Suicide prevention: Introducing the Lothian Safekeeping Plan© for parents as a clinical innovation for use alongside safety plans for children and young people.

TOPIC: Internationally, preventing suicide in children and young people is a priority and there are a range of preventative approaches available for health professionals to use, including brief interventions. Safety planning is one such brief intervention. Safety plans have long been recommended for use with young people who are suicidal but, these were initially developed for adults. A recent scoping review revealed safety plans need to be tailored to children and young people. This review also identified an important practice gap, that parents also require plans supporting them to keep their child safe. PURPOSE: This paper highlights how a Scottish clinical child and adolescent mental health setting in the UK's National Health Service developed and implemented evidence-based safety plans for suicidality-the Lothian Safety Plan for young people and the Lothian Safekeeping Plan for parents. This paper outlines both plans and gives recommendations for their use by healthcare professionals. The parental Lothian Safekeeping Plan is discussed in more depth as this is a novel intervention. CONCLUSION: The Lothian Safekeeping Plan is a clinically led evidence-based practice innovation. It is a specific suicide prevention plan for use by parents as an additional, complementary, and enhanced resource to the Lothian Safety Plan for young people. It is recommended that healthcare professionals also use a parental safety plan when supporting young people presenting with suicidal crisis. Further research is needed to evaluate the impact of these plans.

Accelerating the development of a psychological intervention to restore treatment decision-making capacity in patients with schizophrenia-spectrum disorder: a study protocol for a multi-site, assessor-blinded, pilot Umbrella trial (the DEC:IDES trial).

BACKGROUND: A high proportion of patients diagnosed with schizophrenia-spectrum disorders will at some point in their lives be assessed as not having the capacity to make their own decisions about pharmacological treatment or inpatient care ('capacity'). Few will be helped to regain it before these interventions proceed. This is partly because effective and safe methods to do so are lacking. Our aim is to accelerate their development by testing, for the first time in mental healthcare, the feasibility, acceptability and safety of running an 'Umbrella' trial. This involves running, concurrently and under one multi-site infrastructure, multiple assessor-blind randomised controlled trials, each of which is designed to examine the effect on capacity of improving a single psychological mechanism ('mechanism'). Our primary objectives are to demonstrate feasibility of (i) recruitment and (ii) data retention on the MacArthur Competence Assessment Tool-Treatment (MacCAT-T; planned primary outcome for a future trial) at end-of-treatment. We selected three mechanisms to test: 'self-stigma', low self-esteem and the 'jumping to conclusions' bias. Each is highly prevalent in psychosis, responsive to psychological intervention, and hypothesised to contribute to impaired capacity. METHODS: Sixty participants with schizophrenia-spectrum diagnoses, impaired capacity and one or more mechanism(s) will be recruited from outpatient and inpatient mental health services in three UK sites (Lothian, Scotland; Lancashire and Pennine; North West England). Those lacking capacity to consent to research could take part if the key criteria were met, including either proxy consent (Scotland) or favourable Consultee advice (England). They will be allocated to one of three randomised controlled trials, depending on which mechanism(s) they have. They will then be randomised to receive, over an 8-week period and in addition to treatment as usual (TAU), 6 sessions of either a psychological intervention which targets the mechanism, or 6 sessions of assessment of the causes of their incapacity (control condition). Participants are assessed at 0 (baseline), 8 (end-of-treatment) and 24 (follow-up) weeks post-randomisation using measures of capacity (MacCAT-T), mechanism, adverse events, psychotic symptoms, subjective recovery, quality of life, service use, anxiety, core schemata and depression. Two nested qualitative studies will be conducted; one to understand participant and clinician experiences and one to investigate the validity of MacCAT-T appreciation ratings. DISCUSSION: This will be the first Umbrella trial in mental healthcare. It will produce the first 3 single-blind randomised controlled trials of psychological interventions to support treatment decision-making in schizophrenia-spectrum disorder. Demonstrating feasibility will have significant implications not only for those seeking to support capacity in psychosis, but also for those who wish to accelerate the development of psychological interventions for other conditions. TRIAL REGISTRATION: ClinicalTrials.gov NCT04309435 . Pre-registered on 16 March 2020.

Suicide prevention: What does the evidence show for the effectiveness of safety planning for children and young people? - A systematic scoping review.

