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Background:Negative beliefs about the self, including low self-compassion, have been identified as a putative causal factor in the occurrence of paranoia. Therefore, improving self-compassion may be one route to reduce paranoia.Aims:To assess the feasibility, acceptability, and potential clinical effects of a brief compassionate imagery intervention for patients with persecutory delusions.Method:Twelve patients with persecutory delusions received an individual four-session compassionate imagery intervention. Assessments of self-concept and paranoia were completed before treatment, immediately after treatment, and at 1-month follow-up. A qualitative study exploring participants’ experiences of the treatment was also completed.Results:Twelve out of 14 eligible patients referred to the study agreed to take part. All participants completed all therapy sessions and assessments. Post-treatment, there were improvements in self-compassion (change score –0.64, 95% CI –1.04, –0.24, d = –1.78), negative beliefs about the self (change score 2.42, 95% CI –0.37, 5.20, d = 0.51), and paranoia (change score 10.08, 95% CI 3.47, 16.69, d = 0.61). There were no serious adverse events. Three themes emerged from the qualitative analysis: ‘effortful learning’, ‘seeing change’ and ‘taking it forward’. Participants described a process of active and effortful engagement in therapy which was rewarded with positive changes, including feeling calmer, gaining clarity, and developing acceptance.Conclusion:This uncontrolled feasibility study indicates that a brief compassionate imagery intervention for patients with persecutory delusions is feasible, acceptable, and may lead to clinical benefits.

Purpose Parenting behaviours—including the extent to which parents are protective, hostile, or caring—likely impacts whether a child develops a sense of vulnerability that carries forward into adulthood. Ideas of vulnerability are a contributory factor to the occurrence of paranoia. Our aim was to assess whether there is an association between specific parenting behaviours and paranoia. Method We examined cross-sectional associations of parenting and paranoia in an epidemiologically representative cohort of 10,148 adolescents (National Comorbidity Survey-Adolescents; NCS-A) and a second dataset of 1286 adults in Oxfordshire. Further, a network analysis was conducted with paranoia, parenting behaviours, and cognitive-affective variables (compassion, self-esteem, anxiety, and depression). Overprotectiveness, verbal abuse, physical abuse, and amount of care were assessed in mothers and fathers separately. Results Nearly all parenting variables were significantly associated with paranoia, with parental verbal and physical abuse showing the largest associations. For example, the odds of reporting paranoia was over four times higher for those in the adult sample reporting a lot of paternal verbal abuse, compared to those reporting none (OR = 4.12, p Conclusion There are associations between participants’ self-reported experiences of parental behaviours and paranoia. Despite being associated with paranoia, cognitive-affective variables did not appear to mediate the relationship between parenting and paranoia, which is surprising. What might explain the link therefore remains to be determined.

Background Patients in psychiatric wards typically have very limited access to individual psychological therapy. Inpatients often have significant time available, and an important transition back to everyday life to prepare for—but historically, there have been few trained therapists available on wards for the delivery of evidence-based therapy. Automated virtual reality (VR) therapy may be one route to increase the provision of powerful psychological treatments in psychiatric hospitals. The gameChange automated VR cognitive therapy is targeted at helping patients overcome anxious avoidance and re-engage in everyday situations (such as walking down the street, taking a bus, or going to a shop). This treatment target may fit well for many patients preparing for discharge. However, little is known about how VR therapy may be viewed in this setting. Objective The objectives of the study are to explore psychiatric hospital staff and patients’ initial expectations of VR therapy, to gather patient and staff views of an automated VR cognitive therapy (gameChange) after briefly experiencing it, and to identify potential differences across National Health Service (NHS) mental health trusts for implementation. Guided by an implementation framework, the knowledge gained from this study will be used to assess the feasibility of VR treatment adoption into psychiatric hospitals. Methods Focus groups will be conducted with NHS staff and patients in acute psychiatric wards at 5 NHS mental health trusts across England. Staff and patients will be interviewed in separate groups. Individual interviews will also be conducted when preferred by a participant. Within each of the 5 trusts, 1 to 2 wards will be visited. A total of 8-15 staff and patients per ward will be recruited, with a minimum total of 50 staff and patients recruited across all sites. Focus group questions have been derived from the nonadoption, abandonment, and challenges to the scale-up, spread, and sustainability (NASSS) framework. Focus groups will discuss expectations of VR therapy before participants are given the opportunity to briefly try the gameChange VR therapy. Questions will then focus on opinions about the therapy and investigate feasibility of adoption, with particular consideration given to site specific issues. A thematic analysis will be conducted. Results As of May 15, 2020, 1 patient focus group has been conducted. Conclusions The study will provide unique insight from patients and staff into the potential for implementing automated VR therapy in psychiatric wards. Perspectives will be captured both on the use of immersive technology hardware and therapy-specific issues in such settings. International Registered Report Identifier (IRRID) DERR1-10.2196/20300

