Effects of a novel, brief psychological therapy (Managing Unusual Sensory Experiences) for hallucinations in first episode psychosis (MUSE FEP): Findings from an exploratory randomised controlled trial.

Hallucinations are a common feature of psychosis, yet access to effective psychological treatment is limited. The Managing Unusual Sensory Experiences for First-Episode-Psychosis (MUSE-FEP) trial aimed to establish the feasibility and acceptability of a brief, hallucination-specific, digitally provided treatment, delivered by a non-specialist workforce for people with psychosis. MUSE uses psychoeducation about the causal mechanisms of hallucinations and tailored interventions to help a person understand and manage their experiences. We undertook a two-site, single-blind (rater) Randomised Controlled Trial and recruited 82 participants who were allocated 1:1 to MUSE and treatment as usual (TAU) (n = 40) or TAU alone (n = 42). Participants completed assessments before and after treatment (2 months), and at follow up (3-4 months). Information on recruitment rates, adherence, and completion of outcome assessments was collected. Analyses focussed on feasibility outcomes and initial estimates of intervention effects to inform a future trial. The trial is registered with the ISRCTN registry 16793301. Criteria for the feasibility of trial methodology and intervention delivery were met. The trial exceeded the recruitment target, had high retention rates (87.8%) at end of treatment, and at follow up (86.6%), with good acceptability of treatment. There were 3 serious adverse events in the therapy group, and 5 in the TAU group. Improvements were evident in both groups at the end of treatment and follow up, with a particular benefit in perceived recovery in the MUSE group. We showed it was feasible to increase access to psychological intervention but a definitive trial requires further changes to the trial design or treatment.

Use of a targeted, computer/web-based guided self-help psychoeducation toolkit for distressing hallucinations (MUSE) in people with an at-risk mental state for psychosis: protocol for a randomised controlled feasibility trial.

INTRODUCTION: Individuals who access at-risk mental state (ARMS) services often have unusual sensory experiences and levels of distress that lead them to seek help. The Managing Unusual Sensory Experiences (MUSE) treatment is a brief symptom targeted intervention that draws on psychological explanations to help account for unusual experiences. Practitioners use formulation and behavioural experiments to support individuals to make sense of their experiences and enhance coping strategies. The primary objective of this feasibility trial is to resolve key uncertainties before a definitive trial and inform parameters of a future fully powered trial. METHODS AND ANALYSIS: 88 participants aged 14-35 accepted into ARMS services, experiencing hallucinations/unusual sensory experiences which are considered by the patient to be a key target problem will be recruited from UK National Health Service (NHS) sites and randomised using 1:1 allocation (stratified by site, gender, and age) to either 6-8 sessions of MUSE or time-matched treatment as usual. Participants and therapists will be unblinded, research assessors are blinded. Blinded assessment will occur at baseline, 12 weeks and 20 weeks postrandomisation. Data will be reported in line with Consolidated Standards of Reporting Trials. Primary trial outcomes are feasibility outcomes, primary participant outcomes are functioning and hallucinations. Additional analysis will investigate potential psychological mechanisms and secondary mental well-being outcomes. Trial progression criteria follows signal of efficacy and uses an analytical framework with a traffic-light system to determine viability of a future trial. Subsequent analysis of the NHS England Mental Health Services Data Set 3 years postrandomisation will assess long-term transition to psychosis. ETHICS AND DISSEMINATION: This trial has received Research Ethics Committee approval (Newcastle North Tyneside 1 REC; 23/NE/0032). Participants provide written informed consent; young people provide assent with parental consent. Dissemination will be to ARMS Services, participants, public and patient forums, peer-reviewed publications and conferences. TRIAL REGISTRATION NUMBER: ISRCTN58558617.

The Oxford Agoraphobic Avoidance Scale.

BACKGROUND: Agoraphobic avoidance of everyday situations is a common feature in many mental health disorders. Avoidance can be due to a variety of fears, including concerns about negative social evaluation, panicking, and harm from others. The result is inactivity and isolation. Behavioural avoidance tasks (BATs) provide an objective assessment of avoidance and in situ anxiety but are challenging to administer and lack standardisation. Our aim was to draw on the principles of BATs to develop a self-report measure of agoraphobia symptoms. METHOD: The scale was developed with 194 patients with agoraphobia in the context of psychosis, 427 individuals in the general population with high levels of agoraphobia, and 1094 individuals with low levels of agoraphobia. Factor analysis, item response theory, and receiver operating characteristic analyses were used. Validity was assessed against a BAT, actigraphy data, and an existing agoraphobia measure. Test-retest reliability was assessed with 264 participants. RESULTS: An eight-item questionnaire with avoidance and distress response scales was developed. The avoidance and distress scales each had an excellent model fit and reliably assessed agoraphobic symptoms across the severity spectrum. All items were highly discriminative (avoidance: a = 1.24-5.43; distress: a = 1.60-5.48), indicating that small increases in agoraphobic symptoms led to a high probability of item endorsement. The scale demonstrated good internal reliability, test-retest reliability, and validity. CONCLUSIONS: The Oxford Agoraphobic Avoidance Scale has excellent psychometric properties. Clinical cut-offs and score ranges are provided. This precise assessment tool may help focus attention on the clinically important problem of agoraphobic avoidance.

Prevalence of multisensory hallucinations in people at risk of transition to psychosis.

Hallucinations can occur in single or multiple sensory modalities. Greater attention has been paid to single sensory experiences with a comparative neglect of hallucinations that occur across two or more sensory modalities (multisensory hallucinations). This study explored how common these experiences were in people at risk of transition to psychosis (n=105) and considered whether a greater number of hallucinatory experiences increased delusional ideation and reduced functioning, both of which are associated with a greater risk of transition to psychosis. Participants reported a range of unusual sensory experiences, with two or three being common. However, when a strict definition of hallucinations was applied, in which the experience has the quality of a real perception and in which the person believes them to be real experiences, then multisensory experiences were rare and when reported, single sensory hallucinations in the auditory domain were most common. The number of unusual sensory experiences or hallucinations was not significantly associated with greater delusional ideation or poorer functioning. Theoretical and clinical implications are discussed.

What is the frequency and nature of visual hallucinations in non-clinical participants?

OBJECTIVES: There is a paucity of psychological treatments for visual hallucinations (VH). A key aspect in the psychological treatment of hallucination-related distress is normalisation to explain that these experiences are commonplace and can be non-distressing. In order to normalise VH, it is vital that more is known about VH in non-clinical populations. This study investigated the prevalence, content, context, appraisals, distress, and behavioural reactions to VH in a non-clinical sample. DESIGN: A cross-sectional study was conducted. METHODS: 466 students completed the Multi-Modality Unusual Sensory Experiences Questionnaire-VH subscale with additional contextual follow-up questions. RESULTS: Of the 466 participants, 395 (84.8%) reported anomalous visual experiences. 176 (37.77%) participants reported VH similar to the content seen in psychosis. Of the overall sample, 17.38% felt their experience met the VH definition. Participants mainly saw figures, when alone and in the evening. Participants endorsed normalising appraisals: 112 out of 176 (78.87%) believed their mind was playing tricks on them and 83 (58.45%) believed they were tired. However, many also believed the VH was a threat to their mental (66, 46.48%) or physical well-being (41, 28.87%). These negative appraisals were associated with distress. CONCLUSION: VH are seemingly common in non-clinical populations and are similar in a number of ways to those of people with psychosis. Awareness that VH occur on a continuum could normalise people's experiences and reduce their negative appraisals and related distress.

Prevalence and nature of multi-sensory and multi-modal hallucinations in people with first episode psychosis.

Hallucinations can occur in single or multiple sensory modalities. This study explored how common these experiences were in people with first episode of psychosis (n = 82). Particular attention was paid to the number of modalities reported and whether the experiences were seen to be linked temporally and thematically. It was predicted that those people reporting a greater number of hallucinations would report more delusional ideation, greater levels of distress generally and lower functioning. All participants reported hallucinations in the auditory domain, given the nature of the recruitment. The participants also reported a range of other unusual sensory experiences, with visual and tactile hallucinations being reported by over half. Moreover, single sensory experiences or unimodal hallucinations were less common than two or more hallucination modalities which was reported by 78% of the participants. The number of hallucinations was significantly associated with greater delusional ideation and higher levels of general distress, but not with reduced functioning. It is clear there is a need to refine psychological treatments so that they are better matched to the actual experiences reported by people with psychosis. Theoretical implications are also considered.

Virtual reality (VR) therapy for patients with psychosis: satisfaction and side effects.

BACKGROUND: Automated virtual reality therapies are being developed to increase access to psychological interventions. We assessed the experience with one such therapy of patients diagnosed with psychosis, including satisfaction, side effects, and positive experiences of access to the technology. We tested whether side effects affected therapy. METHODS: In a clinical trial 122 patients diagnosed with psychosis completed baseline measures of psychiatric symptoms, received gameChange VR therapy, and then completed a satisfaction questionnaire, the Oxford-VR Side Effects Checklist, and outcome measures. RESULTS: 79 (65.8%) patients were very satisfied with VR therapy, 37 (30.8%) were mostly satisfied, 3 (2.5%) were indifferent/mildly dissatisfied, and 1 (0.8%) person was quite dissatisfied. The most common side effects were: difficulties concentrating because of thinking about what might be happening in the room (n = 17, 14.2%); lasting headache (n = 10, 8.3%); and the headset causing feelings of panic (n = 9, 7.4%). Side effects formed three factors: difficulties concentrating when wearing a headset, feelings of panic using VR, and worries following VR. The occurrence of side effects was not associated with number of VR sessions, therapy outcomes, or psychiatric symptoms. Difficulties concentrating in VR were associated with slightly lower satisfaction. VR therapy provision and engagement made patients feel: proud (n = 99, 81.8%); valued (n = 97, 80.2%); and optimistic (n = 96, 79.3%). CONCLUSIONS: Patients with psychosis were generally very positive towards the VR therapy, valued having the opportunity to try the technology, and experienced few adverse effects. Side effects did not significantly impact VR therapy. Patient experience of VR is likely to facilitate widespread adoption.

Agoraphobic avoidance in patients with psychosis: Severity and response to automated VR therapy in a secondary analysis of a randomised controlled clinical trial.

BACKGROUND: The social withdrawal of many patients with psychosis can be conceptualised as agoraphobic avoidance due to a range of long-standing fears. We hypothesised that greater severity of agoraphobic avoidance is associated with higher levels of psychiatric symptoms and lower levels of quality of life. We also hypothesised that patients with severe agoraphobic avoidance would experience a range of benefits from an automated virtual reality (VR) therapy that allows them to practise everyday anxiety-provoking situations in simulated environments. METHODS: 345 patients with psychosis in a randomised controlled trial were categorised into average, moderate, high, and severe avoidance groups using the Oxford Agoraphobic Avoidance Scale. Associations of agoraphobia severity with symptom and functioning variables, and response over six months to brief automated VR therapy (gameChange), were tested. RESULTS: Greater severity of agoraphobic avoidance was associated with higher levels of persecutory ideation, auditory hallucinations, depression, hopelessness, and threat cognitions, and lower levels of meaningful activity, quality of life, and perceptions of recovery. Patients with severe agoraphobia showed the greatest benefits with gameChange VR therapy, with significant improvements at end of treatment in agoraphobic avoidance, agoraphobic distress, ideas of reference, persecutory ideation, paranoia worries, recovering quality of life, and perceived recovery, but no significant improvements in depression, suicidal ideation, or health-related quality of life. CONCLUSIONS: Patients with psychosis with severe agoraphobic avoidance, such as being unable to leave the home, have high clinical need. Automated VR therapy can deliver clinical improvement in agoraphobia for these patients, leading to a number of wider benefits.

Managing Unusual Sensory Experiences in People with First-Episode Psychosis (MUSE FEP): a study protocol for a single-blind parallel-group randomised controlled feasibility trial.

INTRODUCTION: Hallucinations (hearing or seeing things that others do not) are a common feature of psychosis, causing significant distress and disability. Existing treatments such as cognitive-behavioural therapy for psychosis (CBTp) have modest benefits, and there is a lack of CBTp-trained staff. Shorter, targeted treatments that focus on specific symptoms delivered by a non-specialist workforce could substantially increase access to treatment.Managing Unusual Sensory Experiences (MUSE) explains why people have hallucinations and helps the person to develop and use coping strategies to reduce distress. MUSE focuses only on hallucinations, and treatment is short (four to six, 1-hour sessions per week). It is a digital intervention, run on National Health Service (NHS) laptops, which provides information about hallucinations in an engaging way, using audio, video and animated content. Crucially, it is designed for use by non-specialist staff like community psychiatric nurses. METHODS AND ANALYSIS: The study is a two-arm feasibility randomised controlled trial comparing MUSE and treatment as usual (TAU) (n=40) to TAU alone (n=40), recruiting across two NHS Trusts, using 1:1 allocation and blind assessments before and after treatment (2 months) and at follow-up (3 months). Quantitative information on recruitment rates, adherence and completion of outcome assessments will be collected. Qualitative interviews will capture service users' experience of therapy and clinicians' experiences of the training and supervision in MUSE. Clinicians will also be asked about factors affecting uptake, adherence and facilitators/barriers to implementation. Analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of the qualitative interviews will assess the acceptability of the training, intervention and trial procedures. ETHICS AND DISSEMINATION: The trial has received NHS Ethical and Health Research Authority approval. Findings will be disseminated directly to participants and services, as well as through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN16793301.

Automated virtual reality therapy to treat agoraphobic avoidance and distress in patients with psychosis (gameChange): a multicentre, parallel-group, single-blind, randomised, controlled trial in England with mediation and moderation analyses.

BACKGROUND: Automated delivery of psychological therapy using immersive technologies such as virtual reality (VR) might greatly increase the availability of effective help for patients. We aimed to evaluate the efficacy of an automated VR cognitive therapy (gameChange) to treat avoidance and distress in patients with psychosis, and to analyse how and in whom it might work. METHODS: We did a parallel-group, single-blind, randomised, controlled trial across nine National Health Service trusts in England. Eligible patients were aged 16 years or older, with a clinical diagnosis of a schizophrenia spectrum disorder or an affective diagnosis with psychotic symptoms, and had self-reported difficulties going outside due to anxiety. Patients were randomly assigned (1:1) to either gameChange VR therapy plus usual care or usual care alone, using a permuted blocks algorithm with randomly varying block size, stratified by study site and service type. gameChange VR therapy was provided in approximately six sessions over 6 weeks. Trial assessors were masked to group allocation. Outcomes were assessed at 0, 6 (primary endpoint), and 26 weeks after randomisation. The primary outcome was avoidance of, and distress in, everyday situations, assessed using the self-reported Oxford Agoraphobic Avoidance Scale (O-AS). Outcome analyses were done in the intention-to-treat population (ie, all participants who were assigned to a study group for whom data were available). We performed planned mediation and moderation analyses to test the effects of gameChange VR therapy when added to usual care. This trial is registered with the ISRCTN registry, 17308399. FINDINGS: Between July 25, 2019, and May 7, 2021 (with a pause in recruitment from March 16, 2020, to Sept 14, 2020, due to COVID-19 pandemic restrictions), 551 patients were assessed for eligibility and 346 were enrolled. 231 (67%) patients were men and 111 (32%) were women, 294 (85%) were White, and the mean age was 37·2 years (SD 12·5). 174 patients were randomly assigned to the gameChange VR therapy group and 172 to the usual care alone group. Compared with the usual care alone group, the gameChange VR therapy group had significant reductions in agoraphobic avoidance (O-AS adjusted mean difference -0·47, 95% CI -0·88 to -0·06; n=320; Cohen's d -0·18; p=0·026) and distress (-4·33, -7·78 to -0·87; n=322; -0·26; p=0·014) at 6 weeks. Reductions in threat cognitions and within-situation defence behaviours mediated treatment outcomes. The greater the severity of anxious fears and avoidance, the greater the treatment benefits. There was no significant difference in the occurrence of serious adverse events between the gameChange VR therapy group (12 events in nine patients) and the usual care alone group (eight events in seven patients; p=0·37). INTERPRETATION: Automated VR therapy led to significant reductions in anxious avoidance of, and distress in, everyday situations compared with usual care alone. The mediation analysis indicated that the VR therapy worked in accordance with the cognitive model by reducing anxious thoughts and associated protective behaviours. The moderation analysis indicated that the VR therapy particularly benefited patients with severe agoraphobic avoidance, such as not being able to leave the home unaccompanied. gameChange VR therapy has the potential to increase the provision of effective psychological therapy for psychosis, particularly for patients who find it difficult to leave their home, visit local amenities, or use public transport. FUNDING: National Institute of Health Research Invention for Innovation programme, National Institute of Health Research Oxford Health Biomedical Research Centre.

Understanding agoraphobic avoidance: the development of the Oxford Cognitions and Defences Questionnaire (O-CDQ).

BACKGROUND: Many patients with mental health disorders become increasingly isolated at home due to anxiety about going outside. A cognitive perspective on this difficulty is that threat cognitions lead to the safety-seeking behavioural response of agoraphobic avoidance. AIMS: We sought to develop a brief questionnaire, suitable for research and clinical practice, to assess a wide range of cognitions likely to lead to agoraphobic avoidance. We also included two additional subscales assessing two types of safety-seeking defensive responses: anxious avoidance and within-situation safety behaviours. METHOD: 198 patients with psychosis and agoraphobic avoidance and 1947 non-clinical individuals completed the item pool and measures of agoraphobic avoidance, generalised anxiety, social anxiety, depression and paranoia. Factor analyses were used to derive the Oxford Cognitions and Defences Questionnaire (O-CDQ). RESULTS: The O-CDQ consists of three subscales: threat cognitions (14 items), anxious avoidance (11 items), and within-situation safety behaviours (8 items). Separate confirmatory factor analyses demonstrated a good model fit for all subscales. The cognitions subscale was significantly associated with agoraphobic avoidance (r = .672, p < .001), social anxiety (r = .617, p < .001), generalized anxiety (r = .746, p < .001), depression (r = .619, p < .001) and paranoia (r = .655, p < .001). Additionally, both the O-CDQ avoidance (r = .867, p < .001) and within-situation safety behaviours (r = .757, p < .001) subscales were highly correlated with agoraphobic avoidance. The O-CDQ demonstrated excellent internal consistency (cognitions Cronbach's alpha = .93, avoidance Cronbach's alpha = .94, within-situation Cronbach's alpha = .93) and test-re-test reliability (cognitions ICC = 0.88, avoidance ICC = 0.92, within-situation ICC = 0.89). CONCLUSIONS: The O-CDQ, consisting of three separate scales, has excellent psychometric properties and may prove a helpful tool for understanding agoraphobic avoidance across mental health disorders.

Managing unusual sensory experiences: A feasibility trial in an At Risk Mental States for psychosis group.

OBJECTIVES: To conduct a feasibility study on a new, tablet-delivered treatment for unusual sensory experiences in service-users with an At Risk Mental States for psychosis. DESIGN: A mixed method design was employed, using content analysis to investigate whether service-users and therapists found the new treatment acceptable and helpful. We also collected data on the impact of treatment, but without a control group could not make any claims about effectiveness. METHODS: Eligible participants were contacted before starting treatment and offered the chance to participate. Assessments were conducted before and after the treatment, which typically was completed in 4-6 sessions by an accredited CBT therapist. A structured interview was used to collect qualitative feedback. RESULTS: Qualitative feedback suggested that the treatment was acceptable to service-users and therapists, and the progression criteria were met for recruitment, retention, and adherence to treatment. CONCLUSIONS: The new treatment targeting subtypes of auditory and visual hallucinations was acceptable to service-users and the benefits of addressing psychological mechanisms thought to contribute to hallucinations was supported by qualitative feedback. PRACTITIONER POINTS: A novel treatment has been developed for unusual sensory experiences based on subtyping voices and using technology to help explain psychological mechanisms that may be linked to hallucinations. The treatment was acceptable to service users and therapists in At Risk Mental States for psychosis services with qualitative feedback supporting the approach. The treatment may be particularly useful in preventing the progressions of psychosis as people who have not developed fixed ideas about the origin of the experiences may be more open to alternative explanations.

Prevalence and characteristics of multi-modal hallucinations in people with psychosis who experience visual hallucinations.

Hallucinations can occur in single or multiple sensory modalities. Historically, greater attention has been paid to single sensory modality experiences with a comparative neglect of hallucinations that occur across two or more sensory modalities (multi-modal hallucinations). With growing evidence suggesting that visual hallucinations may be experienced along with other hallucinations, this study aimed to explore multi-modal hallucinations in a sample of people with psychotic disorders who reported visual hallucinations (n = 22). No participants reported just visual hallucinations i.e. all reported related or unrelated auditory hallucinations. Twenty-one participants reported multi-modal hallucinations that were serial in nature, whereby they saw visual hallucinations and heard unrelated auditory hallucinations at other times. Nineteen people out of the twenty two also reported simultaneous multi-modal hallucinations, with the most common being an image that talked to and touched them. Multi-modal related and simultaneous hallucinations appeared to be associated with greater conviction that the experiences were real, and greater distress. Theoretical and clinical implications of multi-modal hallucinations are discussed.

Measures of visual hallucinations: Review and recommendations.

BACKGROUND: Studies designed to investigate visual hallucinations (VH) require reliable and valid measures that can appropriately capture peoples' experiences. This review aimed to assess the psychometric rigour and usefulness of VH measures. METHOD: A systematic literature search was carried out against inclusion criteria (e.g. more than one specific question on VH, measures for adults in clinical and non-clinical populations). Eighteen measures were identified and rated against an adapted evaluation grid, which included essential criteria such as clear purpose and definition, psychometric properties including reliability and validity, and appropriate exploration of visual hallucinations. RESULTS: Measures could be categorised into 3 groups; those for general psychotic symptoms, those for all hallucinations, or those specifically for visual hallucinations. With one exception (the North East Visual Hallucinations Inventory), the measures were considered to be limited as they often targeted one population and hence lacked generalisability, or were limited in the characteristics of the visions that were described, or that psychometric properties were not adequately evaluated. CONCLUSIONS: Measures of VH require further development. The need to establish a clearer definition of VH is essential to provide clarity and consistency within research and practice. Measures need to demonstrate good psychometric properties to indicate robustness whilst being sensitive to change to help in the evaluation of treatments. Other recommendations include developing cross-cultural measures and involving service users in item development.

Reality monitoring performance and the role of visual imagery in visual hallucinations.

BACKGROUND: Auditory Hallucinations may arise from people confusing their own inner speech with external spoken speech. People with visual hallucinations (VH) may similarly confuse vivid mental imagery with external events. This paper reports two experiments exploring confusion between internal and external visual material. METHOD: Experiment 1 examined reality monitoring in people with psychosis; those with visual hallucinations (n = 16) and those without (n = 15). Experiment 2 used two non-clinical groups of people with high or low predisposition to VH (HVH, n = 26, LVH, n = 21). All participants completed the same reality monitoring task. Participants in Experiment 2 also completed measures of imagery. RESULTS: Psychosis patients with VH demonstrated biased reality monitoring, where they misremembered items that had been presented as words as having been presented as pictures. Patients without VH did not show this bias. In Experiment 2, the HVH group demonstrated the same bias in reality monitoring that psychosis patients with VH had shown. The LVH group did not show this bias. In addition, the HVH group reported more vivid imagery and particularly more negative imagery. CONCLUSIONS: Both studies found that people with visual hallucinations or prone-ness to such experiences confused their inner visual experiences with external images. Vivid imagery was also related to proneness to VH. Hence, vivid imagery and reality monitoring confusion could be contributory factors to understanding VH.