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Recruiting NCT07246356

Feasibility and Efficacy of GTEP for Birth Trauma

No phase Interventional PTSD (Childbirth-Related) Psychological Wellbeing Bonding

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Group Traumatic Episode Protocol (GTEP).
Who it may be relevant to
Registry conditions: PTSD (Childbirth-Related), Psychological Wellbeing, Bonding. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • PTSD Checklist for DSM-5 (PCL-5) [Time frame: From enrolment to post-treatment follow-up session, from baseline up to 24 weeks.]
Secondary outcome measures (6)
  • City Birth Trauma Scale (CiBTS) [Time frame: 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.]
  • Parental Bonding Questionnaire (PBQ) [Time frame: 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]
  • 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.]
  • 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.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • Black Country Healthcare NHS Foundation Trust — Wolverhampton

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. PMID 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. PMID 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. PMID 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 st PMID 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

Identifiers

NCT: NCT07246356 · RG_24-029 · 341922

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