History of multiple trauma, early intervention for psychosis, post-traumatic stress disorder Mental and Behavioural Disorders
Conditions
Interventions
A multi-site feasibility randomised control trial will be conducted to investigate recruitment and intervention delivery parameters and obtain initial evidence as to whether the trial process and outc
Sponsors
University College London
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Service user participants: Eligible participants will: 1. Report a history of multiple trauma (i.e. more than one event in the Trauma and Life Events (TALE) checklist that ended at least a month ago and that still affects them (operationalised as TALE 21c item >= 5) 2. Report intrusive trauma experiences as described below in 2.1 and/or 2.2: 2.1. At least subthreshold post-traumatic symptoms in the previous week (i.e., score of at least 2 on items 1-5) in the PTSD Checklist for DSM-5 (PCL-5) and/or 2.2. Current distressing symptoms of psychosis (i.e. a score of 2 or above on the intensity of distress in the PSYRATS Delusions/Hallucinations or in the Adapted PSYRATS for Hallucinations in Other Modalities that are thematically linked to trauma (identified using an adapted version of section C of the TVAQ and reporting a score >0. 3. In the caseload of an EIP 4. Judged by the EIP care coordinator as clinically stable 5. Aged at least 18 years 6. Have the capacity to give consent at the time of recruitment. Please note individuals will not be excluded based on whether they are a voluntary or under section of the Mental Health Act (2007), but rather on their capacity to consent to participating in research. A key principle of the Mental Capacity Act (2005) is decision-specific, and many patients who are admitted to hospital under section retain the capacity to decide whether or not to take part in research and should therefore not be unfairly denied this opportunity. Clinician participants (for the interviews NET intervention evaluation): Eligible participants will be: 1. Completed Narrative Exposure Therapy Training 2. Currently working or have worked in an NHS Early Intervention for Psychosis during the trial 3. Have delivered at least one session of NET with a client in EIP 4. Be from a range of professional backgrounds, including band psychologists (band 7/8a), CBT therapists (band 7), mental health nurses and occupational therapists (band 5/6) (or professionals with equivalent experience, including those in the final year of training) within EIP.
Exclusion criteria
Exclusion criteria: Service user participants: Participants will be excluded if they: 1. Had a primary diagnosis of substance/alcohol dependence, intellectual disability or cognitive dysfunction 2. Received a trauma-focused intervention from a qualified therapist for PTSD within the past 3 months 3. Insufficient English to provide informed consent or complete assessments without help from an interpreter 4. Lack the capacity to consent Clinician participants: None specified.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcomes as of 22/05/2026: 1. Feasibility outcomes: 1.1. Recruitment: Number of eligible referrals received and willingness to consent and be randomised, recorded from the start of recruitment to the end of recruitment 1.2. Attrition: 1.2.1. Assessment retention: Number of participants who are lost to end-of-treatment assessment (4 months) and follow-up assessment (8 months) points 1.2.2. Therapy engagement: Intervention-specific data will include therapy engagement and the number of sessions attended, measured by the end of therapy, around 4 months 1.2. Acceptability of measures, assessed by non-response rates to questionnaires and items, and by the Feedback about Measures Tool completed by both groups at the three timepoints (baseline, 4 months [end of treatment] and 8-month follow-up) 1.3. Safety will be assessed through monitoring and assessing adverse events from randomisation to 8 months 2. Primary outcomes (whose feasibility is being assessed are for a future trial): the following primary outcome candidates are completed by both groups at the three timepoints (baseline, 4 months [end of treatment] and 8 months follow-up): 2.1. PTSD: Severity of PTSD and severity of complex PTSD (cPTSD): 2.1.1. PTSD measured using the Checklist for DSM-5 (PCL-5) 2.1.2. Complex PTSD symptoms measured using the International Trauma Questionnaire (ITQ) 2.2. Psychotic symptom severity measured using the psychotic symptom rating scales for voices and distressing beliefs (PSYRATS) and the Hallucinations in Other Modalities adapted PSYRATS Previous primary outcomes: 1. Feasibility outcomes: 1.1. Recruitment: Number of eligible referrals received and willingness to consent and be randomised, recorded from the start of recruitment to the end of recruitment 1.2. Attrition: 1.2.1. Assessment retention: Number of participants who are lost to end-of-treatment assessment (4 months) and follow-up assessment (8 months) points 1.2.2. Therapy engagement: Intervention-speci | — |
Secondary
| Measure | Time frame |
|---|---|
| Current key secondary outcomes as of 22/05/2026: Secondary outcomes (whose feasibility is being assessed are for a future trial): Completed by both groups at the three timepoints (baseline, 4 months [end of treatment] and 8-month follow-up) include: 1. PTSD/complex PTSD caseness (meeting diagnostic criteria according to the ITQ for PTSD and/or cPTSD) 2. Severity of disturbances in self-organization (DSO) (subscale in the ITQ) 3. Recovery from psychosis measured a service user-defined measure of recovery, Questionnaire about the Process of Recovery (QPR) 4. Dissociation measured using the Shutdown Dissociation Scale (Shut-D) 5. Paranoia measured using the revised Green et al. paranoid thought scales (R-GPTS) 6. Guilt and shame measured using the 12-item Event Related Brief Shame and Guilt Scale (ERB-SGS) 7. Emotional distress measured using the Depression Anxiety Stress Scales (DASS-21) 8. Narrative identity measured using the Awareness of Narrative Identity Questionnaire (ANIQ) Economic evaluation outcomes: 1. The EQ-5D-5L tool to measure quality of life adjusted years QALYs will be included to pilot its use for health economic analysis in a full trial, alongside the Client Service Receipt Inventory (CSRI). NET therapy group only: Feasibility of collecting outcomes to monitor the evolution of therapy (participants allocated to receive NET only): 1. Experience Sampling Method (ESM): Daily entering of data on a mobile app ( https://m-path.io/landing/) from 1 week pre (post randomisation) to 1 week post NET therapy completion. Areas covered include PTSD and CPTSD symptoms, unusual distressing experiences of psychosis, paranoia, mood, social connection, hope and context. 2. NET therapy weekly session monitoring: PTSD intrusions, unusual experiences, paranoia, hope, risk, therapeutic alliance, cultural humility, current distress and session feedback. Acceptability of collecting daily ESM data during therapy and weekly outcome monitoring will be assessed by non-respon | — |
Countries
England, United Kingdom
Contacts
Public ContactMiriam Fornells-Ambrojo
Outcome results
None listed