A Study to Explore the Feasibility and Efficacy of Group Traumatic Episode Protocol (GTEP) for Reducing Trauma Symptoms Following a Traumatic Birthing Experience
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- PTSD Checklist for DSM-5 (PCL-5)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
GTEP
Participants will receive the GTEP intervention, delivered online.
干预措施: Group Traumatic Episode Protocol (GTEP) (Behavioral)
结局指标
主要结局
PTSD Checklist for DSM-5 (PCL-5)
时间窗: 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.
次要结局
- 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.)