Effects of Actissist, a digital health intervention for early psychosis: A randomized clinical trial.

Schizophrenia affects 24 million people worldwide. Digital health interventions drawing on psychological principles have been developed, but their effectiveness remains unclear. This parallel, assessor-blinded, randomized clinical trial aimed to investigate whether a cognitive behaviour therapy-informed digital health intervention (Actissist app) confers added benefit on psychotic symptoms over and above remote symptom monitoring (ClinTouch app). Participants recruited from UK community health services were randomized 1:1 to receive either Actissist plus treatment as usual (TAU) or ClinTouch plus TAU. Eligible participants were adults with schizophrenia-spectrum psychosis within five years of first episode onset meeting a criterion level of positive symptoms severity. The primary outcome was Positive and Negative Syndrome Scale (PANSS) symptoms total score at 12 weeks post-randomization. Intention-to-treat analysis included 172 participants, with 149 participants (86.6 %) providing primary outcome data. Actissist plus TAU was not associated with greater reduction than an active control remote symptom monitoring app (ClinTouch) in PANSS total score at post-randomization. There were no significant effects between groups across secondary measures. There were no serious adverse reactions. Both groups improved on the primary psychotic symptoms measure at primary end-point and on secondary measures over time. The Actissist app is safe but not superior to digital symptom monitoring.

"If You Don't Eat, You Can Get Drunk Faster": A Qualitative Investigation of Food and Alcohol Disturbance (FAD) Expectancies.

Background: Food and alcohol disturbance (FAD; i.e., use of any compensatory behavior within the context of a drinking episode to offset alcohol-related calories and/or enhance the effects of alcohol) is prevalent among U.S. college students and associated with negative consequences. Expectancies for anticipated outcomes of alcohol use and thinness/restriction behaviors, which comprise FAD, serve as promising targets of intervention for these behaviors individually; however, no study to date has identified or examined FAD expectancies, specifically. Objectives: The purpose of this study was to qualitatively examine the positive and negative FAD expectancies described by students experienced with FAD. Methods: Semi-structured open-ended interviews were conducted with 22 undergraduates with a lifetime history of FAD behavior (72.7% female, 77.3% white non-Hispanic, Mage=20.14). Results: Positive FAD expectancy themes included: Mood Improvement, Appearance/Weight-related Benefits, Alcohol Enhancement, and Social Approval and Connectedness. Negative FAD expectancy themes included: Reputational and Social Concerns, Negative Physical Consequences, Negative Psychological Consequences, and Cognitive and Behavioral Impairment. Conclusions: Results suggest that while there are many similarities, FAD expectancies are distinct from existing alcohol and thinness/restriction expectancies. Specifically, the Mood Improvement theme conceptualizes mood-related improvement within the context of both positive and negative reinforcement and both the Social Approval and Connectedness and Social and Reputational Consequences themes focus on the ways in which one's peers may view and interact with others. Findings lay the groundwork for identifying expectancies that underlie FAD behaviors and provide directions for future research and intervention efforts.

Examining the Relation Between Social Anxiety and Cannabis Problems Among College Students Through Coping-Related Expectancies and Motives.

Objective: College students high in social anxiety are at increased risk for cannabis-related problems. This may be particularly true when they hold strong coping-related expectancies and motives for cannabis. However, few studies have examined these constructs together in accordance with the motivational model, which posits that substance use is proximally influenced by motives and more distally influenced by expectancies. Thus, the current study examined whether the relation between social anxiety and cannabis-related problems was indirectly explained through coping-related expectancies, motives, and cannabis use. Method: Past-month cannabis users (N = 660; 71.6% female, 47.3% white non-Hispanic) from seven U.S. universities completed an online survey assessing social anxiety, and cannabis use frequency, problems, expectancies, and motives. A saturated path model examined social anxiety as a predictor of cannabis problems via coping-related expectancies and motives, and cannabis frequency. Results: There was a positive indirect effect of social anxiety on cannabis problems through cognitive and behavioral impairment expectancies, depression coping motives, and cannabis use. Social anxiety also indirectly positively related to cannabis problems via social and sexual facilitation expectancies, social anxiety coping motives, and cannabis use. Further, social anxiety indirectly positively related to cannabis problems through relaxation and tension reduction expectancies, both depression and social anxiety coping motives, and cannabis use. These indirect effects were invariant by sex assigned at birth. Conclusions: Results support using a theory-informed model of coping-related cannabis cognitions to understand the relation between social anxiety and cannabis problems. Interventions that modify coping-related cognitions may reduce cannabis-related problems in college students high in social anxiety.

