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.

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.

Identifying types of problems and relative priorities in the problem lists of participants in CBT for psychosis trials.

BACKGROUND: There is wide variation in the problems prioritised by people with psychosis in cognitive behavioural therapy for psychosis (CBTp). While research trials and mental health services have often prioritised reduction in psychiatric symptoms, service users may prioritise issues not directly related to psychosis. This discrepancy suggests potential challenges in treatment outcome research. AIMS: The present study aimed to examine the types of problems that were recorded on problem lists generated in CBTp trials. METHOD: Problem and goals lists for 110 participants were extracted from CBTp therapy notes. Subsequently, problems were coded into 23 distinct categories by pooling together items that appeared thematically related. RESULTS: More than half of participants (59.62%) listed a non-psychosis-related priority problem, and 22.12% did not list any psychosis related problems. Chi-square tests indicated there was no difference between participants from early intervention (EI) and other services in terms of priority problem (χ2 = 0.06, p = .804), but that those from EI were more likely to include any psychosis-related problems in their lists (χ2 = 6.66, p = .010). CONCLUSIONS: The findings of this study suggest that psychiatric symptom reduction is not the primary goal of CBTp for most service users, particularly those who are not under the care of EI services. The implications for future research and clinical practice are discussed.

Estimating the Economic Value of Automated Virtual Reality Cognitive Therapy for Treating Agoraphobic Avoidance in Patients With Psychosis: Findings From the gameChange Randomized Controlled Clinical Trial.

BACKGROUND: An automated virtual reality cognitive therapy (gameChange) has demonstrated its effectiveness to treat agoraphobia in patients with psychosis, especially for high or severe anxious avoidance. Its economic value to the health care system is not yet established. OBJECTIVE: In this study, we aimed to estimate the potential economic value of gameChange for the UK National Health Service (NHS) and establish the maximum cost-effective price per patient. METHODS: Using data from a randomized controlled trial with 346 patients with psychosis (ISRCTN17308399), we estimated differences in health-related quality of life, health and social care costs, and wider societal costs for patients receiving virtual reality therapy in addition to treatment as usual compared with treatment as usual alone. The maximum cost-effective prices of gameChange were calculated based on UK cost-effectiveness thresholds. The sensitivity of the results to analytical assumptions was tested. RESULTS: Patients allocated to gameChange reported higher quality-adjusted life years (0.008 QALYs, 95% CI -0.010 to 0.026) and lower NHS and social care costs (-£105, 95% CI -£1135 to £924) compared with treatment as usual (£1=US $1.28); however, these differences were not statistically significant. gameChange was estimated to be worth up to £341 per patient from an NHS and social care (NHS and personal social services) perspective or £1967 per patient from a wider societal perspective. In patients with high or severe anxious avoidance, maximum cost-effective prices rose to £877 and £3073 per patient from an NHS and personal social services perspective and societal perspective, respectively. CONCLUSIONS: gameChange is a promising, cost-effective intervention for the UK NHS and is particularly valuable for patients with high or severe anxious avoidance. This presents an opportunity to expand cost-effective psychological treatment coverage for a population with significant health needs. TRIAL REGISTRATION: ISRCTN Registry ISRCTN17308399; https://www.isrctn.com/ISRCTN17308399. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2019-031606.

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.

Development and initial evaluation of a measure of positive beliefs about dissociative experiences.

Theoretical models and qualitative research suggest that dissociation can be functional in some circumstances, despite being a cause of concern for many. This is the first study that evaluates a novel questionnaire on positive appraisals of dissociation (the Positive Beliefs about Dissociation Questionnaire; PBD-Q), and its link with dissociation frequency and related distress. Development of items was based on lived experience expertise within the research team and qualitative findings. Items were refined through cognitive interviewing with people with lived experience of dissociation prior to deployment using an online survey. A sample of 228 participants scoring >10 on the Dissociative Experiences Scale (DES-II) completed a battery of measures comprising the PBD-Q and a previously developed measure of negative beliefs of dissociation. Exploratory factor analysis revealed three factors: positive beliefs about emotion management, positive beliefs about self-expression, and positive beliefs about maintaining social image. Within this particular sample the PBD-Q showed excellent internal consistency, face validity, convergent validity, and test-retest reliability. Higher scores on the PBD-Q were significantly related to higher frequencies of dissociative experiences as well as dissociation-related distress. The factor structure remained stable when the analyses were restricted to individuals scoring >30 on the DES-II. In conclusion, our findings indicate that positive beliefs about dissociation can be reliably and validly measured in adults who experience levels of dissociation that are higher than the general population. These beliefs could be involved in the maintenance of dissociation and represent promising targets for future research, clinical assessment, and treatment.

ENDOCRINE OUTCOMES OF TRANSSPHENOIDAL SURGERY FOR PITUITARY APOPLEXY VERSUS ELECTIVE SURGERY FOR PITUITARY ADENOMA.

Objective: To determine the rate of hormone replacement therapy (HRT) after transsphenoidal surgery (TSS) for pituitary apoplexy (PA) versus elective resection of a null cell (NC) macroadenoma. Methods: A retrospective cohort study was performed. Data was collected on all consecutive patients who underwent TSS from December 31, 2000 to December 31, 2016. Patients were split into two groups: (1) patients that presented with PA, and (2) patients that underwent elective TSS for NC macroadenoma. Postoperative pituitary function was determined by examining HRT, hormone lab values, and an evaluation by an endocrinologist for each patient. The odds ratio (OR) was calculated to determine if there was an association between PA and the need for HRT after surgery when compared to elective resection of a NC macroadenoma. Results: The need for HRT was significantly higher following surgery for PA compared to resection of a NC macroadenoma (14.7% versus 2.9%, OR = 5.690; 95% confidence interval (CI) = 1.439 to 22.500; P = .013). Conclusion: There is an increased need for hormone replacement therapy after surgery in patients with PA versus patients undergoing elective resection of a NC macroadenoma. Further studies are warranted to strengthen this data and help determine further predictors of the need for HRT. Abbreviations: BNP = brain natriuretic peptide; CI = confidence interval; DDAVP = desmopressin acetate; GH = growth hormone; HRT = hormone replacement therapy; MRI = magnetic resonance imaging; NC = null cell (adenoma); OR = odds ratio; PA = pituitary apoplexy; TSS = transsphenoidal surgery.

Environmental impacts of abrasive blasting of transmission towers in protected areas.

In Australia, and other parts of the world, tower infrastructure in electricity transmission networks are nearing the end of their asset life. In changing economic, political and regulatory environments Transmission Network Service Providers are implementing new approaches to asset management and reinvestment, such as refurbishment to extend the life of existing assets, instead of replacement. As part of these refurbishment efforts, abrasive blasting and recoating is being employed to remove corrosion and extend the life of steel electricity transmission towers. New controls and procedures have been developed to manage the most likely impacts associated with the abrasive blasting of transmission towers. However, little or no data have been available on the environmental impacts of abrasive blasting or the effectiveness of management procedures currently being used to mitigate potential adverse environmental impacts.We conducted an integrated study on the impacts of abrasive blasting, which brought together on-site research; modelling; and controlled laboratory trials. The study was undertaken during a transmission tower refurbishment project within the World Heritage listed Wet Tropics Region in Queensland, Australia. Measured metal deposition around towers due to blasting, was primarily as large particles (>PM10) at 12-30 m from the tower. Soil concentrations of metals were highest under towers, with a small number of samples showing elevated zinc at 12-30 m. The presence of spent abrasive media and dust on the geofabric material used under the towers and up to 15 m from the tower base, as part of control measures used to contain the abrasive products, indicates that deposition also occurs between 0 and 12 m from the tower.The potential impacts of the abrasive blasting technique on plants and invertebrates appear to be low. Five species of tropical rainforest tree seedlings exposed to abrasive blasting dust at worst-case levels had no negative impact on physiological performance or plant health. This research will assist Transmission Network Service Providers and other operators of corroded linear infrastructure to plan and implement mitigating management actions and procedures during abrasive blasting projects and assist regulators and the community to better understand the impacts of the practice.

The effect of thought importance on stress responses: a test of the metacognitive model.

Negative metacognitive beliefs are central determinants of distress in the metacognitive model of psychological vulnerability to stress. The current study tested this assertion in 75 undergraduate students assigned to either experimental (metacognitive belief manipulation) or control (no metacognitive belief manipulation) condition. All participants underwent a fake EEG, where they were told that the EEG would detect negative thoughts. The experimental subjects were informed that if they had a negative thought they may be exposed to a contingent burst of loud noise, while the control condition was told that they may be exposed to a burst of loud noise at random. Participants also underwent the Trier Social Stress Test. The results showed that on physiological measures (skin conductance level) there were no significant differences between groups. However, on self-report measures (positive and negative affect) participants in the experimental condition reported greater levels of negative affect and lower levels of positive affect in response to stress and maintained low positive affect at recovery. The results are consistent with the metacognitive model and suggest that metacognitive beliefs impact on positive and negative affect in reaction to and recovery from stress exposure.

"I Believe I Know Better Even than the Psychiatrists What Caused It": Exploring the Development of Causal Beliefs in People Experiencing Psychosis.

This study aimed to describe the causal beliefs of individuals experiencing psychosis, specifically exploring how they are developed and maintained. Individuals with experience of psychosis were recruited from mental health services for in-depth interviews. A thematic analysis was used to analyse transcripts and key themes were identified. Fifteen interviews were conducted. Individuals were engaged in the process of exploring explanations for their experiences and reported sophisticated models of causation. Participants described a change in their beliefs, with the cause of their experiences not immediately clear. Individuals generated their models via external (family, professionals) and internal (evaluative, positive affect) processes and reported differing levels of conviction in relation to their beliefs. Clinicians should take the opportunity to explore the causal beliefs of their service-users, as they are able to provide intelligent and thoughtful explanatory models. In particular, clinicians should be aware of the emotional impact of different aetiological models and their personal role in the development of a client's beliefs.

Are experiences of psychosis associated with unhelpful metacognitive coping strategies? A systematic review of the evidence.

This review investigated whether unhelpful metacognitive coping strategies, such as attentional biases, worry, rumination, and thought control, are associated with experiences of psychosis. These processes, known collectively as the Cognitive Attentional Syndrome (CAS), form a central tenet of the Self-Regulatory Executive Function model. Three research questions based on assumptions underlying the CAS were addressed. It was predicted that processes of (a) self-focused processing, (b) negative perseverative thinking (worry and rumination), and (c) counterproductive thought control would be associated with experiences of psychosis. A comprehensive search of the literature identified 51 eligible studies: 17 investigated self-focused attention, 25 investigated perseverative processing (worry: n = 18; rumination: n = 10), and 9 investigated thought control strategies. Findings indicated that unhelpful metacognitive coping strategies associated with the CAS are related to experiences of psychosis and appear to share important relationships with distress. Implications for future research and clinical practice are discussed.

Assessment of metacognitive beliefs in an at risk mental state for psychosis: A validation study of the Metacognitions Questionnaire-30.

AIM: The Metacognitions Questionnaire-30 (MCQ-30) has been used to assess metacognitive beliefs in a range of mental health problems. The aim of this study is to assess the validity of the MCQ-30 in people at risk for psychosis. METHODS: One hundred eighty-five participants meeting criteria for an at risk mental state completed the MCQ-30 as part of their involvement in a randomized controlled trial. Confirmatory and exploratory factor analyses were conducted to assess factor structure and construct validity. RESULTS: Confirmatory factor analyses confirmed the original five-factor structure of the MCQ-30. Examination of principal component analysis and parallel analysis outputs also suggested a five-factor structure. Correlation analyses including measures of depression, social anxiety, and beliefs about paranoia showed evidence of convergent validity. Discriminant validity was supported using the normalizing subscale of the beliefs about paranoia tool. CONCLUSIONS: The MCQ-30 demonstrated good fit using the original five-factor model, acceptable to very good internal consistency of items was evident and clinical usefulness in those at risk for psychosis was demonstrated.

Delivery of cognitive-behaviour therapy for psychosis: a service user preference trial.

BACKGROUND: Clinical guidelines recommend cognitive behaviour therapy (CBT) for people with psychosis, however, implementation is poor and not everyone wishes to engage with therapy. Understanding service user (SU) preferences for receiving such treatments is a priority for services. AIMS: To explore SU preferences and outcomes of different methods of delivering CBT for psychosis. METHOD: SUs experiencing psychosis could choose between treatment as usual (TAU); TAU plus telephone-delivered CBT with self-help, CBT recovery manual (TS); high support CBT (HS - TAU plus TS plus group sessions) or randomisation. Participants received their option of choice and were followed-up on several outcomes over 9 and 15 months. RESULTS: Of 89 people recruited, three chose to be randomised and 86 expressed a treatment preference (32 chose TAU, 34 chose TS, 23 chose HS). There were few differences between those who chose therapy compared to those who chose TAU. Those who had more positive impacts from their symptoms were significantly more likely to choose TAU. CONCLUSIONS: Most people had strong preferences about treatment delivery and a substantial number did not wish to receive additional therapy. These findings have to be considered when planning and allocating resources for people with psychosis.

An Integrative Cognitive Model of Internalized Stigma in Psychosis.

BACKGROUND: Internalized stigma is a significant difficulty for those who experience psychosis, but it has never been conceptualized using cognitive theory. AIMS: The aim of this paper is to outline a cognitive model conceptualizing internalized stigma experienced by people who also experience psychosis. METHOD: Previous literature is reviewed, critiqued and synthesized to develop the model. It draws upon previous social cognitive models of internalized stigma and integrates cognitive behavioural theory and social mentality theory. RESULTS: This paper identifies key cognitive, behavioural and emotional processes that contribute to the development and maintenance of internalized stigma, whilst also recognizing the central importance of cultural context in creating negative stereotypes of psychosis. Moreover, therapeutic strategies to alleviate internalized stigma are identified. A case example is explored and a formulation and brief intervention plan was developed in order to illustrate the model in practice. CONCLUSION: An integrative cognitive model is presented, which can be used to develop individualized case formulations, which can guide cognitive behavioural interventions targeting internalized stigma in those who experience psychosis. More research is required to examine the efficacy of such interventions. In addition, it is imperative to continue to research interventions that create change in stigma at a societal level.

An exploration of the relationship between use of safety-seeking behaviours and psychosis: A systematic review and meta-analysis.

Safety-seeking behaviours are responses employed to protect against perceived threat. In relation to anxiety disorders, safety-seeking behaviours have been implicated in both the formation and maintenance of distress. Several studies have highlighted similar findings in relation to psychosis; however, this literature has not yet been synthesized. This review is, therefore, being conducted in order to synthesize the literature on safety seeking in people with psychosis to increase the understanding of this relationship. A systematic search identified and included 43 studies comprising 2,592 participants, published between 1995 and 2015. The results indicated that people experiencing psychosis commonly respond to their experiences with behavioural and cognitive strategies intended to manage their difficulties. In relation to safety seeking, avoidance, and resistance, there was a pattern that these responses are associated with increased distress and appraisals of threat. The results relating to engagement response styles showed the opposite pattern. These results provide support for cognitive models of safety seeking and psychosis with many of the meta-analyses reported here showing a clear pattern of association between behavioural responses and distress. However, the results reported within individual studies are mixed. This appears to be particularly true with the response style of distraction, with our analyses unable to clarify this relationship. It is possible that the mixed results could reflect the complexities in defining safety seeking and distinguishing it from coping in this population. The clinical implications of this are discussed.

The Impact of Causal Explanations on Outcome in People Experiencing Psychosis: A Systematic Review.

Findings suggest that the way an individual understands their experiences has important consequences on subsequent health behaviour. One aspect of an individual's understanding is what they believe has caused their experiences. This has been associated with treatment outcome and attitudes towards mental health problems. The aim of this systematic review was to examine the impact of causal beliefs on treatment outcome and stigma in people experiencing psychosis. Three main databases were searched and 21 articles that investigated various aspects of treatment outcome, and stigma in relation to causal beliefs was included in the review. Overall, there were a small number of replicated findings which limits the interpretation of results. There is an indication that causal explanations are associated with various treatment outcomes, including attitudes towards treatment and satisfaction with therapeutic relationships as well as internalized stigma. Spiritual beliefs appeared to be adopted as a coping mechanism and a way to reduce stigma but did not appear to be associated with treatment outcome. Individuals with psychosis do appear to develop causal beliefs that may be associated with engagement with services and treatment, as well as impacting on their attitudes towards themselves and others with mental illness. This may have important implications for clinical practice. Copyright © 2016 John Wiley & Sons, Ltd. KEY PRACTITIONER MESSAGE: Individuals who have experience of psychosis develop their own subjective causal explanations, and these can be complex and contradictory. An individual's causal explanation may influence how they engage with services and treatment, as well as providing a way of coming to terms with their difficulties. Causal explanations may also contribute to the experience of stigma, which is often a significant barrier to recovery for this client group.

Shared treatment decision-making and empowerment-related outcomes in psychosis: systematic review and meta-analysis.

BACKGROUND: In the UK almost 60% of people with a diagnosis of schizophrenia who use mental health services say they are not involved in decisions about their treatment. Guidelines and policy documents recommend that shared decision-making should be implemented, yet whether it leads to greater treatment-related empowerment for this group has not been systematically assessed. AIMS: To examine the effects of shared decision-making on indices of treatment-related empowerment of people with psychosis. METHOD: We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) of shared decision-making concerning current or future treatment for psychosis (PROSPERO registration CRD42013006161). Primary outcomes were indices of treatment-related empowerment and objective coercion (compulsory treatment). Secondary outcomes were treatment decision-making ability and the quality of the therapeutic relationship. RESULTS: We identified 11 RCTs. Small beneficial effects of increased shared decision-making were found on indices of treatment-related empowerment (6 RCTs; g = 0.30, 95% CI 0.09-0.51), although the effect was smaller if trials with >25% missing data were excluded. There was a trend towards shared decision-making for future care leading to reduced use of compulsory treatment over 15-18 months (3 RCTs; RR = 0.59, 95% CI 0.35-1.02), with a number needed to treat of approximately 10 (95% CI 5-∞). No clear effect on treatment decision-making ability (3 RCTs) or the quality of the therapeutic relationship (8 RCTs) was found, but data were heterogeneous. CONCLUSIONS: For people with psychosis the implementation of shared treatment decision-making appears to have small beneficial effects on indices of treatment-related empowerment, but more direct evidence is required.

Longitudinal predictors of subjective recovery in psychosis.

BACKGROUND: Research has highlighted the importance of recovery as defined by the service user, and suggests a link to negative emotion, although little is known about the role of negative emotion in predicting subjective recovery. AIMS: To investigate longitudinal predictors of variability in recovery scores with a focus on the role of negative emotion. METHOD: Participants (n = 110) with experience of psychosis completed measures of psychiatric symptoms, social functioning, subjective recovery, depression, hopelessness and self-esteem at baseline and 6 months later. Path analysis was used to examine predictive factors for recovery and negative emotion. RESULTS: Subjective recovery scores were predicted by negative emotion, positive self-esteem and hopelessness, and to a lesser extent by symptoms and functioning. Current recovery score was not predicted by past recovery score after accounting for past symptoms, current hopelessness and current positive self-esteem. CONCLUSIONS: Psychosocial factors and negative emotion appear to be the strongest longitudinal predictors of variation in subjective recovery, rather than psychiatric symptoms.

NICE v. SIGN on psychosis and schizophrenia: same roots, similar guidelines, different interpretations.

A recent editorial claimed that the 2014 National Institute for Health and Care Excellence (NICE) guideline on psychosis and schizophrenia, unlike its equivalent 2013 Scottish Intercollegiate Guidelines Network (SIGN) guideline, is biased towards psychosocial treatments and against drug treatments. In this paper we underline that the NICE and SIGN guidelines recommend similar interventions, but that the NICE guideline has more rigorous methodology. Our analysis suggests that the authors of the editorial appear to have succumbed to bias themselves.

Design and protocol for the Focusing on Clozapine Unresponsive Symptoms (FOCUS) trial: a randomised controlled trial.

BACKGROUND: For around a third of people with a diagnosis of schizophrenia, the condition proves to respond poorly to treatment with many typical and atypical antipsychotics. This is commonly referred to as treatment-resistant schizophrenia. Clozapine is the only antipsychotic with convincing efficacy for people whose symptoms are considered treatment-resistant to antipsychotic medication. However, 30-40 % of such conditions will have an insufficient response to the drug. Cognitive behavioural therapy has been shown to be an effective treatment for schizophrenia when delivered in combination with antipsychotic medication, with several meta-analyses showing robust support for this approach. However, the evidence for the effectiveness of cognitive behavioural therapy for people with a schizophrenia diagnosis whose symptoms are treatment-resistant to antipsychotic medication is limited. There is a clinical and economic need to evaluate treatments to improve outcomes for people with such conditions. METHODS/DESIGN: A parallel group, prospective randomised, open, blinded evaluation of outcomes design will be used to compare a standardised cognitive behavioural therapy intervention added to treatment as usual versus treatment as usual alone (the comparator group) for individuals with a diagnosis of schizophrenia for whom an adequate trial of clozapine has either not been possible due to tolerability problems or was not associated with a sufficient therapeutic response. The trial will be conducted across five sites in the United Kingdom. DISCUSSION: The recruitment target of 485 was achieved, with a final recruitment total of 487. This trial is the largest definitive, pragmatic clinical and cost-effectiveness trial of cognitive behavioural therapy for people with schizophrenia whose symptoms have failed to show an adequate response to clozapine treatment. Using a prognostic risk model, baseline information will be used to explore whether there are identifiable subgroups for which the treatment effect is greatest. TRIAL REGISTRATION: Current Controlled Trials ISRCTN99672552 . Registered 29(th) November 2012.