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.
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. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Black Country Healthcare NHS Foundation Trust
Wolverhampton, United Kingdom
RECRUITINGPTSD 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.
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.
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.
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.
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.
Time frame: From session 2 to post-treatment follow up session, up to 24 weeks.
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.
Time frame: From session 2 to post-treatment follow up session, up to 24 weeks.
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.
Time frame: From session 2 to post-treatment follow up session, up to 24 weeks.
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