Background: Sleep disturbance is a common clinical issue for patients with psychosis. It has been identified as a putative causal factor in the onset and persistence of psychotic experiences (paranoia and hallucinations). Hence sleep disruption may be a potential treatment target to prevent the onset of psychosis and reduce persistent psychotic experiences. The aim of this review is to describe developments in understanding the nature, causal role, and treatment of sleep disruption in psychosis. Method: A systematic literature search was conducted to identify studies, published in the last five years, investigating subjective sleep disruption and psychotic experiences. Results: Fifty-eight papers were identified: 37 clinical and 21 non-clinical studies. The studies were correlational (n = 38; 20 clinical, 18 non-clinical), treatment (n = 7; 1 non-clinical), qualitative accounts (n = 6 clinical), prevalence estimates (n = 5 clinical), and experimental tests (n = 2 non-clinical). Insomnia (50%) and nightmare disorder (48%) are the most prevalent sleep problems found in patients. Sleep disruption predicts the onset and persistence of psychotic experiences such as paranoia and hallucinations, with negative affect identified as a partial mediator of this relationship. Patients recognise the detrimental effects of disrupted sleep and are keen for treatment. All psychological intervention studies reported large effect size improvements in sleep and there may be modest resultant improvements in psychotic experiences. Conclusions: Sleep disruption is a treatable clinical problem in patients with psychosis. It is important to treat in its own right but may also lessen psychotic experiences. Research is required on how this knowledge can be implemented in clinical services.

Paranoia may build on negative beliefs held both about the self and others. Compassionate imagery may be one way of reducing such negative beliefs, and hence paranoia. Two studies tested this idea, one targeting compassion for the self and one targeting compassion for others. Two-hundred individuals from the general population scoring highly for paranoia were recruited. The studies used a randomised controlled experimental design, with embedded tests for mediation. Study one targeted self-compassion via creation of a compassionate coach (CC) image. Study two targeted compassion for others via loving kindness meditation (LKM). Individuals repeatedly entered neutral virtual reality social environments. Changes in compassion and paranoia were assessed. Compared to controls, the CC group increased in self-compassion (group difference = 2.12, C.I. = 1.57;2.67, p = d = 1.4) and decreased in paranoia (group difference = −1.73, C.I. = −2.48; −0.98, p = d = 0.8). Change in self-compassion explained 57% of change in paranoia. Compared to controls, the LKM group increased their compassion for others (group difference = 3.26, C.I. = 2.72;3.80, p = d = 1.7), and decreased in paranoia (group difference = −1.70, C.I. = −2.50; −0.89, p = d = 0.8). Change in compassion for others explained 67% of change in paranoia. Targeting negative beliefs about the self and others using compassionate imagery causes reductions in paranoia. Tests in clinical populations are indicated.

Anticipation of pleasure – a key aspect of hedonic experience - is a motivating factor for engaging in activities. Low levels of anticipatory pleasure and activity are found in individuals with psychosis. Cognitive factors (e.g., working memory and IQ) have been a focus of explanation for anticipation of pleasure in psychosis. However, cognitive factors do not fully account for such difficulties. It is plausible that emotional factors (e.g., depression, self-beliefs) also contribute. We examined anticipatory pleasure in relation to cognitive and emotional processes in patients with current psychosis. 128 patients with persecutory delusions in the context of non-affective psychosis completed assessments of anticipatory pleasure, cognitive functioning, emotional processes, and activity. Lower anticipatory pleasure was significantly associated with depression, insomnia, negative-self beliefs, suicidal ideation, poorer psychological wellbeing, and paranoia-related avoidance. There were no significant associations with working memory, physical activity, or meaningful activity. Emotional factors may play a more significant role than cognitive difficulties in the experience of anhedonia in psychosis. However, the cross-sectional design precludes causal inferences. Future research should examine whether, for example, improving self-concept or reducing paranoia-related avoidance leads to improvement in anticipatory pleasure in patients with psychosis.

BackgroundAdolescence can be a challenging time, characterized by self-consciousness, heightened regard for peer acceptance, and fear of rejection. Interpersonal concerns are amplified by unpredictable social interactions, both online and offline. This developmental and social context is potentially conducive to the emergence of paranoia. However, research on paranoia during adolescence is scarce.MethodOur aim was to examine the prevalence, structure, and probabilistic causal mechanisms of adolescent paranoia. A representative school cohort of 801 adolescents (11–15 y) completed measures of paranoia and a range of affective, cognitive, and social factors. A Bayesian approach with Directed Acyclic Graphs (DAGs) was used to assess the causal interactions with paranoia.ResultsParanoid thoughts were very common, followed a continuous distribution, and were hierarchically structured. There was an overall paranoia factor, with sub-factors of social fears, physical threat fears, and conspiracy concerns. With all other variables controlled, DAG analysis identified paranoia had dependent relationships with negative affect, peer difficulties, bullying, and cognitive-affective responses to social media. The causal directions could not be fully determined, but it was more likely that negative affect contributed to paranoia and paranoia impacted peer relationships. Problematic social media use did not causally influence paranoia.ConclusionsThere is a continuum of paranoia in adolescence and occasional suspicions are common at this age. Anxiety and depression are closely connected with paranoia and may causally contribute to its development. Paranoia may negatively impact adolescent peer relationships. The clinical significance of paranoia in adolescents accessing mental health services must now be established.

Paranoia builds upon feelings of vulnerability. Our clinical experience indicates that negative body image, including concerns regarding weight, may be one source feeling vulnerable and hence raise the risk of paranoia. There has been no empirical test of an association between body image and paranoia. Our aim was to provide the first test of this issue by examining in epidemiologically representative cohorts the cross-sectional associations between proxy measures of body image and paranoia. This was an initial exploration of a potentially important but overlooked issue. Data were used from 5515 participants in the US National Comorbidity Survey-Replication (NCS-R). To validate the findings, the analyses were replicated with 10,113 participants in the US National Comorbidity Survey–Adolescents (NCS-A). Concerns about weight were associated with paranoia in the NCS-R (OR = 1.48, p= 0.006, CI = 1.123, 1.955) and NCS-A (OR= 1.67, p

Background There are high rates of obesity and low self-esteem in patients with psychosis. The occurrence of negative voice content directly about appearance is therefore plausible. Derogatory comments about appearance are likely to be distressing, increase depression and contribute to social withdrawal. Aims To systematically assess the occurrence of voice content regarding appearance and identify correlates. Method Sixty patients experiencing verbal auditory hallucinations at least once a week in the context of non-affective psychosis completed a measure assessing positive and negative voice content about appearance. They also completed assessments about body image, self-esteem, psychiatric symptoms and well-being. Results Fifty-five (91.7%) participants reported hearing voices comment on their appearance. A total of 54 (90%) patients reported negative voice content about their appearance with 30 (50%) patients experienced negative appearance comments on a daily basis. The most common negative comment was ‘the voices tell me that I am ugly’ (n = 48, 80%). There were 39 (65%) patients who reported positive voice content on appearance. The most frequent positive comment was ‘I look as nice as other people’ (n = 26, 43.3%). Negative voice content about appearance was associated with body image concerns, paranoia, voice hearing severity, depression, worry, negative self-beliefs and safety-seeking behaviours. Positive appearance voice content was associated with greater body esteem and well-being and lower levels of depression and insomnia. Conclusions Voice content about appearance is very common for patients seen in clinical services. Negative voice content may reflect – and subsequently reinforce – negative beliefs about one's appearance, low self-esteem, worry and paranoia. Declaration of interest None.