WHAT IS KNOWN ON THE SUBJECT?: Suicide prevention is an international healthcare priority. There is an urgent need to use approaches that are helpful and follow research evidence. Safety planning is now widely used in suicide prevention; however, it was developed for use with adults, and little is known about its effectiveness for children/young people. WHAT THE PAPER ADDS TO EXISTING KNOWLEDGE?: This systematic scoping review brings together all research evidence since 2008 that reported how effective safety planning is for children/young people. Findings highlight that when healthcare professionals help children/young people who are suicidal, they need to ensure that the safety plan is completed collaboratively with healthcare professionals and children/young people and that it is appropriate for their age and development. There is also need for healthcare professionals to better recognize and respond to the needs of parents/carers who are caring for a child/young person with suicidal ideations/behaviours. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: There is some research indicating that safety planning is effective for use with children/young people, but such evidence has primarily been obtained from females and there is need for more evidence from male study populations. Further research on its use is needed for certain groups of children/young people including those who are care experienced, or identify as lesbian, gay, bisexual and transgender. This review highlighted that healthcare professionals need specific training before they deliver safety planning for children/young people. It was identified that parents/carers have additional needs and should be involved in safety planning. An additional resource specifically for parents/carers should be developed. ABSTRACT: INTRODUCTION: Suicide is a leading cause of death for children and young people and its prevention is a global priority. Many Mental Health Services employ safety planning as a brief intervention. There is some evidence of safety planning effectiveness for adults, but little is known about its effectiveness with young people. AIM: To synthesize research reporting safety planning effectiveness for children/young people with suicidal ideation and identify good practice recommendations. INCLUSION CRITERIA: The review relates to safety planning around suicide prevention for children/young people aged less than 18 years, even if it was within a wider intervention. The review was inclusive of all clinical areas (including mental health, primary care, etc), any geographical location or social economic status and inclusivity around the method of delivery. METHODS: A systematic scoping review of literature reporting effectiveness data for the use of safety planning with children/young people with suicidal ideation. The systematic scoping review protocol (pre-registered with Open Science Framework) followed Joanna Briggs Institute conduct guidance and PRISMA-ScR checklist. DATA ANALYSIS AND PRESENTATION: Fifteen studies were reported during 2008-2021. Overall, there is promising, but limited, evidence of effectiveness for safety planning for children/young people but with complete evidence gaps for some demographic sub-groups. Evidence determined that healthcare professionals should deliver a safety planning intervention that is completed collaboratively, developmentally appropriate, and recognizes parental/carer involvement. DISCUSSION AND IMPLICATIONS FOR PRACTICE: Further research is needed but current evidence suggests safety planning should be a routine part of care packages for children/young people with suicidal ideation proportionate to their needs. Developing/implementing these plans needs bespoke health professional training and additional support and resources for parents/carers should be developed.

The HEADS: UP Development Study: Working with Key Stakeholders to Adapt a Mindfulness-Based Stress Reduction Course for People with Anxiety and Depression after Stroke.

BACKGROUND: Following stroke, rates of mood disorder are and remain high at five years (anxiety 34.4%; depression 23%). Structured mindfulness-based stress reduction (MBSR) courses are effective in a range of health conditions, but stroke survivors find adherence challenging. We aimed to adapt a standard MBSR course specifically for people affected by stroke. METHODS: We recruited stroke survivors and family members with symptoms of anxiety and/or depression to take part in a co-development study comprising two rounds of MBSR 'taster' sessions, followed by focus groups in which views were sought on the practices sampled. Data were collected in October 2017 and May 2018 and were analysed using framework analysis, informed adaptations to mindfulness materials and delivery. RESULTS: Twenty-eight stroke survivors and seven family members participated. Nineteen (76%) stroke survivors had anxiety; 15 (60%) had depression. Five (71.4%) family members reported anxiety; n = 4 (57.1%) depression. Thirty participants attended the first round of taster sessions and focus groups; twenty (66%) the second and three (10%) were unable to attend either round. Framework analysis informed adaptations to course delivery, practices, and materials, ultimately resulting in a stroke-specific MBSR course, HEADS: UP (Helping Ease Anxiety and Depression after Stroke). CONCLUSIONS: HEADS: UP may provide a feasible, appropriate, and meaningful self-management intervention to help alleviate symptoms of mood disorder.

A pilot cluster randomised controlled trial of a peer-delivered outreach community-based smoking cessation intervention for women living in disadvantaged communities in Ireland.