Understanding the Factors That Contribute to Creating a Collaborative Psychological Formulation: A Qualitative Systematic Review.

OBJECTIVES: Creating a formulation is one of the key competencies of a clinical psychologist and is understood to be important for guiding therapeutic input and understanding client distress. However, client experience of formulations can vary, with some reporting it is unhelpful and distressing. This novel review explores the experiences of clinicians and clients when creating a formulation, specifically the barriers and facilitators to collaborating on a formulation. This ultimately aims to improve client experience and engagement in formulation. METHODS: A systematic search of PubMed, Web of Science, PsycINFO and EMBASE was conducted using PRISMA guidelines. The protocol was registered on PROSPERO. This search was conducted using terms related to 'psychological formulation' and 'experience'. Nineteen qualitative papers met inclusion criteria and were appraised using the Critical Appraisal Skills Programme. Findings that pertained to formulation were thematically synthesised. RESULTS: Three analytical themes were identified: toleration of the formulation process-'a necessary evil', which highlights the potential emotional impact of formulation on the client and indicates the importance of responding to client readiness and expectations of formulation; development of the therapeutic relationship-'it's like a two way thing, isn't it?', which suggests that client empowerment, adapting to client needs and clinicians creating a safe and containing environment facilitated the formulation process; systemic factors-'walking a tightrope', which highlights the constraints of resources and team dynamics in therapists' ability to engage in collaborative formulation. CONCLUSION: Facilitators to a collaborative formulation include the following: simple formulations, thorough assessment and preparation for formulation, 'doing with' activities such as timelines and diagrams and working environments that include supportive colleagues and time for reflection and training.

Risk factors for vascular injuries in anterior lumbar interbody fusion: a single-institution retrospective study.

OBJECTIVE: Vascular injuries in anterior lumbar interbody fusion (ALIF) occur due to the vascular manipulation needed to achieve optimal disc space exposure. In this study, the authors aimed to evaluate intraoperative vascular injuries in patients undergoing single- and multilevel ALIF at a large tertiary academic center. METHODS: Prospectively collected data specifically addressing postoperative complications in patients who underwent ALIF by neurosurgery spine faculty working with a specialized vascular surgeon were retrospectively reviewed. Demographic characteristics and intraoperative data were collected. Patients were split into vascular injury and non-vascular injury groups. Outcome comparisons were conducted using the chi-square exact and Wilcoxon rank-sum tests for categorical and continuous data, respectively. Logistic regression was used to investigate associations with vascular injury, with univariate analysis first conducted to identify candidate associations. Based on these results, variables demonstrating a between-groups test statistic of p < 0.10 were included in the multivariate analysis to determine the independent predictors of vascular injuries. RESULTS: In total, 323 patients who underwent ALIF procedures were identified: 51% were male (n = 166) and 49% were female (n = 157). The mean age was 57.1 years, with 56% (n = 182) having undergone prior lumbar surgery. Vascular injuries were encountered intraoperatively in 7.1% (n = 23) of patients, and the majority (91% [n = 21]) involved the left common iliac vein. Patients with vascular injuries were statistically older (mean 63.6 vs 56.6 years), had greater incidence rates of coronary artery disease, opioid use, multilevel ALIF surgery involving the L2-3 level, and surgery involving multiple disc spaces, had more multilevel anterior instrumentation, and experienced greater blood loss during surgery and longer length of stay (all p < 0.05). Overall, there was 1 death (0.3%) secondary to aortic artery injury. Multivariate analysis identified opioid use, multilevel ALIF involving L2-3, and multiple interbodies as statistically independent predictors of vascular injury (all p < 0.05). CONCLUSIONS: Identifying patient risk factors can reduce the risk of vascular injuries in ALIF. Opioid use, multilevel ALIF involving L2-3, and multiple interbodies were independent predictors of vascular injuries in ALIF.

The Effect of the Coronavirus Disease 2019 Pandemic on Pituitary Surgery.