BackgroundThe Green et al., Paranoid Thoughts Scale (GPTS) – comprising two 16-item scales assessing ideas of reference (Part A) and ideas of persecution (Part B) – was developed over a decade ago. Our aim was to conduct the first large-scale psychometric evaluation.MethodsIn total, 10 551 individuals provided GPTS data. Four hundred and twenty-two patients with psychosis and 805 non-clinical individuals completed GPTS Parts A and B. An additional 1743 patients with psychosis and 7581 non-clinical individuals completed GPTS Part B. Factor analysis, item response theory, and receiver operating characteristic analyses were conducted.ResultsThe original two-factor structure of the GPTS had an inadequate model fit: Part A did not form a unidimensional scale and multiple items were locally dependant. A Revised-GPTS (R-GPTS) was formed, comprising eight-item ideas of reference and 10-item ideas of persecution subscales, which had an excellent model fit. All items in the new Reference (a = 2.09–3.67) and Persecution (a = 2.37–4.38) scales were strongly discriminative of shifts in paranoia and had high reliability across the spectrum of severity (a > 0.90). The R-GPTS score ranges are: average (Reference: 0–9; Persecution: 0–4); elevated (Reference: 10–15; Persecution: 5–10); moderately severe (Reference: 16–20; Persecution:11–17); severe (Reference: 21–24; Persecution: 18–27); and very severe (Reference: 25+; Persecution: 28+). Recommended cut-offs on the persecution scale are 11 to discriminate clinical levels of persecutory ideation and 18 for a likely persecutory delusion.ConclusionsThe psychometric evaluation indicated a need to improve the GPTS. The R-GPTS is a more precise measure, has excellent psychometric properties, and is recommended for future studies of paranoia.

Background The period before the formation of a persecutory delusion may provide causal insights. Patient accounts are invaluable in informing this understanding. Aims To inform the understanding of delusion formation, we asked patients about the occurrence of potential causal factors – identified from a cognitive model – before delusion onset. Method A total of 100 patients with persecutory delusions completed a checklist about their subjective experiences in the weeks before belief onset. The checklist included items concerning worry, images, low self-esteem, poor sleep, mood dysregulation, dissociation, manic-type symptoms, aberrant salience, hallucinations, substance use and stressors. Time to reach certainty in the delusion was also assessed. Results Most commonly it took patients several months to reach delusion certainty (n = 30), although other patients took a few weeks (n = 24), years (n = 21), knew instantly (n = 17) or took a few days (n = 6). The most frequent experiences occurring before delusion onset were: low self-confidence (n = 84); excessive worry (n = 80); not feeling like normal self (n = 77); difficulties concentrating (n = 77); going over problems again and again (n = 75); being very negative about the self (n = 75); images of bad things happening (n = 75); and sleep problems (n = 75). The average number of experiences occurring was high (mean 23.5, s.d. = 8.7). The experiences clustered into six main types, with patients reporting an average of 5.4 (s.d. = 1.0) different types. Conclusions Patients report numerous different experiences in the period before full persecutory delusion onset that could be contributory causal factors, consistent with a complex multifactorial view of delusion occurrence. This study, however, relied on retrospective self-report and could not determine causality. Declaration of interest None.

Background To determine the prevalence of suicidal ideation and behaviour - and their correlates - in patients with persecutory delusions. Methods 110 patients with persecutory delusions in the context of non-affective psychosis were assessed for suicidal thoughts and behaviours over the past month. Symptom and psychological assessments were also completed. Results The severity of suicidal ideation was: no suicidal ideation (n = 26, 23.6%); wish to be dead (n = 21, 19.1%); nonspecific active suicidal thoughts (n = 14, 12.7%); suicidal thoughts with methods but no intent (n = 29, 26.4%); suicidal thoughts with intent but no specific plan (n = 13, 11.8%); and suicidal intent with plan (n = 7, 6.4%). In the past month, five patients (4.5%) had made an actual, interrupted, or aborted suicide attempt. The severity of suicidal ideation was associated with higher levels of depression, paranoia, hallucinations, anger, insomnia, negative beliefs about the self and others, pessimism, worry, and delusion safety-seeking behaviours and lower levels of psychological well-being and reward responsiveness. Severity of ideation was not associated with cannabis or alcohol use, working memory, pain, or meaningful activity levels. Conclusions Patients with persecutory delusions are typically in a severe state of psychological stress, and at risk of suicide, as indicated by very high levels of suicidal ideation. This exploratory study also identifies correlates of suicidal ideation that could be investigated in causal research designs.

Background: Treatment approaches for patients with psychosis need major improvement. Our approach to improvement is twofold: target putative causal mechanisms for psychotic experiences that are treatable and that patients wish treated. This leads to greater treatment engagement and clinical benefit. To inform mental health service provision we assessed the presence of treatable causal mechanisms and patient treatment preferences. Methods: Patients with non-affective psychosis attending NHS mental health services completed assessments of paranoia, hallucinations, anxious avoidance, worry, self-esteem, insomnia, analytic reasoning, psychological well-being, and treatment preferences. Results: 1809 patients participated. Severe paranoia was present in 53.4% and frequent voices in 48.2%. Of the causal mechanisms, severe worry was present in 67.7%, avoidance at agoraphobic levels in 64.5%, analytic reasoning difficulties in 55.9%, insomnia in 50.1%, poor psychological well-being in 44.3%, strongly negative self-beliefs in 36.6%, and weak positive self-beliefs in 19.2%. Treatment target preferences were: feeling happier (63.2%), worrying less (63.1%), increasing self-confidence (62.1%), increasing activities (59.6%), improving decision-making (56.5%), feeling safer (53.0%), sleeping better (52.3%), and coping with voices (45.3%). Patients with current paranoia and/or hallucinations had higher levels of the causal factors and of wanting these difficulties treated. Conclusions: Patients with non-affective psychosis have high levels of treatable problems such as agoraphobic avoidance, worry, low self-esteem, and insomnia and they would like these difficulties treated. Successful treatment of these difficulties is also likely to decrease psychotic experiences such as paranoia.

Objective Persecutory delusions typically build on feelings of inter-personal vulnerability linked to negative views of the self. Negative body image is an overlooked aspect of this link between the self-concept and paranoia. Design This study explores body image from the first-person perspective of patients with persecutory delusions. Method Semi-structured interviews, analysed using interpretative phenomenological analysis, were conducted with twelve patients with persecutory delusions in the context of psychotic disorders. Results Four super-ordinate themes emerged. First, appearance as a source of threat accounted for how negative body image increased feelings of vulnerability and fed into the content of paranoia and voices (e.g., ‘I feel that everybody is noticing that I'm getting bigger and bigger and laughing at me’). Second, there was the negative impact of uncontrollable and unwanted weight gain, especially following antipsychotic medication (e.g., ‘I ballooned up to 23 stone’). Third, feeling stuck captured the hopelessness and resignation in relation to appearance (e.g., ‘I've become so accustomed to being overweight that I've accepted it as my lot’). Finally, looking well symbolises feeling well represented the importance of appearance in determining mental well-being (e.g., ‘If I've got clean clothes and I put makeup on, at least I feel that I'm looking after myself’). Conclusions Patients with persecutory delusions described appearance-related concerns making them feel negative towards themselves, inferior to other people, and vulnerable to harm. Appearance-related distress was broader than weight gain, including dissatisfaction with skin, clothing, and attractiveness. Negative body image may be a contributory factor in the occurrence of paranoia. Practitioner points - Body image concerns may be of particular relevance in patients with persecutory delusions due to weight gain, inactivity, and medication side effects. - Body image concerns include weight gain and broader aspects of appearance. - Negative body image contributes to feelings of vulnerability, potentially worsening paranoid fears. - It may be helpful for practitioners to explore the psychological impact of weight gain and body image concerns in patients with psychosis.

Background Precise assessment tools for psychotic experiences in young people may help identify symptoms early and facilitate advances in treatment. In this study we provide an exemplar - with a paranoia scale for youth – for improving measurement precision for psychotic experiences using item response theory (IRT). We evaluate the psychometric properties of the new measure, test for measurement invariance, and assess its potential for computerised adaptive testing (CAT). Method The 18-item Bird Checklist of Adolescent Paranoia (B-CAP) was completed by 1102 adolescents including 301 patients with mental health problems and 801 from the general population. After excluding outliers (n = 10), IRT was used to examine item properties, test reliability, and measurement invariance. The properties of an adaptive B-CAP were assessed using a simulation of 10,000 responses. Results All B-CAP items were highly discriminative (a = 1.14–2.77), whereby small shifts in paranoia led to a higher probability of item endorsement. Test reliability was high (a > 0.90) across a wide range of paranoia severity (θ = −0.45–3.36), with the greatest precision at elevated levels. All items were invariant for gender, age, and population groups. The simulated adaptive B-CAP performed with high accuracy and required only 5–6 items at higher levels of paranoia severity. Conclusions The B-CAP is a reliable assessment tool with excellent psychometric properties to assess both non-clinical and clinical levels of paranoia in young people, with potential as an efficient adaptive test. In future, these approaches could be used to develop a multidimensional CAT to assess the full range of psychotic experiences in youth.

