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Background: Suicidal thoughts, acts, plans and deaths are considerably more prevalent in people with non-affective psychosis, including schizophrenia, compared to the general population. Social isolation and interpersonal difficulties have been implicated in pathways which underpin suicidal experiences in people with severe mental health problems. However, the interactions between psychotic experiences, such as hallucinations and paranoia, suicidal experiences, and the presence, and indeed, absence of interpersonal relationships is poorly understood and insufficiently explored. The current study sought to contribute to this understanding., Methods: An inductive thematic analysis was conducted on transcripts of 22, individual, semi-structured interviews with adult participants who had both non-affective psychosis and recent suicidal experiences. A purposive sampling strategy was used. Trustworthiness of the analysis was assured with researcher triangulation., Results: Participants relayed both positive and negative experiences of interpersonal relationships. A novel conceptual model is presented reflecting a highly complex interplay between a range of different suicidal experiences, psychosis, and aspects of interpersonal relationships. Three themes fed into this interplay, depicting dynamics between perceptions of i. not mattering and mattering, ii. becoming disconnected from other people, and iii. constraints versus freedom associated with sharing suicidal and psychotic experiences with others., Conclusion: This study revealed a detailed insight into ways in which interpersonal relationships are perceived to interact with psychotic and suicidal experiences in ways that can be both beneficial and challenging. This is important from scientific and clinical perspectives for understanding the complex pathways involved in suicidal experiences., Trial Registration: ClinicalTrials.gov (NCT03114917), 14 th April 2017. ISRCTN (reference ISRCTN17776666 .); 5 th June 2017). Registration was recorded prior to participant recruitment commencing., (© 2023. The Author(s).)

Background: There is good evidence that psychological interventions improve patient well-being and independent living, but patients on acute mental health wards often do not have access to evidence-based psychological therapies which are strongly advised by NICE guidance for severe mental health problems. The overall aim of this programme of work is to increase patient access to psychological therapies on acute mental health inpatient wards. Stage one of the programme (which is complete) aimed to identify barriers and facilitators to delivering therapy in these settings through a large qualitative study. The key output of stage one was an intervention protocol that is designed to be delivered on acute wards to increase patient access to psychologically-informed care and therapy. Stage two of the programme aims to test the effects of the intervention on patient wellbeing and serious incidents on the ward (primary outcomes), patient social functioning and symptoms, staff burnout, ward atmosphere from staff and patient perspectives and cost effectiveness of the intervention (secondary outcomes)., Methods: The study is a single blind, pragmatic, cluster randomised controlled trial and will recruit thirty-four wards across England that will be randomised to receive the new intervention plus treatment as usual, or treatment as usual only. Primary and secondary outcomes will be assessed at baseline and 6-month and 9-month follow-ups, with serious incidents on the ward collected at an additional 3-month follow-up., Discussion: The key output will be a potentially effective and cost-effective ward-based psychological intervention that increases patient access to psychological therapy in inpatient settings, is feasible to deliver in inpatient settings and is acceptable to patients., Trial Registration Number: ClinicalTrials.gov Identifier: NCT03950388. Registered 15 th May 2019. https://clinicaltrials.gov/ct2/show/NCT03950388., (© 2022. The Author(s).)

Background: Suicidal ideation is a key precursor for suicide attempts and suicide deaths. Performing routine screening of suicide precursors can help identify people who are at high risk of death by suicide. This is, arguably, an important suicide prevention effort. The aim of this study was to assess the validity, reliability, and factor structure of the Suicidal Ideation Attributes Scale (SIDAS) in a three-month longitudinal study with people with a diagnosis of schizophrenia or non-affective psychosis and experiences of suicidal ideation and/or behaviours. It was predicted that the SIDAS would have high internal consistency, test-retest reliability, convergent, discriminant and construct validity., Methods: Ninety-nine participants experiencing psychosis completed the SIDAS at baseline and 89 participants completed it 3 months later. Additionally, participants completed a demographic questionnaire, the Beck Scale for Suicide Ideation, the Beck Hopelessness Scale, and the Defeat and Entrapment Scales. The internal consistency, test-retest reliability, convergent validity, and discriminant validity of the SIDAS were investigated in comparison to other constructs. Factor analysis was performed to examine the factor structure of the scale., Results: Principal component analysis yielded a theoretically coherent one-dimensional factor structure of SIDAS, suggesting good construct validity (PCA = .71). The SIDAS had high internal consistency (α = .89) and good test-retest reliability (α = .73). It was highly correlated with other self-report measures, including the Beck Scale for Suicide Ideation, Beck Hopelessness Scale, Defeat and Entrapment scales, indicating excellent construct validity., Conclusion: The SIDAS is a valid and reliable self-report instrument for assessing the severity of suicidal ideation in a population of people with a diagnosis of schizophrenia or non-affective psychosis. Further research should test the psychometric properties of the scale in individuals experiencing different mental health problems in cross-cultural settings, in order to establish its broader validity, reliability, and clinical utility., (© 2021. The Author(s).)