OBJECTIVE: As the coronavirus disease 2019 (COVID-19) pandemic spread to the United States in 2020, there was an impetus toward postponing or ceasing nonurgent transsphenoidal pituitary surgeries to prevent the spread of the virus. Some centers encouraged transcranial approaches for patients with declining neurologic function. However, no large-scale data exist evaluating the effects that this situation had on national pituitary practice patterns. METHODS: Pituitary surgeries in the National Inpatient Sample were identified from 2017 to 2020. Surgeries in 2020 were compared with the 3 years previously to determine any differences in demographics, surgical trends/approaches, and perioperative outcomes. RESULTS: In 2020, there was a decline in overall pituitary surgeries (34.2 vs. 36.3%; odds ratio (OR), 0.88; P < 0.001) yet transsphenoidal approaches represented a higher proportion of interventions (69.0 vs. 64.9%; P < 0.001). Neurosurgical complications were higher (51.9 vs. 47.4%; OR, 1.13; P < 0.001) and patients were less likely to be discharged home (86.4 vs. 88.5%; OR, 0.84; P < 0.001). This finding was especially true in April 2020 during the first peak in COVID-19 cases, when transcranial approaches and odds of mortality/complications were highest. CONCLUSIONS: In 2020, transsphenoidal surgery remained the preferred approach for pituitary tumor resection despite initial recommendations against the approach to prevent COVID-19 spread. Pituitary surgeries had a higher risk of periprocedural complications despite accounting for preoperative comorbidities, COVID-19 infection status, and surgical approach, suggesting that an overwhelmed hospital system can negatively influence surgical outcomes in noninfected patients.

Generation of single-cysteine E. coli ProQ variants to study RNA-protein interaction mechanisms.

ProQ is a FinO-domain protein found in E. coli and other proteobacteria that has a global RNA-binding profile. In order to probe the detailed mechanism of RNA interactions, we have developed a collection of 13 E. coli ProQ variants that possess single-cysteine residues at varied positions on the surface of the N-terminal FinO domain and retain the ability to bind well to RNA. This set of variant ProQ proteins will support future biochemical and biophysical studies to map the orientation of bound RNAs to different sites around the ProQ protein, shedding light on the mechanism of ProQ-RNA interactions.

Co-producing digital mental health interventions: A systematic review.

Objective: Smartphone apps (apps) are widely recognised as promising tools for improving access to mental healthcare. However, a key challenge is the development of digital interventions that are acceptable to end users. Co-production with providers and stakeholders is increasingly positioned as the gold standard for improving uptake, engagement, and healthcare outcomes. Nevertheless, clear guidance around the process of co-production is lacking. The objectives of this review were to: (i) present an overview of the methods and approaches to co-production when designing, producing, and evaluating digital mental health interventions; and (ii) explore the barriers and facilitators affecting co-production in this context. Methods: A pre-registered (CRD42023414007) systematic review was completed in accordance with The Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. Five databases were searched. A co-produced bespoke quality appraisal tool was developed with an expert by experience to assess the quality of the co-production methods and approaches. A narrative synthesis was conducted. Results: Twenty-six studies across 24 digital mental health interventions met inclusion criteria. App interventions were rarely co-produced with end users throughout all stages of design, development, and evaluation. Co-producing digital mental health interventions added value by creating culturally sensitive and acceptable interventions. Reported challenges included resource issues exacerbated by the digital nature of the intervention, variability across stakeholder suggestions, and power imbalances between stakeholders and researchers. Conclusions: Variation in approaches to co-producing digital mental health interventions is evident, with inconsistencies between stakeholder groups involved, stage of involvement, stakeholders' roles and methods employed.

Infrasellar Nasopharyngeal Craniopharyngiomas: An Individual Participant Data Meta-Analysis and Review of the Literature.

