NHS service users who meet at-risk mental state (ARMS) criteria, operationally defined using the Comprehensive Assessment of At-Risk Mental States (CAARMS) interview Mental and Behavioural Disorders
Conditions
Interventions
Participants will be randomised using a ratio of 1:1:1 to one of three different groups including:
1. Eye Movement and Desensitization Reprocessing (EMDR) plus treatment as usual (TAU) - EMDR involve
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for the feasibility randomised controlled trial (RCT): 1. 16 years of age or older 2. Meeting at-risk mental state (ARMS) for psychosis criteria as defined by the Comprehensive Assessment of At-Risk Mental States (CAARMS) 3. Capacity and willingness to provide informed consent 4. Reported exposure to at least one potentially traumatic life event, as assessed by the Trauma and Life Events checklist (TALE) Inclusion criteria for the nested qualitative study with RCT participants: 1. Participated in the feasibility RCT 2. Capacity and willingness to provide informed consent Inclusion criteria for nested qualitative study with NHS professional stakeholders: 1. Being a RESTART trial therapist and/or an NHS professional who worked in services involved in the RESTART feasibility RCT 2. Capacity and willingness to provide informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria for a feasibility randomised controlled trial (RCT): 1. Under 16 years of age 2. Non-English speaking or requiring an interpreter for the intervention (the assessment battery at present can only be delivered in English) 3. Evidence of recent or past transition from at-risk mental state (ARMS) for psychosis status to first episode psychosis (FEP), operationally defined as meeting Comprehensive Assessment of At-Risk Mental States (CAARMS) transition criteria (i.e., history of a treated or untreated psychotic episode of one week’s duration or longer) and/or previous or current treatment with antipsychotics at a dose of over 5 mg of haloperidol or equivalent for over 3 weeks 4. Judged by the assigned care coordinator/responsible clinician and the research team as not being sufficiently clinically stable to engage safely in a clinical trial of trauma-focused therapy (e.g., acutely suicidal and suicide attempt in the previous two months; in a current mental health crisis; not in stable housing) Exclusion criteria for nested qualitative study RCT participants: 1. Unwilling or unable to provide consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of a future definitive trial: 1. The feasibility of trial recruitment and retention and EMDR and TF-CBT engagement to inform a future definitive trial, by establishing the number of participants identified, approached, consented and randomised, and the percentage of participants retained at the 9-month follow-up, and the number of sessions attended by participants allocated to the EMDR+TAU and TF-CBT+TAU arms of the trial, respectively. Data pertaining to recruitment, retention and engagement with the interventions considered in the trial will be gathered via the collection of detailed information on the participants' flow in the RCT, aligned with all relevant fields of the CONSORT framework for feasibility studies as well as information on the number of sessions attended by each individual participant allocated to the EMDR+TAU and TF-CBT+TAU arms of the trial. 2. Sample size calculations for a future larger scale trial informed by examining the 'promise of efficacy' of EMDR and TF-CBT on important quantitative clinical outcomes in this client group at baseline and the 9-month follow-up and the variance of these outcomes. 3. The feasibility of extracting, via case note reviews, information on psychological interventions and mental health support received as part of usual NHS care (i.e. treatment as usual [TAU]), and information suggestive of a possible transition to first episode psychosis up to 12 months after participant allocation to treatment. 4. The acceptability of the trauma-focussed therapies (i.e. EMDR and TF-CBT) and trial procedures (including randomisation and intended outcome measures to be considered in a future larger scale trial and measures that will enable the possible mechanisms of actions of trauma therapies in people with an At Risk Mental State (ARMS) in a definitive trial) to trial participants via the analysis of transcripts of qualitative interviews with trial participants collected following the 9-month follow-up assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| The outcome measures that will be evaluated within this feasibility study have been adapted from previous studies by the research team, including clinical trials of trauma-focused therapy in people with first-episode psychosis and cohort studies examining the impact of trauma in people with an At Risk Mental State (ARMS), and are as follows: Trauma symptom measures, completed at baseline and 9 months post-baseline: 1. Trauma, measured using the International Trauma Questionnaire 2. Post-Traumatic Stress Checklist for DSM-5 3. Dissociative Subtype of PTSD Scale Process of recovery measures, completed at baseline and 9 months post-baseline: 1. Questionnaire about the Process of Recovery Other symptom measures, completed at baseline and 9 months post-baseline: 1. General Anxiety Disorder Scale (7-item version) Health-related quality of life/health economic measures, completed at baseline and 9 months post-baseline: 1. EuroQoL 5-Dimension Level (EQ-5D-5L) 2. Adapted version of the Economic Patient Questionnaire Mechanisms of action of trauma-focussed therapy measures, completed at baseline and 9 months post-baseline: 1. Trauma Memory Questionnaire 2. Brief Post-Traumatic Cognitions Inventory 3. Metacognitions Questionnaire for Post-Traumatic Stress 4. Cognitive Attentional Syndrome Questionnaire 5. Post-Traumatic Growth Inventory Short-Form 6. Expectations of Therapy Questionnaire (developed by lived experience consultants in the research team) to measure/capture common concerns that trauma survivors may have about engaging in trauma focussed interventions and that may have relevance to their individual likelihood of engaging versus discontinuing the interventions offered as part of the trial. With participants' consent, participants will be audio-recorded while completing this measure and asked to elaborate on their answers using techniques/prompts drawn from 'Cognitive Interviewing' methods, to enable an embedded validation of this scale within this trial and to | — |
Countries
England, United Kingdom
Contacts
Public ContactKim Cartwright
Outcome results
None listed