Background: There is an apparent reluctance to engage 'vulnerable' participants in conversation about sensitive topics such as suicide and violence and this can often lead to a paucity of research in these areas. This study aimed to explore the experiences of male prisoners taking part in quantitative and qualitative research on suicide and violence., Methods: Participants at four male prisons completed a visual analogue scale of mood before and after data collection for both a cross-sectional study and also a qualitative interview. Participants were also asked to give three words to describe their experience of participation. A paired samples T-test was conducted to explore the difference in pre- and post-mood ratings, and content analysis was conducted to explore the positive and negative comments on participants' experiences., Results: Overall, participants' mood significantly improved after participating in a cross-sectional study about suicide and violence (from 4.8 out of 10 to 5.3, p = 0.016), and there was no significant change in mood following participation in a related qualitative study (5.1 to 5.0, p = 0.793). Participants primarily described their experiences as positive, stating that the process had been satisfying, calming, interesting, enlightening and beneficial. A smaller number of participants described their experiences as stressful, challenging, saddening, uncomfortable and bizarre., Conclusions: This study has found that researching sensitive topics such as suicide and violence with male prisoners did not have a negative impact on mood, rather that participants largely enjoyed the experience. These findings dispel the myth that research about sensitive topics with prisoners is too risky and could inform how future researchers assess levels of risk to participants., (© 2021. The Author(s).)

Background: The experience of psychosis and associated discrimination can be a barrier to forming and maintaining romantic relationships. Sexual health interventions within mental health services often focus on contraception and reducing risk. There are no known studies that seek to understand what support, if any, people who experience psychosis want regarding psychosocial aspects of intimate relationships., Methods: To address this gap in the literature, qualitative data was collected to investigate how people with experience of psychosis conceptualise romantic relationships and what support they would like in this area of their lives. Semi-structured interviews were conducted with 10 mental health service users (four women, six men) with experience of psychosis. Interviews were analysed from a critical realist social constructionism perspective using thematic analysis., Results: Stigma was a prominent theme, described as impacting numerous aspects of romantic relationships. Power imbalance within services meant participants were wary of having conversations about relationships with professionals and identified a therapeutic alliance as a prerequisite. However, abusive relationships were highlighted as a needed area for support by services., Conclusion: Services should be trauma-informed and help those in abusive relationships. The power and autonomy of people with experience of psychosis should be maintained in any discussions or interventions regarding intimate relationships. A strong therapeutic alliance is essential for any work in this area.