BACKGROUND: Craniopharyngiomas are benign tumors of the anterior skull base arising from epithelial remnants of Rathke pouch. They mainly occur in the suprasellar space, can be incredibly debilitating, and remain difficult to resect as they frequently involve critical neurovascular structures. Although it is embryologically possible for craniopharyngiomas to arise extracranially along the entire migrational path of Rathke pouch, these remain exceedingly rare, especially among adults, and can be mistaken for nasopharyngeal cancer. As such, minimal data exist evaluating the management and outcomes of such lesions. We evaluated our institutional experience with purely infrasellar nasopharyngeal craniopharyngiomas and obtained individual patient data reported in the contemporary literature to better characterize the demographics, presentation, surgical management, and long-term outcomes of these lesions. METHODS: A systematic review of the literature was performed to identify previously published cases of purely infrasellar nasopharyngeal craniopharyngioma in 3 electronic databases: MEDLINE (PubMed), Embase, and Scopus. Search terms were "infrasellar craniopharyngioma" and "nasopharyngeal craniopharyngioma." RESULTS: We identified 25 cases, in which 72% of patients presented with symptoms of nasal obstruction, epistaxis, or headache. An endoscopic approach was performed in 40% of cases; 83.3% of all patients had gross total resection, with 60% having no recurrence at a median follow-up of 13 months. No postoperative complications were reported. Tumor location involving the cavernous sinus was associated with incomplete resection (100%) compared with tumors not involving the cavernous sinus (87%) (P = 0.033). CONCLUSIONS: While uncommon, infrasellar nasopharyngeal craniopharyngiomas appear to have better perioperative and long-term surgical outcomes than their suprasellar counterparts.

The revised Psychosis Attachment Measure: further psychometric evidence.

PURPOSE: Disorganised attachment is a key concept in understanding the development of psychosis. However, existing questionnaires of adult attachment do not adequately measure this construct hindering future research into the psychosocial causes of psychosis. The most widely measure of adult attachment in people experiencing psychosis is the Psychosis Attachment Measure (PAM). The measure has recently been revised to include disorganised attachment items. This study develops previous research by providing a rigorous examination the psychometric properties of the revised questionnaire (PAM-R). METHODS: A total of 407 participants with self-reported experiences of psychosis completed a battery of questionnaires which included the PAM-R and other measures which were conceptually related to the concept of disorganised attachment. RESULTS: Confirmatory factor analysis (CFA) indicated a three-factor solution with factors corresponding to anxious, avoidant, and disorganised attachment. The majority of the fit statistics were acceptable with the exception of the RMSEA statistic. Internal consistency and test-retest reliability were good for all subscales. The disorganised subscale correlated in expected directions with other measures of attachment, dissociation, trauma, and psychotic experiences. CONCLUSION: The PAM-R is a valid and reliable measure of adult attachment. It is a practical assessment tool for clinicians and researchers to measure insecure and disorganised attachment patterns that is acceptable to people experiencing psychosis.

Widening the Operative Corridor-Evaluating the Transcortical Approach to Giant Falcine Meningiomas.

BACKGROUND: Giant falcine meningiomas are surgically complex as they are deep in location, concealed by normal brain parenchyma, in close proximity to various neurovascular structures, and frequently involve the falx bilaterally. Although classically accessed using a bifrontal craniotomy and interhemispheric approach, little data exist on alternative operative corridors for these challenging tumors. We evaluated perioperative and long-term outcomes in patients undergoing transcortical resection of giant bilateral falcine meningiomas. METHODS: From 2013 to 2022, fourteen patients with giant bilateral falcine meningiomas treated via a transcortical approach at our institution were identified. Perioperative and long-term outcomes were evaluated to determine predictors of adverse events. Corticectomy depth was also analyzed to determine if it correlated with increased postoperative seizure rates. RESULTS: 57.1% of cases were WHO grade 2 meningiomas. Average tumor volume was 77.8 ± 46.5 cm3 and near/gross total resection was achieved in 78.6% of patients. No patient developed a venous infarct or had seizures in the 6 months after surgery. Average corticectomy depth was 0.83 ± 0.71 cm and increasing corticectomy depth did not correlate with higher risk of postoperative seizures (P = 0.44). Increasing extent of tumor resection correlated with lower tumor grade (P = 0.011) and only 1 patient required repeat resection during a median follow-period of 24.9 months. CONCLUSIONS: The transcortical approach is a safe alternative corridor for accessing giant, falcine meningiomas, and postoperative seizures were not found to correlate with increasing corticectomy depth. Further prospective studies are necessary to determine the best approach to these surgically complex lesions.

The key components of a clinical psychology formulation: A consensus study.

