Eye movement desensitization and reprocessing group therapy for frontline and emergency workers in response to the COVID-19 pandemic
| ISRCTN | ISRCTN16933691 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16933691 |
| Secondary identifying numbers | CBPS19200030-R2 |
- Submission date
- 05/07/2021
- Registration date
- 14/07/2021
- Last edited
- 18/04/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
As the coronavirus (COVID-19) pandemic spreads throughout the world, it is generating widespread anxiety, fear, stress, and trauma. People are experiencing a widespread disruption in their lives. One of the populations that this research is particularly interested in is front line health, emergency and social care workers experiencing psychological distress and trauma in response to COVID-19. The aim of this study to explore the effectiveness of an internationally recognized trauma treatment Eye Movement Desensitization and Reprocessing (EMDR) therapy (endorsed by the World Health Organisation and the International Society for Traumatic Stress Studies), delivered in a group format intensively using an online platform. The researchers want to determine whether the therapy is safe, effective, efficient and relevant. EMDR therapy is an evidence-based treatment for Post-Traumatic Stress Disorder (PTSD) and complex PTSD and is practised throughout the world.
Who can participate?
Front line health, emergency and social care workers (aged 18 years and above) experiencing psychological distress and trauma in response to COVID-19
What does the study involve?
Participants are randomly allocated into two groups. The first group will receive four therapy sessions of online group EMDR therapy equal to 8-10 hours of treatment. The treatment will consist of four sessions, run over the course of 1 week, on Monday, Wednesday, Thursday and Saturday evening between 6 pm and 8 pm. This is known as ‘intensive treatment’. The second group receives a delayed treatment intervention, which is exactly the same treatment as the first group but 1 month later. The researchers can then compare the effect of the treatment on both groups.
What are the possible benefits and risks of participating?
The benefits of taking part in the study are that it contributes towards a better understanding of early intervention psychological treatments, and how treatment can be offered as video-conference psychotherapy.
Where is the study run from?
Trauma Recovery Network (Ireland)
When is the study starting and how long is it expected to run for?
June 2020 to February 2022
Who is funding the study?
1. Trauma Response Network Ireland (Ireland)
2. EMDR All Ireland Association (Ireland)
Who is the main contact?
Dr Derek Farrell
d.farrell@worc.ac.uk
Contact information
Scientific
University of Worcester
Henwick Grove
Worcester
WR2 6AJ
United Kingdom
 ORCID ID |
0000-0002-9898-8031 |
|---|---|
| Phone | +44 (0)1905542443 |
| d.farrell@worc.ac.uk |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Treatment |
| Participant information sheet | 40123_PIS_07Jul20.docx |
| Scientific title | Early intervention eye movement desensitization and reprocessing therapy (virtual group traumatic episode protocol) for front line health, emergency and social care workers experiencing psychological distress and trauma in response to COVID-19 – a randomized control study |
| Study acronym | VGTEP RCT |
| Study objectives | As the coronavirus (COVID-19) pandemic spreads throughout the world as a highly infectious disease-causing severe acute respiratory symptoms, it is also generating widespread anxiety, fear, stress and trauma. Both the virus, and the subsequent management of the pandemic – including social isolation and physical distancing, distressing symptoms, hospitalisation, and for some, death, creates a powerful trauma ripple effect. People are experiencing widespread disruption to their normal lives. Those at the acute end being frontline/emergency/ keyworkers in health and social care. This is a contemporaneous, clinical research project under the auspices of Eye Movement Desensitization and Reprocessing (EMDR) All Ireland/Trauma Recovery Network Ireland in conjunction with five UK Higher Education Institutions: University of Worcester, Queens University – Belfast, Ulster University, Bath Spa University and Northumbria University. Its primary research participant group are frontline/emergency/keyworker health and social care workers in response to the COVID-19 pandemic with particular focus upon its impact in the Republic of Ireland (ROI). The research focus is that of psychological trauma experienced by the research participant group and the impact of an early intervention using an empirically supported psychological treatment intervention. Ostensibly, this is a feasibility study, however, it also represents a groundbreaking collaboration of many academic institutions, under the auspices of EMDR All Ireland, in addressing the psychological wellbeing and mental health of frontline/emergency/keyworkers in regard to psychological trauma as a direct consequence of COVID-19, whilst at the same time acknowledge the importance of social distancing. The primary focus of this research relates to the psychological health and well-being of the target population. The research is interested in exploring the effectiveness of the following: 1. An internationally recognized trauma treatment - EMDR therapy endorsed by the World Health Organization (2013) and the International Society for Traumatic Stress Studies (2019) 2. Delivered in a group format 3. Delivered intensively 4. Using an online platform This EMDR Group intervention is known as the Group Traumatic Episode Protocol (GTEP). As the researchers will be testing an online version, this is known as VGTEP. They want to determine that the treatment intervention is safe, effective, efficient and relevant. Research Questions: 1. Is Early Intervention EMDR Group Therapy (VGTEP) a relevant and effective treatment intervention for frontline/emergency/keyworkers in the Republic of Ireland (ROI), who experience psychological trauma in response to COVID-19 with regards to both recruitment & retention to the study? 2. Is Early Intervention EMDR Group Therapy (VGTEP) a safe, effective and efficient treatment intervention for frontline/emergency/keyworkers in ROI, who experience psychological trauma in response to COVID-19 with regards to trauma sequelae and co-morbid symptoms? |
| Ethics approval(s) | Approved 16/07/2020, University of Worcester (College of Health, Life and Environmental Sciences, Research Office, St John's Campus, University of Worcester, Worcester, UK; +44 (0)1905 542767; ethics@worc.ac.uk), ref: CBPS19200030-R2 |
| Health condition(s) or problem(s) studied | Post-traumatic stress disorder |
| Intervention | The research will utilise a randomised control trial design (RCT) of two cohorts using a delayed treatment intervention: Experimental Cohort 1: EMDR therapy VGTEP Treatment (four sessions of 2 to 2.5 hours duration which equates to 8-10 hours of treatment intervention) in a 1-week period Control Cohort 2: Treatment as Usual (TAU) (4 weeks) + Delayed intervention of EMDR therapy VGTEP. Treatment will also be over a 1-week period. EMDR therapy - group intervention (group traumatic events protocol) delivered as a video-conference psychotherapy |
| Intervention type | Other |
| Primary outcome measure | 1. Subjective levels of distress or disturbance measured using the Subjective Unit of Disturbance/ Distress (SUD) scale at pre, post, 1-month and 6-month follow-up 2. Severity of anxiety symptoms measured using the Generalized Anxiety Disorder Assessment (GAD-7) at pre, post, 1-month and 6-month follow-up 3. Severity of depression symptoms measured using the Patient Health Questionnaire (PHQ-9) at pre, post, 1-month and 6-month follow-up 4. Core features of PTSD and CPTSD measured using the International Trauma Questionnaire (ITQ) at pre, post, 1-month and 6-month follow-up |
| Secondary outcome measures | 1. Imbalance between work effort and reward measured using the Effort-Reward Imbalance Questionnaire (ERI) at pre, post, 1-month and 6-month follow-up 2. Perceived transgressions, betrayals, or violations to an individual’s moral code measured using the Moral Injury Event Scale (MIES) at pre, post, 1-month and 6-month follow-up 3. Health status measured using the EQ-5D at pre, post, 1-month and 6-month follow-up 4. Exposure to adverse childhood experiences measured using the Adverse Childhood Experience International Questionnaire (ACE-IQ) at pre timepoint only 5. Exposure to benevolent factors in childhood measured using the Benevolent Childhood Experiences Score (BCEs) at pre timepoint only |
| Overall study start date | 30/06/2020 |
| Completion date | 01/02/2022 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 72 |
| Total final enrolment | 136 |
| Key inclusion criteria | 1. Adults (aged 18 years and above) 2. Front line health, emergency & social care workers experiencing psychological distress & trauma in response to COVID-19 3. Currently in active employment 4. Symptoms indicative of psychological distress and impact of psychological well-being and functioning 5. Impact of Events Scale-Revised Score of 24 and above |
| Key exclusion criteria | 1. Currently not in active service 2. Currently in receipt of psychiatric or psychological treatment 3. Suicidal ideation |
| Date of first enrolment | 01/07/2020 |
| Date of final enrolment | 30/06/2021 |
Locations
Countries of recruitment
- Ireland
Study participating centre
A96 KE47
Ireland
Sponsor information
Charity
Dun Laoghaire
Dublin
A96 KE47
Ireland
| Phone | +353 (0)1 902 5020 |
|---|---|
| trnireland@gmail.com | |
| Website | https://trnireland.ie/ |
Funders
Funder type
Charity
No information available
No information available
Results and Publications
| Intention to publish date | 30/04/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | The intention is to publish in Frontiers in Psychology |
| IPD sharing plan | All the raw data for the study has been placed in an international repository at https://osf.io/ty7xe/ |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 07/07/2020 | 04/08/2021 | No | Yes | |
| Results article | 23/03/2023 | 18/04/2023 | Yes | No |
Additional files
Editorial Notes
18/04/2023: Publication reference added.
04/08/2021: The participant information sheet was uploaded as an additional file.
13/07/2021: Trial's existence confirmed by the University of Worcester.
