Early online trauma-focused group intervention for perinatal trauma during the COVID-19 pandemic
| ISRCTN | ISRCTN68624341 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68624341 |
| IRAS number | 269534 |
| Secondary identifying numbers | IRAS 269534 |
- Submission date
- 09/08/2021
- Registration date
- 19/08/2021
- Last edited
- 13/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Post-traumatic stress disorder (PTSD) following childbirth is experienced by up to 15.7% of women. There currently is no routine intervention for preventing postpartum PTSD. Eye Movement Desensitisation and reprocessing (EMDR) is one of two treatments recommended by NICE for PTSD. EMDR is based on the adaptive information processing theory that explains how a traumatic event can disrupt the way information is handled in the brain. The traumatic memory remains unprocessed in the brain, resulting in symptoms of post-traumatic stress. EMDR is thought to work by sensory stimulation including eye movements that process traumatic memories, just as our eyes move during REM sleep.
This study aims to compare an online trauma-informed early EMDR group intervention with usual care in preventing post-traumatic stress disorder in women who have experienced a caesarean section. The study will also investigate users' experience of the intervention and compare the intervention with usual care in reducing symptoms of depression.
Who can participate?
Women aged over 18 years who have had a recent caesarean section and are willing to take part in a 3-week online group intervention
What does the study involve?
Participants will be randomly allocated to either receive the online EMDR group intervention or usual standard care. The early EMDR group intervention will include three 90-minute face to face online sessions over 3 weeks. The early EMDR intervention will consist of resilience-building techniques and eye movement exercises that have been found to be beneficial in helping people deal with strong emotional experiences, manage strong emotions, and improve wellbeing. All participants will be asked to complete online questionnaires at 12 weeks after the birth.
What are the possible benefits and risks of participating?
Participants may benefit from receiving a new type of online intervention that is supported by evidence for reducing stress. The information we get from this study may help doctors to provide supportive therapy for women who have had a traumatic birth experience. Participants will not receive financial payment for taking part in this study. However, with consent, their names will be entered into a draw to receive a Smart Trike.
The risk of taking part could be that participants become upset when thinking about their recent birth experience. As is the case with all psychological interventions, the researchers cannot guarantee that the online EMDR group intervention will benefit everyone who receives it.
Where is the study run from?
Ulster University (UK)
When is the study starting and how long is it expected to run for?
January 2019 to June 2022
Who is funding the study?
Department for the Economy, Northern Ireland (UK)
Who is the main contact?
Prof. Marlene Sinclair
m.sinclair1@ulster.ac.uk
Contact information
Scientific
12J09, Shore Road
Ulster University
Jordanstown
Newtownabbey
BT37 0QB
United Kingdom
 ORCID ID |
0000-0003-4444-1505 |
|---|---|
| Phone | +44 (0)2890368118 |
| m.sinclair1@ulster.ac.uk |
Public
12J09, Shore Road
Jordanstown Campus
Newtownabbey
BT37 0QB
United Kingdom
| Phone | +44 (0)7725 727 383 |
|---|---|
| miller-p6@ulster.ac.uk |
Study information
| Study design | Multicentre interventional single-blind randomized parallel-group study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A multicentre, randomised, parallel-group study to compare the effectiveness of an early eye movement desensitisation and reprocessing group intervention with care as usual in preventing post-traumatic stress symptoms in women who have experienced a traumatic birth |
| Study acronym | INTEGRATE |
| Study objectives | Is an early eye movement desensitisation and reprocessing (EMDR) online group intervention more effective than care as usual in preventing post-traumatic stress in women who have experienced a traumatic birth? |