OBJECTIVE: Psychological formulation is a key competency for clinical psychologists. However, there is a lack of consensus regarding the key components and processes of formulation that are hypothesized to contribute to poor reliability of formulations. The aim of this study was to develop consensus on the essential components of a formulation to inform training for clinical psychologists and best practice guidelines. METHODS: A Delphi methodology was used. Items were generated from the literature and discussed and refined with a panel of experts (n = 10). In round one, 110 clinical psychologists in the United Kingdom rated the importance of components of formulation via an online questionnaire. Criteria for consensus were applied and statements were rerated in round two if consensus was not achieved. RESULTS: Consensus was achieved on 30 items, with 18 statements regarding components of a formulation and 12 statements regarding formulation process. Items that clinicians agreed upon emphasized the importance of integrating sociocultural, biological, strengths and personal meaning alongside well-established theoretical frameworks. Consensus was not reached on 20 items, including whether a formulation should be parsimonious or adhere to a model. CONCLUSION: Our findings provide mixed evidence regarding consensus on the key components of formulation. There was an agreement that formulation should be client-led and incorporate strengths and sociocultural factors. Further research should explore client perspectives on the key components of formulation and how these compare to the clinicians' perspectives.

Working alliance in treating staff and patients with Schizophrenia Spectrum Disorder living in Residential Facilities.

OBJECTIVES: Working Alliance (WA) is important in the care of patients with Schizophrenia Spectrum Disorders (SSD). This study aims to determine which sociodemographic and clinical factors are associated with WA, as assessed by patients and staff members in Residential Facilities (RFs), and may predict WA dyads' discrepancies. METHODS: Three hundred and three SSD patients and 165 healthcare workers were recruited from 98 RFs and characterized for sociodemographic features. WA was rated by the Working Alliance Inventory (WAI) for patients (WAI-P) and staff members (WAI-T). SSD patients were assessed for the severity of psychopathology and psychosocial functioning. RESULTS: Pearson's correlation revealed a positive correlation (ρ = .314; p < .001) between WAI-P and WAI-T ratings. Linear regression showed that patients with higher education reported lower WAI-P ratings (ß = -.50, p = .044), while not being engaged in work or study was associated with lower WAI-T scores (ß = -4.17, p = .015). A shorter lifetime hospitalization was associated with higher WAI-P ratings (ß = 5.90, p = .008), while higher psychopathology severity negatively predicted WAI-T (ß = -.10, p = .002) and WAI-P ratings (ß = -.19, p < .001). Better functioning level positively foresaw WAI-T (ß = .14, p < .001) and WAI-P ratings (ß = .12, p < .001). Regarding discrepancies, staff members' age was associated with higher dyads discrepancy in Total scale and Agreement subscale scores, which were also associated with more severe negative symptoms, while patients' age was negatively correlated to Relationship subscale discrepancy. CONCLUSIONS: This study provides insight into the factors that influence WA in SSD patients and health workers in RFs. The findings address interventions to improve WA and ultimately patient outcomes.

Rathke's cleft cysts causing Cushing's disease: Two unique cases and review of the literature.

Background: The presentation of isolated Rathke's cleft cysts (RCC) without any associated pituitary adenoma in patients with symptoms consistent with Cushing's disease (CD) remains exceedingly rare. As such, we aim to present two cases of RCC presenting with CD with a resultant resolution of their CD following surgical resection. Case Description: Here, we present two cases of RCCs presenting with symptoms suggestive of CD. A functional pituitary microadenoma was the presumed diagnosis based on initial clinical presentation and diagnostic imaging suggesting a pituitary lesion. However, pathology results demonstrated no evidence of adenoma but cysts lined with columnar epithelia consistent with RCC. Complete surgical resection was achieved in both patients through endoscopic endonasal pituitary resection with postoperative symptomatic resolution and normalization of cortisol levels. In addition, we discuss the literature on this rare presentation and suggest a pathological mechanism for this unique presentation of RCC-causing CD. Conclusion: Surgical resection of RCC may provide a "biochemical cure" for patients presenting with CD, as demonstrated by these two unique cases. The clinical features, histological findings, and possible pathological mechanisms for this unique presentation of RCC causing CD discussed lay the groundwork for future studies into the pathophysiology of RCC and CD.

Staff support for workplace trauma: a freedom of information act request survey for NHS trusts providing mental health care in England.

