Comparing remote and face-to-face delivery of eye movement desensitisation and reprocessing (EMDR) therapy for post-traumatic stress disorder in military veterans
| ISRCTN | ISRCTN13912752 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13912752 |
| IRAS number | 301730 |
| Secondary identifying numbers | SPON1872-21, IRAS 301730, CPMS 54173 |
- Submission date
- 17/08/2022
- Registration date
- 30/09/2022
- Last edited
- 07/12/2023
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Eye movement desensitization and reprocessing (EMDR) is a type of therapy used for post-traumatic stress disorder (PTSD). By encouraging patients to focus on a traumatic memory while simultaneously receiving stimuli in a rhythmic left-right pattern, such as eye movements, the therapy has been associated with a reduction in traumatic stress symptoms. The main aim of the proposed research is to determine whether remotely delivered EMDR has the potential to reduce traumatic stress symptoms in British military veterans with combat-related PTSD.
Who can participate?
Adult patients who meet specific criteria for combat-related PTSD
What does the study involve?
This is an exploratory study to assess fidelity, adherence and factors that influence the outcome. All treatment will be delivered through Veterans’ NHS Wales. Face-to-face treatment will occur in usual clinics; remote treatment will take place via Attend Anywhere. All recruitment and research interviews will be undertaken remotely.
The main aim of the proposed research is to determine whether remotely delivered EMDR has the potential to reduce traumatic stress symptoms in British military veterans with combat-related PTSD.
The main objective is to answer the following research questions:
1. For British military veterans with combat-related PTSD, does remotely delivered EMDR reduce symptoms of PTSD to a significantly greater degree than a waiting list?
2. For British military veterans with combat-related PTSD, does remotely delivered EMDR reduce symptoms of PTSD to a similar degree as face-to-face delivered EMDR?
3. For British military veterans with combat-related PTSD, what is the impact of remotely delivered EMDR on quality of life, functioning, symptoms of depression, symptoms of anxiety, insomnia, alcohol and illicit substance use, and perceived social support?
4. Is remotely delivered EMDR acceptable to British military veterans with combat-related PTSD and those delivering the intervention?
5. What is the likely effect size of remotely delivered EMDR?
6. What factors may impact the effect and successful roll-out of remotely delivered EMDR for combat-related PTSD, if it is shown to be effective?
7. Can the results from this study be used in the planning of a phase III definitive trial?
8. Is a phase III study advisable and feasible?
What are the possible benefits and risks of participating?
Benefits and risks not provided at time of registration
Where is the study run from?
Cardiff University (United Kingdom)
When is the study starting and how long is it expected to run for?
July 2021 to August 2024
Who is funding the study?
1. Health and Care Research Wales (United Kingdom)
2. TEC Cymru (United Kingdom)
Who is the main contact?
Prof Jonathan Bisson (United Kingdom)
bissonJI@cardiff.ac.uk
Contact information
Principal Investigator
Hadyn Ellis Building
Maindy Road
Cardiff
CF24 4HQ
United Kingdom
 ORCID ID |
0000-0001-5170-1243 |
|---|---|
| Phone | +44 (0)29 2068 8486 |
| bissonJI@cardiff.ac.uk |
Study information
| Study design | Exploratory single-blind randomized parallel-group-assigned controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Feasibility randomised controlled trial of remotely delivered eye-movement desensitisation and reprocessing (EMDR) versus face-to-face EMDR for post-traumatic stress disorder (PTSD) in military veterans |
| Study objectives | The study proposes that remotely delivered eye-movement desensitisation and reprocessing (EMDR) has the potential to reduce traumatic stress symptoms in British military veterans with combat-related PTSD |
| Ethics approval(s) | Approved 21/04/2022, Wales Research Ethics Committee 5 (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 (0)1686 252101, +44 (0)2920 230457, +44 (0)7920 565664; Wales.REC5@wales.nhs.uk), ref: 22/WA/0062 |
| Health condition(s) or problem(s) studied | Combat-related post-traumatic stress disorder (PTSD) |
| Intervention | Study design: The study will be an exploratory single-blind randomised parallel group controlled trial with nested process evaluation to assess fidelity, adherence and factors that influence the outcome. Setting: All treatment will be delivered through Veterans’ NHS Wales. Face-to-face treatment will occur in usual clinics; remote treatment will take place via Attend Anywhere. All recruitment and research interviews will be undertaken remotely. Sample size: A standard power calculation is not appropriate for a Phase II exploratory trial but, based on previous research, we believe that a sample size of 20 per group will be sufficient to allow us to achieve our objectives. For the qualitative arm of the study, the sample size will be guided by preliminary analysis and constant comparison (comparing and contrasting themes from other interviews) during each data collection phase, until the research team is satisfied that there is data saturation and no new themes which are important to the research question arise. However, it is helpful to have a guide to sample size for study planning. Based on previous research, we propose that interviews will be conducted with around 10 participants who receive treatment remotely, purposively sampled, and all therapists. Groups: 1. Eye-movement desensitisation and reprocessing (EMDR) delivered remotely 2. Eye-movement desensitisation and reprocessing (EMDR) delivered face-to-face 3. Waiting list |
