A Study to Explore the Feasibility and Efficacy of Group Traumatic Episode Protocol (GTEP) for Reducing Trauma Symptoms Following a Traumatic Birthing Experience
Phase: NA
Conditions: PTSD (Childbirth-Related), Psychological Wellbeing, Bonding
Sponsor: University of Birmingham

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STUDY PROTOCOL 
 
 
 
 
 
 
 
Title: A study to explore the feasibility and efficacy of Group Traumatic Episode Protocol 
(GTEP) for reducing trauma symptoms in individuals following a traumatic birthing 
experience. 
 
NCT number: NCT07246356 
 
Date of document: 13/11/2025 
 
Version: 1.3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Title page 
Full/long title of the project: 
A study to explore the feasibility and efficacy of Group Traumatic Episode Protocol (GTEP) for 
reducing trauma symptoms following a traumatic birthing experience.  
 
Short title/acronym 
The efficacy of GTEP for birth trauma.  
 
Sponsor: 
University of Birmingham 
researchgovernance@contacts.bham.ac.uk 
Protocol version number and date 
Protocol version number: 
1.3 
Protocol version date: 
13.11.2025 
 
Research reference numbers 
IRAS number: 
341922 
Sponsor/RG number: 
RG_24-029 
REC reference number: 
 
Public registry number: 
 
Funder number: 
 
This protocol has regard for the HRA guidance.  

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Signature page 
The undersigned confirm that the following protocol has been agreed and accepted and that the CI agrees to 
adhere to the signed University of Birmingham’s sponsorship CI declaration. 
I agree to ensure that the confidential information contained in this document will not be used for any other 
purpose other than the evaluation or conduct of the investigation without the prior written consent of the 
Sponsor 
I also confirm that I will make the findings publicly available through publication or other dissemination tools 
without any unnecessary delay and that an honest accurate and transparent account of the project will be 
given; and that any discrepancies from the project as planned in this protocol will be explained. 
 
Full project title: 
A study to explore the feasibility and efficacy of Group Traumatic Episode 
Protocol (GTEP) for reducing trauma symptoms in individuals following a 
traumatic birthing experience. 
Protocol version number: 
v 1.3 
Protocol version date: 
13/11/2025 
 
Sponsor statement  
Where the University of Birmingham takes on the sponsor role for protocol development oversight, the signing 
of the IRAS form by the sponsor will serve as confirmation of approval of this protocol. 
 
 
 
 

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Table of contents 
 
Title page .................................................................................................................................................................. 2 
Full/long title of the project ................................................................................................................................. 2 
Short title/acronym .............................................................................................................................................. 2 
Protocol version number and date ...................................................................................................................... 2 
Research reference numbers ............................................................................................................................... 2 
Signature page ......................................................................................................................................................... 3 
Sponsor statement ............................................................................................................................................... 3 
Table of contents ..................................................................................................................................................... 4 
Key contacts ............................................................................................................................................................. 6 
Project summary ...................................................................................................................................................... 6 
Funding and support in kind .................................................................................................................................... 8 
Role of sponsor and funder ...................................................................................................................................... 8 
Roles & responsibilities of management committees/groups & individuals .......................................................... 8 
Patient & public involvement group .................................................................................................................... 8 
Protocol contributors ............................................................................................................................................... 8 
Key words ................................................................................................................................................................. 8 
Project flow chart ..................................................................................................................................................... 9 
Protocol ..................................................................................................................................................................10 
1. 
13 
2. 
13 
3. 
14 
4. 
14 
4.1. 
15 
4.2. 
16 
5. 
16 
6. 
22 
7. 
22 
7.1. 
22 
7.1.1. 
22 
7.1.2. 
23 
7.2. 
23 
7.2.1. 
24 
7.2.2. 
24 
7.3. 
24 
7.3.1. 
25 
7.3.2. 
25 

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8. 
26 
9. 
26 
10. 
26 
10.1. 
27 
10.2. 
28 
10.2.1. 
28 
10.2.2. 
28 
10.3. 
29 
10.4. 
29 
10.5. 
29 
10.6. 
29 
10.7. 
30 
10.8. 
31 
10.9. 
31 
11. 
31 
11.1. 
31 
11.2. 
31 
12. 
32 
13. 
36 
13.1. 
36 
13.2. 
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Key contacts 
Role/function 
Role and Organisation 
Contact details 
Dr Rachel Strachan - Principal 
Investigator and External Supervisor  
Consultant Clinical Psychologist, Black 
Country Healthcare NHS Foundation 
Trust  
rachel.strachan@nhs.net 
Grace Rodgers - Chief Investigator 
Doctoral student, University of 
Birmingham 
gxr327@student.bham.ac.uk 
Dr Alice Welham - Co-Investigator and 
Internal Supervisor  
Clinical Psychologist and Associate 
Professor, University of Birmingham 
a.welham@bham.ac.uk 
Habibah Zeb – Co-Investigator  
Assistant Psychologist, Black Country 
Healthcare NHS Foundation Trust 
habibah.zeb@nhs.net 
 
Project summary 
 
Project Title:  
A study to explore the feasibility and efficacy of 
Group Traumatic Episode Protocol (GTEP) for 
reducing trauma symptoms following a traumatic 
birthing experience. 
Short Title:  
The efficacy of GTEP for birth trauma. 
Research question/aim:  
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. 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   
 
This study aims to help to address a current gap in 
literature, contribute to the growing evidence base 
for GTEP and allow more individuals to access 
appropriate and effective support within clinical 
services. This may potentially reduce waiting times 
for psychological interventions within secondary 
care services (if an effective group intervention is 
able to be offered).  
Project Design:  
This study will use a pre-post design, with outcome 
measure questionnaires completed at two time 
points (before and after the GTEP intervention, T1 
and T8).  
In addition, the PCL-5 outcome measure 
questionnaire will be given at 8 time points (i.e., 
during the pre-intervention home visit, before 

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sessions 2, 3, 4, 5, 6 and 7 and during the post-
intervention follow-up).  
Participants will be offered 6 sessions: 
● 
Session 1 – Pre-intervention appointment 
at participant’s home.   
● 
Sessions 2, 3, 4, 5, 6 and 7 – GTEP sessions 
completed via Zoom.  
● 
Session 8 - Post-intervention follow-up 
(either at participant’s home or via phone 
call). 
 
This design was chosen as we want to know the 
impact of the GTEP intervention in reducing trauma 
symptoms, as well as improving parental well-being 
and parent-infant bonding. The administration of 
pre-post outcome measures will allow us to track 
any significant changes in scores.  
 
A study feasibility measure (Weiner et al., 2017) will 
also be administered to evaluate the feasibility of 
the intervention for this population. Further data, 
including recruitment rates and drop-outs will be 
used to determine feasibility / acceptability. 
Feedback will also be gathered from participants 
and facilitators of the group to evaluate feasibility 
and efficacy. 
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. All eligible participants (according to the 
inclusion/exclusion criteria) will be offered to take 
part in the group. 
 
All potentially eligible participants (identified from 
the BCPMHS) will be contacted via phone call to 
discuss the research project and GTEP group and 
gain verbal consent to send them the PIS and 
Consent Form via email/text message system 
(dependent on individual preference). Participants 
who express an interest in taking part will then be 
offered a 1:1 home visit (this is session 1 of the 
intervention). During this visit, the group/project 
will be discussed further and eligibility for the group 
will be determined. The participant will also have 
the opportunity to ask any questions they have, and 
outcome measure data will be collected.  
Planned Recruitment Target:  
We are hoping that the group will be run on a rolling 
basis, with approximately 5 participants in each 
group. We will continue to collect outcome measure 
data until the appropriate number of participants 
have been reached.  
 

