The RESTART trial
Research type
Research Study
Full title
The RESTART trial: A feasibility clinical trial of psychological therapies for trauma in people with an At Risk Mental State
IRAS ID
323676
Contact name
Filippo Varese
Contact email
Sponsor organisation
University of Manchester
ISRCTN Number
ISRCTN76699092
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
Many young people and adults who are at high risk of developing psychosis have a history of traumatic life experiences. The psychological and emotional impacts of these traumatic experiences are, however, often not considered in routine psychological therapies that are offered to this clinical group. Previous research has shown that people with trauma can have more severe long-term mental health prognoses, and also that specific psychological therapies focused on trauma are safe and acceptable in people who have already 'transitioned' to a first full-blown episode of psychosis. In this trial, we will extend these findings and explore the safety, acceptability, and feasibility of psychological therapies focussed on trauma for people who have unusual experiences sufficiently severe to suggest they might at risk of a future episode of psychosis.
The RESTART clinical trial is a feasibility study which aims to clarify the feasibility of a future larger-scale randomised controlled trial to test the efficacy of two psychological therapies focussed on trauma in people with an 'At Risk Mental State' (ARMS). These are trauma-focussed cognitive behavioural therapy (TF-CBT) and Eye Movement Desensitisation and Reprocessing (EMDR).
75 people who have been assessed as having an ARMS and have had traumatic experiences in the past will be randomly assigned to receiving either their usual NHS treatment or TF-CBT or EMDR (in addition to their usual treatment). The trial will collect a range of clinical measures as well as interviews with participants to test a range of outcomes to understand if a future larger scale trial will be warranted and achievable.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
23/WM/0113
Date of REC Opinion
22 May 2023
REC opinion
Favourable Opinion