Over the past 20 years the importance of psychological processes in psychosis has gained increasing attention. However, it is key to determine the causal status of these processes in order to inform understanding and identify treatment targets. Studies that directly manipulate a psychological mechanism provide the most robust causal evidence. This review evaluates for the first time the extent of manipulationist causal evidence for the role of specific psychological mechanisms in delusions and hallucinations. A systematic search identified controlled experiments or targeted interventions that both manipulated a specific psychological mechanism and measured the effect on individual psychotic experiences. Forty-three manipulationist studies were found of which 40 measured paranoia, 11 measured hallucinations, and two measured grandiosity. Twenty-eight studies were experiments and 15 were targeted intervention trials. Only 18 used clinical samples. Manipulation of the specified psychological mechanism was demonstrated in 35 cases. Of these, 28 found a subsequent change in a psychotic experience. Negative affect and related psychological processing in relation to paranoia have been most tested. There is a small body of direct causal evidence for the role of psychological mechanisms in psychotic experiences – that highlight important novel treatment directions – but the manipulationist approach has been used too infrequently.

Aims and method: To assess clinicians’ views about their understanding and treatment of sleep problems in people with non-affective psychosis. An online survey was emailed to adult mental health teams in two NHS trusts.\ud \ud Results: One hundred and eleven clinicians completed the survey. All clinicians reported disrupted sleep in their patients, and endorsed the view that sleep and psychotic experiences each exacerbate the other. However, most clinicians (n = 92, 82%) assessed sleep problems informally, rather than using standard assessment measures. There was infrequent use of the recommended cognitive-behavioural treatments for sleep problems such as persistent insomnia, with the approaches typically used being sleep hygiene and medications instead.\ud \ud Clinical implications: Clinicians recognise the importance of sleep in psychosis, but the use of formal assessments and recommended treatments is limited. Barriers to treatment implementation identified by the clinicians related to services (e.g. lack of time), patients (e.g. their lifestyle) and environmental features of inpatient settings.

We view sleep disruption as a contributory causal factor in the development of psychotic experiences. Clinical trials indicate that psychological interventions targeting insomnia result in improvements in both sleep and psychotic experiences. The aim of this study was to gain the perspective of young people at ultra-high risk of psychosis on their sleep problems and associated psychological treatment. Interviews were conducted with 11 patients, aged 15–22 years, at ultra-high risk of psychosis who had received a psychological sleep intervention. Responses were analyzed using thematic analysis. Disrupted sleep timing and a lack of routine were the characteristic hallmarks of participants' sleep problems. Sleep disturbance, psychological wellbeing, and functioning had a reciprocal relationship. There were negative expectations prior to therapy, however meaningful improvements occurred in sleep, mood, and functioning. The active implementation of therapy techniques was highlighted as important. These findings indicate that the treatment of sleep problems is highly valued and has a meaningful impact on wellbeing in young people at ultra-high risk of psychosis.

Paranoia may be a significant concern during adolescence, but there has been little research on excessive mistrust in young people. In this longitudinal study we set out to test the predictive ability of a number of cognitive, affective, and social factors in the early development of paranoia in a clinical adolescent population. Thirty four help-seeking adolescents, aged 11-16 years, reporting paranoid thoughts and attending mental health services were recruited. Self-report and interview assessments of paranoia were conducted at baseline. Measures relating to a cognitive model of persecutory delusions were completed. Paranoia was reassessed after three months with thirty three participants. Significant predictors of paranoia persistence were anxiety, depression, worry, negative self-beliefs, perceptual anomalies, insomnia, affective reactivity, bullying, and cyber victimization. No effect was found for reasoning bias or negative perceptions of academic ability, social competence, and physical appearance. In conclusion, many of the maintenance factors implicated in adult paranoia are likely to prove important in the early development of paranoia in young people. Further experimental and treatment studies are now needed to examine the causal role of these factors in the occurrence of paranoia in adolescents.