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A priori power analysis was conducted using 
G*Power for a minimum sample size calculation. 
Results showed that to achieve 80% power for 
detecting a medium effect size, using a significance 
level of 0.05, a sample size of 28 will be adequate.   
Follow-up Duration:  
Participants will be offered a post-intervention 
follow-up session 2-6 weeks after the final online 
GTEP session. This can be offered as a virtual 
appointment or home visit depending on the 
participant’s preference. The final outcome 
measures will be completed during this session (T8).  
Planned study period:  
The planned study period will run between October 
2024 – September 2026.  
Funding and support in kind 
This is a doctoral project as part of the Doctorate in Clinical Psychology (DClinPsy) and 
therefore no external funding has been secured. Any costs incurred will be covered by the 
University of Birmingham.  
Role of sponsor and funder 
The project is being sponsored by the University of Birmingham.  
The research team named above hold responsibility for the project design, conduct, data analysis and 
interpretation, manuscript writing and dissemination of results.  
Roles & responsibilities of management committees/groups & individuals 
There are no other committees, groups or individuals involved in the project beside those named above and 
the sponsorship from the University of Birmingham.  
 
Patient & public involvement group 
Service users from the BCPMHS have been involved in a trial GTEP group to explore initial acceptability of the 
group. Following feedback from the service users, the structure of the group has been changed and the 
number of online GTEP sessions has been changed from four to six, to allow more time for stabilisation, 
education about the group and for group members to get to know each other. 
 
The research team has also informally sought feedback from other services who have previously conducted 
GTEP groups through the GTEP Special Interest Group (SIG). This has allowed the research team to understand 
what has worked well previously and gather ideas for this current group.  
Protocol contributors 
The protocol contributors are: 
● 
Dr Rachel Strachan (PI) (External to UoB) 
● 
Dr Alice Welham (Co-Investigator) 
● 
Grace Rodgers (CI) 
● 
Habibah Zeb (Co-Investigator) (External to UoB) 
 
These individuals form the research team involved in this project.  

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Key words/Abbreviations 
 
T1, T2, T3, T4, T5, T6, T7 and T8 
Time point 1, time point 2, time 
point 3, time point 4, time point 
5, time point 6, time point 7 and 
time point 8 
PCL-5 
PTSD Checklist for DSM-5 
City BiTS 
City Birth Trauma Scale  
CORE-10 
Clinical Outcomes in Routine 
Evaluation 10 
PBQ 
Postpartum Bonding Questionnaire 
GTEP 
Group Traumatic Episode Protocol 
CI 
Chief Investigator  
PI 
Principal Investigator  
BCPMHS 
Black Country Perinatal Mental 
Health Service  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Project flow chart 
This flowchart describes the procedure for the research study. We are planning to continue the GTEP group on 
a rolling basis and collect outcome measure data until an appropriate number of participants have been 
recruited. It is anticipated that this procedure will be the same for all groups.  
 
 
 
 

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As the research team member completing the 1:1 review session is also a member of the clinical team co-
facilitating the GTEP group within the BCPMHS, they will be able to assess whether the participant can be 

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discharged from the BCPMHS psychology team or be added to the waiting list for 1:1 work.  They will also be 
able to discuss this with other members of the psychology team within the BCPMHS if needed. It is part of 
standard care for participants to be reviewed following a psychological intervention, and the participants usual 
care within the BCPMHS will not be affected if they are discharged from the psychology team. They will still be 
able to access support from other professionals within the team, if this is required and appropriate.  
The waiting list for 1:1 work forms part of the standard care within the BCPMHS psychology team. 

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Protocol 
 
1. Background 
 
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 (PTSD-UK). 
Research has found there to be an increased risk of postpartum depression, postpartum 
psychosis and anxiety following a complicated or traumatic childbirth (Ertan et al., 2021), 
along with reduced parent-infant bonding at 1, 6 and 12-months postpartum (Kjerluff et al., 
2021). Suicide has been found to be the leading cause of direct maternal death between 6-
12 months postpartum (MBRRACE-UK, 2023), thus demonstrating a need for both clinical 
and research focus in this area. Furthermore, parents of babies admitted to a neonatal unit 
have been found to experience significant trauma symptoms, depression, anxiety and stress 
(Dickinson et al., 2022), as well as high prevalence of sleep disturbances and fatigue (Busse 
et al., 2013), suggesting that additional experiences surrounding the birth, not just the 
childbirth itself, can be traumatic.  
Group Traumatic Episode Protocol (GTEP) is a version of Eye Movement Desensitization 
and Reprocessing (EMDR) developed by Shapiro (2013), to be used in group settings. 
Individual EMDR has been found to be effective at reducing PTSD symptoms at 6-weeks 
postpartum (Chiorino et al., 2020), but there is no research to date exploring the efficacy of 
GTEP for trauma symptoms related to birth. 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 (Lehnung et al., 
2017; Yurtsever et al., 2018; Roberts, 2018; Tsouvelas et al., 2019; Farrell et al., 2023; Pink 
et al., 2022). Given the prevalence of birth trauma and the subsequent detrimental 
consequences on parental mental health, this study hopes to add to the growing evidence 
base and if found to be effective, allow more individuals to access appropriate support more 
quickly.  
2. Rationale  
This research will aim to evaluate the feasibility and potential efficacy of GTEP for individuals 
who have experienced birth trauma. As there is no existing research investigating this, there 
is a need for this study to address  
 

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this gap in the literature. Given the prevalence of traumatic birthing experiences, the 
subsequent effects on parental wellbeing, and the demand on specialist perinatal services, 
this research will also help inform the development of these services and allow more 
individuals to access appropriate support more quickly. This is especially important in this 
population given the detrimental effects of birth trauma on postnatal mental health in 
women/birthing people. Furthermore, research has found that poor parental mental health 
can affect a child’s attachment, and their cognitive, social and emotional development 
(Manning and Gregoire, 2009), with maternal anxiety being associated with poor educational 
attainment (Ayano et al., 2022). 
Although individual EMDR has been found to be effective for reducing birth trauma 
symptoms and there is a strong evidence base, this research will be the first to explore 
GTEP (a form of group EMDR) with this population and will likely have important clinical 
implications in informing the way that trauma symptoms related to a traumatic birthing 
experience are treated within mental health services.  
 
3. Theoretical framework 
This piece of research sits within the growing evidence base for the use of GTEP in clinical 
settings. GTEP is a group version of the Recent Traumatic Episode Protocol (R-TEP) 
developed by Shapiro and Laub (2008), which conceptualises that recent traumatic events 
have not had time to conceptualise and remain fragmented for an individual. GTEP aims to 
keep many of the R-TEP principles (e.g., history taking, preparation and stabilisation, and 
episode processing). It has been found to be effective with refugee populations, adult cancer 
patients, healthcare workers, female victims of intimate partner violence and genocide 
survivors, but no research to date has explored its efficacy within a perinatal population. 
Therefore, this research will aim to address this gap in literature.  
4. Research question/aims 
This research aims to evaluate the feasibility and acceptability of GTEP for individuals 
following a traumatic birthing experience. A further aim is to evaluate the initial efficacy of 
GTEP reducing trauma symptoms in individuals who have had a traumatic birthing 
experience. In addition, it will also explore the initial effectiveness of GTEP in improving 
parental wellbeing and the parent-infant relationship.  
 

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4.1. 
Objectives 
Objectives 
Outcome Measures (to achieve this 
objective)  
Primary Objective: 
To assess the feasibility and acceptability of 
the GTEP intervention for a birth trauma 
population.  
 
