The EASE trial: Trauma-focused therapy in early psychosis

ISRCTN	ISRCTN16689792
DOI	https://doi.org/10.1186/ISRCTN16689792
Central Portfolio Management System (CPMS)	60392
National Institute for Health and Care Research (NIHR)	168901
Sponsor	Greater Manchester Mental Health NHS Foundation Trust
Funder	National Institute for Health and Care Research

Submission date: 14/07/2026
Registration date: 11/08/2026
Last edited: 11/08/2026

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
Psychosis can cause distressing experiences such as hearing voices, unusual beliefs and paranoia. Many people with psychosis have experienced traumatic life events, which may contribute to the development and persistence of their symptoms.

Eye Movement Desensitisation and Reprocessing for psychosis (EMDRp) is a talking therapy designed to help people process traumatic experiences. Previous research suggests that EMDR may improve trauma-related symptoms, but it is not yet known whether it can also reduce psychotic symptoms in people experiencing psychosis for the first time.
This study aims to investigate whether EMDRp, alongside usual care, is more effective than usual care alone in reducing psychotic symptoms in people receiving support from Early Intervention in Psychosis (EIP) services who have experienced trauma.

Who can participate?
People aged 16 years and over who are receiving support from an NHS Early Intervention in Psychosis service, have active psychotic symptoms, have experienced at least one traumatic life event that continues to affect their mental health, and can provide informed consent.

What does the study involve?
A total of 314 participants will be randomly allocated to one of two groups:

- EMDRp plus treatment as usual
- Treatment as usual only

Treatment as usual will consist of the standard care provided by participants' EIP teams, which may include medication, psychological support and other treatments.
Participants allocated to the EMDRp group will receive up to 16 therapy sessions over six months. Sessions may take place in person or remotely, depending on participant preference.
Participants in both groups will complete assessments over 12 months. These assessments will measure psychotic symptoms, recovery, trauma symptoms, mood, quality of life and day-to-day functioning.
Some participants will also be invited to take part in an interview about their experiences of the therapy.

What are the possible benefits and risks of participating?
Participants may benefit from receiving additional psychological therapy that could help reduce the impact of trauma and psychotic symptoms. The findings may help improve treatment options for people experiencing psychosis in the future.
Some participants may find discussing traumatic experiences upsetting or emotionally challenging. Appropriate clinical support will be available throughout the study.

Where is the study run from?
NHS Early Intervention in Psychosis services across England, including sites in Manchester, London, Chorley, Southport and Northumberland.

When is the study starting and how long is it expected to run for?
September 2026 to May 2029.

Who is funding the study?
National Institute for Health and Care Research (NIHR), UK.

Who is the main contact?
Professor Filippo Varese, filippo.varese@manchester.ac.uk.

Contact information

Prof Filippo Varese
Principal investigator

University of Manchester
Division of Psychology and Mental Health
School of Health Sciences
Manchester
M13 9PL
United Kingdom

ORCID ID	0000-0001-7244-598X
Phone	+44 7970553732
Email	filippo.varese@manchester.ac.uk

Dr Kate Allsopp
Scientific, Public

C-TRU
Research and Innovation
Greater Manchester Mental Health NHS Foundation Trust
Building B, One Central Park
Northampton Rd
Manchester
M40 5BP
United Kingdom

