Eye movement desensitisation and reprocessing therapy for depression

ISRCTN	ISRCTN13955131
DOI	https://doi.org/10.1186/ISRCTN13955131
IRAS number	338392
Secondary identifying numbers	CPMS 60219, NIHR160513

Submission date: 20/06/2025
Registration date: 30/07/2025
Last edited: 30/07/2025

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Ms Leonora Cotton
Public

Bristol Trials Centre, Bristol Medical School, University of Bristol, 1-5 Whiteladies Rd, Clifton, Avon
Bristol
BS8 1NU
United Kingdom

ORCID ID	0009-0004-2107-0670
Phone	+44 (0)117 45 50797
Email	Eye-d-trial@bristol.ac.uk

Prof Nicola Wiles
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

ORCID ID	0000-0002-5250-3553
Phone	+44 (0) 117 33 13358
Email	Nicola.Wiles@bristol.ac.uk

Study information

Study design	Interventional randomised controlled trial with nested qualitative study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a 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	Depressive symptoms will be measured using the Beck Depression Inventory (BDI-II) as a continuous variable at 26 weeks post-randomisation
Secondary outcome measures	1. Proportional change in depressive symptoms will be measured using the Beck Depression Inventory-II (BDI-II) at 26 and 52 weeks post-randomisation 2. Remission of depressive symptoms (BDI-II < 10) will be measured using the Beck Depression Inventory-II (BDI-II) at 26 and 52 weeks post-randomisation 3. Symptoms of depression will be measured using the Patient Health Questionnaire-9 (PHQ-9) at 26 and 52 weeks post-randomisation 4. Symptoms of anxiety will be measured using the Generalized Anxiety Disorder-7 (GAD-7) at 26 and 52 weeks post-randomisation 5. Impairment in functioning will be measured using the Work and Social Adjustment Scale (WSAS) at 26 and 52 weeks post-randomisation 6. Quality of life will be measured using the EuroQol five-dimension five-level scale (EQ-5D-5L) at 26 and 52 weeks post-randomisation 7. Capability will be measured using the ICEpop CAPability measure for Adults (ICECAP-A) at 26 and 52 weeks post-randomisation 8. Continuous score on the Beck Depression Inventory-II (BDI-II) will also be measured at 52 weeks post-randomisation Data on PHQ-9 and GAD-7 will also be collected as part of the brief follow-ups at 2, 8, 16 & 39 weeks
Overall study start date	01/03/2025
Completion date	31/12/2028

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 380; UK Sample Size: 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

England
United Kingdom

Study participating centres

University of Exeter

Health and Community Sciences
Exeter
-
United Kingdom

University College London

Division of Psychiatry
London
-
United Kingdom

University of Bristol

Centre for Academic Mental Health
Population Health Sciences
Canynge Hall, 39 Whatley Road
Bristol
BS8 2PS
United Kingdom

Sponsor information

University of Bristol
University/education

Augustine's Courtyard, Orchard Lane
Bristol
BS8 1TH
England
United Kingdom

Phone	+44 (0)117 455 3343
Email	research-governance@bristol.ac.uk
Website	https://bristol.ac.uk/
"ROR"	https://ror.org/0524sp257

Funders

Funder type

Government

National Institute for Health and Care Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	30/04/2030
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	Planned publication in a peer-reviewed journal
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date

Editorial Notes

20/05/2025: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).