Feasibility will be measured through using 
the Acceptability of Intervention Measure 
(AIM), Feasibility of Intervention Measure 
(FIM) and Intervention Appropriateness 
Measure (IAM) (Weiner et al., 2017). These 
questions will be asked at the beginning of 
each session from T2 – T8.  
These questions will also be asked to 
facilitators, before and after the 
intervention.  
Further qualitative open-ended questions 
relating to the feasibility and acceptability of 
the intervention will be asked to participants 
at the post-group follow up. 
Group facilitators will also be asked for 
qualitative feedback.  
 
Data regarding recruitment, drop-outs and 
attendance rates will also be used.  
 
 
 
 
 
 
Secondary Objective  
To assess any changes in trauma 
symptoms following participation in the 
GTEP intervention for individuals who have 
had a traumatic birthing experience.  
 
Trauma symptoms will be measured using 
the PTSD Checklist for DMS-5 (PCL-5) 
(Blevins et al., 2015).  
Childbirth-specific trauma symptoms will be 
measured using the City Birth Trauma 
Scale (City BiTS) (Ayers et al., 2018).  
These measures have been validated for 
use.  
 
The PCL-5 will be completed at 8 time-
points: 
● During pre-intervention home visit 
(session 1 of the intervention) (T1) 
● Before session 2 of the intervention 
(T2) 
● Before session 3 of the intervention 
(T3) 
● Before session 4 of the intervention 
(T4) 

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● Before session 5 of the intervention 
(T5) 
● Before session 6 of the intervention 
(T6) 
● Before session 7 of the intervention 
(T7) 
● During the post-intervention follow-
up session (T8) 
 
The City BiTS scale will be completed at T1 
and T8. 
 
 
 
 
Secondary Objective: 
To assess any changes in the wellbeing of 
the birthing parent following the GTEP 
intervention.    
 
Wellbeing will be measured using the 
Clinical Outcomes in Routine Evaluation 10 
(CORE-10) (Barkham et al., 2013).  
 
The CORE-10 will be completed at T1 and 
T8.  
 
Secondary Objective: 
To assess any change in parent-infant 
bonding following the GTEP intervention.  
 
Parent-infant bonding will be measuring 
using the Parental Bonding Questionnaire 
(PBQ) (Brockington et al., 2001) 
 
The PBQ will be completed at T1 and T8.  
 
4.2. 
Outcome 
Potential outcomes of this study include: 
● To contribute to the growing evidence base for the use of GTEP in clinical settings, 
with individuals who have experienced a traumatic event. 
● Be the first study to explore the efficacy of GTEP for individuals with a traumatic 
birthing experience, within a secondary care service.  
● Help to inform the treatment for individuals who have had a traumatic birthing 
experience. 
● Enable more individuals to access treatment in a timely way as group interventions 
can be offered more quickly than individual interventions. This, in turn, could also 
reduce pressure on specialist services as the interventions could be offered within 
maternity and primary care (e.g., Talking Therapies). This could result in less 
referrals being made into secondary care services and a reduction in waiting times 
within these services.   
 
5. Design and methods of data collection and data analysis 
 
Project Design: This study will adopt a pre-post experimental design to explore the feasibility 
and initial efficacy of GTEP on reducing trauma symptoms for individuals who have 

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experienced a traumatic birthing experience. The outcome measures will be completed 
before and after the intervention, to determine any changes.  
 
Participants will be recruited from the BCPMHS, which is part of the Black Country 
Healthcare NHS Foundation Trust. Potentially eligible participants (i.e., those reporting 
trauma symptoms following a birthing experience in the last 18 months), will be identified at 
any point during their care with the BCPMHS. For example, during their initial assessment 
with the service, during a psychology drop-in session with members of the MDT, during an 
appointment with another discipline within the team. These individuals will be asked by the 
clinician conducting the assessment / appointment / lead clinician involved in their care 
whether they are willing to be contacted by a member of the research team to discuss the 
research study.  
Individuals will then be contacted by a member of the research team via telephone to 
discuss the research project/GTEP group. During this discussion, information will be 
provided about the group and research study and the research team member will check 
eligibility regarding access to technology and internet access. Verbal consent to send the 
PIS and consent form via Accurax will be sought and this verbal consent will be documented 
in their clinical notes. A member of the clinical team will have already reviewed the 
individual’s clinical notes to determine initial eligibility (e.g., age, symptoms of birth trauma 
following a birth within the last 18 months, English language speaking). If the individual does 
not have access to technology but would like to engage in the group, then we can put them 
in contact with the Digital Inclusion Project within the Black Country Healthcare NHS 
Foundation Trust to help with this. Following this telephone call and if the individual 
expresses an interest in the study, they will be sent a link via Accurax to an MS Forms 
containing the Participant Information Sheet (PIS) and Consent Form. Accurax has been 
approved for use by the BCPMHS. A home visit will then be arranged with the participant 
and consent will be taken at the beginning of this appointment to ensure they have 
consented. If they do not consent, then the session will end and no research activities will 
occur. The PIS and consent form will have been sent via Accurax prior to this session for the 
participant to read and process, but paper forms can also be taken to the session if 
necessary.  
 
During this session (providing that consent has been obtained at the beginning of the 
appointment), the staff member will determine whether the individual is able to engage in a 
group therapy based on their clinical presentation. For example, individuals presenting with 
high levels of dissociation and/or anxiety may not be suitable for the group. This staff 
member will be a member of the psychology clinical team (likely to be the Trainee Clinical 
Psychologist on placement with the BCPMHS) so will be appropriately qualified to determine 
eligibility. They will also be able to discuss with other members of the psychology team 
should there be any questions or concerns about participant suitability. Eligibility according 
to any inclusion/exclusion criteria that have not yet been covered will also be established. 
The consent form will be uploaded to Rio once completed, so therefore will remain as part of 
their record. However, should the participant not be deemed suitable for the group at a later 
date (e.g., during this visit), then a progress note will be added to Rio explaining this and the 
reason for it. As questionnaire data will have been completed on Rio, this will also remain on 
their record.  

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The outcome measures for T1 will be completed during this home visit, on a laptop with the 
team member. These outcome measures will be completed and stored on the individual’s 
clinical record (using the system Rio). There can be a second staff member not involved in 
the group to help support the completion of these measures, if necessary.  
 
It is anticipated that the group will then be completed on a rolling basis until an appropriate 
number of participants and data have been gathered.  
 
Participants will be offered six online group GTEP sessions conducted via Zoom (sessions 2 
– 7 of the intervention). Either a UoB or BCPMHS Zoom account will be used for this. No 
personal accounts will be used and the sessions will not be recorded. These sessions will be 
conducted by 2-3 Clinical Psychologists (depending on numbers in the group) within the 
BCPMHS who have been trained in EMDR and GTEP. There will also be a Trainee Clinical 
Psychologist present within the group, who will be an ‘emotional support person’ and provide 
additional support in break out rooms/phone call after the session should a participant 
require this. All participants will be offered a catch-up phone call between sessions, 
regardless of whether they have reported distress during the session. Each session will be 
1.5 hours long. The initial sessions will be focused on the group participants getting to know 
each other, psychoeducation about trauma, preparation for processing work, basic 
grounding and stabilisation techniques. This will likely involve breathing techniques and 
imagery techniques, such as ‘safe place’ imagery. The following sessions will focus on the 
processing of the traumatic memory, using GTEP principles. This processing will focus on 
different ‘Points of Disturbance’ (PODs) associated with the traumatic memory. The exact 
processing will be unique to each individual and dependent on their own PODs. This session 
structure will depend on clinical judgment and group presentation and will respond to the 
needs of the group as required regarding the content of the sessions. For example, if it is felt 
that more than two sessions are needed for grounding and psychoeducation, then there will 
be flexibility within the session plans to do this.  
 
