Introduction
Psychosis affects 0.7% of the population, causing significant personal and societal burden and poor recovery outcomes (e.g. Fineberg et al. Reference Fineberg, Haddad, Carpenter, Gannon, Sharpe, Young and Sahakian2013; Jääskeläinen et al. Reference Jääskeläinen, Juola, Hirvonen, McGrath, Saha, Isohanni and Miettunen2013). Current guidelines (e.g. NICE, 2014) recommend pharmacological and psychological interventions, but treatment effects are often modest and variable (Bighelli et al., Reference Bighelli, Salanti, Huhn, Schneider-Thoma, Krause, Reitmeir and Leucht2018; Cramer & Rosenheck, Reference Cramer and Rosenheck2006; Jauhar et al., Reference Jauhar, McKenna, Radua, Fung, Salvador and Laws2014; Wykes, Steel, Everitt, & Tarrier, Reference Wykes, Steel, Everitt and Tarrier2008). It is imperative that these outcomes are improved, particularly in relation to ‘early’ or ‘first episode psychosis’ – a crucial period when targeted support might heighten chances of recovery, prevent adverse outcomes and reduce the patient burden that may be brought about by adverse reactions to currently recommended treatments e.g. antipsychotic medication side effects.
Meta-analyses have demonstrated a robust association between trauma exposure and risk of psychosis (e.g. Pastore, de Girolamo, Tafuri, Tomasicchio, & Margari, Reference Pastore, de Girolamo, Tafuri, Tomasicchio and Margari2022; Varese et al., Reference Varese, Smeets, Drukker, Lieverse, Lataster, Viechtbauer and Bentall2012) as well as associations with more severe symptom profiles, adverse prognoses, and severe comorbidities (e.g. Alameda et al. Reference Alameda, Christy, Rodriguez, Salazar de Pablo, Thrush, Shen and Murray2021; Bailey et al. Reference Bailey, Alvarez-Jimenez, Garcia-Sanchez, Hulbert, Barlow and Bendall2018). Trauma and its psychological sequelae are particularly prevalent in people with early psychosis (Rodrigues & Anderson, Reference Rodrigues and Anderson2017). However, most trauma-focused intervention trials exclude people with psychotic symptoms (e.g. Ronconi, Shiner, & Watts, Reference Ronconi, Shiner and Watts2014). Eye Movement Desensitization and Reprocessing (EMDR) is a recommended treatment for trauma (e.g. NICE, 2018) that has been receiving growing empirical scrutiny in clients with complex mental health presentations beyond PTSD (e.g. Perlini et al., Reference Perlini, Donisi, Rossetti, Moltrasio, Bellani and Brambilla2020). Clinical trials focusing on people with life-time diagnoses of psychosis with comorbid PTSD have found that EMDR can improve PTSD and paranoid symptoms (de Bont et al., Reference de Bont, van den Berg, van der Vleugel, de Roos, de Jongh, van der Gaag and van Minnen2016; van den Berg et al., Reference van den Berg, de Bont, van der Vleugel, de Roos, de Jongh, Van Minnen and van der Gaag2015), stimulating efforts to adapt it for clients with psychosis (Phillips, Maguire, McSherry, & Pinto, Reference Phillips, Maguire, McSherry and Pinto2021). As existing randomized controlled trials as so far only focused on patients with comorbid PTSD diagnoses, research is therefore needed to establish whether EMDR is effective at ameliorating symptoms in patients with early psychosis who have significant lifetime trauma and active or ongoing psychotic symptoms, whether or not they present with comorbid PTSD.
Building on work by others (e.g. van den Berg, van der Vleugel, Staring, De Bont, & De Jongh, Reference van den Berg, van der Vleugel, Staring, De Bont and De Jongh2013), we conducted a feasibility trial of an ‘EMDR for psychosis’ (EMDRp) intervention developed by clinicians in Lancashire (UK) to address the needs of clients with early psychosis, focusing on uncertainties that must be addressed ahead of large-scale trials to evaluate the efficacy and cost effectiveness of this intervention.
Methods
The Trial protocol and feasibility criteria were pre-specified (ISRCTN 16262847; Varese et al., Reference Varese, Sellwood, Aseem, Awenat, Bird, Bhutani and Bentall2021). The study received approval from a National Health Service (NHS) Ethics committee and the NHS Health Research Authority (HRA). Research and treatment delivery procedures were adapted over the course of the trial in response to issues brought about by the COVID-19 pandemic as briefly described below, and in more detail in Supplementary Material 1 in accordance with the CONSERVE (CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstances) framework (Orkin et al., Reference Orkin, Gill, Ghersi, Campbell, Sugarman and Emsley2021).
Design
A single-blind, parallel group RCT design with random allocation to two arms: 16 sessions of EMDRp over 6 months alongside Treatment As Usual (EMDRp + TAU) v. TAU alone. Participants in both arms were assessed at baseline, 6- and 12-months post-randomization.
Procedure and participants
Participants were recruited from four Early Intervention (EI) services in Lancashire and South Cumbria (UK). Staff identified and approached prospective participants, and the research team obtained informed consent from those interested. Participants were screened using the Positive and Negative Syndrome Scale (PANSS; Kay, Fiszbein, & Opler, Reference Kay, Fiszbein and Opler1987) and a modified version of the Trauma Screening Questionnaire (TSQ), a brief 10-item screener for trauma and post-traumatic symptoms used in previous trials of trauma-focused therapy for people with psychosis (de Bont et al., Reference de Bont, van den Berg, van der Vleugel, de Roos, de Jongh, van der Gaag and van Minnen2015). Follow-up assessments were conducted by research assistants (RAs) blind to treatment allocation. Early in the trial, assessments took place in person either at the participant's home or at local NHS facilities but during restrictions due to the COVID-19 pandemic, were conducted over the telephone or via video calls. When restrictions eased, participants were given a choice of remote or face-to-face assessments.
Inclusion criteria were: (a) aged at least 16 years; (b) capacity and willingness to provide informed consent; (c) ICD-10 diagnosis of schizophrenia-spectrum disorders or meeting local EI psychosis support criteria, operationally defined using the PANSS and/or the psychosis transition criteria of the Comprehensive Assessment of At-Risk Mental States (Yung et al., Reference Yung, Yung, Pan Yuen, McGorry, Phillips, Kelly and Buckby2005); (d) having recent contact with EI services and an assigned care-coordinator; (e) being within 3 years from psychosis onset; judged by their responsible clinician as being clinically stable (i.e. no antipsychotic treatment change in the previous month, not actively suicidal in the previous 2 months); (f) reporting at least 1 traumatic event on the TSQ and at least subsyndromal post-traumatic symptom in the previous week (scores >0 on TSQ items 3.1 to 3.5); (g) meeting criterion level of positive symptoms severity (score ⩾3 on PANSS P1, P3, P5, or P6)
Exclusion criteria included: (a) primary diagnosis of substance/alcohol dependence or evidence of severe intellectual disability or cognitive dysfunction (as provided by the clinical team); (b) requiring an interpreter; (c) receipt of EMDR from a qualified psychological therapist in accordance with NICE guidance (NICE, 2018) in the previous 12 months.
Randomization
Participants Were randomly allocated on a 1:1 ratio to receive either TAU or EMDRp + TAU using a pseudo-random list with random permuted blocks of varying sizes hosted at an online randomization service (www.sealedenvelope.com). The allocation sequence was concealed from the research team, and RAs conducting the follow-up assessments were blind to treatment allocation.
EMDRp
The Emdrp intervention was consistent with the standard EMDR protocol (Shapiro, Reference Shapiro2001), with phases adapted or expanded to address the needs of clients with psychosis, based on previous work by others (van den Berg et al., Reference van den Berg, van der Vleugel, Staring, De Bont and De Jongh2013) and pilot work by the research team (Ward-Brown et al., Reference Ward-Brown, Keane, Bhutani, Malkin, Sellwood and Varese2018). For further details of the protocol and adaptations, see Varese et al. (Reference Varese, Sellwood, Aseem, Awenat, Bird, Bhutani and Bentall2021). The manualized intervention allowed up to 16 sessions over 6 months and was delivered by three accredited EMDR therapists who received an initial 3-day training workshop on the protocol and attended fortnightly group supervision led by two EMDR consultants. Sessions were recorded for supervision purposes. Treatment fidelity was evaluated in a subsample of recordings using the EMDR Fidelity Rating Scale (EFRS; Korn, Maxfield, Smyth, & Stickgold, Reference Korn, Maxfield, Smyth and Stickgold2017), rated by two EMDR consultants who developed the study intervention. EMDRp sessions were initially delivered in person at local NHS facilities. Following the onset of the pandemic, treatment was delivered remotely via video calls. When restrictions eased, participants were given a choice on whether to attend therapy in person or remotely.
TAU
Participants Allocated to the TAU arm received treatment in line with national clinical guidelines (NICE, 2014) from their EI care team. Case notes reviews were conducted to monitor the care received by these participants and recorded what proportion of TAU participants received EMDR or other individually prescribed psychological interventions during the trial.
Assessments and outcomes
Feasibility outcomes
There were four feasibility outcomes: (a) recruitment of EI participants into a trial of EMDRp; (b) levels of trial retention; (c) the therapists' ability to deliver EMDRp in EI settings with sufficient fidelity to the treatment protocol; and (c) levels of engagement of EI clients in EMDRp. These were operationalized a priori using a three-level ‘traffic light’ approach (Avery et al., Reference Avery, Williamson, Gamble, Francischetto, Metcalfe, Davidson and Blazeby2017) with thresholds to indicate, for each outcome, whether a future larger-scale trial would be feasible using the current design (‘green’), whether the trial would be feasible if modifications were applied (‘amber’), or whether there are unresolvable issues that would jeopardize a future trial (‘red’). The outcomes and thresholds were approved by an independent trial steering committee, and are reported in full in Supplementary Material 2. In brief, a future larger-scale trial was regarded as feasible (‘green’) if: (a) three or more participants were recruited and randomized per month; (b) at least 70% of participant were retained at post-randomization assessments; (c) at least 70% of EMDRp + TAU participants attended 8 out of 16 planned EMDRp sessions; and (d) over 80% of rated therapy recordings received at least acceptable EFRS ratings.
Rater-blinded and self-report measures
We gathered descriptive clinical and demographic information alongside the Trauma and Life Events checklist (TALE; Carr, Hardy, & Fornells-Ambrojo, Reference Carr, Hardy and Fornells-Ambrojo2018), a 20-item tool to screen for exposure to potentially traumatic events. To examine the ‘promise of efficacy’ of EMDRp, several interview and self-report measures were administered at both baseline and post-randomization assessments. All assessors received training and ongoing supervision in the administration and scoring of all rater-blind clinical interviews and demonstrated excellent reliability against ratings produced by expert raters. Data collected at the three assessment points included:
The PANSS, a widely used scale for rating semi-structured interviews assessing the presence and severity of 30 psychotic and other symptoms of psychopathology, each scored on a 7-point rating scale (1 = symptoms absent; 7 = extreme symptom severity). While the PANSS total score is most frequently reported in RCTs, recent factor analytic studies have uncovered a more complex latent structure corresponding to positive symptoms, negative symptoms, excitative symptoms, affective symptoms, and symptoms of cognitive disorganization (Shafer & Dazzi, Reference Shafer and Dazzi2019). Here, we report analyses focused on PANSS total scores; a more detailed breakdown of PANSS subscales can in be found in Supplementary Material 3.
The Psychotic Symptom Rating Scales (PSYRATS; Haddock, McCarron, Tarrier, & Faragher, Reference Haddock, McCarron, Tarrier and Faragher1999), a widely used semi-structured interview comprising 17 items assessing dimensional features of auditory hallucinations (PSYRATS-AH; 11 items) and delusions (PSYRATS-D; 6 items). Items are scored on a five-point ordinal scale (0 = least severe; 4 = most severe). Here we report analyses based on PSYRATS-AH and PSYRATS-D total scores. A more detailed breakdown of PSYRATS-AH and PSYRATS-D scores informed by recent factor analytic studies (Woodward et al., Reference Woodward, Jung, Hwang, Yin, Taylor, Menon and Erickson2014) can in be found in Supplementary Material 3.
The Personal and Social Performance Scale (PSP; Morosini, Magliano, Brambilla, Ugolini, & Pioli, Reference Morosini, Magliano, Brambilla, Ugolini and Pioli2000), an interviewer-rated measure of functioning across four domains: socially useful activities, personal and social relationships, self-care and disturbing/aggressive behavior. Each domain is rated on a six-point scale measuring the level of functioning (absent = 1; very severe = 6) and the scores are then pooled on a 10-point interval scale to provide an overall score out of 100.
The Questionnaire about the Process of Recovery (QPR; Neil et al., Reference Neil, Kilbride, Pitt, Nothard, Welford, Sellwood and Morrison2009) is a 22-item self-report measure assessing intrapersonal and interpersonal features of personal recovery, developed in collaboration with people with lived experience of psychosis. Items are scored on a 5-point scale (0 = disagree strongly; 4 = strongly agree), with higher scores being indicative of greater perceived personal recovery. Used as an outcome measure in several RCTs of psychological therapies for psychosis, the QPR has also been endorsed as a routine outcome measure in EI services in England (NHSE, 2016).
The Green et al., Paranoid Thoughts Scale (GPTS; Green et al., Reference Green, Freeman, Kuipers, Bebbington, Fowler, Dunn and Garety2008), a 32-item self-report measure assessing paranoid thinking. Each GPTS item is scored on a 5-point Likert scale (1 = not at all; 5 = totally).
The PTSD Checklist for DSM-5 (PCL-5; Weathers et al., Reference Weathers, Litz, Keane, Palmieri, Marx and Schnurr2013) is a 20-item self-report questionnaire based on the DSM-5 criteria for PTSD. Items are scored using a 5-point scale (0 = not at all; 4 = extremely). In addition to providing a total PTSD severity score (range 0–80), the PCL-5 can be used to identify participants presenting clinically significant post-traumatic symptoms i.e. PTSD severity scores >31, which are indicative of possible PTSD ‘caseness’.
The International Trauma Questionnaire (ITQ; Cloitre et al., Reference Cloitre, Shevlin, Brewin, Bisson, Roberts, Maercker and Hyland2018), an 18-item self-report measure assessing post-traumatic symptoms over the previous month consistent with ICD-11 diagnostic criteria for PTSD and Complex PTSD (CPTSD). Items are scored on 5-point scales (0 = not at all; 4 = extremely). The questionnaire provides a dimensional PTSD score (six items measuring PTSD symptoms) and a dimensional ‘disturbances in self-organization’ (DSO) score, reflecting the additional symptoms that characterize CPTSD. A diagnostic algorithm can be applied to ITQ scores to identify individuals with probable ICD-11 diagnosis of PTSD or CPTSD (Cloitre et al., Reference Cloitre, Shevlin, Brewin, Bisson, Roberts, Maercker and Hyland2018).
The Dissociative Experiences Scale-II (DES-II; Carlson & Putnam, Reference Carlson and Putnam1993), a widely used self-report measure of dissociation symptoms and experiences. Each item is rated on a 0–100% scale, reflecting the estimated amount of time a participant experiences a dissociative event(s) in their daily life. As one of the DES-II items reflects experiences that are common in people with psychosis (hearing voices), the mean DES-II score used in the present analyses was estimated using the remaining 27 items.
The EQ-5D-5L (Janssen et al., Reference Janssen, Pickard, Golicki, Gudex, Niewada, Scalone and Busschbach2013) is a self-report measure of overall health across five dimensions: physical mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale also includes a visual analog scale (EQ-VAS) where participants rate their perceived overall health from 0 (the worst health imaginable) to 100 (the best health imaginable). While the EQ-5D-5L is used predominantly for health economics analyses and was administered in this trial to evaluate the viability of collecting this information alongside service use data in a future larger-scale trial, the EQ-VAS was used as a quantitative health outcome measure reflecting the respondent's own judgment.
The General Anxiety Disorder scale (GAD-7; Spitzer, Kroenke, Williams, & Löwe, Reference Spitzer, Kroenke, Williams and Löwe2006), a frequently used self-report measure of anxiety, comprises seven items rated on a 4-point scale (0 = not at all; 3 = nearly every day).
The Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, Reference Kroenke, Spitzer and Williams2001), a nine-item self-report measures of low mood and depression frequently used alongside the GAD-7 and each item is scored similarly.
Adverse events
In line with Good Clinical Practice and the UK Policy Framework for Health and Social Care Research (HRA, 2023), we monitored all adverse events (AEs) experienced by participants over the course of the trial. HRA guidance was followed to classify and report serious adverse events (SAEs; i.e. resulting in death; life-threatening; requiring new or prolonged hospitalizations; resulting in persistent or significant disability/incapacity). All AEs and SAEs were assessed for relatedness to the trial by a clinically qualified senior researcher and the chair of the independent trial steering committee.
Data analysis
Descriptive statistics were used to summarize the flow of participants across the trial, in accordance with CONSORT fields for feasibility trials (Eldridge et al., Reference Eldridge, Chan, Campbell, Bond, Hopewell, Thabane and Lancaster2016) and to compare observed data against a-priori feasibility thresholds (Varese et al., Reference Varese, Sellwood, Aseem, Awenat, Bird, Bhutani and Bentall2021). As per protocol, no formal hypothesis testing was carried out to compare the two trial arms for clinical effectiveness. Summary statistics (Mean, SD, % of missing data) were tabulated for each measure by trial arm for each time point (baseline, 6-month follow-up and 12-month-follow up). In line with methodological/statistical proposals for reconciling recommendations to refrain from conventional inferential testing (via estimation of treatment effects with 95% CIs) and the benefits of providing evidence in support of the ‘promise of efficacy’ of novel interventions to inform future larger-scale evaluations (Lee, Whitehead, Jacques, & Julious, Reference Lee, Whitehead, Jacques and Julious2014), we calculated unadjusted mean differences and their associated 80% CI at 6 months and 12 months as well as their corresponding standardized mean difference (Cohen's d).
Results
The Consort diagram is shown in Fig. 1. Between June 2019 and April 2021 (with a suspension of recruitment between March and July 2020 because of COVID-19 restrictions), 108 service users were referred. We assessed for eligibility 69 individuals, randomizing 60 to either receiving EMDRp + TAU (n = 31) or TAU only (n = 29). Six-month follow-ups were completed between January 2020 and January 2022, and the 12-month follow-up assessments between July 2020 and May 2022.
Figure 1. CONSORT diagram.
Feasibility outcomes
Recruitment and retention
We recruited 100% of our target sample of 60, averaging three randomizations in each month of active recruitment (green progression zone). Fifty participants (83%) completed at least one assessment follow-up (green); 45 (75%) completed 6-month assessments (green) and 42 (70.0%) completed 12-month assessments (green). Trial retention was comparable across arms, with 83.9 and 82.7% of participants completing at least one post-randomization assessment in the EMDRp + TAU and TAU groups respectively. Retention in the two arms was similar at the 6-month (80.6% v. 69.0%; χ2 = 1.09, p = 0.296) and 12-month follow-ups (71.0% v. 69.0%; χ2 = 0.02, p = 0.865) but noticeably lower for the 34 participants recruited prior to the onset of the COVID-19 pandemic (69.7% at 6-month and 63.6% at 12-month) compared to 27 recruited following the implementation of COVID-related procedural adaptations (81.5% at 6-months and 77.8% at 12-months).
Therapy engagement
Following the onset of the pandemic, treatment had to be suspended until procedures could be adapted to enable the remote delivery of the intervention, and until the necessary research governance approvals to re-initiate the trial had been obtained. Ten participants in the EMDRp + TAU arm receiving treatment in March 2020, had their treatment suspended until July 2020. Eight subsequently resumed therapy remotely, and we extended the therapy window for affected participants to enable the delivery of up to 16 sessions of EMDRp as per protocol and in light of ethical concerns related to the sudden withdrawal of therapy. Twenty-three EMDRp + TAU participants (74.2%) received eight or more sessions of EMDRp (green progression zone); four did not attend any. The remainder dropped out before session 8 due to withdrawal from the trial (two participants), engagement difficulties with both EI services and the trial (4) and deciding to prioritize other psychological therapies offered by EI services as per TAU (2). Participants received on average 10.8 EMDRp sessions (range 0–16; median = 12), with those attending at least 1 session receiving a mean of 12.4 sessions (range 2–16; median = 16). Ten participants attended therapy sessions entirely face-to-face, eight entirely remotely, and nine a combination of remote and face-to-face sessions.
EMDR fidelity
All therapists demonstrated adequate or very good EFRS scores across all 37 sessions (11% of 334 sessions delivered); 96.7% of rated sessions had adequate ratings or higher (green progression zone).
Rater-blinded and self-report measures
Baseline characteristics are summarized in Table 1. Further detail on participants' trauma history are provided in Table 2, indicating that virtually every participant in the trial reported repeated (98% of the sample) and multiple (100%) exposures to the traumatic events assessed by the TALE, with high levels of perceived impact of these events on their ongoing difficulties (M = 8.10, s.d. = 1.55 out of a possible highest score of 10).
Table 1. Baseline demographic and clinical characteristics of the trial sample
a Calculated using the Defined Daily Dose (DDD) method (Leucht, Samara, Heres, & Davis, Reference Leucht, Samara, Heres and Davis2016).
Table 2. TALE data for the 60 randomized participants
There were 15 blind breaks (randomization assignments revealed to assessors) over the follow-up period. Except for one case, it was possible to re-allocate participants to a different blind assessor for the completion of the assessments. When this was not possible, the PANSS, PSYRATS, and PSP were rated by a blind assessor based on a recording of the assessment interview. Descriptive statistics of the measures collected at the three assessment points are summarized in Table 3, with summary statistics for each measure tabulated by trial arm for each time point.
Table 3. Mental health outcome data at baseline and follow-up assessments
Based on the 80% CIs, at the 6-month follow-up assessment there was potential indication of treatment effect in favour of the EMDRp + TAU arm on measures of total psychotic symptom severity (PANSS total score), subjective recovery from psychosis (QPR), post-traumatic symptoms (PCL-5 total score and the ITQ PTSD) symptoms of anxiety and depression (GAD-7 and PHQ-9) and self-reported general health status (EQ-VAS). At 12-months, evidence of promise of the intervention remained for both PTSD symptoms and general health status, whereas signals of efficacy for other outcomes were more modest compared to 6-month follow- up. Inspection of scores indicates that this was likely not due to exacerbation of symptoms in the EMDRp + TAU arm (i.e. treatment gains were maintained) but rather improvements in the TAU group between the 6- and 12-month follow-up assessment. We calculated odds ratios with 80% CIs reflecting the odds of presenting clinically significant post-traumatic symptoms on the PCL-5 (scores >31, indicative of possible DSM-5 PTSD diagnosis) and the ITQ (meeting the ICD-11 diagnostic criteria for PTSD and CPTSD) in the intervention arm compared to TAU (see Table 4). Being allocated to the EMDRp + TAU arm was related to lower odds of meeting criteria for PTSD on the ITQ and PCL-5 at both 6-months and 12-months and with lower odds of meeting criteria for CPTSD at the 12-months.
Table 4. Probable presence of DSM-5 and ICD-11 post-traumatic stress diagnoses at the three assessment points
Adverse events
We recorded 60 AEs; 13 were rated as SAEs (4 in the EMDRp + TAU arm, 8 in TAU and 1 pre- randomization). No SAEs were related to the trial procedures or intervention. More non-serious events were recorded in the EMDRp + TAU arm compared to TAU (33 v. 14), mostly consisting in expected adverse reactions (i.e. transient and mild exacerbations of symptoms coinciding with the onset of trauma memory reprocessing work).
TAU Psychological interventions
Case note reviews indicated that many TAU participants accessed a range of psychological therapies over the trial follow-up period. By the 12-month follow-up assessment, 66% of TAU participants had accessed or already completed a psychological therapy offered by EI or other NHS services, including. CBT (16 participants), EMDR (two participants) and Dialectical Behavior Therapy (one participant). The access to psychological treatments by the TAU only group should be considered when interpreting the differences in clinical outcomes above.
Discussion
This is the first randomized controlled trial to evaluate the feasibility of a trial of trauma-focused therapy for early psychosis clients. We found it is possible to recruit and retain a sufficient number of service users in UK EI settings to enable a larger scale evaluation of EMDRp. Consistent with previous research with people with first episode psychosis (e.g. Buswell, Haime, Lloyd-Evans, & Billings, Reference Buswell, Haime, Lloyd-Evans and Billings2021; Vila-Badia et al., Reference Vila-Badia, Butjosa, Del Cacho, Serra-Arumí, Esteban-Sanjusto, Ochoa and Usall2021), all participants reported multiple and repeated exposures to traumatic events, with particularly high levels of perceived impact on ongoing difficulties of trial participants. Although our inclusion criteria were purposely broad to include participants with subsyndromal post-traumatic symptoms, many met the criteria for probable PTSD and/or Complex PTSD, which is again congruent with past research (e.g. Panayi et al., Reference Panayi, Berry, Sellwood, Campodonico, Bentall and Varese2022; Rodrigues & Anderson, Reference Rodrigues and Anderson2017). Future evaluations of trauma therapies in patients with psychosis may benefit from using similarly broad inclusion criteria.
We found that the EMDRp intervention can be delivered with high levels of fidelity, and that it is possible to engage EI clients in this intervention using both remote and face-to-face means. Although some clients struggled to engage, this was expected given that avoidance is a common response to trauma, and given that the intervention involved exposure to trauma-related memories and images. Our levels of treatment drop-out were similar to past trials of trauma-focused therapies (Lewis, Roberts, Gibson, & Bisson, Reference Lewis, Roberts, Gibson and Bisson2020), suggesting that clients with early psychosis may not find this treatment any less tolerable than other patient groups.
While the safety of the therapy can only be established via a larger-scale trial, our data suggest that EMDRp has a promising safety profile, as no SAEs were related to the intervention or trial procedures. The higher number of non-serious AEs observed in the EMDRp + TAU group may be a by-product of the more intensive scrutiny of participant allocated to this trial arm who had regular contact with EMDR therapists. As in previous trials (e.g. Lewis et al., Reference Lewis, Roberts, Gibson and Bisson2020), transient and mild exacerbations of distress in response to trauma memory reprocessing work typically did not require a change in care provision and were usually resolved by the next therapy session. Future trials of trauma-focused therapies in this client group may nonetheless benefit from more sensitive assessments of potential symptom exacerbation during therapy, e.g., via analysis of brief questionnaires collected at each therapy session (Burger et al., Reference Burger, Hardy, van der Linden, van Zelst, de Bont, van der Vleugel and van den Berg2023).
The findings also support the ‘promise of efficacy’ of EMDRp as a potentially valuable intervention for EI service users with a trauma history. At the end of treatment, EMDRp showed promise of benefit on a range of outcomes frequently considered in trials of psychological therapy for early psychosis, including overall psychotic symptom severity and subjective recovery from psychosis. Whilst other psychosis-related outcomes showed no robust promise of efficacy in this small trial, promising findings were observed in relation to improved affective symptoms, general health status and post-traumatic symptoms. As often seen in psychotherapy trials, between-group differences at the 12-month follow-up were less pronounced but continued to show potential benefit on post-traumatic symptoms and general health status.
The findings from this study indicate the feasibility and desirability of conducting a multi-center trial to evaluate the efficacy of EMDRp for patients suffering from early psychosis. Whilst this feasibility study reports preliminary evidence that EMDRp can be a valuable addition to usual care provided by EI services, our findings should be interpreted with caution. The trial followed a pre-registered protocol and prespecified thresholds to evaluate the feasibility of a future multi-center evaluation of EMDRp. However, the delivery of the trial was severely affected by the COVID-19 pandemic, resulting in several procedural adaptations which are here reported transparently in line with CONSERVE guidelines. Of note, the unexpected circumstances of the COVID-19 pandemic allowed us to demonstrate that it is possible to safely deliver trauma-focused therapy in clients with complex/severe mental health problems using remote means, therefore adding to emerging evidence base on the acceptability and efficacy of ‘teletherapy’ for severe mental health problems and survivors of complex trauma. The trial was single-center study, and therefore findings may not generalize to other EI settings in the UK or other countries. As there was no active treatment control arm, the study cannot clarify the relative effectiveness of EMDRp compared to other psychosocial intervention for psychosis. The signals of efficacy observed across varied mental health outcomes are nonetheless encouraging, especially considering the high levels of uptake of psychological therapies in participants allocated to the TAU arm. Future trials evaluating the efficacy of EMDRp may therefore benefit from procedural and analytic strategies to account for the high levels of uptake of psychological interventions in TAU provided by EI services. Furthermore, mechanistic research informed by the growing evidence on the potential mediators of the trauma-psychosis relationship (Williams, Bucci, Berry, & Varese, Reference Williams, Bucci, Berry and Varese2018) and the neural and psychological mechanisms of action of EMDR in other patient groups (e.g. Landin-Romero, Moreno-Alcazar, Pagani, & Amann, Reference Landin-Romero, Moreno-Alcazar, Pagani and Amann2018) may be integrated in future efficacy trials to clarify how EMRPp may bring about benefit on valued outcomes for early psychosis clients, and inform subsequent measures to maximize the effectiveness of this treatment approach for early psychosis.
Supplementary material
The supplementary material for this article can be found at https://doi.org/10.1017/S0033291723002532.
Acknowledgements
The EASE Feasibility trial team thanks the Early Intervention staff at Lancashire and South Cumbria NHS Foundation Trust who referred to and supported the delivery of the study, and the service users who took part in this trial. We are grateful for the support of the independent chair of our Trial Steering Committee (TSC), Professor Andrew Gumley, and the other members of the TSC. We also thank the members of the Lived Experience Advisory Panel (LEAP) of the Manchester Complex Trauma and Resilience Research Unit for their advice and guidance, and Dr Kate Allsopp, Dr Kim Cartwright and Ms Alice Newton for the coordination of the Patient and Public Involvement consultations conducted with LEAP over the course of the study.
Funding statement
This project is funded by the National Institute for Health and Care Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0317-20037). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
Competing interests
Co-authors Logie, Keane, and Malkin are involved in the delivery of EMDR training workshops and events. All other co-authors have no conflicts of interest to declare.
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