Eye movement desensitisation and reprocessing therapy for depression
| ISRCTN | ISRCTN13955131 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13955131 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 338392 |
| Protocol serial number | CPMS 60219, NIHR160513 |
| Sponsor | University of Bristol |
| Funder | National Institute for Health and Care Research |
- Submission date
- 20/06/2025
- Registration date
- 30/07/2025
- Last edited
- 30/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Depression is a common condition in primary care and a leading cause of disability and lost work days. Only half of patients respond to the most common treatments (antidepressants and cognitive behavioural therapy (CBT)). Eye movement desensitisation and reprocessing therapy (EMDR) is a NICE-recommended trauma-focused intervention for post-traumatic stress disorder (PTSD). The protocol has been adapted for depression. It emphasises the importance of reprocessing dysfunctionally stored memories that may arise after stressful life events (e.g. job loss) or traumatic experiences (e.g. childhood abuse) and which may predispose to and maintain depression. Targeting memories linked to depression using EMDR provides a new avenue for treatment that may act via different mechanisms. There is some evidence that EMDR may reduce depressive symptoms. However, there is no robust evidence of efficacy, and it is unclear how EMDR works.
This study aims to establish the effects of EMDR (in addition to usual GP care (UC)) compared with UC for patients with depression in primary care. An embedded mechanistic study will determine whether key memory-processing mechanisms mediate reductions in depression and if working memory capacity is associated with treatment response. A nested qualitative study will examine the acceptability of EMDR for depression, further explore mechanisms, and identify possible causes of differing responses. An intervention costing exercise will estimate the cost of delivering EMDR in the NHS
Who can participate?
Adult patients over 18 years old who are currently depressed, not already receiving a talking therapy and who are willing to work on the memories of past stressful experiences related to their depression.
What does the study involve?
Participants will be randomly assigned to one of two groups:
- EMDR Therapy - where they are offered up to 18 individual EMDR sessions with a therapist. Each session will last up to 90 minutes and will usually take place weekly. Therapy will be provided in person.
- Usual Care - Participants continue to receive usual care from their GP.
For both groups, participants will be asked to fill in short questionnaires at 2, 8, 16 and 39 weeks, and some longer questionnaires at 26 and 52 weeks after joining the study. They may also be approached for an interview about their views of EMDR and/or their experiences of taking part in the study.
What are the possible benefits and risks of participating?
Participants will have an opportunity to help evaluate this new treatment for depression, which they will hopefully find interesting and rewarding. Whether they are allocated EMDR or usual care, it is hoped that this treatment will help them develop ways of managing their depression better. However, this cannot be guaranteed.
As with any talking therapy for depression, participants may find EMDR therapy sessions emotionally challenging or upsetting. The experienced therapists will be able to provide support within the EMDR sessions. As part of the questionnaires, participants will be asked about difficult or stressful events that have happened in their lives. They will also be asked about the memories of events that they think might be related to their depression. This will help the researchers to understand how EMDR therapy works. These questions may be difficult to answer. The researchers will also approach the screening appointment and interviews in a sensitive and supportive way. They will be able to contact a study clinician to offer support if necessary. If there are concerns about a participant’s safety or the safety of others, the researchers may have to inform the participant’s GP. Wherever possible, they would speak with the participant beforehand. They would only pass information to the GP without the participant’s agreement if they had immediate concerns for the participant’s welfare, or the welfare of others (for example, if the participant disclosed having thoughts of harming themselves, or someone else).
Where is the study run from?
If allocated to EMDR, this would be provided in person and would take place at their GP surgery, other NHS premises or local University site (depending on local arrangements). Follow-up questionnaires can be completed by videocall, telephone, or, where feasible, in person. There is also the option to complete questionnaires by post or online.
When is the study starting and how long is it expected to run for?
March 2025 to December 2028
Who is funding the study?
National Institute for Health and Care Research, UK
Who is the main contact?
Eye-d-trial@bristol.ac.uk
Contact information
Public
Bristol Trials Centre, Bristol Medical School, University of Bristol, 1-5 Whiteladies Rd, Clifton, Avon
Bristol
BS8 1NU
United Kingdom
| 0009-0004-2107-0670 | |
| Phone | +44 (0)117 45 50797 |
| Eye-d-trial@bristol.ac.uk |
Scientific, Principal investigator
Centre for Academic Mental Health, Population Health Sciences, Bristol
Medical School, University of Bristol, Canynge Hall, Clifton
Bristol
BS8 2PN
United Kingdom
| 0000-0002-5250-3553 | |
| Phone | +44 (0) 117 33 13358 |
| Nicola.Wiles@bristol.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomised controlled trial with nested qualitative study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised controlled trial evaluating the efficacy and mechanisms of eye movement desensitisation and reprocessing therapy (EMDR) compared to treatment as usual for adults with depression in primary care |
| Study acronym | EYE-D |
| Study objectives | To establish the efficacy of eye movement desensitisation and reprocessing therapy (EMDR) (in addition to usual GP care (UC)) compared with UC for adult patients with depression in UK primary care. The null hypothesis is that there is no difference in depressive symptoms (mean BDI-II score) at 26 weeks post-randomisation between intervention and comparator groups. An embedded mechanistic study will determine whether reductions in depression are mediated via key memory-processing mechanisms and if working memory capacity is associated with treatment response. A nested qualitative study will examine the acceptability of EMDR for depression, the application of EMDR for depression compared to PTSD, further explore mechanisms, and identify possible causes of differing responses that could explain trial results. An intervention costing exercise will estimate the cost of delivering EMDR in the NHS. |
| Ethics approval(s) |
Submitted 08/07/2025, South West - Frenchay Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8106, 2071048075 ; frenchay.rec@hra.nhs.uk), ref: 25/SW/0087 |
| Health condition(s) or problem(s) studied | Mood [affective] disorders |
| Intervention | - |
| Intervention type | Other |
| Primary outcome measure(s) |
Depressive symptoms will be measured using the Beck Depression Inventory (BDI-II) as a continuous variable at 26 weeks post-randomisation |
| Key secondary outcome measure(s) |
1. Proportional change in depressive symptoms will be measured using the Beck Depression Inventory-II (BDI-II) at 26 and 52 weeks post-randomisation |
| Completion date | 31/12/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 380 |
| Key inclusion criteria | 1. Aged ≥18 years 2. Have a BDI-II score ≥14 3. Meet ICD-10 depression criteria 4. Are willing to discuss past stressful experiences related to their depression |
| Key exclusion criteria | 1. Have a diagnosis of PTSD/complex PTSD 2. Have a substance use disorder (including alcohol dependence) within the last 12 months 3. Have bipolar disorder, schizophrenia or psychosis 4. *Have a current diagnosis of moderate/severe personality disorder 5. Have a dissociative disorder 6. Have dementia 7. Are currently under secondary care for depression (including those referred but not yet seen) at eligibility screening 8. *Have a history of repeated contacts with secondary care services or community mental health teams 9. *Have a history of repeated self-harm 10. Are currently receiving psychotherapy for depression at eligibility screening 11. Unable to complete self-administered questionnaires in English 12. Taking part in another trial of an intervention for mental health *Criteria at the discretion of the clinical PI, who will use their judgement in deciding if the patient should be excluded based on these factors |
| Date of first enrolment | 01/11/2025 |
| Date of final enrolment | 31/10/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Exeter
-
United Kingdom
London
-
United Kingdom
Population Health Sciences
Canynge Hall, 39 Whatley Road
Bristol
BS8 2PS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/05/2025: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).