Background: AVATAR therapy is a novel intervention targeting distressing auditory verbal hallucinations (henceforth 'voices'). A digital simulation (avatar) of the voice is created and used in a three-way dialogue between participant, avatar and therapist. To date, therapy has been delivered over 6 sessions, comprising an initial phase, focusing on standing up to a hostile avatar, and a second phase in which the avatar concedes and focus shifts to individualised treatment targets, including beliefs about voices. The first fully powered randomised trial found AVATAR therapy resulted in a rapid and substantial fall in voice frequency and associated distress that was superior to supportive counselling at 12 weeks. The main objective of this AVATAR2 trial is to test the efficacy of two forms of AVATAR therapy in reducing voice-related distress: AVATAR-brief (standardised focus on exposure, assertiveness and self-esteem) and AVATAR-extended (phase 1 mirroring AVATAR-brief augmented by a formulation-driven phase 2). Secondary objectives include the examination of additional voice, wellbeing and mood outcomes, the exploration of mediators and moderators of therapy response, and examining cost-effectiveness of both forms of therapy compared with usual treatment (TAU)., Methods: This multi-site parallel group randomised controlled trial will independently randomise 345 individuals to receive AVATAR-brief (6 sessions) plus TAU or AVATAR-extended (12 sessions) plus TAU or TAU alone (1:1:1 allocation). Participants will be people with a diagnosis of schizophrenia spectrum and other psychotic disorders who have heard distressing voices for more than 6 months. The primary outcome is the PSYRATS Auditory Hallucinations Distress dimension score at 16 and 28 weeks, conducted by blinded assessors. Statistical analysis will follow the intention-to-treat principle and data will be analysed using linear mixed models. Mediation and moderation analyses using contemporary causal inference methods will be conducted as secondary analyses. Service costs will be calculated, and cost-effectiveness assessed in terms of quality-adjusted life years accrued., Discussion: This study will clarify optimal therapy delivery, test efficacy in a multi-site study and enable the testing of the AVATAR software platform, therapy training and provision in NHS settings., Trial Registration: ISRCTN registry ISRCTN55682735 . Registered on 22 January 2020. The trial is funded by the Wellcome Trust (WT).

Background: Suicide is a leading cause of death globally. Suicide deaths are elevated in those experiencing severe mental health problems, including schizophrenia. Psychological talking therapies are a potentially effective means of alleviating suicidal thoughts, plans, and attempts. However, talking therapies need to i) focus on suicidal experiences directly and explicitly, and ii) be based on testable psychological mechanisms. The Cognitive AppRoaches to coMbatting Suicidality (CARMS) project is a Randomised Controlled Trial (RCT) which aims to investigate both the efficacy and the underlying mechanisms of a psychological talking therapy for people who have been recently suicidal and have non-affective psychosis., Methods: The CARMS trial is a two-armed single-blind RCT comparing a psychological talking therapy (Cognitive Behavioural Suicide Prevention for psychosis [CBSPp]) plus Treatment As Usual (TAU) with TAU alone. There are primary and secondary suicidality outcome variables, plus mechanistic, clinical, and health economic outcomes measured over time. The primary outcome is a measure of suicidal ideation at 6 months after baseline. The target sample size is 250, with approximately 125 randomised to each arm of the trial, and an assumption of up to 25% attrition. Hence, the overall recruitment target is up to 333. An intention to treat analysis will be used with primary stratification based on National Health Service (NHS) recruitment site and antidepressant prescription medication. Recruitment will be from NHS mental health services in the North West of England, UK. Participants must be 18 or over; be under the care of mental health services; have mental health problems which meet ICD-10 non-affective psychosis criteria; and have experienced self-reported suicidal thoughts, plans, and/or attempts in the 3 months prior to recruitment. Nested qualitative work will investigate the pathways to suicidality, experiences of the therapy, and identify potential implementation challenges beyond a trial setting as perceived by numerous stake-holders., Discussion: This trial has important implications for countering suicidal experiences for people with psychosis. It will provide definitive evidence about the efficacy of the CBSPp therapy; the psychological mechanisms which lead to suicidal experiences; and provide an understanding of what is required to implement the intervention into services should it be efficacious., Trial Registration: ClinicalTrials.gov (NCT03114917), 14th April 2017. ISRCTN (reference ISRCTN17776666 https://doi.org/10.1186/ISRCTN17776666); 5th June 2017). Registration was recorded prior to participant recruitment commencing.

