Feasibility and Efficacy of GTEP for Birth Trauma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorUniversity of Birmingham
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Group Traumatic Episode Protocol (GTEP)
BehavioralGTEP 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: GTEPExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
From enrolment to post-treatment follow-up session, from baseline up to 24 weeks.Secondary outcomes
1
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.2
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.3
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.4
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. 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-interventionOther outcomes
1
G-TEP Participant Survey
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.2
G-TEP facilitator survey
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
Up to 12 weeks post-intervention.3
G-TEP Stakeholder questionnaire
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.
Time frame
Throughout study completion, an average of 6 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov