The voice characterisation checklist: psychometric properties of a brief clinical assessment of voices as social agents.

Aim: There is growing interest in tailoring psychological interventions for distressing voices and a need for reliable tools to assess phenomenological features which might influence treatment response. This study examines the reliability and internal consistency of the Voice Characterisation Checklist (VoCC), a novel 10-item tool which assesses degree of voice characterisation, identified as relevant to a new wave of relational approaches. Methods: The sample comprised participants experiencing distressing voices, recruited at baseline on the AVATAR2 trial between January 2021 and July 2022 (n = 170). Inter-rater reliability (IRR) and internal consistency analyses (Cronbach's alpha) were conducted. Results: The majority of participants reported some degree of voice personification (94%) with high endorsement of voices as distinct auditory experiences (87%) with basic attributes of gender and age (82%). While most identified a voice intention (75%) and personality (76%), attribution of mental states (35%) to the voice ('What are they thinking?') and a known historical relationship (36%) were less common. The internal consistency of the VoCC was acceptable (10 items, α = 0.71). IRR analysis indicated acceptable to excellent reliability at the item-level for 9/10 items and moderate agreement between raters' global (binary) classification of more vs. less highly characterised voices, κ = 0.549 (95% CI, 0.240-0.859), p < 0.05. Conclusion: The VoCC is a reliable and internally consistent tool for assessing voice characterisation and will be used to test whether voice characterisation moderates treatment outcome to AVATAR therapy. There is potential wider utility within clinical trials of other relational therapies as well as routine clinical practice.

Virtual reality-based assessment and treatment of social functioning impairments in psychosis: a systematic review.

People with psychosis can experience social functioning impairments. Virtual reality (VR) has been used to assess and treat these difficulties. This systematic review (Prospero CRD42015026288) provides an evaluation of these VR applications. PsycINFO, MEDLINE, Embase, Web of Science, Cochrane Library, and Scopus were searched until May 2020. The Effective Public Health Practice Project (EPHPP) Quality Assessment Tool was used to assess studies. Database searching identified 3810 titles. Fifty-eight studies (published 2005-2020; N = 2,853), comprising twenty-six head-mounted display studies (20 assessment, 6 treatment) and thirty-two immersive 2D screen studies (23 assessment, 9 treatment), were included. There were forty-eight observational studies and ten randomised controlled trials, with 1570 participants (of which, 185 were at ultra-high risk of psychosis) in VR test groups. Nearly half the studies were published since 2016. Assessments targeted cognitive and behavioural indicators of social functioning, e.g. paranoia, eye gaze, or interpersonal distance. Treatments promoted cognitive-behavioural social skills or job interview training. Studies indicate feasibility, acceptability, and effectiveness of VR for social functioning impairments in psychosis. Limitations of studies include the narrow scope of social functioning, small sample sizes, and limited randomised controlled trials and standardised interventions. Findings suggest VR has potential to be integrated with existing psychological approaches.

The Early Youth Engagement in first episode psychosis (EYE-2) study: pragmatic cluster randomised controlled trial of implementation, effectiveness and cost-effectiveness of a team-based motivational engagement intervention to improve engagement.

BACKGROUND: Early Intervention in Psychosis (EIP) services improve health outcomes for young people with psychosis in the medium-long term, but 25% of young people disengage in the first 12 months with costs to their mental health, families, society and the NHS. This study will evaluate the effectiveness, cost-effectiveness and implementation of a team-based motivational Early Youth Engagement (EYE-2) intervention. METHOD: The study design is a cluster randomised controlled trial (RCT) with economic evaluation, comparing the EYE-2 intervention + standardised EIP service to standardised EIP service alone, with randomisation at the team level. A process evaluation will evaluate the delivery of the intervention qualitatively and quantitatively across contexts. The setting is 20 EIP teams in 5 sites: Manchester, South London, East Anglia, Thames Valley and Hampshire. Participants are young people (14-35 years) with first episode psychosis, and EIP staff. The intervention is the team-based motivational engagement (EYE-2) intervention, delivered alongside standardised EIP services, and supported by additional training, website, booklets and social groups. The comparator is the standardised EIP service. Both interventions are delivered by EIP clinicians. The primary outcome is time to disengagement (time in days from date of allocation to care coordinator to date of last contact following refusal to engage with EIP service, or lack of response to EIP contact for a consecutive 3-month period). Secondary outcomes include mental and physical health, deaths, social and occupational function, recovery, satisfaction and service use at 6, 12, 18 and 24 months. A 12-month within-trial economic evaluation will investigate cost-effectiveness from a societal perspective and from an NHS perspective. DISCUSSION: The trial will provide the first test of an engagement intervention in standardised care, with the potential for significant impact on the mental health and wellbeing of young people and their families, and economic benefits for services. The intervention will be highly scalable, supported by the toolkit including manuals, commissioning guide, training and resources, adapted to meet the needs of the diverse EIP population, and based on an in-depth process evaluation. TRIAL REGISTRATION: ISRCTN 51629746 prospectively registered 7th May 2019. Date assigned 10th May 2019.

Improving Access to psychological therapies for people with severe mental illness (IAPT-SMI): Lessons from the South London and Maudsley psychosis demonstration site.

Implementation of evidence-based cognitive behavioural therapy for psychosis (CBTp) remains low in routine services. The United Kingdom Improving Access to Psychological Therapies for people with Severe Mental Illness (IAPT-SMI) initiative aimed to address this issue. The project evaluated whether existing services could improve access to CBTp and demonstrate effectiveness using a systematic approach to therapy provision and outcome monitoring (in a similar way to the Improving Access to Psychological Therapies (IAPT) model for people with anxiety and depression). We report the clinical outcomes and key learning points from the South London and Maudsley NHS Foundation Trust IAPT-SMI demonstration site for psychosis. Additional funding enabled increased therapist capacity within existing secondary care community mental health services. Self-reported wellbeing and psychotic symptom outcomes were assessed, alongside service use and social/occupational functioning. Accepted referrals/year increased by 89% (2011/12: n = 106/year; 2012-2015: n = 200/year); 90% engaged (attended ≥5 sessions) irrespective of ethnicity, age and gender. The assessment protocol proved feasible, and pre-post outcomes (n = 280) showed clinical improvements and reduced service use, with medium effects. We conclude that, with appropriate service structure, investment allocated specifically for competent therapy provision leads to increased and effective delivery of CBTp. Our framework is replicable in other settings and can inform the wider implementation of psychological therapies for psychosis.

Improving implementation of evidence based practice for people with psychosis through training the wider workforce: Results of the GOALS feasibility randomised controlled trial.

BACKGROUND AND OBJECTIVES: There is a pressing need to improve access to evidence-based practice for people with psychosis. The primary aim of this study was to assess clinical feasibility of a manualised, evidence-based CBT intervention (GOALS) targeting a personalised recovery goal, delivered by the frontline workforce, following brief training. Secondly, we aimed to conduct preliminary statistical analyses of key outcomes and costs. METHODS: The GOALS study is a feasibility randomised controlled trial (ISRCTN 73188383). 75 participants with current psychosis were recruited and randomly allocated to receive either treatment as usual alone or with GOALS therapy. RESULTS: Brief training enabled frontline staff to deliver the therapy according to protocol and 74% of therapy participants partially or fully achieved their goals. There were significant improvements with a moderate effect size of 0.56 on goal attainment. However, preliminary statistical analyses found no significant differences between groups on our primary outcome of activity levels or other secondary outcomes Health economic analysis found that point estimates of costs, controlling for baseline costs, implied savings (even including intervention costs), but the difference was not statistically significant. LIMITATIONS: The study was designed as a feasibility RCT, and therefore the results of secondary estimates of efficacy effects should be treated with caution. CONCLUSIONS: This approach holds promise in supporting people with psychosis to reach personal recovery goals, cost effectively.

The effects of an Audio Visual Assisted Therapy Aid for Refractory auditory hallucinations (AVATAR therapy): study protocol for a randomised controlled trial.

BACKGROUND: Psychological interventions which adopt an explicitly interpersonal approach are a recent development in the treatment of distressing voices. AVATAR therapy is one such approach which creates a direct dialogue between a voice-hearer and a computerised representation of their persecutory voice (the avatar) through which the person may be supported to gain a sense of greater power and control. The main objective of the trial is to test the clinical efficacy of this therapy to reduce the frequency and severity of auditory verbal hallucinations (AVH). Secondary objectives of the study are to explore explanatory mechanisms of action and potential moderators, to carry out a qualitative evaluation of participants' experience and to conduct an economic evaluation. METHODS/DESIGN: The AVATAR randomised clinical trial will independently randomise 142 participants to receive either 7 sessions of AVATAR therapy or supportive counselling (SC). The study population will be individuals with schizophrenia spectrum and other psychotic disorders who report hearing persistent distressing voices, for more than 12 months, which are unresponsive or only partially responsive to antipsychotic medication. The main hypotheses are that, compared to SC, AVATAR therapy will reduce the frequency and severity of AVH and will also reduce the reported omnipotence and malevolence of these voices. Assessments will occur at 0 weeks (baseline), 12 weeks (post-intervention) and 24 weeks (follow-up), and will be carried out by blinded assessors. Both interventions will be delivered in a community-based mental health centre. Therapy competence and adherence will be monitored in both groups. Statistical analysis will follow the intention-to-treat principle and data will be analysed using a mixed (random) effects model at each post treatment time point separately. A formal mediation and moderator analysis using contemporary causal inference methods will be conducted as a secondary analysis. The trial is funded by the Welcome Trust (WT). DISCUSSION: AVATAR therapy showed promising effects in a pilot study, but the efficacy of the approach needs to be examined in a larger randomised clinical trial before wider dissemination and implementation in mental health services. TRIAL REGISTRATION: Current Controlled Trials ISRCTN: 65314790 , registration date: 27 March 2013.

Caregiver reports of patient-initiated violence in psychosis.

OBJECTIVE: Aggressive behaviour in psychosis is not uncommon. Community provision for people with psychosis has left informal caregivers to take on a greater role in their care. However, few studies have explored links between patient-initiated violence in mental health caregiving relationships and caregiver functioning. Our study investigated caregiver reports of aggressive acts committed by their relative with psychosis and their links to caregiver appraisals of the caregiving relationship and caregiver outcomes. METHOD: Caregivers of patients with a recent relapse of psychosis, recruited to a psychological therapy trial, completed the audiotaped Camberwell Family Interview at baseline. This semi-structured interview includes questions on the quality of the relationship between caregiver and patient, and patient history of violence. Seventy-two transcripts of interviews were assessed for reports of patient-initiated violence. RESULTS: One-half of the caregiver sample (52.9%) reported an incident of patient-initiated violence during their interview; 62.2% of these involved violence toward themselves, and 24.3% toward property. Reports of patient violence were associated with caregiver ratings of hostility expressed toward patients, lower self-esteem, and emotion-focused coping. People caring on their own were more likely to report incidents of patient violence. Younger patients, males, and inpatients were more frequently identified as having a history of this kind of violence. CONCLUSIONS: Our findings suggested that caregiver reports of patient-initiated violence in psychosis are not uncommon. Mental health staff need to be aware of the risks of such violence for caregivers of people with psychosis, and consider appropriate procedures for minimizing it.

The effects of a brief CBT intervention, delivered by frontline mental health staff, to promote recovery in people with psychosis and comorbid anxiety or depression (the GOALS study): study protocol for a randomized controlled trial.

BACKGROUND: NICE guidance states that cognitive behavioural therapy (CBT) should be offered to all patients with psychosis. However, there is a need to improve access to therapeutic interventions. We aim to train frontline mental health staff to deliver brief, structured CBT-based therapies. We have developed and piloted a manualized intervention to support people with psychosis and anxious avoidance or depression to work towards a personal recovery goal. METHODS/DESIGN: The 'GOALS Study' is a pilot randomized controlled trial comparing usual care plus an 8-week intervention with usual care alone. The key objective is to assess clinical feasibility (recruitment and randomization; compliance with the treatment manual; acceptability and satisfaction; progress towards goals). A secondary objective is a preliminary evaluation of efficacy. Sixty-six participants with a diagnosis of psychosis, plus symptoms of depression or anxiety will be recruited from adult mental health services. Those currently refusing medication, in receipt of CBT, or with a primary diagnosis of an organic mental health problem or substance dependency will be excluded. Following informed consent, randomization will be independent of the trial team, at a 50:50 ratio, at the level of the individual and stratified by main problem focus. Following randomization, participants allocated to the intervention group will begin the 8-week intervention with a local, trained member of staff, supervised by the study coordinator. Outcomes will be assessed blind to treatment condition at 0, 12 and 18 weeks post-randomization. The primary outcome measure for the efficacy analysis will be activity levels at 12 weeks. Secondary outcome measures include mood, psychotic symptoms, quality of life and clinical distress. A health economic analysis comparing service use in each condition will also be performed. Recruitment began in March, 2013 and is ongoing until December, 2014. DISCUSSION: This is the first trial of the GOALS intervention. The approach is brief and staff can be readily trained in its delivery: there is therefore potential to develop a cost-effective intervention that could be widely disseminated. If the trial proves clinically feasible and demonstrates preliminary evidence of efficacy, a large multi-site trial will be warranted. TRIAL REGISTRATION: Current Controlled Trials ISRCTN: 73188383. http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=13538.

Increasing access to psychological therapies for people with psychosis: predictors of successful training.

BACKGROUND: Cognitive behavioural therapy for psychosis (CBTp) is recommended for people with schizophrenia, but routine delivery remains limited. Obstacles to increasing access include inadequate training, organisational support and supervision, resulting in low levels of staff competence and confidence. This study is a preliminary evaluation of a CBTp training programme, designed to overcome these obstacles and to increase routine delivery of competent CBTp. METHOD: Training outcomes for a pilot group and for the first three cohorts to complete training were analysed to identify predictors of successful completion and of therapy delivery after training. RESULTS: Objective competence was attained by 37 students (out of 58), who delivered therapy to over 160 service users. Successful completion was associated with previous CBT therapy experience. Delivery after one year was associated with working in a therapy rather than a care co-ordination role. CONCLUSIONS: The programme succeeded in training therapists to deliver competent therapy. Our results suggest that preliminary training in CBT for other disorders may improve success rates in CBTp. Despite extensive service liaison, delivery remained problematic for care co-ordinators without role change and provision of dedicated time. The findings should inform future implementation strategies.

Effect of early intervention on 5-year outcome in non-affective psychosis.

BACKGROUND: Early specialised care may improve short-term outcome in first-episode non-affective psychosis, but it is unclear if these benefits endure. AIMS: To assess the long-term effect of early intervention in psychosis. METHOD: Individuals with first-episode psychosis were randomised to specialised care or care as usual (trial number: ISRCTN73679874). Outcome after 5 years was assessed by case-note review. RESULTS: There were no significant differences in the admission rate (coefficient 0.096, 95% CI -0.550 to 0.742, P = 0.770) or the mean number of bed days (coefficient 6.344, 95% CI -46 to 58.7, P = 0.810). CONCLUSIONS: These findings that specialist intervention did not markedly improved outcome at 5 years accord with those from a larger OPUS study. The sample size of this study was small and these results should be generalised with caution. More research is needed.

Cost-effectiveness of an early intervention service for people with psychosis.

BACKGROUND: There is concern that delaying treatment for psychosis may have a negative impact on its long-term course. A number of countries have developed early intervention teams but there is limited evidence regarding their cost-effectiveness. AIMS: To compare the costs and cost-effectiveness of an early intervention service in London with standard care. METHOD: Individuals in their first episode of psychosis (or those who had previously discontinued treatment) were recruited to the study. Clinical variables and costs were measured at baseline and then at 6- and 18-month follow-up. Information on quality of life and vocational outcomes were combined with costs to assess cost-effectiveness. RESULTS: A total of 144 people were randomised. Total mean costs were 11,685 pounds sterling in the early intervention group and 14,062 pounds sterling in the standard care group, with the difference not being significant (95% CI -8128 pounds sterling to 3326 pounds sterling). When costs were combined with improved vocational and quality of life outcomes it was shown that early intervention would have a very high likelihood of being cost-effective. CONCLUSIONS: Early intervention did not increase costs and was highly likely to be cost-effective when compared with standard care.

Patient perceptions of caregiver criticism in psychosis: links with patient and caregiver functioning.

Expressed emotion (EE) has been described as a measure of caregivers' appraisals of the quality of their relationship with patients. However, far less is known about how the perception of their caregivers by patients with psychosis is shaped by caregivers' EE, and nothing about the clinical correlates of perceived EE. The current study examines the association of patient ratings of carer criticism with patient and carer characteristics. Patient ratings of carer criticism were also compared with the ratings of the carer derived from the Camberwell Family Interview. Sixty-seven patient-carer dyads participated in the cross-sectional study. Perceived carer criticism was associated with general psychopathology in patients, but not with overall levels of positive or negative symptoms of psychosis. Patients with lower levels of social functioning, higher levels of negative affect, and negative schematic beliefs about other people, tended to perceive greater criticism. Perceptions of carer criticism were associated with Camberwell Family Interview ratings of carer criticism, hostility, and high EE independently of affect, and poorer functioning. High EE was a significant predictor of perceived carer criticism. This study supports the validity of using feedback from patients to assess the emotional climate of the family environment.

The Lambeth Early Onset Crisis Assessment Team Study: general practitioner education and access to an early detection team in first-episode psychosis.

BACKGROUND: There are few evaluations of strategies to improve rates of early detection and treatment of patients with first-episode psychosis. AIMS: To evaluate the effectiveness of a general practitioner (GP) education programme and an early detection assessment team (the Lambeth Early Onset Crisis Assessment Team; LEO CAT) in reducing delays in accessing treatment for first-episode psychosis patients. METHOD: 46 clusters of GP practices randomised to GP education in early detection with direct access to LEO CAT v. care as usual. Primary outcome measures were GP referral rates, duration of untreated psychosis (DUP) and delays in receiving treatment. RESULTS: 150 patients with first-episode psychosis were recruited; 113 were registered with the study GPs, who referred 54 (47.7%) directly to mental health services. Significantly more intervention group GPs (86.1% v. 65.7%) referred their patients directly to mental health services and fewer patients experienced long delays in receiving treatment. However, their overall DUP was unaffected. CONCLUSIONS: Educating GPs improves detection and referral rates of first-episode psychosis patients. An early detection team reduces the long delays in initial assessment and treatment. However, these only impact on the later phases of the DUP. Broader measures, such as public health education, are needed to reduce the earlier delays in DUP.