| Intervention type | Behavioural |
| Primary outcome measure | Diagnosis and severity of PTSD measured using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at baseline, 20 and 40 weeks after randomisation |
| Secondary outcome measures | 1. Presence and severity of PTSD symptoms measured using the PTSD Checklist (PCL) at baseline, 20 and 40 weeks after randomisation 2. Core symptoms of PTSD and complex PTSD measured using the International Trauma Questionnaire (ITQ) at baseline, 20 and 40 weeks after randomisation 3. Impairment in functioning measured using the Work and Social Adjustment Scale (WSAS) at baseline, 20 and 40 weeks after randomisation 4. Severity of depression measured using the Patient Health Questionnaire (PHQ-9) at baseline, 20 and 40 weeks after randomisation 5. Severity of generalised anxiety disorder (GAD) measured using the GAD-7 assessment at baseline, 20 and 40 weeks after randomisation 6. Alcohol harm measured using the Alcohol Use Disorders Test (AUDIT-O) at baseline, 20 and 40 weeks after randomisation 7. Nature, severity, and impact of insomnia measured using the Insomnia Severity Index (ISI) at baseline, 20 and 40 weeks after randomisation 8. Health-related, quality of life measured using the EQ5D-5L at baseline, 20 and 40 weeks after randomisation 9. Digital skills measured using a Digital Ability questionnaire at baseline |
| Overall study start date | 01/07/2021 |
| Completion date | 29/08/2024 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Aged 18 years old and over 2. Informed consent 3. Meet DSM5 criteria for combat-related PTSD 4. Access to stable internet access in a private location |
| Key exclusion criteria | 1. Psychosis 2. DSM5 severe major depressive episode 3. Substance dependence 4. Change in psychotropic medication within one month 5. Suicidal intent |
| Date of first enrolment | 10/10/2022 |
| Date of final enrolment | 19/08/2024 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centres
Heath Park
Cardiff
CF14 4XW
United Kingdom
Seaway Parade Industrial Estate
Baglan
Port Talbot
SA12 7BR
United Kingdom
Albert Road
Pontypridd
CF37 1LB
United Kingdom
Penrhosgarnedd
Bangor
LL57 2PW
United Kingdom
Lodge Road
Caerleon
Newport
NP18 3XQ
United Kingdom
Sponsor information
University/education
McKenzie House, 7th Floor
30-36 Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom
| Phone | +44(0)29 2087 5834 |
|---|---|
| resgov@Cardiff.ac.uk | |
| Website | www.cardiff.ac.uk |
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Health & Care Research Wales, Ymchwil Iechyd a Gofal Cymru, Health Care Research Wales, HCRW
- Location
- United Kingdom
Government organisation / Local government
- Alternative name(s)
- Welsh Government, The Welsh Government
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Dissemination will start at the beginning of the project; early activities will include finalising a strategic dissemination plan, promotion and awareness raising. Findings will be disseminated widely using a variety of tailored methods targeting specific audiences. A summary report of trial results written in lay-language will be sent to study participants and other key stakeholders. We will hold a participant-centred meeting at the end of the study to present the results orally and allow time for questions and clarification. We will send reports of trial results to NHS commissioners and disseminate the findings publicly through news items on the Veterans’ NHS Wales and National Centre for Mental Health (NCMH) websites. We will publicise the trial through social and local media not for recruitment but to inform the public that the trial is running. We have experience of successfully engaging local and national media and will work with the NCMH communications team to formulate strategies for press releases and the dissemination of findings through newspaper articles, television and radio features. Study outcomes will be presented to the academic community at national and international conferences by means of oral presentation, poster presentation, and interactive workshops. We will target conferences likely to be attended by large numbers of therapists and managers working in IAPT and other primary and secondary care NHS psychological treatment services across the UK. We will also disseminate to the third sector and other services likely to deal with individuals with PTSD who could potentially benefit from treatment (e.g. the UK veteran mental health charity Combat Stress). We aim to publish the results in high impact open-access, peer reviewed journals. We expect at least two high impact peer reviewed publications and three conference presentations. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from the National Centre for Mental Health (NCMH) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
07/12/2023: This trial has been terminated prematurely due to a staff shortage.
03/10/2022: Internal review.
13/09/2022: Trial's existence confirmed by Wales Research Ethics Committee 5 Bangor.