For any processing sessions, the script from the GTEP protocol will be followed (see 
Appendix 1).  
 
The participants will then be offered a 1:1 follow-up review between 2-6 weeks after session 
7 (the final GTEP session). This will form session 8 of the intervention and will include a 
debrief about the intervention, complete the outcome measures for T8 and determine if any 
further support is needed.  
 
The feasibility and acceptability of the intervention will also be measured. Feasibility questions about 
the participant’s experience of being part of the group will also be asked, and written responses 
recorded, during this session. We will base questions from Weiner et al’s (2017) Acceptability of 
Intervention Measure (AIM), Intervention Appropriate Measure (IAM) and Feasibility of Intervention 
Measure (FIM) to do this, but these may be adapted based on appropriateness for the population. 
Responses are provided on a Likert scale where 1 = Completely Disagree and 5 = Completely 
Agree.  

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AIM:  
1. "I like the intervention." 
2. "I welcome the intervention." 
3. "This intervention is appealing to me." 
4. "I approve of this intervention." 
 
FIM: 
1. "This intervention seems possible to implement." 
2. "The intervention seems doable for me." 
3. "The intervention is easy to use." 
4. "I can see myself continuing to use this intervention." 
IAM: 
1. "This intervention seems like a good fit for me." 
2. "This intervention seems suitable for my needs." 
3. "This intervention seems appropriate for my situation." 
4. "This intervention makes sense to me." 
These Likert scaled questions will be asked at the beginning of each session (from session 2 
onwards). This will mean we can capture the data of participants, should they drop-out partway 
through the intervention. These will be completed via MS Forms.  
After the intervention, participants will be asked further qualitative questions about their 
experience of being in the group.  This can either be completed online (via MS Forms, with the 
link sent via accurx) or in person, depending on the participant’s preference. Questions for this 
will be based around literature by Sekhon et al’s (2022) Theoretical Framework of Acceptability 
(TFA), to help evaluate the feasibility and acceptability of interventions, but will be adapted for 
this population group. Questions will be themed around their views of the helpfulness of G-TEP, 
potential barriers they faced to engaging in the intervention, suggestions for improvement etc. 
These questions can be completed during session 8 of the intervention (the follow-up session) 
or can be sent via an online link following the end of the intervention. These will be written 
responses, and no audio recording will be conducted. Asking participants questions about their 
experience of psychological interventions should form part of best-practice care, and so this 
process will not deviate from feedback that would be gathered as part of care as usual. This 
information may be used in later qualitative analysis related to feasibility. 
Should a participant not complete the group, or if they are considering discontinuing, they will be 
given the opportunity to give feedback related to this. Again, this will be written, and no audio 
recording will be conducted. This information may be used in later qualitative analysis related to 
feasibility and acceptability.  
 
Group facilitators will also be asked to report on their experiences of running the group. The same 
questions as above (the AIM, FIM and IAM) will be asked (on a Likert scale) to facilitators but again 
will be adapted for appropriateness for this population. These will be asked before and after 
administering the intervention. In addition, the facilitators will also be asked further feedback 

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questions based around domains outlined by Sekhon et al’s (2022) TFA and Bowen et al (2009). 
Questions will likely be about their experience of running the group and about the application of 
GTEP to a birth trauma population more generally. Questions will also be themed around possible 
barriers for attending the group for this population and challenges of delivering this intervention for 
this specific population. This information may be used in later qualitative analysis related to feasibility. 
These questions can either be completed via a paper form in person, or an online form via MS 
Forms.  
 
As per the authorship, there may be minor changes made to the questions to make them 
appropriate for the group being asked (i.e., participants or facilitators).  
 
The written responses will not contain any identifiable information. Responses will be matched to 
participant ID numbers. The information will be stored on a secure shared drive within the 
BCPMHS and then be securely transferred to the UoB Research Data Store for analysis, if 
required.  
 
In regard to usual care, the study will offer an additional intervention (GTEP) to the usual care for 
women under the BCPMHS. Standard care would involve these women being added to a waiting list 
to receive 1:1 psychological support for birth trauma. Instead, if appropriate and eligible, they will be 
offered the group instead. As explained previously, if the participant declines to attend the group or 
they do not meet inclusion/exclusion criteria, they will be offered the standard care of 1:1 work and 
added to the waiting list for this. Similarly, if the participant drop-outs of the group partway through 
or it is determined that they require further support once the group has finished, then they will be 
offered the usual care of 1:1 work, and the added to the waiting list for this. 
 
To increase the number of facilitators involved in the study and to gather further data on the 
feasibility of delivering a G-TEP intervention for a birth trauma population, data will be gathered 
from stakeholders and peers within the G-TEP community. This will involve the use of a 
questionnaire to gather information about their experience of facilitating a G-TEP intervention with 
individuals who have experienced birth trauma, including any barriers they faced. This questionnaire 
will be completed online; a link to an online MS Forms questionnaire will be sent via email (once a 
signed consent form has been received). All data will be anonymised, and no identifiable information 
will be gathered through the questionnaires.  
 
Data Collection:  
All outcome measures (PCL-5, CBTS, CORE 10 and PBQ) will be completed during session 
one of the intervention - the 1:1 home visit (T1), by one of the group facilitators. These will 
be completed on either Rio (the clinical records system used by the BCPMHS) or an MS 
Forms, using the team member’s laptop. The PCL-5 will be repeated before sessions 2 – 7 
of the GTEP group (T2 – T7). These will be completed electronically using MS Forms and 
participants will be sent a link to this. The PCL-5 will be completed again during the post-
intervention home visit (T8), using either Rio or MS forms.  
All other outcome measures will be repeated only at the post-intervention follow-up session 
(T8), either via Rio or using MS Forms.  

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The outcome measure data will not contain any identifiable information, and be linked only 
by participant ID.  
As per the G-TEP protocol, Subjective Units of Distress (SUDs) will also be collected during each 
processing session and may be used in analysis. Final SUDs may also be collected during session 8. As 
outlined in the G-TEP protocol, participants will be asked to rate their level of distress on a scale 
between 1-10 during the processing sessions. Participants will be asked to report their SUDs scores 
to the facilitators via a private chat function on Zoom. These scores will be stored on the password 
protected database, which will be stored on a secure shared drive within the BCPMHS. All 
data will be anonymised and non-identifiable.  
 
Data will be analysed at the University of Birmingham. Research team members external to 
UoB will not be involved in data analysis. Data analysis will be completed by Grace Rodgers, 
Trainee Clinical Psychologist and Dr Alice Welham, Clinical Psychologist/Associate 
Professor, both internal at UoB.  
 
The study will also include other forms of data to help the analysis and evaluation of 
feasibility and acceptability of the intervention. This may include data on participant 
screening, recruitment and retention, session attendance, attrition rates, protocol adherence.  
  
Data analysis:  
Data analysis will be completed using Statistical Package for Social Sciences (SPSS) 
software. Quantitative data analysis will include a pre-and-post-intervention comparison 
scores at both an individual and a group level. Reliable Change Index (RCI) analysis will be 
employed to examine differences on an individual level. Pre-to-post change on a group level 
will be examined using either a bootstrapped paired samples t-test or a matched pairs 
Wilcoxon (depending on N and properties of data distribution). There will likely be an 
emphasis on effect sizes over statistical significance, especially given the possible small 
sample size. Further analyses will be conducted where possible/appropriate to explore 
whether demographic factors (e.g., age, ethnicity) or initial outcome measure scores (e.g., 
the ‘severity’ of symptoms) influenced or predicted any observed changes in scores (e.g., 
correlational or between-subgroups analyses of change scores).  
Depending on the results, the group may be split into "responders" and "non-responders" 
based on the RCI analysis. 
This will potentially then allow appraisal of the degree to which factors like age, initial 
questionnaire scores or time since trauma are statistically related to whether the group is 
associated with a reliable effect. This may involve, for example, Mann-Whitney or between-
participant t tests (e.g., comparing responders and non-responders on age or initial PCL-5 
score). We acknowledge the increased possibility of Type 1 errors due to multiple tests. 
Whilst we intend to emphasise effect sizes over statistical significance, we will consider this 
within our analysis. Bonferroni correction may be too conservative within this project, we will 
report significance of any effects at multiple levels of alpha and consider them within the 
context of the analyses performed. 
 