INTRODUCTION: Workplace trauma in mental health settings is defined as exposure to verbal and physical aggression, witnessing self-harm or hearing about patients' histories of abuse. Support for workplace trauma is important for staff well-being, staff retention and ultimately patient care. Assessing the extent and adequacy of staff support for workplace trauma in mental health settings is important in identifying areas of need and good practice. AIM: To determine what staff support systems are in place for workplace trauma in mental health services across England. METHODS: Freedom of Information Act requests were sent to all 57 National Health Service Trusts providing mental health care in England to identify policies on the support to mental health staff after traumatic incidents that they have experienced in the course of their clinical duties. RESULTS: Fifty-five Trusts provided usable data. Only half provided evidence of a psychologically informed incident response that went beyond a fact-finding exercise and only a fifth of Trusts used an established model for the response process. A small proportion of policies acknowledged workplace traumas related to staff discrimination on the basis of protected characteristics. CONCLUSION: There is insufficient attention to supporting mental health staff with the effects of workplace trauma.

User engagement in a randomised controlled trial for a digital health intervention for early psychosis (Actissist 2.0 trial).

Digital Health Interventions (DHIs) can help support people with mental health problems. Achieving satisfactory levels of patient engagement is a crucial, yet often underexplored, pre-requisite for health improvement. Actissist is a co-produced DHI delivered via a smartphone app for people with early psychosis, based on Cognitive Behaviour Therapy principles. This study describes and compares engagement patterns among participants in the two arms of the Actissist 2.0 randomised controlled trial. Engagement frequency and duration were measured among participants using the Actissist app in the intervention arm (n = 87) and the ClinTouch symptom monitoring only app used as the control condition (n = 81). Overall, 47.1 % of Actissist and 45.7 % of ClinTouch users completed at least a third of scheduled alerts while active in the study. The mean frequency (77.1 versus 60.2 total responses) and the median duration (80 versus 75 days until last response) of engagement were not significantly higher among Actissist users compared to ClinTouch users. Older age, White ethnicity, using their own smartphone device and, among Actissist users, an increased sense of therapeutic alliance were significantly associated with increased engagement. Through exploiting detailed usage data, this study identifies possible participant-level and DHI-level predictors of engagement to inform the practical implementation of future DHIs.

Bilateral Laser Interstitial Thermal Therapy for Butterfly Gliomas Compared With Needle Biopsy: A Preliminary Survival Study.

BACKGROUND AND OBJECTIVES: Bilateral/butterfly glioblastoma (bGBM) has a poor prognosis. Resection of these tumors is limited due to severe comorbidities that arise from surgical procedures. Laser interstitial thermal therapy (LITT) offers a minimally invasive cytoreductive therapy for deep-seated tumors such as bGBM. The objective of this study was to evaluate the safety of bilateral LITT in patients with bGBM. METHODS: Medical records of all consecutive patients diagnosed with bGBM by a single surgeon at a single institution from January 2014 to August 2022 were reviewed. Clinical, safety, and radiographic volumetric data were obtained. In addition, an exploratory analysis of survival was performed. RESULTS: A total of 25 patients were included; 14 underwent biopsy only, and 11 underwent biopsy + LITT (7 underwent bilateral and 4 underwent unilateral LITT). No (0%) intraoperative or postoperative complications were recorded in the treatment group. Tumor volume negatively correlated with extent of treatment (r 2 = 0.44, P = .027). The median progression-free survival was 2.8 months in the biopsy-only group and 5.5 months in the biopsy + LITT group ( P = .026). The median overall survival was 4.3 months in the biopsy-only group and 10.3 months in the biopsy + LITT group ( P = .035). CONCLUSION: Bilateral LITT for bGBM can be safely performed and shows early improvement of the progression-free survival and long-term survival outcomes of these patients.

What should inpatient psychological therapies be for? Qualitative views of service users on outcomes.

