Trauma Therapy for Psychosis: Eye Movement Desensitisation and Reprocessing (EMDR) for people with a psychotic illness
| ISRCTN | ISRCTN43816889 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43816889 |
| Secondary identifying numbers | v1.2 |
- Submission date
- 10/07/2014
- Registration date
- 24/10/2014
- Last edited
- 07/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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 December 2021
Who is funding the study?
Cornwall Partnership NHS Foundation Trust (UK)
Who is the main contact?
Dr Simon Marlow
simonmarlow@nhs.net
Contact information
Scientific
Trengweath Mental Health Unit
Penryn Street
Redruth
TR15 2SP
United Kingdom
| simonmarlow@nhs.net |
Study information
| Study design | Exploratory randomized control study of the treatment effectiveness of EMDR therapy in people with psychosis. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The use of Eye Movement Desensitisation and Reprocessing (EMDR) for the treatment of psychosis |
| Study 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(s) | South West - Cornwall & Plymouth Research Ethics Committee, 05/05/2015, ref: 15/SW/0034 |
| 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 |
| Primary outcome measure | 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 study start date | 01/01/2015 |
| Overall study end date | 01/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 36 |
| Total final enrolment | 36 |
| 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 years |
| 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 | 06/07/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Redruth
TR15 2SP
United Kingdom
Sponsor information
Hospital/treatment centre
C/O Dr Ellen Wilkinson
Trust HQ
Shaw House
Porthpean Road
St Austell
Cornwall
PL26 6AD
England
United Kingdom
"ROR" |
https://ror.org/0517ad239 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/07/2022 |
|---|---|
| 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 high-impact 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 18/11/2023 | 07/12/2023 | Yes | No |
Editorial Notes
07/12/2023: Publication reference and total final enrolment added.
06/07/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/01/2020 to 06/07/2021.
2. The overall trial end date was changed from 01/06/2020 to 01/12/2021.
2. The intention to publish date was changed from 01/01/2021 to 01/07/2022.
07/02/2019: The following changes were made:
1. The recruitment end date was changed from 01/01/2019 to 01/01/2020.
2. The overall trial end date was changed from 01/06/2019 to 01/06/2020.
3. Thee intention to publish date was changed from 01/12/2020 to 01/01/2021.
05/10/2018: Publication and dissemination plan and IPD sharing statement added.
31/01/2018: Recruitment end date was changed from 01/01/2017 to 01/01/2019 and overall trial end date was changed from 01/01/2017 to 01/06/2019.
30/03/2016: Ethics approval information added.
