Black Country Healthcare NHS Foundation Trust
Wolverhampton, WV4 5HN, United Kingdom
Location status: Recruiting
NCT Number: NCT07246356
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.
Interested in participating?
Request Info18 year–65 year
Female
Interventional
Not applicable
Wolverhampton, WV4 5HN, United Kingdom
Location status: Recruiting
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 weeks post-intervention.
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.
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: Throughout study completion, an average of 6 months.
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.
Contact information is provided by the study sponsor or research team.
Grace E Rodgers, Study Chief Investigator
CONTACT
Rachel Strachan, Study Principal Investigator
CONTACT
University of Birmingham
Other
A Study to Explore the Feasibility and Efficacy of Group Traumatic Episode Protocol (GTEP) for Reducing Trauma Symptoms Following a Traumatic Birthing Experience
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07175025
Combat Disorders, Mental Disorders
Indianapolis, Indiana, United States
View Trial DetailsNCT07342530
Breathing Techniques, Mental Disorders
Little Rock, Arkansas, United States
View Trial DetailsNCT05662423
Depression, Postpartum, Depressive Disorder
Boston, Massachusetts, United States
View Trial DetailsNCT07684521
Anxiety, Anxiety Disorders
Los Angeles, California, United States
View Trial Details