Condition category
Mental and Behavioural Disorders
Date applied
30/04/2018
Date assigned
03/05/2018
Last edited
03/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Psychotic illnesses are some of the most disabling illnesses, with more than 21 million people affected worldwide. These illnesses cause a huge burden on sufferers and their families. About 22% of people with an at-risk mental state (ARMS) will make a transition to psychosis within 1 year. Current treatments to prevent the onset of psychosis are not very effective. More than 80% of the people at-risk of psychosis report traumatic events, especially during childhood. Studies suggested that memories of these events can lead to some people developing hallucinations (e.g. hearing voices) and delusions (e.g. paranoid beliefs), which are the most common symptoms of psychotic illnesses. Eye Movement Desensitisation and Reprocessing (EMDR) is a type of trauma-focused therapy which helps people deal with traumatic memories by changing how these are stored, and altering negative beliefs caused by the event (e.g. ‘It is my fault’). EMDR is an effective therapy for post-traumatic stress disorder, another illness caused by memories of traumatic events, but no studies have yet investigated whether EMDR could prevent the onset of psychosis in people at-high risk. To investigate this, a large study is needed. First, however, the aim of this study is to investigate whether such a study would be feasible and acceptable to patients.

Who can participate?
Patients aged 16 or over who are at risk of psychosis and have a history of trauma

What does the study involve?
Participants are randomly allocated to either 12 EMDR sessions or treatment as usual (TAU). Participants are followed up for 1 year, and data is collected on transition to psychosis and severity of symptoms. Patients and therapists are interviewed about their views of EMDR, study materials and participation experiences to help design a large study to find out whether EMDR is effective at preventing the development of psychotic illnesses.

What are the possible benefits and risks of participating?
By taking part in this study, participants will help researchers better understand how to manage individuals who are at risk of developing psychosis. At the end of the study, participants will be sent a summary of the results. Patients will be asked to fill out questionnaires about traumatic experiences they had in the past. This may be upsetting for some of them. However, patients will be told prior to assessment that they do not have to answer a specific question if they do not feel comfortable doing so. Likewise, before the interview, patients will be told that they can stop the interview at any time and without having to give a reason. Their medical care will not be affected. The researchers administering the scales and conducting the interviews have previously worked in the area of mental health and dealt with sensitive issues.

Where is the study run from?
Avon and Wiltshire Mental Health Partnership NHS Trust (UK)

When is the study starting and how long is it expected to run for?
October 2017 to April 2020

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Prof. Stanley Zammit

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stanley Zammit

ORCID ID

http://orcid.org/0000-0002-2647-9211

Contact details

Oakfield House
Oakfield Grove
Bristol
BS8 2BN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

37404

Study information

Scientific title

A feasibility study of eye-movement desensitization and reprocessing (EMDR) in people with an at-risk mental state (ARMS) for psychosis

Acronym

Study hypothesis

Psychotic illnesses are some of the most disabling illnesses, with more than 21 million people affected worldwide. These illnesses cause a huge burden on sufferers and their families. Approximately 22% of people with an at-risk mental state (ARMS) will make a transition to psychosis within 1 year. Current treatments to prevent the onset of psychosis are not very effective.

More than 80% of the people at-risk of psychosis report traumatic events, especially during childhood. Studies suggested that memories of these events can lead to some people developing hallucinations (e.g. hearing voices) and delusions (e.g. paranoid beliefs), which are the most common symptoms of psychotic illnesses. Eye Movement Desensitisation and Reprocessing (EMDR) is a type of trauma-focused therapy which helps people deal with traumatic memories by changing how these are stored, and altering negative beliefs caused by the event (e.g. ‘It is my fault’).

EMDR is an effective therapy for post-traumatic stress disorder, another illness caused by memories of traumatic events, but no studies have yet investigated whether EMDR could prevent the onset of psychosis in people at-high risk. To investigate this, a large randomised-controlled trial is needed. First, however, we need to investigate whether such a trial would be feasible and acceptable to patients.

This study seeks to establish whether it would be feasible to conduct a large multi-centre RCT to evaluate the clinical and cost-effectiveness of EMDR to prevent the onset of psychosis in people with an at-risk mental state.