INTRODUCTION: The health of women in rural communities is adversely impacted by increased rates of tobacco use linked to socio-economic disadvantage (SED) and by limited access to services. We Can Quit (WCQ) is a smoking cessation programme delivered by trained lay women (community facilitators) in local communities, which was developed using a Community-based Participatory Research (CBPR) approach and tailored to women living in SED areas of Ireland. METHODS: The We Can Quit2 (WCQ2) pilot cluster randomised controlled trial with an inbuilt process evaluation was conducted in four matched pairs of urban and semi-rural SED districts (8-10,000 women per district) to assess feasibility. Districts were independently randomised to WCQ (group support +/- nicotine replacement therapy), or to individual support delivered by health professionals. RESULTS: Findings showed that that the WCQ outreach programme is acceptable and feasible to implement for smoking women living in disadvantaged neighbourhoods. A secondary outcome of smoking abstinence (self-report + biochemical validation) demonstrated 27% abstinence in the intervention group versus 17% in usual care at end of programme. Low literacy was highlighted as a major barrier to participants' acceptability. DISCUSSION: The design of our project provides an affordable solution for governments in prioritising outreach smoking cessation in vulnerable populations in countries with rising rates of female lung cancer. Our community-based model using a CBPR approach empowers local women to become trained to deliver smoking cessation programmes within their own local communities. This provides a foundation to create a sustainable and equitable way to address tobacco use in rural communities.

'I'm not going to leave someone to die': carriage of naloxone by police in Scotland within a public health framework: a qualitative study of acceptability and experiences.

BACKGROUND: Scotland has one of the highest rates of drug-related deaths (DRDs) per capita in Europe, the majority of which involve opioids. Naloxone is a medication used to reverse opioid-related overdoses. In efforts to tackle escalating DRDs in many countries, naloxone is increasingly being provided to people who are likely first responders in overdose situations. This includes non-healthcare professionals, such as police officers. A pilot exercise to test the carriage and administration of naloxone by police officers was conducted in selected areas of Scotland between March and October 2021. The aim of the study was to explore the acceptability and experiences of naloxone carriage and administration by police in Scotland. METHODS: The study comprised of two stages. Stage 1 involved in-depth one-to-one qualitative interviews with 19 community stakeholders (people with lived experience, family members, support workers). Stage 2 involved a mixture of in-depth one-to-one interviews and focus groups with 41 police officers. Data were analysed thematically, and the findings from the two stages were triangulated to develop overarching themes and subthemes. RESULTS: By the end of the pilot, 808 police officers had been trained in the use of intranasal naloxone. Voluntary uptake of naloxone kits among police officers who completed training was 81%. There were 51 naloxone administration incidents recorded by police officers at suspected opioid-related overdose incidents during the pilot. Most officers shared positive experiences of naloxone administration. Naloxone as a first aid tool suited their role as first responders and their duty and desire to preserve life. Perceived barriers included concerns about police undertaking health-related work, potential legal liabilities and stigmatising attitudes. The majority of participants (and all community stakeholders) were supportive of the pilot and for it to be expanded across Scotland. CONCLUSIONS: Police carriage of naloxone is an acceptable and potentially valuable harm reduction tool to help tackle the DRDs crisis in Scotland. However, it requires appropriate integration with existing health and social care systems. The intervention lies at the intersection between public health and policing and implies a more explicit public health approach to policing.

Reducing patient delay in acute coronary syndrome: Randomized controlled trial testing effect of behaviour change intervention on intentions to seek help.

OBJECTIVES: The aim of this study was to evaluate the efficacy of a behaviour change intervention to reduce patient delay with symptoms of acute coronary syndrome. DESIGN: A 3-arm web-based, parallel randomized controlled trial. METHODS: The intervention comprised 12 behaviour change techniques (BCTs) embedded in a text-only or text+visual narrative (the techniques were systematically identified through systematic review and a consensus exercise). Between February and November 2017, n = 145 people who had recently experienced acute coronary syndrome were randomly allocated to intervention ('text+visual' or 'text-only') or control. Intentions to phone an ambulance immediately for acute coronary syndrome symptoms were assessed before and after the intervention using symptom scenarios, and the change in intention was compared across the three groups. RESULTS: Significant increases in intention to phone an ambulance immediately for ACS symptoms were seen following the 'text+visual' intervention but not following 'text-only' or control. However, the study was underpowered to detect any significant changes in intention between the 3 groups. There were no unintended effects on intentions for non-urgent symptoms. CONCLUSIONS: A 'text+visual' BCT-based intervention may significantly increase intention to phone an ambulance with symptoms of ACS. Further testing of the effect of the intervention on actual behaviour is required.

A process evaluation of 'We Can Quit': a community-based smoking cessation intervention targeting women from areas of socio-disadvantage in Ireland.

