Condition category
Mental and Behavioural Disorders
Date applied
10/07/2014
Date assigned
24/10/2014
Last edited
30/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Psychosis is a mental illness where those affected hear things that others may not be able to hear, and believe things that others find hard to believe. The suggested therapy is called Eye Movement Desensitisation and Reprocessing (EMDR) and is known to be safe and work well in treating disorders clearly linked to trauma such as Post-Traumatic Stress Disorder (PTSD). Psychosis is understood to be linked with trauma in a similar way to PTSD but this therapy has not been tested for how well it works in this illness. We hope to offer people with psychosis a new brief therapy treatment to reduce the impact of previous difficult or traumatic experiences.

Who can participate?
This study is open to patients who are known to suffer from psychosis and normally have support from the psychiatric services locally.

What does the study involve?
12 patients will be randomly allocated to not receive treatment but continue their normal care with the psychiatric services (treatment as usual). They will be offered the treatment at the end of the study. 24 patients will be randomly allocated to have the EMDR treatment. Everybody will have an interview with a researcher before and after the treatment period, as well 6 months after treatment. At these interviews patients will be assessed on measurement scales that test for the impact of previous traumatic events, the symptoms of psychosis and PTSD, and a measurement of their quality of life.

What are the possible benefits and risks of participating?
We hope to see that patients who receive this treatment have improvements in their symptoms of mental health problems as well as their quality of life. The potential risks of participating include the general risks of participating in a one-to-one therapy. These include increased distress and worsening of symptoms due to the process as well as not getting on with the therapist. These risks will be modified by providing patients with resources and skills to prepare for the treatment including use of relaxation exercises. There is a risk that the patient finds the process difficult and distressing but this risk will be modified by ensuring there is a thorough consent process, recruitment involves the awareness that the therapy is about treating previous traumatic experiences / memories, and the ensuring that patients are briefed about the EMDR therapeutic process before commencing.

Where is the study run from?
The study will be run from Cornwall Foundation NHS Trust (UK) sites. The trust is based at Shaw House, Porthpean Road, St Austell, Cornwall. Bases will include local Community Mental Health Team bases including Trevillis House, Liskeard; Elfordleigh, Launceston; East Resource Centre, Bude; Alexandra House, St Austell; Banham House, Bodmin; Newquay Resource Centre (Roswyth), Newquay; Pydar Street, Truro; Trengweath, Redruth; and Bolitho House, Penzance.

When is the study starting and how long is it expected to run for?
January 2015 to January 2017.

Who is funding the study?
Cornwall Partnership NHS Foundation Trust (UK)

Who is the main contact?
Dr Simon Marlow
simonmarlow@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr Simon Marlow

ORCID ID

Contact details

Trengweath Mental Health Unit
Penryn Street
Redruth
TR15 2SP
United Kingdom
-
simonmarlow@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

v1.2

Study information

Scientific title

The use of Eye Movement Desensitisation and Reprocessing (EMDR) for the treatment of psychosis

Acronym

TTP

Study hypothesis

We hypothesise that a providing EMDR therapy to patients with psychosis will lead to an improvement in the negative impact of a traumatic event, and subsequent improvements in the symptoms of psychosis, quality of life, and symptoms of post-traumatic stress disorder (PTSD).

Ethics approval

South West - Cornwall & Plymouth Research Ethics Committee, 05/05/2015, ref: 15/SW/0034

Study design

Exploratory randomised control study of the treatment effectiveness of EMDR therapy in people with psychosis.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Mental Health Difficuties

Intervention

Patients are randomised to two groups:
1. Eye Movement Desensitisation and Reprocessing Therapy: A course of 8 x 90 minute sessions.
2. The control group will have Treatment As Usual.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Impact of Events Scale (IES) measured at baseline, then after 10 weeks (to allow for the up to 8 week therapy course to complete) and then after 6 months from baseline.

Secondary outcome measures

1. Positive and Negative Symptoms of Schizophrenia Scale (PANSS)
2. Subjective Quality of Life (MANSA)
3. PTSD Checklist (PCL)

The measures will be done at baseline, then after 10 weeks (to allow for the up to 8 week therapy course to complete) and then after 6 months from baseline.

Overall trial start date

01/01/2015

Overall trial end date

01/01/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with a psychotic illness without comorbid PTSD currently receiving care from secondary care psychiatric services between the ages of 18-65.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

36

Participant exclusion criteria

Having a severe learning difficulty, being unable to speak English or travel to the appointments. Having a serious concern about risk or being placed in a locked psychiatric unit.

Recruitment start date

01/01/2015

Recruitment end date

01/01/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Trengweath Mental Health Unit
Penryn Street
Redruth
TR15 2SP
United Kingdom

Sponsor information

Organisation

Cornwall Foundation NHS Trust (UK)

Sponsor details

C/O Dr Ellen Wilkinson
Trust HQ
Shaw House
Porthpean Road
St Austell
Cornwall
PL26 6AD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Cornwall Partnership NHS Foundation Trust (UK) - Research and Development Team

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/03/2016: Ethics approval information added.