Background: Many patients do not respond adequately to current pharmacological or psychological treatments for psychosis. Persistent persecutory delusions are common in clinical services, and cause considerable patient distress and impairment. Our aim has been to build a new translational personalized treatment, with the potential for wide use, that leads to high rates of recovery in persistent persecutory delusions. We have been developing, and evaluating individually, brief modular interventions, each targeting a key causal factor identified from our cognitive model. These modules are now combined in “The Feeling Safe Programme”. Aims: To test the feasibility of a new translational modular treatment for persistent persecutory delusions and provide initial efficacy data. Method: 12 patients with persistent persecutory delusions in the context of non-affective psychosis were offered the 6-month Feeling Safe Programme. After assessment, patients chose from a personalized menu of treatment options. Four weekly baseline assessments were carried out, followed by monthly assessments. Recovery in the delusion was defined as conviction falling below 50% (greater doubt than certainty). Results: 11 patients completed the intervention. One patient withdrew before the first monthly assessment due to physical health problems. An average of 20 sessions (SD = 4.4) were received. Posttreatment, 7 out of 11 (64%) patients had recovery in their persistent delusions. Satisfaction ratings were high. Conclusions: The Feeling Safe Programme is feasible to use and was associated with large clinical benefits. To our knowledge this is the first treatment report focused on delusion recovery. The treatment will be tested in a randomized controlled trial.

We believe that treatments for persecutory delusions can be substantially better. Current standard psychological and pharmacological treatments have small to moderate effects. The severity of the problems associated with paranoia is typically considerable, but the treatments are less effective than those for problems such as anxiety disorders. The isolation, feelings of hopelessness, and missed opportunities for patients with persecutory delusions demand a step change in treatment outcomes.

There has been growing awareness of the high prevalence of negative cognitions about the self in patients with persecutory delusions, and it has been proposed that paranoid fears build upon these perceived vulnerabilities. This study aimed to investigate for the first time a wide range of different conceptualisations of the negative self, and to examine associations with suicidal ideation, in patients with persecutory delusions. Twenty-one patients with persecutory delusions and twenty-one non-clinical individuals completed measures relating to negative self cognitions. The delusions group also completed a measure of suicidal ideation. It was found that the patients with persecutory delusions had low self-compassion, low self-esteem, increased fears of being mad, beliefs of inferiority to others, negative self-schemas, and low positive self-schemas when compared to the non-clinical control group. The effect sizes (Cohen's d) were large, and the different conceptualisations of negative self cognitions were highly associated with one another. Self-stigma did not differ between the two groups. Furthermore, suicidal ideation was highly associated with low self-compassion, low self-esteem, fears of madness, and negative self-schema but not self-stigma. This study shows marked negative self cognitions in patients with persecutory delusions. These are likely to prove targets of clinical interventions, with patient preference most likely determining the best conceptualisation of negative self cognitions for clinicians to use.

BACKGROUND: Persecutory delusions (strong unfounded fears that others intend harm to the person) occur in more than 70 % of the patients diagnosed with schizophrenia. This major psychotic experience is a key clinical target, for which substantial improvement in treatment is needed. Our aim is to use advances in theoretical understanding to develop a much more efficacious treatment that leads to recovery in at least 50 % of people with persistent persecutory delusions. Our cognitive conceptualisation is that persecutory delusions are threat beliefs, developed in the context of genetic and environmental risk, maintained by a number of psychological processes including excessive worry, low self-confidence, intolerance of anxious affect and other internal anomalous experiences, reasoning biases, and safety-seeking strategies. The clinical implication is that safety has to be relearned, by entering the feared situations after reduction of the influence of the maintenance factors. We have been individually evaluating modules targeting causal factors. These will now be tested together as a full treatment, called The Feeling Safe Programme. The treatment is modular, personalised, and includes patient preference. We will test whether the new treatment leads to greater recovery in persistent persecutory delusions, psychological well-being, and activity levels compared to befriending (that is, controlling for therapist attention).METHODS/DESIGN: The Feeling Safe Study is a parallel group randomised controlled trial for 150 patients who have persecutory delusions despite previous treatment in mental health services. Patients will be randomised (1:1 ratio) to The Feeling Safe Programme or befriending (both provided in 20 sessions over 6 months). Standard care will continue as usual. Online randomisation will use a permuted blocks algorithm, with randomly varying block size, stratified by therapist. Assessments, by a rater blind to allocation, will be conducted at 0, 6 (post treatment), and 12 months. The primary outcome is the level of delusional conviction at 6 months. Secondary outcomes include levels of psychological well-being, suicidal ideation, and activity. All main analyses will be intention-to-treat. The trial is funded by the NHS National Institute for Health Research.DISCUSSION: The Feeling Safe study will provide a Phase II evaluation of a new targeted translational psychological treatment for persecutory delusions.TRIAL REGISTRATION: Current Controlled Trials ISRCTN18705064 (registered 11 November 2015).