Background: Suicide is a global problem and suicidal behavior is common in acute psychiatric wards. Inpatient suicides regularly occur with 10.4/100,000 such deaths recorded in the UK in 2016. Inpatient suicides are potentially the most avoidable of all suicides as inpatients have 24-h staff contact. Current inpatient treatment prioritizes maintenance of physical safety by observation, medication and general supportive measures, however efficacious and effective specific treatments are lacking. Psychological treatments have a growing evidence base for suicide prevention yet provision of inpatient therapy is uncommon. The present qualitative study aimed to understand the patient acceptability issues by investigating suicidal inpatients views and expectations of a novel suicide-focussed cognitive behavioural psychological therapy which was nested alongside a pilot clinical trial of the intervention., Methods: Thematic analysis of semi-structured individual qualitative interviews with twenty suicidal psychiatric inpatients to investigate their views and expectations about ward-based suicide-focused psychological treatment., Results: Two main themes were identified. The first, 'A therapy that works', revealed inpatients' views of the necessary components for effective ward-based suicide-focused psychological therapy. The second, 'Concerns about in-patient suicide-focused therapy', depicted their fears about engaging in this treatment. Results suggested that suicide-focused psychological therapy was cautiously welcomed by inpatients' whose narratives expressed their needs, priorities and concerns. Further data analysis enabled formation of a user-informed model of suicide-focussed psychological therapy which offers guidance for researchers and clinicians., Conclusions: We conclude that hospitalization of suicidal individuals offers a critical opportunity to intervene with effective treatment to preserve life and that suicide-focussed psychological therapy is likely to be well received by suicidal inpatients warranting further testing with a sufficiently powered definitive trial. It is important that provision of ward-based psychological therapy for suicidal inpatients addresses the considerable context-specific challenges inherent in this setting., Trial Registration Number: ISRCTN 17890126 , Registry: UK Clinical Trials Gateway, Date of registration: 22/04/15, Date of enrolment of first participant to the trial: 20/05/14 (retrospectively registered).

Background: Suicide is a major cause of preventable death, and suicidal behaviour is prevalent in acute psychiatric wards. People admitted to acute psychiatric wards often experience repeated episodes of suicidal behaviour, causing great distress and heavy use of NHS services. There is little research investigating effective psychological treatments for suicidal patients in inpatient settings although previous research has found support for psychological therapies which specifically target suicidal behaviour. This paper describes the protocol of a single blind RCT to investigate the acceptability and feasibility of a cognitive behavioural intervention targeting suicidality (CBSP) for suicidal people in acute psychiatric wards., Methods/design: A single blind RCT comparing treatment as usual (TAU) to TAU plus Cognitive Behavioural Suicide Prevention (CBSP) therapy (TAU + CBSP). Sixty participants (aged 18-65 years) who are suicidal, or have been within the past 3 months, will be recruited from NHS trusts in the North West of England. Our primary objective is to determine whether CBSP is feasible, acceptable and efficacious when compared to patients who receive TAU alone. Secondary aims are the impact of CBSP on suicidal thinking, behaviours, functioning, quality of life, service use and psychological factors associated with suicide. Assessments take place at baseline, 6 weeks and 6 months (end of treatment). The analysis will report on the feasibility and acceptability of CBSP. Qualitative data from staff and service users will inform feasibility and acceptability data., Discussion: Psychiatric inpatients are a high-risk group and the use of psychological therapies in these settings is rare and requires evaluation. This study is essential to investigate the unique contextual challenges involved in delivering psychological therapy to suicidal inpatients and to identify any necessary modifications required within inpatient settings. The findings will inform a larger, definitive trial., Trial Registration: 15 March 2012, PB-PG-1111-26026, NIHR ISRCTN17890126 .

Background: Cognitive behaviour therapy (CBT) is recommended for the treatment of psychosis; however, only a small proportion of service users have access to this intervention. Smartphone technology using software applications (apps) could increase access to psychological approaches for psychosis. This paper reports the protocol development for a clinical trial of smartphone-based CBT., Methods/design: We present a study protocol that describes a single-blind randomised controlled trial comparing a cognitive behaviour therapy-informed software application (Actissist) plus Treatment As Usual (TAU) with a symptom monitoring software application (ClinTouch) plus TAU in early psychosis. The study consists of a 12-week intervention period. We aim to recruit and randomly assign 36 participants registered with early intervention services (EIS) across the North West of England, UK in a 2:1 ratio to each arm of the trial. Our primary objective is to determine whether in people with early psychosis the Actissist app is feasible to deliver and acceptable to use. Secondary aims are to determine whether Actissist impacts on predictors of first episode psychosis (FEP) relapse and enhances user empowerment, functioning and quality of life. Assessments will take place at baseline, 12 weeks (post-treatment) and 22-weeks (10 weeks post-treatment) by assessors blind to treatment condition. The trial will report on the feasibility and acceptability of Actissist and compare outcomes between the randomised arms. The study also incorporates semi-structured interviews about the experience of participating in the Actissist trial that will be qualitatively analysed to inform future developments of the Actissist protocol and app., Discussion: To our knowledge, this is the first controlled trial to test the feasibility, acceptability, uptake, attrition and potential efficacy of a CBT-informed smartphone app for early psychosis. Mobile applications designed to deliver a psychologically-informed intervention offer new possibilities to extend the reach of traditional mental health service delivery across a range of serious mental health problems and provide choice about available care., Trial Registration: ISRCTN34966555. Date of first registration: 12 June 2014.

