Bonding, Psychological Wellbeing, PTSD (Childbirth-Related)
Conditions
Keywords
GTEP, Group EMDR, Birth trauma, Psychological wellbeing, Perinatal, Parent infant bonding
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.
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
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.
Sponsors
University of Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Checklist for DSM-5 (PCL-5) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| City Birth Trauma Scale (CiBTS) | 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. |
| Clinical Outcomes in Routine Evaluation 10 (CORE-10) | 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. |
| Parental Bonding Questionnaire (PBQ) | 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. |
| 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 | 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. |
| 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. | 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. |
| Intervention Appropriateness Measure (IAM) | 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. |
Countries
United Kingdom
Contacts
CONTACTGrace E Rodgers, Study Chief Investigator
CONTACTRachel Strachan, Study Principal Investigator
PRINCIPAL_INVESTIGATORRachel Strachan, Study Principal Investigator
Black Country Healthcare NHS Foundation Trust
STUDY_CHAIRAlice Welham, Study Co-Investigator
University of Birmingham
Outcome results
None listed