Phone	+441612710737
Email	kate.allsopp@gmmh.nhs.uk

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Parallel
Purpose	Treatment
Scientific title	Trauma-focused therapy in early psychosis: A randomised controlled trial assessing the efficacy and mechanisms of action of Eye Movement Desensitization and Reprocessing for psychosis (EMDRp) in comparison to treatment as usual in Early Intervention settings
Study acronym	EASE
Study objectives	The trial aims to test the clinical efficacy of EMDRp (Eye Movement Desensitisation Reprogramming for psychosis) in reducing overall psychotic symptoms when compared to treatment as usual (TAU) for users of EIP services who have a history of trauma, and to examine the degree to which EMDRp +TAU impacts psychotic symptoms via changes in trauma memory characteristics and reductions in maladaptive beliefs. The specific aims and hypotheses are: Efficacy Objectives 1. Aims: 1.1. Primary: To examine the clinical efficacy of EMDRp in reducing overall psychotic symptoms when compared to TAU for EIP service users with a history of trauma. 1.2. Secondary: To determine whether the treatment gains of EMDRp extend to other valued secondary outcomes (perceived personal recovery, severity of hallucinations, delusions, persecutory ideas and paranoid thinking, post-traumatic sequelae, affective symptoms, personal and social functioning, and health-related quality of life). 2. Hypotheses: 2.1. (Primary efficacy hypothesis) EMDRp+TAU will lead to improved overall psychotic symptoms (PANSS scores) at the end-of-treatment (6-month follow-up) compared to TAU. 2.2. The treatment effect of EMDRp+TAU on overall psychotic symptoms will be maintained at the 12-month follow-up. 2.3. EMDRp+TAU will lead to improved personal recovery, post-traumatic sequelae, affective symptoms (e.g. anxiety and depression) and the severity of participants’ hallucinations, delusions, persecutory ideas / paranoid thinking, functioning and quality of life at the end-of treatment (6-month follow-up) and 12-month follow-up compared to TAU. 2.4. Treatment effects will remain evident after accounting for the effect of concomitant psychological therapies delivered as part of TAU. Mechanistic objectives 1. Aims: 1.1. To examine the degree to which EMDRp+TAU impacts on psychotic symptoms via changes in trauma memory characteristics and reductions in maladaptive beliefs. 2. Hypotheses: 2.1. EMDRp+TAU will improve key mechanistic measures targeted by the intervention: trauma memory characteristics and negative self-beliefs targeted as part of EMDR interventions. 2.3. Treatment effects on PANSS at 6-months and 12-month follow-up assessments will be mediated via changes in key mechanistic measures at the 4-month post-randomisation (mechanistic) assessment.
Ethics approval(s)	Approved 30/04/2026, North West Liverpool Central Research Ethics Commitee (2 Redman Place, Stratford, London, E201JQ, United Kingdom; +44 02071048340; liverpoolcentral.rec@hra.nhs.uk), ref: 26/NW/0046
Health condition(s) or problem(s) studied	The target population for this multi-centre RCT is individuals engaging with Early Intervention for Psychosis NHS services, who present with co-occurring psychotic symptoms and a history of trauma affecting their current mental health.
Intervention	Randomisation processes Participants will be randomised to each trial arm (either EMDRp + TAU or TAU only) on a 1:1 ratio. Randomisation (at the individual level) will be stratified by site and generated using randomly-permuted blocks of varying size, and will be implemented using a centralised, independent and concealed randomisation service at King’s Clinical Trials Unit (KCTU). The randomisation service is web-based, and randomisation will only be known to unblinded staff such as Trial Managers and therapists. Treatment summary Control group: Treatment as Usual (TAU) TAU will be the standard care provided by participants’ Early Intervention for Psychosis (EIP) teams - including social, psychological, medical, or other treatments as decided by the care team. As such, treatment offer and uptake will vary on an individual basis, e.g. due to the person’s most pressing clinical needs, service offer and capacity, and patient choice. Access to TAU in either arm of the trial will be delivered and directed by EIP teams, without any interference or influence from the study team. Treatment: EMDRp (Eye Movement Desensitisation Reprogramming for psychosis) intervention Participants allocated to the EMDRp + TAU arm will receive up to 16 sessions of EMDR (up to 90 minutes per session), over a 6-month treatment window, in addition to TAU. Access to TAU will not be restricted in any way. Therapy delivery will be in person (e.g. participant’s home, NHS premises) or remote, depending on participant preference. EMDR is a protocolised therapy designed to reprocess adverse or traumatic life experiences, and related distress. EMDRp (EMDR for psychosis) is consistent with the standard EMDR protocol, but tailored to the needs of clients with early psychosis. An EMDRp manual has already been evaluated and implemented successfully in our feasibility trial. EMDRp will be delivered by dedicated EMDR therapists, additionally trained in EMDRp, and attend fortnightly supervision sessions with experienced EMDR supervisors. Treatment fidelity will be monitored using procedures already successfully implemented in the EASE feasibility RCT.
Intervention type	Behavioural
Primary outcome measure(s)	Overall psychotic symptoms measured using the total score of the Positive and Negative Syndrome Scale (PANSS) at baseline and 6 months
Key secondary outcome measure(s)	Recovery measured using the Questionnaire about the Process of Recovery (QPR) at baseline, 6 and 12 months Severity of delusions and hallucinations measured using the Psychotic Symptoms Rating Scale (PSYRATS) and the Multi-Modal Hallucinations Inventory at baseline, 6 and 12 months Persecutory ideas and referential thinking (aspects of paranoia) measured using the Revised Green et al. Paranoid Thoughts Scale (R-GPTS) at baseline, 6 and 12 months Symptoms of post-traumatic stress disorder (PTSD) and and complex PTSD (CPTSD), as per ICD-11, measured using the International Trauma Questionnaire (ITQ) at baseline, 6 and 12 months Symptoms of PTSD as per DSM-5 measured using the PTSD Checklist for DSM-5 (PCL-5) at baseline, 6 and 12 months Symptoms of oppression-based traumatisation measured using the Oppression-Based Traumatic Stress Inventory (OBTSI) at baseline, 6 and 12 months Trauma-related dissociation measured using the Dissociative Subtype of PTSD Scale (DSPS) at baseline, 6 and 12 months Depression measured using the Patient Health Questionnaire (PHQ-9) at baseline, 6 and 12 months Anxiety measured using the General Anxiety Disorder scale (GAD-7) at baseline, 6 and 12 months Functioning measured using the Personal and Social Performance Scale (PSP) at baseline, 6 and 12 months Health-related quality of life measured using the EQ-5D-5L at baseline, 6 and 12 months Mental health-related quality of life measured using the Recovering Quality of Life (ReQoL) at baseline, 6 and 12 months Trauma memory characteristics measured using the Adapted Trauma Memory Quality Questionnaire (ATMQQ) at baseline, 4, 6, and 12 months Negative beliefs about self and others measured using the Brief Core Schema Scale (BCSS) at baseline, 4, 6, and 12 months Experiences of the EMDR intervention measured using semi-structured qualitative interviews at post-treatment
Completion date	31/05/2029