Data gathered from the SUDs may also be used in analysis.  
 
Descriptive statistics will also be used where appropriate.  
 

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Qualitative analysis may be conducted related to the feasibility questions outlined above. 
Qualitative analysis will also be conducted on questionnaire responses from G-TEP peers 
and stakeholders.  
 
Data relating to feasibility and acceptability (e.g., recruitment, screening, retention, 
attendance) may also be used in the analysis.   
 
6. Project setting 
This study will be conducted within the BCPMHS. This setting enables access to individuals 
who have experienced a traumatic birthing experience and require a psychological 
intervention to address this. Participants will be recruited at any point during their care with 
the BCPMHS. Session 1 of the intervention will take place in the participant’s homes and the 
GTEP group (session 2 – 7) will be conducted via Zoom. The post-intervention follow-up 
(session 8) will either be conducted on the telephone or at the participant’s home, depending 
on their preference. 
All participants will continue to access treatment-as-usual from other disciplines within the 
perinatal service (e.g., psychiatry, nursery nurse).  
 
7. Participant recruitment 
This project will recruit individuals who have had a traumatic birthing experience (the birth 
itself, the postnatal hospital stay, and/or any neonatal admissions) within the last 18 months. 
They will be identified through self-reported trauma symptoms (e.g., flashbacks, nightmares) 
at initial assessment within the service (usually with a mental health clinician), or at a 
subsequent appointment with any staff member within the service.  
 
7.1. 
Eligibility criteria: 
7.1.1. 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).1 
● Access to technology (e.g., laptop, internet connection) to be able to access the 
online group.2  
● 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.  
 
1It was decided to include individuals experiencing trauma symptoms related to the postnatal hospital 
stay/neonatal admission as well as the birth itself, as clinical experience has shown that individuals often report 
these aspects of the birthing experience to be the most traumatic. This will allow more individuals to be recruited 
into the study.  
 
2 Where this is not available, we are able to refer to a digital inclusion project within the Black Country NHS 
Foundation Trust who will be able to provide support.  
 

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● Capacity to consent to engage in the GTEP group and research study.  
 
7.1.2. 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.3  
● Significant sensory impairment (e.g., needing a British Sign Language interpreter).  
 
 
In regard to the group facilitators, these will be psychological professionals (likely Clinical 
Psychologists) working with the BCPMHS who have received training on EMDR and GTEP. 
They will be approached by a member of the research team to discuss being involved in 
research study. An initial conversation about the study will then be arranged, either in-person 
or over a phone call / online video conferencing platform. They will also be given the 
facilitators PIS to read at this point (either in person or sent via MS Forms). Following this 
conversation, if they are happy to be involved, a consent form will need to be signed and 
returned within two weeks of the initial conversation.  
Given the nature of the GTEP and that fact it is forming part of clinical practice / therapeutic 
offering within the psychology team in the BCPMHS, should facilitators not want to be 
involved in the research study element of the group (i.e., answering questions regarding the 
group’s feasibility), they will likely still be able to be a part of facilitating the group clinically.  
 
Stakeholders and peers from the G-TEP community will be recruited via social media. This 
will be through an email mailing list for a Special Interest Group (SIG) for professionals with 
an interest in G-TEP and birth trauma. An advert will also be published on a WhatsApp 
group for professionals who work within perinatal mental health services and use EMDR in 
their practice. It is commonplace for adverts for relevant research studies to be advertised 
through these channels. Only those with routine access to the mailing list, WhatsApp group 
etc will send the invites and adverts.  
Participants will be instructed to contact the CI via email if they are interested in taking part. 
A PIS and consent form will then be sent via email, and once returned, a link to the online 
MS Forms questionnaire will be sent, again via email. Any professional who has either 
completed, attempted or considered running a G-TEP intervention for individuals with birth 
trauma will be eligible to take part. Participants will need to be UK-based.  
 
The hard copies or MS Forms of the consent forms will also be kept as part of the research 
file / data, which will be kept at the University of Birmingham for 10 years. 
 
7.2. 
Sampling 
 
 
3 This has been implemented due to the risk of a trauma intervention causing a deterioration in the participants’ 
mental health and the possible difficulties of managing risk within a group setting. While there is no current 
evidence base for this intervention, it feels safer to continue supporting these individuals on a 1:1 basis.  
 
 

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7.2.1. Size of sample 
We are hoping to recruit approximately five participants per group. A priori power analysis 
was conducted using G*Power for a minimum sample size calculation. Results showed that 
to achieve 80% power for detecting a medium effect size, using a significance level of 0.05, 
a sample size of 28 will be adequate. The groups and data collection will aim to be continued 
on a rolling basis until a suitable number of participants have been recruited and data has 
been collected. The planned sample size is 28 based on the above power calculation.  
 
7.2.2. Sampling technique 
All eligible participants (according to the above criteria) will be offered to take part. 
Participants can be identified at any point during their time with the BCPMHS. Some 
participants may be identified during their initial assessment into the service. The assessing 
clinician, from the BCPMHS (the direct care team), will identify any potential participants 
(i.e., reporting a traumatic birthing experience within the last 18 months) during this 
assessment. Anyone that appears initially eligible will be asked during this initial assessment 
if they would be happy for a member of the research / clinical team to call them to discuss 
the group/research project. Verbal consent will be gained from the individual for this contact, 
and consent to use their contact details for this purpose. All assessments are discussed 
within the MDT meeting and if deemed potentially appropriate for the group / research study, 
a team member will contact them via phone to discuss the research study and send a link to 
the PIS and consent form.  
Contact numbers will be accessed via the clinical records system, by a member of the 
clinical  team. As the research team will also be working within the BCPMHS they will be 
able to access participant’s contact details, as the individual will have consented for the team 
to have their contact details on referral to the service. It will also be documented on the initial 
assessment clinical note that a discussion was had with the individual about the potential for 
the GTEP group / research project involvement.  
Additionally, participants may also be identified during other points in their care. For 
example, they may be identified during a psychology consultation drop-in session, during an 
MDT discussion that happens within a team meeting, following an appointment with another 
discipline with the team. If a potential participant is identified in this way, the staff member 
from the BCPMHS who has had previous contact with the individual (e.g., psychiatry, 
nursery nurse, care co-ordinator), will have a discussion with the individual about the GTEP 
group. As per best practice, they will be asked if they are happy for a member of the team 
involved in the project to contact them to discuss this further. If happy, the above process will 
be followed by contacting via phone and sending a consent form and PIS.  
 
7.3. 
Recruitment 
Participants will be recruited via the Black Country Perinatal Mental Health Service. Eligible 
participants will be identified either from an assessment / by other team members within the 
service, at any point during the care under the BCPMHS (as described above). If they are 
interested in the study/happy for a research team member to contact them via phone, then 
they will receive a phone call to discuss the project in more detail. If they are still interested, 
a link to a PIS/consent form will be sent following this phone call, and the consent form will 
be completed at the beginning of the home visit to ensure the participant has given 
appropriate consent for this session to take place.  