BACKGROUND: Smoking poses a serious risk of early preventable death and disease especially for women living with socio-economic disadvantage (SED). A smoking cessation programme, 'We Can Quit', was developed in Ireland tailored to SED women. This includes group-based support delivered by trained lay local community facilitators (CFs) and free nicotine replacement therapy (NRT). The intervention was pilot tested in a cluster randomised controlled trial, 'We Can Quit 2'. This paper reports on the WCQ2 process evaluation which assessed feasibility and acceptability of the programme and trial processes. METHODS: Embedded qualitative design using the UK Medical Research Council's process evaluation framework. Semi-structured interviews with trial participants (N = 21) and CFs (N = 8). Thematic analysis was utilised. RESULTS: Peer-modelling, a non-judgemental environment, CFs facilitation of group support were viewed as acceptable programme related factors. Some participants expressed concerns about NRT side effects. Provision of free NRT was welcomed and accepted by participants, although structural barriers made access challenging. Pharmacists took on a role that became larger than originally envisaged - and the majority provided additional support to women in their quit attempts between group meetings which augmented and supplemented the intervention sessions provided by the CFs. Participants reported good acceptance of repeated measures for data collection, but mixed acceptability of provision of saliva samples. Low literacy affected the feasibility of some women to fully engage with programme and trial-related materials. This was despite efforts made by intervention developers and the trial team to make materials (e.g., participant intervention booklet; consent forms and participant information leaflets) accessible while also meeting requirements under 2018 European General Data Protection Regulation legislation. Hypothetical scenarios of direct (e.g., researcher present during programme delivery) and indirect (e.g., audio recordings of programme sessions) observational fidelity assessments for a future definitive trial (DT) were acceptable. CONCLUSIONS: Intervention and trial-related processes were generally feasible and acceptable to participants and CFs. Any future DT will need to take further steps to mitigate structural barriers to accessing free NRT; and the established problem of low literacy and low educational attainment in SED areas, while continuing to comply within the contemporary legislative research environment. TRIAL REGISTRATION: WCQ2 pilot trial ( ISRCTN74721694 ).

The effectiveness of smoking cessation interventions for socio-economically disadvantaged women: a systematic review and meta-analysis.

INTRODUCTION: This systematic review and meta-analysis assessed the effectiveness of smoking cessation interventions among women smokers in low socio-economic status (SES) groups or women living in disadvantaged areas who are historically underserved by smoking cessation services. METHODS: A systematic literature search was conducted using MEDLINE (OVID), EMBASE, Cochrane, CINAHL, PsychINFO and Web of Science databases. Eligibility criteria included randomised controlled trials of any smoking cessation intervention among women in low SES groups or living in socio-economically disadvantaged areas. A random effects meta-analysis assessed effectiveness of interventions on smoking cessation. Risk of bias was assessed with the Cochrane Risk of Bias tool. The GRADE approach established certainty of evidence. RESULTS: A total of 396 studies were screened for eligibility and 11 (6153 female participants) were included. Seven studies targeted women-only. 5/11 tested a form of face-to-face support. A pooled effect size was estimated in 10/11 studies. At end of treatment, two-thirds more low SES women who received a smoking cessation intervention were more likely to stop smoking than women in control groups (risk ratio (RR) 1.68, 95% CI 1.36-2.08, I2= 34%). The effect was reduced but remained significant when longest available follow-up periods were pooled (RR 1.23, 95% CI 1.04-1.48, I2 = 0%). There was moderate-to-high risk of bias in most studies. Certainty of evidence was low. CONCLUSIONS: Behavioural and behavioural + pharmacotherapy interventions for smoking cessation targeting women in low SES groups or women living in areas of disadvantage were effective in the short term. However, longer follow-up periods indicated reduced effectiveness. Future studies to explore ways to prevent smoking relapse in this population are needed. SYSTEMATIC REVIEW REGISTRATION: PROSPERO: CRD42019130160.

The We Can Quit2 Smoking Cessation Trial: Knowledge Exchange and Dissemination Following a Community-Based Participatory Research Approach.

