Feasibility and Efficacy of GTEP for Birth Trauma

NCT07246356 | Recruiting

• 2 other identifiers: RG_24-029341922
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PTSD (Childbirth-Related); Psychological Wellbeing; Bonding

Keywords

GTEP; Group EMDR; Birth trauma; Psychological wellbeing; Perinatal; Parent infant bonding

Outcome Measures

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.

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

Secondary Outcomes (6)

• City Birth Trauma Scale (CiBTS)

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

• Clinical Outcomes in Routine Evaluation 10 (CORE-10)

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

• Parental Bonding Questionnaire (PBQ)

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

• Acceptability of Intervention Measure (AIM)

  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)

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

Other Outcomes (3)

• G-TEP Participant Survey

  Up to 12 weeks post-intervention.

• G-TEP facilitator survey

  Up to 12 weeks post-intervention.

• G-TEP Stakeholder questionnaire

  Throughout study completion, an average of 6 months.

Study Arms (1)

GTEP

EXPERIMENTAL

Participants will receive the GTEP intervention, delivered online.

Behavioral: Group Traumatic Episode Protocol (GTEP)

Interventions

Group Traumatic Episode Protocol (GTEP) BEHAVIORAL

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.

GTEP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Birmingham: lead

Study Sites (1)

Black Country Healthcare NHS Foundation Trust

Wolverhampton, WV4 5HN, United Kingdom

RECRUITING

Related Publications (14)

• 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.

  PMID: 33726703 BACKGROUND

• 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.

  PMID: 33756149 BACKGROUND

• 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.

  PMID: 29946275 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 37063579 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 30279664 BACKGROUND

• 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.

  PMID: 26606250 BACKGROUND

• 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.

  PMID: 28851459 BACKGROUND

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

  BACKGROUND

• 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

  BACKGROUND

Related Links

• PTSD UK

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Birth Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Wounds and Injuries

Study Officials

• Rachel Strachan, Study Principal Investigator

  Black Country Healthcare NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Alice Welham, Study Co-Investigator

  University of Birmingham

  STUDY CHAIR

Central Study Contacts

Grace E Rodgers, Study Chief Investigator

CONTACT

+44 7817937825; gxr327@student.bham.ac.uk

Rachel Strachan, Study Principal Investigator

CONTACT

rachel.strachan1@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: November 24, 2025
• Study Start: June 19, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 19, 2026

Record last verified: 2025-07

Locations

GB (1)