Ethics approval

South West - Exeter Research Ethics Committee, 19/03/2018, ref: 18/SW/0037

Study design

Randomised; Interventional; Design type: Treatment, Prevention, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

See additional files

Condition

Specialty: Mental Health, Primary sub-specialty: Psychosis; UKCRC code/ Disease: Mental Health/ Organic, including symptomatic, mental disorders

Intervention

Randomization will take place by means of a remote automated telephone service administered by the Bristol Randomised Trials Collaboration (BRTC). Randomization will be minimized by psychotic symptom severity and patients will be categorized based on the positive symptoms of CAARMS (i.e, sum of Unusual Thoughts, Non-Bizarre Ideas, and Perceptual Abnormalities Global Ratings scales), with cut-off at 11 on this scale.

Participants will be randomly allocated to eye-movement desensitization and reprocessing (EMDR) sessions or treatment as usual (TAU). Patients allocated to EMDR will receive up to 12 sessions of manualized, weekly, face-to-face EMDR therapy. Each session will last approximately 90 minutes. EMDR therapy sessions will be held by trained EMDR therapists at the EI services. Participants will be followed up for 1 year, and data on transition to psychosis and severity of symptoms will be collected. Patients and therapists will be interviewed about their views of EMDR, study materials and participation experiences by telephone or face-to-face at the EI services. Follow-up assessment at 4, 8 and 12 months post-randomization. This will take place either at the EI Services or at participants' home.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Transition to psychosis assessed at 12 months post-randomization from clinical records (measured as an ICD-10 diagnosis of psychosis) or, if patients have dropped out of the Early Intervention Services, researchers will invite participants for an appointment where, via the CAARMS, it will be established whether they transitioned to psychosis.

Secondary outcome measures

1. Severity of psychotic symptoms, measured using PANSS, PSYRAT and CAPE-42
2. Severity of PTSD symptoms, measured using PCL-5
3. Severity of depression and anxiety, measured using PHQ-9 and GAD-7
4. Impaired functioning, measured using Work and Social Adjustment Scale (WSAS)
5. Health status, measured using EQ-5D-L
6. Drug use, measured using DAST 10
7. Medication use, measured with self-report questionnaires
8. Resource data use, measured with self-report questionnaires
All secondary outcomes apart from resource data use will be assessed at baseline, 4, 8 and 12 months post-randomization. Resource use will be assessed only at 4, 8 and 12 months post randomization.

Overall trial start date

03/10/2017

Overall trial end date

30/04/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Those aged 16 years or over who are at risk of psychosis (as defined in the Comprehensive Assessment of At-Risk Mental States (CAARMS) (A. R. Yung et al., 2005)
2. Presence of at least one positive symptom (perceptual abnormality, unusual thought, or non-bizarre ideas) scored ≥3 on CAARMS
3. History of traumatic experience as defined in ICD-10 F43.1, occurring prior to onset of first positive symptom
4. Presence of 1 or more symptoms of re-living, avoidance, hyper-arousal, or cognitive distortions in relation to the traumatic experience (assessed using the PTSD Checklist for DSM-V (PCL5) during the last month (Bovin et al., 2016))

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 40; UK Sample Size: 40

Participant exclusion criteria

1. People with past history of treated or untreated psychotic illness or learning disability
2. Current use of antipsychotics
3. Currently receiving psychological therapy
4. Completed a trauma-focused psychological therapy in the last 2 years
5. Insufficient fluency in English
6. Lacking mental capacity to provide valid informed consent

Recruitment start date

01/05/2018

Recruitment end date

30/04/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Avon and Wiltshire Mental Health Partnership NHS Trust
BS15 9TR
United Kingdom

Sponsor information

Organisation

University of Bristol

Sponsor details

Senate House
Tyndall Avenue
Clifton
Bristol
BS8 1TH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Bristol Biomedical Research Centre; Grant Codes: BRC-1215-20011

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trialists intend to publish the results of the study in high impact peer reviewed journals. This will be done in two stages: qualitative data will be published within 12 months of finishing qualitative data collection (approximately September 2020), and quantitative results within 12 months after the trial end date (approximately August 2021).

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Stanley Zammit. Data will be available 1 year after the end of the study.

Intention to publish date

01/08/2021

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

03/05/2018: Uploaded protocol Version 1, 11 January 2018 (not peer-reviewed).