A Study to Explore the Feasibility and Efficacy of Group Traumatic Episode Protocol (GTEP) for Reducing Trauma Symptoms Following a Traumatic Birthing Experience
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Birmingham
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- PTSD Checklist for DSM-5 (PCL-5)
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts 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).
Arms & Interventions
GTEP
Participants will receive the GTEP intervention, delivered online.
Intervention: Group Traumatic Episode Protocol (GTEP) (Behavioral)
Outcomes
Primary Outcomes
PTSD Checklist for DSM-5 (PCL-5)
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.
Secondary Outcomes
- 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)
- 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.)
- 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.)
- City Birth Trauma Scale (CiBTS)(From enrolment through to post-intervention follow-up, from baseline up to 24 weeks.)
- Clinical Outcomes in Routine Evaluation 10 (CORE-10)(From enrolment through to post-intervention follow-up session, from baseline up to 24 weeks.)
- Parental Bonding Questionnaire (PBQ)(From enrolment through to post-intervention follow-up session, from baseline up to 24 weeks.)