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7.3.1. Sample identification 
Participants will only be identified and recruited from the BCPMHS. Staff members within the 
perinatal service will identify potential participants during an initial assessment and further 
information (including consent form and PIS) will be provided in a phone call with a member 
of the clinical/research team. Eligible participants might also be identified from the 
psychology waiting list or by other clinicians / during other appointments within the 
BCPMHS, as described above. 
Participants will not be provided with any financial incentive for participation in the study.  
 
7.3.2. Consent 
Informed consent will be obtained prior to the participant completing any activities that are 
for the purpose of the research study. Information about the study will be provided via phone 
call following identification of them being a potentially eligible participant (if they have 
confirmed their interest in the group/study). Following this phone call, participants will be 
sent a link to an MS Forms with the PIS and Consent Form (if they are still interested) for 
them to read and process the information. A home visit will be arranged, and consent will be 
taken in-person at the beginning of the session (before any further activities take place) to 
ensure the participant has given appropriate consent. If they do not consent, the session will 
be ended, and no further activity will take place.  
Participants have a right to withdraw at any time during the research study. If they choose to 
withdraw, they will be added onto the waiting list for a psychology assessment and/or 
therapeutic intervention, as appropriate (depending on where they were in the service 
referral process at time of recruitment). This is the procedure of standard care within the 
service.  
All participants will continue to receive ‘treatment as usual’ within the perinatal service 
whether they engage with the research study or not (e.g., access to other members of the 
multidisciplinary team, psychiatry, nursery nurse etc).  
If a participant withdraws, as they would have consented to the procedures they had already 
undergone, data will be retained and used in analysis if appropriate. 
 
Translation for participants 
Participants will be required to have a proficient level of verbal English to be able to access 
and engage with the group. We will not be able to provide a translator during the group, so 
part of the pre-assessment visit will involve determining that the participant has proficient 
levels of English in order to engage with the group. This will be done through checking their 
understanding of the verbal information being provided and assessing how far they are able 
to engage in conversations in English.  
 
Participants will not be excluded for not having written English ability (e.g., being unable to 
read/write). In this instance, information would be delivered verbally/in pictures rather than 
written. If required, the PIS and consent form will be verbally read to the participants by a 
member of the research team, should they not be able to read English sufficiently to 
understand the documents. In the unlikely event of the participant being unable to write their 
own signature, we will ask them to put an X in the appropriate boxes on the consent form. 
The research team member involved will witness signature the consent form to confirm 

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appropriate consent has been gathered. In this instance, there will also be another witness in 
addition to the person taking consent.  
 
Reasonable adjustments will also be made for individuals with learning differences - e.g., 
provide group materials in alternative formats, using pictures as required 
 
8. Storage and analysis of human tissue 
 
N/A for this study.  
 
9. Safety reporting 
Any untoward events will be logged on a database, but not reported. This will be for events 
that are not directly related to the study intervention.  
Any adverse events that could be directly related to the intervention, will be logged and 
reported as per UoB processes 
 
10. Ethical and regulatory considerations 
Risk: One of the main ethical considerations for this study, is the potential impact on participants 
through the GTEP intervention and processing of their traumatic experience. There may be a risk of 
this intervention temporarily increasing distress or discomfort. To mitigate this risk, there will be 
breakout rooms available during the sessions for participants to use if they need extra  
support from one of the facilitators. All participants will also be offered a catch-up call in between 
sessions, regardless of whether they have reported distress. As participants will be under the care of 
the BCPMHS, they will be able to access the duty system should they require further support 
outside of the GTEP session times. Participants will be informed of this process during the 1:1 home 
visit pre-assessment and reminded throughout.  
If the participant is identified as needing extra support during the phone calls, then they can be put 
on the Duty list for a check-in phone call. This might be done by Duty clinician, their care co-
ordinator, any member of staff within the BCPMHS due to have contact with them. This will all be 
discussed at an MDT and the most appropriate clinician to offer this support will be identified. If the 
participant continues to report high levels of distress, then they may be offered 1:1 psychology 
support instead, as per the usual care within the service.  
If support is required from the Home Treatment Team, then a referral can be made for this. All 
decisions regarding extra support will be made as a MDT.  
 
Confidentiality: Given that the group is being completed online, the research team will ensure that 
participants have access to a confidential space within their homes to engage with the group. This is 
one of the inclusion criteria for participation in the study.  If a participant does not have access to a 
confidential space, they will be offered 1:1 treatment within the service (depending on their need) 
rather than the GTEP group. The 1:1 psychology work and corresponding waiting list forms part of 
the standard care within the BCPMHS.  
 
Ensuring ‘treatment as usual’: all individuals who participate in the group will still be offered 
‘treatment-as-usual' within the perinatal service. They will have access to usual support from other 
disciplines within the multidisciplinary team to ensure that their participation in the group does not 

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get in the way of this. If the participant requires further 1:1 psychological support following the 
group, then this will be reviewed and discussed during the post-intervention follow-up session. The 
care team will be informed of the outcome of this decision, and a clinical letter will be sent to their 
GP.  
 
Access to technology as a barrier: We will ensure that a lack of access to technology (i.e., laptop, 
internet connection) does not act as a barrier for an individual receiving appropriate support. If an 
individual does not have access to this, then we will refer them to the digital inclusion project within 
the Black Country NHS Foundation Trust.  
If this is not possible, then the individual will be offered 1:1 support rather than the group, as per 
standard care in the service.  
 
Informed consent: Before agreeing to take part in the study, potential participants will be provided 
with a PIS and given the opportunity to discuss the group/research study with members of the team 
via a phone call. No form of deception will be used in this study and participants will be informed of 
their right to withdraw at any point. Should they withdraw from the study, they will be offered a 1:1 
appointment with a member of the perinatal team to discuss what further psychological support will 
be needed, and they will be offered 1:1 sessions, if required.  
 
Questionnaire burden: We anticipate that the questionnaires completed at T1 and T8 (pre-and-post 
intervention) will take approximately 20-30 minutes to complete. These can be completed with 
support from a member of the research team if needed. We anticipate that the PCL-5 outcome 
measure completed alone at T2, T3, T4, T5, T6 and T7 will take approximately 5-minutes to 
complete. Members of the research and clinical team will be available to provide support with 
completion of questionnaires should the participants require this.  
 
10.1. Assessment and management of risk 
Lone working: The 1:1 home visits (session 1 of the intervention) will be completed by a 
single member of the clinical/research team, in the patient’s home. Given this, the team 
member will follow the lone working policy within the Black Country Perinatal Service.  
 
 
Risk: There is a risk of the group content (i.e., processing of their traumatic birthing 
experience) may cause distress and increase risk of participants. If there are any concerns 
around the safety of a group participant, then a member of the clinical team will contact the 
participant to discuss this.  
 
Should these concerns remain following this contact, then the process for managing risk 
within the Black Country Perinatal Service will be followed. This document can be found as 
part of the Documents Pack for this study.  
Any concerns around risk will be documented on the patient’s clinical notes. As the GP will 
have been informed about the participant’s engagement with the group, they will also be 
informed about any concerns regarding a participant’s escalating risk via letter.  
 

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Safeguarding: All participants will be informed that should a member of the team feel there is 
a risk of harm to themselves/someone else, then this information will need to be shared with 
relevant parties. If any safeguarding concerns arise within the group, then the process for 
managing safeguarding concerns within the Black Country Perinatal Service will be followed. 
This document can be found as part of the Documents Pack for this study.  
 
Risk to researchers: There is also a potential risk to researchers’ wellbeing around exposure to birth 
trauma experiences. Other members of the research/clinical team will be available for supervision 
and debrief, if required. 
 
