • Group EMDR
  • Birth trauma
  • Psychological wellbeing
  • Perinatal
  • Parent infant bonding
03

In context

Stress Disorders, Post-Traumatic

2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.

This study's planned enrollment of 10 is below the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

University of Birmingham is the lead sponsor of 182 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    GTEP

    Participants will receive the GTEP intervention, delivered online.

    Behavioral: Group Traumatic Episode Protocol (GTEP)

Interventions

  • BehavioralGroup 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.

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What researchers measure

Primary outcomes

  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.

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

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

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

Other outcomes

  1. G-TEP Participant Survey

    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.

    Time frame: Up to 12 weeks post-intervention.

  2. G-TEP facilitator survey

    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.

    Time frame: Up to 12 weeks post-intervention.

  3. G-TEP Stakeholder questionnaire

    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.

    Time frame: Throughout study completion, an average of 6 months.

07

Study locations

1 of 1 sites recruiting
08

References and documents

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

Related links

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07246356
Responsible party
Sponsor
First posted
Nov 24, 2025
Start date
Jun 19, 2025
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Feb 19, 2026

Study contacts

Grace E Rodgers, Study Chief Investigator
Contact
gxr327@student.bham.ac.uk
+44 7817937825
Rachel Strachan, Study Principal Investigator
Contact
rachel.strachan1@nhs.net
Rachel Strachan, Study Principal Investigator
principal investigator · Black Country Healthcare NHS Foundation Trust
Alice Welham, Study Co-Investigator
study chair · University of Birmingham

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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