EASE: Trauma-focused therapy in early psychosis

Overview

Are you interested in therapy for difficult life experiences?
The EASE study is trying a new therapy for people having unusual sensory experiences to process distressing memories and feelings.
This could be for you if you are:
  • Currently being supported by an early intervention for psychosis (EIP) team
  • Aged 16 years or older
You would receive:
  • Psychological assessments
  • 50% chance of receiving the therapy
  • Compensation for your time
Interested in taking part in this study? 

Planned end date

31 May 2029 15:18

Conditions

Other

People types

Adolescent 13 - 17,Adult 18+

Inclusion Criteria

The study population will be adult EIP service users with a history of trauma.
Inclusion criteria for the RCT:
1. Meeting EIP service entry criteria for FEP support, operationally defined using the PANSS and/or the psychosis transition criteria of the Comprehensive Assessment of At-Risk Mental States;
2. Have an assigned key worker;
3. Aged > = 16 years;
4. Willing and able to provide informed consent;
5. Judged by their responsible clinician as clinically stable (no medication changes in past month; no current suicidal intent and no suicide attempt in past 2 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, with reported impact on current mental health problems, operationalised as a score > = 5 on item 21c of the TALE (i.e. a threshold met by all participants recruited for our feasibility RCT which enabled us to successfully identify participants for whom a psychological intervention for trauma would be appropriate and valued by trial participants).
Inclusion criteria for the nested qualitative study:
1. Participants allocated to the EMDRp + TAU arm of the trial and who gave consent to be approached for research opportunities;
2. Capacity and willingness to provide informed consent.

Exclusion Criteria

Exclusion criteria for the RCT:
1. Moderate/severe/profound intellectual disability;
2. Previous receipt of EMDR from a qualified psychological therapist in accordance with NICE guidelines.
3. Requiring an interpreter to participate in research assessments and therapy. However, participants meeting this criterion will be triaged to a Study Within A Trial [SWAT] undertaken with participants who require interpreters to access the intervention and trial procedures;
Exclusion criteria for the nested qualitative study:
1. Unwilling or unable to provide consent
Exclusion criteria for the SWAT:
1. Meeting any of exclusion criteria 1-3 for the RCT
2. Requiring study materials in any language other than the 6 languages in which we will be providing translated study materials (see A17-1, SWAT inclusion criteria).