10.2. 
Research ethics committee (REC) and other regulatory review & reports 
Before the start of the project, a favourable opinion will be sought from a REC (NHS REC) 
for the protocol, informed consent forms and other relevant documents. We will 
adhere to the following requirements: 
● Substantial amendments that require review by NHS REC will not be implemented 
until that review is in place and other mechanisms are in place to implement this at 
site 
● All correspondence with the REC will be retained 
● It is the CI’s responsibility to keep the sponsor updated as required 
● The CI will notify the REC and sponsor of the end of the project 
● If the project is ended prematurely, the CI will notify the REC and sponsor, including 
the reasons for the premature termination 
● Within one year after the end of the project, the CI will submit a final report with the 
results, including any publications/abstracts, to the REC and sponsor. 
10.3. 
 
10.3.1. Regulatory review & compliance  
● Before any site can enrol participants into the project, the CI/Principal Investigator 
or designee will ensure that appropriate approvals from participating organisations 
are in place.  
● For any amendment to the project, the CI or designee, in agreement with the 
sponsor will submit information to the appropriate body in order for them to issue 
approval for the amendment. The CI or designee will work with sites (R&D 
departments at NHS sites as well as the project delivery team) so they can put the 
necessary arrangements in place to implement the amendment to confirm their 
support for the project as amended. 
● The University of Birmingham’s Clinical Research Compliance Team may carry out 
compliance visits to monitor adherence with applicable standards and regulations. 
 
 
 
10.3.2. Amendments  
Any amendments to the protocol will be completed by the CI. Decisions about whether an 
amendment is substantial or non-substantial will be decided by the CI and PI, and other 
members of the research team stated above. Amendment history will be tracked by having 
multiple versions of the protocol document, with the file names clearly noting the most recent 
version (e.g., v1.1., 1.2, 1.,3 etc).  
 

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10.4. Peer review 
This protocol has been reviewed by staff members within the Black Country Perinatal Mental 
Health Service and at the University of Birmingham. 
It will also be reviewed by the Research and Development Team within the Black Country 
NHS Foundation Trust.  
 
10.5. Patient & public involvement 
The BCPMHS have run a preliminary GTEP group (not involved in the research project) to 
gather initial feedback on the acceptability of the group for use with a birth trauma 
population. Based on feedback from participants in this group, the following decisions have 
been made about the project: 
● The number of online sessions increased from 4 to 6 sessions. These six sessions 
will include three stabilisation sessions and three processing sessions. This will allow 
more time for stabilisation techniques to be practised and developed. It will also allow 
time to build relationships between group members and facilitators, and hopefully 
promote a sense of safety within the group. 
● More stringent screening procedures regarding participant suitability. This includes 
assessing potential participant’s presentation in terms of their ability to tolerate a 
group setting. Participants presenting with high levels of anxiety about the group 
and/or high levels of dissociation may not be appropriate for the group and will be 
offered 1:1 support instead.  
 
We have also sought informal feedback from services that have run GTEP groups in other 
regions, through the GTEP Special Interest Group (SIG).  
 
10.6. Protocol compliance  
Accidental protocol deviations can happen at any time. They must be adequately 
documented on the relevant forms and reported to the CI and Sponsor immediately  
Significant deviations from the protocol which are found to frequently recur are not 
acceptable; these will require immediate action and could potentially be classified as a 
serious breach. 
 
10.7. Data protection and confidentiality  
All investigators and site staff must comply with the requirements of the Data Protection Act 
2018 with regards to the collection, storage, processing and disclosure of personal 
information and will uphold the Act’s core principles. 
Data management:  
Throughout the project, and afterwards, the data will be stored in line with data protection 
regulations (i.e. UK GDPR & the Data Protection Act, 2018).  
Participant’s contact details (including phone number and email address) will be required to 
arrange the 1:1 home visit (session 1 of the intervention) and send out Zoom links for the 
GTEP groups sessions. They will also be required to provide a summary of the research 
findings to the participants, should they request this. This information will be stored on Rio, 
as per service standards. We will also access demographic information from Rio. There will 
be a box on the consent form for participants to confirm they are happy for their Rio data to 
be used for this purpose.  
 

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As the worksheets will be completed by participants at their homes during the online 
sessions, they can either keep them or we can destroy them (e.g., shredding) if they would 
prefer.   
The outcome measures will be completed, and stored on Rio, as per service standards. The 
numerical participant data (e.g., questionnaire scores) will also be transferred to a password 
protected database, which will be stored on a secure shared drive within the BCPMHS. Only 
members of the research team involved with this project will be able to access the database. 
While we require the data to be identifiable (e.g., to update the data following each session), 
the participants will be given a participant number on the database and a separate document 
linking participant number to individual will be created and stored separately to the database. 
Only team members directly involved in the research study will be able to access this 
information. Once we no longer require data to be identifiable, a separate spreadsheet 
without any identifiable information will be created, and any identifiable data will be deleted. 
For example, we will replace ‘date of birth’ to ‘age by nearest year’. Should data need to be 
taken ‘off site’ (e.g., from the BCPMHS shared drive), all identifiable data will be removed. 
The data will be stored on the BCPMHS shared drive during data collection, and then be 
securely transferred to the UoB Research Data Store for analysis. Should this database be 
taken off site (e.g., for data analysis at UoB), all identifiable information will be removed.  
The consent forms from MS Forms will be uploaded to Rio as part of their record, so will 
remain on the clinical record. They will also be kept as part of the research file / data, which 
will be kept at the University of Birmingham for 10 years.  
The feasibility questionnaires from MS Forms will be kept as part of the research file / data, 
which will be kept at the University of Birmingham for 10 years. They will be anonymised, 
and no identifiable information will be used. Responses will be linked to study ID.  
Feasibility questionnaires completed by G-TEP stakeholders and peers will also be kept at 
the University of Birmingham for 10 years. These will be pseudonymised, and no identifiable 
information will be used. Responses will be linked to participant ID.  
 
Data will be kept on the University of Birmingham Research Data Store (RDS) which is 
backed-up and encrypted. The data will be accessed by the research team only.  The 
research data will be owned by the University of Birmingham.  
 
Data about session attendance will be captured on Rio, as per service standards.  
The anonymised databases will be kept for up to 10 years following the end of 
study/publication. The data stored on the NHS site will be destroyed once the data  has been 
transferred to UoB. The questionnaire data will remain on the participant’s Rio records, as 
per standard practice within the service.  
 
The only individuals able to access the participant’s personal data (aside from their usual 
care team within the perinatal service), will be the research team members.  
 
10.8. Indemnity 
The University of Birmingham has in force a Public Liability Policy and/or Clinical Trials 
Policy which provides cover for claims for ‘negligent harm’ and the activities here are 
included within that coverage.  

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10.9. End of study and archiving 
The data will be archived on the University of Birmingham’s BEAR archive. Data will be 
anonymised prior to archiving to ensure there is no patient identifiable information. Data will 
be kept for up to 10 years following the end of the study/publication.  
 
10.10. Access to the final dataset 
The researchers named in this document will have access to the final dataset.  
 
11. Dissemination policy 
11.1. Dissemination policy 
The data arising from this project will be jointly owned by the Black Country NHS Foundation 
Trust and the University of Birmingham. On completion of the project, the data will be 
analysed and tabulated and a final report prepared.  
The investigators will have the right to publish the data at the end of the study.  
Study participants will notify us via the consent form if they wish to be informed of the results 
of the study, by provision of the publication. This will be disseminated to them via email, and 
they will have given consent for their email addresses to be used for this purpose.  
 