BACKGROUND: There is limited research on what, when and how outcomes should be measured in psychological therapy trials in acute mental health inpatient wards. OBJECTIVES: This study aimed to consider what outcomes service users think are important to measure. METHODS: This qualitative study explored the views of 14 participants, who had an inpatient admission within the last year, on outcomes of psychological therapies using semistructured interviews. Data were analysed using thematic analysis from a critical realist perspective with both inductive and deductive coding. RESULTS: The 126 outcomes that were important to participants were mapped onto an established taxonomy of outcomes across different health areas and the socioecological framework to consider the wider context and help summarise the outcomes. Most of the outcomes were mapped to the intrapersonal and interpersonal level. In addition to the outcome mapping, three themes were constructed from the qualitative data: (1) I am not a problem I am a person, (2) Feeling cared for and loved, (3) What does getting better look like. CONCLUSIONS: Our results highlight the need for patient-reported outcomes which are cocreated with service users, disseminating research and training on preventing dehumanising experiences, enhancing psychological safety and therapeutic relationships and improving access to psychological therapy. PATIENT OR PUBLIC CONTRIBUTION: The wider People with Personal Experience Involvement Committee at the University of Bath were consulted which included a focus group during the early planning stages. We also collaborated with a person with personal experience, at every stage of the research. This included developing our research question and aims, protocol, participant documents (e.g., information and debrief forms), advertisement and recruitment strategy, interview topic guide, the codes, the final themes and quotes and reviewing the manuscript. People with lived experience of being admitted to an acute mental health inpatient ward participated in our study.

Increasing access to CBT for psychosis patients: study protocol for a randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE3).

BACKGROUND: The National Institute for Health and Care Excellence (NICE) recommends that cognitive behaviour therapy (CBT) is offered to all patients with a psychosis diagnosis. However, only a minority of psychosis patients in England and Wales are offered CBT. This is attributable, in part, to the resource-intensive nature of CBT. One response to this problem has been the development of CBT in brief formats that are targeted at a single symptom and are deliverable by briefly trained therapists. We have developed Guided self-help CBT (the GiVE intervention) as a brief form of CBT for distressing voices and reported evidence for the feasibility of a randomised controlled trial (RCT) when the intervention was delivered by briefly trained therapists (assistant psychologists). This study will investigate the clinical and cost-effectiveness of the GiVE intervention when delivered by assistant psychologists following a brief training. METHODS: This study is a pragmatic, two-arm, parallel group, superiority RCT comparing the GiVE intervention (delivered by assistant psychologists) and treatment as usual to treatment as usual alone, recruiting across three sites, using 1:1 allocation and blind post-treatment and follow-up assessments. A nested qualitative study will develop a model for implementation. DISCUSSION: If the GiVE intervention is found to be effective when delivered by assistant psychologists, this intervention could significantly contribute to increasing access to evidence-based psychological interventions for psychosis patients. Furthermore, implementation across secondary care services within the UK's National Health Service may pave the way for other symptom-specific and less resource-intensive CBT-informed interventions for psychosis patients to be developed and evaluated. TRIAL REGISTRATION: Current Controlled Trials ISRCTN registration number: 12748453. Registered on 28 September 2022.

A two-arm, randomised feasibility trial using link workers to improve dental visiting in people with severe mental illness: a protocol paper.

BACKGROUND: People with severe mental illness (e.g. psychosis, bipolar disorder) experience poor oral health compared to the general population as shown by more decayed, missing and filled teeth and a higher prevalence of periodontal disease. Attending dental services allows treatment of oral health problems and support for prevention. However, people with severe mental illness face multiple barriers to attending routine dental appointments and often struggle to access care. Link work interventions use non-clinical support staff to afford vulnerable populations the capacity, opportunity, and motivation to navigate use of services. The authors have co-developed with service users a link work intervention for supporting people with severe mental illness to access routine dental appointments. The Mouth Matters in Mental Health Study aims to explore the feasibility and acceptability of this intervention within the context of a feasibility randomised controlled trial (RCT) measuring outcomes related to the recruitment of participants, completion of assessments, and adherence to the intervention. The trial will closely monitor the safety of the intervention and trial procedures. METHODS: A feasibility RCT with 1:1 allocation to two arms: treatment as usual (control) or treatment as usual plus a link work intervention (treatment). The intervention consists of six sessions with a link worker over 9 months. Participants will be adults with severe mental illness receiving clinical input from secondary care mental health service and who have not attended a planned dental appointment in the past 3 years. Assessments will take place at baseline and after 9 months. The target recruitment total is 84 participants from across three NHS Trusts. A subset of participants and key stakeholders will complete qualitative interviews to explore the acceptability of the intervention and trial procedures. DISCUSSION: The link work intervention aims to improve dental access and reduce oral health inequalities in people with severe mental illness. There is a dearth of research relating to interventions that attempt to improve oral health outcomes in people with mental illness and the collected feasibility data will offer insights into this important area. TRIAL REGISTRATION: The trial was preregistered on ISRCTN (ISRCTN13650779) and ClinicalTrials.gov (NCT05545228).