| Ethics approval(s) | Approved 05/07/2021, Health and Social Care Research Ethics Committee (HSC REC A) (Office for Research Ethics Committees Northern Ireland (ORECNI), Business Services Organisation, Lissue Industrial Estate West, 5 Rathdown Walk, Moira Road, Lisburn, BT28 2RF, UK; +44 (0)28 9536 1400; info.orecni@hscni.net), REC ref: 21/NI/0067 |
| Health condition(s) or problem(s) studied | Post-traumatic stress disorder and depression in women who have experienced perinatal trauma |
| Intervention | Adaptive Information Processing (AIP) informed early Eye Movement Desensitisation Reprocessing (EMDR) psychological intervention compared to control treatment as usual (TAU). Randomisation to each arm by computer-generated randomisation list. Dose: 3 x 90 minute sessions. Women in the intervention group will be invited to receive three 90-minute intervention sessions in a group setting, delivered by midwives who have been trained in facilitating EMDR, comprising of psychoeducation, emotional regulation techniques and eye movement reprocessing exercises. Women will be in the study for 16 weeks. Women in the intervention and care as usual groups will be asked to fill in online self-complete questionnaires before the intervention at up to 3 weeks postpartum and after the intervention at 12 weeks postpartum. A clinician-administered interview will be conducted at 12 weeks postpartum. |
| Intervention type | Behavioural |
| Primary outcome measure | Post-traumatic stress disorder measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), Impact of Events Scale - revised (IES-R) and Posttraumatic Stress Disorder Checklist (PCL-5) at baseline and at 12 weeks postpartum |
| Secondary outcome measures | Depression measured by the Edinburgh Postnatal Depression Scale (EPDS) at baseline and at 12 weeks postpartum |
| Overall study start date | 21/01/2019 |
| Completion date | 30/06/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 96 |
| Key inclusion criteria | 1. Women who have had a caesarean birth 2. Women who have experienced their birth as traumatic 3. Women who meet subclinical symptom criteria for PTSD under 33 on the impact of event scale 4. Aged over 18 years with the legal capacity to consent 5. Willingness and ability to attend three online intervention sessions |
| Key exclusion criteria | 1. Score over >35 on the Dissociative Experience Scale 2. Presence of severe psychiatric disorder such as psychosis, bipolar or active suicide risk 3. Women currently diagnosed with PTSD 4. Presence of severe medical conditions including traumatic brain injuries 5. Currently receiving psychological treatment 6. Drug or alcohol abuse 7. Overt dementia 8. Ongoing injected or oral corticosteroid treatment 9. Women who have absolutely no social and familial support 10. Women who are critically ill |
| Date of first enrolment | 18/10/2021 |
| Date of final enrolment | 20/02/2022 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Craigavon
BT63 5QQ
United Kingdom
Sponsor information
University/education
26A20, Shore Road
Jordanstown Campus
Newtownabbey
BT37 0QB
Northern Ireland
United Kingdom
| Phone | +44 (0)2890 366629 |
|---|---|
| n.curry@ulster.ac.uk | |
| Website | http://www.ulster.ac.uk/ |
"ROR" |
https://ror.org/01yp9g959 |
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | 01/02/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | A study protocol will be published in a peer-reviewed journal. Results will be published in a peer-reviewed journal and posted on the Doctoral Midwifery Research Society and Centre for Maternal, Fetal and Infant Research websites and disseminated to participants at their request. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.2 | 01/09/2021 | 10/09/2021 | No | No |
| HRA research summary | 26/07/2023 | No | No |
Additional files
Editorial Notes
13/10/2021: The recruitment start date has been changed from 30/09/2021 to 18/10/2021.
27/09/2021: The recruitment start date has been changed from 10/09/2021 to 30/09/2021.
10/09/2021: The following changes have been made:
1. The recruitment start date has been changed from 03/09/2021 to 10/09/2021.
2. The protocol (not peer reviewed) has been uploaded as an additional file.
24/08/2021: The following changes were made to the trial record:
1. A typographical error in the study hypothesis was corrected.
2. A typographical error in the plain English summary was corrected.
20/08/2021: Internal review.
18/08/2021: Trial's existence confirmed by the University of Ulster.