Introduction: The aims of these studies were to identify the cytokine and chemokine expression profile of nucleus pulposus (NP) cells and to determine the relationships between NP cell cytokine and chemokine production and the characteristic tissue changes seen during intervertebral disc (IVD) degeneration., Methods: Real-time q-PCR cDNA Low Density Array (LDA) was used to investigate the expression of 91 cytokine and chemokine associated genes in NP cells from degenerate human IVDs. Further real-time q-PCR was used to investigate 30 selected cytokine and chemokine associated genes in NP cells from non-degenerate and degenerate IVDs and those from IVDs with immune cell infiltrates (‘infiltrated’). Immunohistochemistry (IHC) was performed for four selected cytokines and chemokines to confirm and localize protein expression in human NP tissue samples., Results: LDA identified the expression of numerous cytokine and chemokine associated genes including 15 novel cytokines and chemokines. Further q-PCR gene expression studies identified differential expression patterns in NP cells derived from non-degenerate, degenerate and infiltrated IVDs. IHC confirmed NP cells as a source of IL-16, CCL2, CCL7 and CXCL8 and that protein expression of CCL2, CCL7 and CXCL8 increases concordant with histological degenerative tissue changes., Conclusions: Our data indicates that NP cells are a source of cytokines and chemokines within the IVD and that these expression patterns are altered in IVD pathology. These findings may be important for the correct assessment of the ‘degenerate niche’ prior to autologous or allogeneic cell transplantation for biological therapy of the degenerate IVD.

Background: Mental health problems commonly begin in adolescence when the majority of people are living with family. This can be a frightening time for relatives who often have little knowledge of what is happening or how to manage it. The UK National Health Service has a commitment to support relatives in order to reduce their distress, but research studies have shown that this can lead to a better outcome for service users as well. Unfortunately, many relatives do not get the kind of support they need. We aim to evaluate the feasibility, acceptability and effectiveness of providing and supporting a Relatives' Education and Coping Toolkit (REACT) for relatives of people with recent onset psychosis., Methods: The study is a randomised control trial. Trial Registration for Current Controlled Trials ISRCTN69299093. Relatives of people receiving treatment from the Early Intervention Service for psychosis are randomly allocated to receive either Treatment As Usual (TAU) or TAU plus the REACT intervention. The main aims of the study are to: (i) determine the acceptability of a supported self-management intervention; (ii) determine preference for type of support; (iii) assess the feasibility of the design; (iv) identify the barriers and solutions to offering support for self-management approaches within the NHS; (v) estimate the likely effect size of the impact of the intervention on outcome for relatives; (vi) gain detailed feedback about the barriers and solutions to using a self-management approach; (vii) describe the way in which the intervention is used. Outcomes will be assessed from baseline and at 6 month follow-up., Discussion: The intervention is compared to current treatment in a sample of participants highly representative of relatives in routine early intervention services across the UK. The intervention is protocolised, offered within routine practice by existing staff and extensive process data is being collected. Randomisation is independent; all assessments are made by blind raters. The limitations of the study are the lack of control over how the intervention is delivered, the short follow-up period, and the lack of assessment of service user outcomes. Despite these, the findings will inform future effectiveness trials and contribute to the growing evidence base for supported self-mangement interventions in mental health.