BACKGROUND: 'We Can Quit2' pilot randomised controlled trial determined the feasibility [of conducting a community-based trial of We Can Quit, a peer-delivered stop-smoking programme (group support, combination nicotine replacement therapy (NRT), and tailored individual support) for women living in socioeconomically disadvantaged areas in Ireland. Lessons from a knowledge exchange (KE) workshop that reengaged trial stakeholders are presented. METHODS: The trial dissemination plan included invitation of community, regional and national stakeholders (n = 176) to a KE interactive workshop, who received an accessible brief beforehand. Trial findings were presented. Enhancements to community engagement, participants' recruitment and retention, and policy priorities arising from the research were discussed. Field notes and responses to a post-event anonymous questionnaire were analysed using thematic content analysis. RESULTS: Workshop attendees (41/176, 23%) recommended: dedicated additional time to engage community stakeholders; social prescribing pathways to enhance recruitment; more adaptation of trial-related information and assistance in completion of data forms for low literacy individuals; encouraging women to join healthy community programmes to facilitate retention and sustainability; removal of barriers to access NRT; and ongoing provision of cessation services tailored to disadvantaged groups. CONCLUSIONS: The findings are relevant to the implementation of other community-based health interventions for disadvantaged groups, to policy makers and to service providers.

An application of PRECIS-2 to evaluate trial design in a pilot cluster randomised controlled trial of a community-based smoking cessation intervention for women living in disadvantaged areas of Ireland.

BACKGROUND: "We Can Quit2" (WCQ2) was a pilot cluster randomised controlled trial with an embedded process evaluation assessing the feasibility and acceptability of 'We Can Quit' (WCQ, a peer-delivered community-based stop-smoking programme for women in disadvantaged communities. The control group comprised 'enhanced usual care' offered by the Irish Health Service Executive (HSE). The PRagmatic Explanatory Continuum Indicator Summary (PRECIS-2) is a tool to assess whether a trial design is more explanatory (working under ideal conditions) or pragmatic (working under 'real-world' conditions). The aim of this paper was to retrospectively evaluate the WCQ2 pilot trial using PRECIS-2 to inform the decision-making process on progression to a future definitive trial (DT). METHODS: The WCQ2 trial protocol and HSE standard stop-smoking service were described across the nine PRECIS-2 domains: eligibility, recruitment, setting, organisation, flexibility-delivery, flexibility-adherence, follow-up and primary outcome. Team members scored the domains as pragmatic or explanatory for each arm in a half-day workshop. RESULTS: Seven team members (practitioners and researchers) assessed the overall trial design as more explanatory than pragmatic. Important differences emerged between the two arms. WCQ targeted adult women from disadvantaged communities whereas HSE run a limited enhanced service for all quitters. Trial recruitment was challenging, intense efforts were needed as the trial proceeded. WCQ was delivered in a non-clinical community setting, HSE services in a clinical setting. WCQ organisation was co-designed with community partners and comprises peer-to-peer group support delivered by trained lay community facilitators, whereas HSE one-to-one support is delivered by Smoking Cessation Officers with a clinical background. Only WCQ allowed flexibility in delivery and adherence. Follow-up was more intensive in WCQ. Greater efforts to improve participant retention will be required in a future DT. CONCLUSIONS: PRECIS-2 allowed the reflection of practitioners and researchers on similarities and differences between intervention and control arms. Results will inform the decision on progression to an effectiveness DT, which will require more a pragmatic and less explanatory design. This novel use of PRECIS-2 to retrospectively evaluate a complex community-based pilot trial in advance of a full DT will also support learning for those undertaking hybrid trials of implementation and effectiveness. TRIAL REGISTRATION: This trial is registered with the ISRCTN registry ( No. 74721694 ).

Dose-response effects of selective serotonin reuptake inhibitor monotherapy for the treatment of depression: systematic review of reviews and meta-narrative synthesis.

Objective: To assess and clarify the relations between selective serotonin reuptake inhibitor (SSRI) dose efficacy, acceptability (early treatment discontinuation (dropouts)), and tolerability (reported adverse drug effects), and critically evaluate methods previously used to examine SSRI dose-response effects for the treatment of depression in adults. Design: Systematic review of reviews and meta-narrative synthesis. Data sources: Embase, Medline, PsycINFO, Scopus, and the Cochrane Collaboration library, from 1975 to December 2021. Reference lists of national depression treatment guidelines were systemically searched by hand. Eligibility criteria for selecting studies: Reviews assessing SSRI monotherapy dose-response effects for the treatment of depression in adults (age ≥18 years) reporting efficacy, acceptability, or tolerability. Reviews meeting inclusion criteria had a high degree of heterogeneity, due to methodological diversity; therefore, a meta-narrative synthesis approach was applied. Standard daily doses were defined as 20 mg citalopram, fluoxetine, paroxetine; 50 mg sertraline; and 10 mg escitalopram. