Eye movement desensitization and reprocessing therapy as video-conference psychotherapy
| ISRCTN | ISRCTN12099530 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12099530 |
| Secondary identifying numbers | CBPS19200031-R2 |
- Submission date
- 30/06/2021
- Registration date
- 13/07/2021
- Last edited
- 26/07/2022
- 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 a consequence of the COVID-19 pandemic many psychological treatments have moved to online delivery. This is what is referred to as video-conference psychotherapy (VCP), using platforms such as Zoom, Google Meet, FaceTime and Skype. The aim of this study is to explore how a specific trauma treatment (eye movement desensitization and reprocessing [EMDR]) could be delivered in this way. The researchers want to test whether delivering EMDR as a VCP is relevant, safe, effective, and efficient as a psychological treatment intervention. They also want to explore whether treatment delivered this way would be useful for a trauma memory that the research participant would be invited to not disclose. The reason for this is to test whether working in this particular way could be helpful for shame-based memories. This first study is a pilot to test out what actually occurs during a one-session treatment intervention known as EMDR Blind 2 Therapist.
Who can participate?
As this is a pilot study the researchers want to test it on frontline mental health workers. Testing it on experienced mental health workers would then provide a stronger understanding of what happens when using EMDR therapy as a VCP, before testing it with a distinct clinical population.
What does the study involve?
Participants are asked to work on a trauma memory of an adverse life event that causes them upset in the present. They are reminded that they are under no obligation to reveal anything about the memory itself. The one-session treatment involves trauma processing of this difficult memory. The study tests how the memory itself changes in regards to disturbance, believability, intensity, vividness, and emotionality. This helps to better understanding in more detail what changes are occurring, or not, during the treatment session.
What are the potential benefits or risks in participating?
As this part of the study is testing the treatment on experienced mental health workers the risks are extremely low. Working with a difficult memory can sometimes be upsetting, but the participants recruited to the study have the opportunity of working with international experts in this approach, and are offered additional help and support after the session if required.
Where is the study run from?
The University of Worcester (UK)
When is the study starting and when is it expected to finish?
July 2020 to April 2021
Who is funding the study?
Colloquy Psychological Trauma Interventions (UK)
Who is the mina contact?
Dr Derek Farrell MBE
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 | Interventional non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | 40101_PIS.docx |
| Scientific title | A Stage 1 pilot cohort exploring the use of eye movement desensitization and reprocessing therapy as video-conference psychotherapy during COVID-19 for frontline mental health workers – a proof of concept study utilising a virtual blind 2 therapist protocol |
| Study acronym | VB2T |
| Study objectives | This stage 1 pilot study used a pre-test/post-test design taking measures before and after a one-session treatment using the Eye Movement Desensitization and Reprocessing (EMDR) virtual blind 2 therapist (VB2T) protocol, including 1-month and 6-month follow-up to determine the impact of the treatment intervention on the pilot cohort. The rationale for an experimental design as a stage 1 research project was to determine proof of concept before proceeding to stage 2 involving a quasi-experimental design utilising a distinct control group. The longer-term strategy is for phases 1 and 2 to support a more significant funding application utilising a randomised control design incorporating a delayed treatment paradigm. Hypothesis 1: EMDR's fitness for purpose as a video-conference psychotherapy (VCP) - safety Hypothesis 2: EMDR's distinctiveness as a VCP - treating trauma memories Hypothesis 3: EMDR as a VCP is relevant as a clinical intervention in treating trauma Hypothesis 4: EMDR as a VCP is efficient in comparison with 'in-person' treatment |
| Ethics approval(s) | Approved 07/07/2020, College of Health, Life and Environmental Sciences Research Ethics Panel (Research Office, St John’s Campus, University of Worcester, UK; +44 (0)1905 54 2767; ethics@worc.ac.uk); ref: CBPS19200031-R2 |
| Health condition(s) or problem(s) studied | A memory of an adverse life event that causes a disturbing memory trace measured by Subjective Unit of Distress (SUD) |
| Intervention | One session treatment intervention using an EMDR therapy Blind 2 therapist treatment intervention delivered as video-conference psychotherapy (VCP) EMDR is an evidence-based treatment for PTSD and complex PTSD. The treatment involves activating a memory of an adverse life event that causes a level of distress in the here and now. EMDR involves the use of bi-focal stimulation, which puts a loading on working memory in the brain, which then helps to help process the memory so that the memory is remembered, rather than re-experienced. This trial is firstly testing the use of this intervention remotely as video-conference psychotherapy, and secondly, by working on a memory of an adverse life event that the research participant does not disclose. Follow-up is provided at both 1 month and 6 months. |
| Intervention type | Other |
| Primary outcome measure | Measured at pre and post-treatment sessions, and at 1- and 6-month follow-up: 1. Distress or disturbance measured using the Subjective Unit of Disturbance (SUD) scale 2. Cognitive structure assessed using the Validity of Cognition Scale (VOC) 3. Vividness of the target memory measured using the Memory Vividness (MV) and Emotionality (ME) scale 4. Intensity of the target memory measured using the Memory Intensity (MI) scale 5. Adversity during childhood measured using the Adverse Childhood Experiences Scale (ACE) 6. Positive early life experiences measured using the Benevolent Childhood Experiences (BCEs) 7. Time (minutes) using the metric period recommended by EMDRIA sessions (60–90 minutes) from the commencement of Phase 3 – Assessment, to the completion of Phase 7 – Closure (including debrief) 8. Cost per session measured using economic modeling from the University of Worcester |
| Secondary outcome measures | Qualitative data collected via semi-structured interviews at 1-month follow up: 1. Research participant's experience of the trauma memory currently 2. Experience of EMDR as a video-conference psychotherapy 3. Experience of the remotEMDR software 4. Evaluation on the part of the therapist in the treatment session 5. Subjective views on any potential risk factors and benefits of the intervention 6. Integration into clinical practice |
| Overall study start date | 07/07/2020 |
| Completion date | 30/04/2021 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 17 |
| Total final enrolment | 24 |
| Key inclusion criteria | Current inclusion criteria as of 22/03/2022: 1. Frontline mental health workers 2. Currently clinically active and practising 3. Encountered an adverse life event that generated a presently held, subjective level of disturbance 4. Willingness to be a client for a one-session intervention using the EMDR therapy B2T protocol as a VCP, using the remotEMDR platform Previous inclusion criteria: 1. EMDR Europe Accredited Consultant working within the UK 2. Currently clinically active and practising EMDR therapy 3. Encountered an adverse life event that generated a presently held, subjective level of disturbance 4. Willingness to be a client for a one-session intervention using the EMDR therapy B2T protocol as a VCP, using the remotEMDR platform |
| Key exclusion criteria | Current exclusion criteria as of 22/03/2022: 1. Not in active clinical service as a frontline worker 2. Currently in receipt of psychiatric or psychological services 3. Suicidal ideation Previous exclusion criteria: 1. EMDR Europe Accredited Consultant not in active service 2. Currently in receipt of psychiatric or psychological services 3. Suicidal ideation |
| Date of first enrolment | 08/07/2020 |
| Date of final enrolment | 16/08/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Worcester
WR2 6AJ
United Kingdom
Sponsor information
University/education
c/o Charlotte Wasilewski
Research & KE Support Officer (Pre-Award)
Research & KE Office
Worcester
WR2 6AJ
England
United Kingdom
| Phone | +44 (0)7931 135871 |
|---|---|
| c.wasilewski@worc.ac.uk | |
| Website | https://www.worcester.ac.uk/ |
"ROR" |
https://ror.org/00v6s9648 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/09/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Paper 1: Pilot project data (quantitative data set only) Paper 2: Meta-analysis of the data set comparing with previous EMDR blind 2 therapist published study Paper 3: Qualitative data set from the study Conference submission to EMDRIA International Conference 2022 & EMDR Europe Conference 2022 (updated 22/03/2022: EMDR Europe Conference 2023) |
| IPD sharing plan | All the raw data for the study has been placed in the Open Source Repository at https://osf.io/ty7xe/ |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 03/08/2021 | No | Yes | ||
| Results article | 06/07/2022 | 26/07/2022 | Yes | No |
Additional files
Editorial Notes
26/07/2022: Publication reference added.
22/03/2022: The following changes were made to the trial record:
1. The scientific title was changed from 'A Stage 1 pilot cohort exploring the use of eye movement desensitization and reprocessing therapy as video-conference psychotherapy during COVID-19 – a proof of concept study utilising a virtual blind 2 therapist protocol' to 'A Stage 1 pilot cohort exploring the use of eye movement desensitization and reprocessing therapy as video-conference psychotherapy during COVID-19 for frontline mental health workers – a proof of concept study utilising a virtual blind 2 therapist protocol'.
2. The inclusion and exclusion criteria and the publication and dissemination plan were updated.
3. The intention to publish date was changed from 01/09/2021 to 01/09/2022.
03/08/2021: The participant information sheet was uploaded as an additional file.
06/07/2021: Trial's existence confirmed by the University of Worcester.