11.2. Authorship eligibility guidelines and any intended use of professional writers 
The members of the research team outlined in this protocol document will be granted 
authorship on the final report. Order of authorship will be determined by level of 
responsibility in this project.  
 

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12. References 
 
Ayano, G., Lin, A., Dachew, B. A., Tait, R., Betts, K., & Alati, R. (2022). The impact of parental 
mental health problems on the educational outcomes of their offspring: Findings from the 
Raine Study. Australian & New Zealand Journal of Psychiatry, 56(5), 510–524. 
https://doi.org/10.1177/00048674211025633 
  
Ayers, S., Wright, D. B., & Thornton, A. (2018). Development of a Measure of Postpartum PTSD: 
The City Birth Trauma Scale. Frontiers in Psychiatry, 9. 
https://doi.org/10.3389/fpsyt.2018.00409 
  
Barkham, M., Bewick, B., Mullin, T., Gilbody, S., Connell, J., Cahill, J., Mellor-Clark, J., Richards, 
D., Unsworth, G., & Evans, C. (2013). The CORE-10: A short measure of psychological 
distress for routine use in the psychological therapies. Counselling and Psychotherapy 
Research, 13, 3–13. https://doi.org/10.1080/14733145.2012.729069 
  
Birth Trauma and Post Natal PTSD – PTSD UK. (n.d.). Retrieved 13 March 2024, from 
https://www.ptsduk.org/what-is-ptsd/causes-of-ptsd/post-natal-ptsd/ 
  
Blevins, C. A., Weathers, F. W., Davis, M. T., Witte, T. K., & Domino, J. L. (2015). The Posttraumatic 
Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric 
Evaluation. Journal of Traumatic Stress, 28(6), 489–498. https://doi.org/10.1002/jts.22059 
  
Brockington, I. F., Oates, J., George, S., Turner, D., Vostanis, P., Sullivan, M., Loh, C., & Murdoch, C. 
(2001). A Screening Questionnaire for mother-infant bonding disorders. Archives of Women’s 
Mental Health, 3(4), 133–140. https://doi.org/10.1007/s007370170010 
  
Busse, M., Stromgren, K., Thorngate, L., & Thomas, K. A. (2013). Parent Responses to Stress: 
PROMIS in the NICU. Critical Care Nurse, 33(4), 52–60. https://doi.org/10.4037/ccn2013715 
 
 
Chiorino, V., Cattaneo, M. C., Macchi, E. A., Salerno, R., Roveraro, S., Bertolucci, G. G., Mosca, F., 
Fumagalli, M., Cortinovis, I., Carletto, S., & Fernandez, I. (2020). The EMDR Recent Birth 

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Trauma Protocol: A pilot randomised clinical trial after traumatic childbirth. Psychology & 
Health, 35(7), 795–810. https://doi.org/10.1080/08870446.2019.1699088 
 
Dickinson, C., Vangaveti, V., & Browne, A. (2022). Psychological impact of neonatal intensive care 
unit admissions on parents: A regional perspective. Australian Journal of Rural Health, 30(3), 
373–384. https://doi.org/10.1111/ajr.12841 
  
Ertan, D., Hingray, C., Burlacu, E., Sterlé, A., & El-Hage, W. (2021). Post-traumatic stress disorder 
following childbirth. BMC Psychiatry, 21(1), 155. https://doi.org/10.1186/s12888-021-03158-
6 
  
  
Farrell, D., Moran, J., Miller, P. W., Knibbs, L., Papanikolopoulos, P., McGowan, I., Mattheß, C., & 
Kiernan, M. D. (2023). Group early intervention eye movement desensitization and 
reprocessing therapy as a video-conference psychotherapy with frontline/emergency workers 
in response to the COVID-19 pandemic in the treatment of post-traumatic stress disorder and 
moral 
injury—An 
RCT 
study. 
Frontiers 
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Psychology, 
14. 
https://doi.org/10.3389/fpsyg.2023.1129912 
  
Kjerulff, K. H., Attanasio, L. B., Sznajder, K. K., & Brubaker, L. H. (2021). A prospective cohort 
study of post-traumatic stress disorder and maternal-infant bonding after first childbirth. 

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Journal of Psychosomatic Research, 144, 110424. 
https://doi.org/10.1016/j.jpsychores.2021.110424 
  
Lehnung, M., Shapiro, E., Schreiber, M., & Hofmann, A. (2017). Evaluating the EMDR Group 
Traumatic Episode Protocol With Refugees: A Field Study. Journal of EMDR Practice and 
Research, 11(3), 129–138. https://doi.org/10.1891/1933-3196.11.3.129 
 
Manning, C., & Gregoire, A. (2009). Effects of parental mental illness on children. Psychiatry, 8(1), 7–
9. https://doi.org/10.1016/j.mppsy.2008.10.012 
 
  
MBRRACE-UK. Saving Lives, Improving Mothers' Care State of the Nation Surveillance Report: 
Surveillance findings from the UK Confidential Enquiries into Maternal Deaths 2019-21. 
Oxford: National Perinatal Epidemiology Unit, University of Oxford 2023 
  
Pink, J., Ghomi, M., Smart, T., & Richardson, T. (2022). Effects of EMDR Group Traumatic Episode 
Protocol on Burnout Within IAPT Healthcare Professionals: A Feasibility and Acceptability 
Study. 
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215–227. 
https://doi.org/10.1891/EMDR-2022-0029 
  
Roberts, A. K. P. (2018). The effects of the EMDR group traumatic episode protocol with cancer 
survivors. 
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105–117. 
https://doi.org/10.1891/1933-3196.12.3.105 
  
Shapiro, E (2013). “The EMDR Group Traumatic Episode Protocol.” Presentation to the EMDR 
Turkey Conference, Istanbul, Turkey.  
Shapiro, E., & Laub, B. (2008). Early EMDR Intervention (EEI): A Summary, a Theoretical Model, 
and the Recent Traumatic Episode Protocol (R-TEP). Journal of EMDR Practice and 
Research, 2(2), 79–96. https://doi.org/10.1891/1933-3196.2.2.79 
Tsouvelas, G., Chondrokouki, M., Nikolaidis, G., & Shapiro, E. (2019). A vicarious trauma preventive 
approach. The Group Traumatic Episode Protocol EMDR and workplace affect in 

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professionals 
who 
work 
with 
child 
abuse 
and 
neglect. 
2, 
130–138. 
https://doi.org/10.26386/obrela.v2i3.123 
 
Weiner, B.J., Lewis, C.C., Stanick, C. et al. Psychometric assessment of three newly developed 
implementation 
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(2017). 
https://doi.org/10.1186/s13012-017-0635-3 
  
Yurtsever, A., Konuk, E., Akyüz, T., Zat, Z., Tükel, F., Çetinkaya, M., Savran, C., & Shapiro, E. 
(2018). An Eye Movement Desensitization and Reprocessing (EMDR) Group Intervention for 
Syrian Refugees With Post-Traumatic Stress Symptoms: Results of a Randomized Controlled 
Trial. Frontiers in Psychology, 9. https://doi.org/10.3389/fpsyg.2018.00493 
  
  
  
 
 
 

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13. Appendices 
13.1. 
Appendix 1 – required documentation 
13.2. 
Appendix 1a – GTEP Protocol 
 
 
 

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Worksheet to be completed during GTEP Sessions:  
 
 
 
 
 
 
 
 
 
 
 
 

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13.3. 
Appendix 2 – amendment history 
The following amendments and/or administrative changes have been made to this protocol since the 
implementation of the first approved version 
Amendment 
number 
Date of 
amendment 
Protocol 
version number 
Type of 
amendment 
Summary of amendment