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	16 Years
Upper age limit	99 Years
Sex	All
Target sample size at registration	314
Key inclusion criteria	1. Meeting Early Intervention for Psychosis (EIP) service entry criteria for First Episode Psychosis (FEP) support, operationally defined using the Positive and Negative Syndrome Scale (PANSS) and/or the psychosis transition criteria of the Comprehensive Assessment of At Risk Mental States (CAARMS) or other locally approved clinical definition of FEP 2. Have an assigned key worker / care coordinator, to enable appropriate risk management at time of trial enrolment 3. Aged ≥ 16 years 4. Willing and able to provide informed consent 5. Judged by their responsible clinician and/or clinically qualified members of the research team as clinically stable (e.g. no medication changes in past month; no current suicidal intent and no suicide attempt in past two months; sufficient substance misuse management and/or stable accommodation to enable reliable engagement in EIP psychological therapies) 6. Active psychotic symptoms indicated by a score of at least 3 (i.e. symptom present) on the P1 (delusions), P3 (hallucinations), P5 (grandiosity) or P6 (suspiciousness/paranoia) items of the PANSS 7. Reporting at least 1 traumatic event on the Trauma and Life Events (TALE) checklist (Carr et al., 2018a), with reported impact on current mental health problems, operationalised as a score ≥5 on item 21c of the TALE
Key exclusion criteria	1. Moderate/severe/profound intellectual disability 2. Non-English speaking 3. Previous receipt of EMDR from a qualified psychological therapist in accordance with NICE guidelines
Date of first enrolment	01/09/2026
Date of final enrolment	31/03/2028

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Greater Manchester Mental Health NHS Foundation Trust

Complex Trauma and Resilience Unit (C-TRU)
GMMH Research & Innovation Office
1st Floor, Building B
One Central Park
Manchester
M40 5BP
England

South London and Maudsley NHS Foundation Trust

Early Intervention Services
190 Kennington Lane
London
SE11 5DL
England

Lancashire and South Cumbria NHS Foundation Trust

Tudor House
18 Euxton Lane
Chorley
PR7 1PS
England

Mersey Care NHS Foundation Trust

Early Intervention Services
Hatley Hospital
1B Curzon Road
Southport
PR8 6PL
England

Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust

Early Intervention in Psychosis Service
Greenacres Centre
Green Lane
Ashington
Northumberland
NE63 8BL
England

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

14/07/2026: Study's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).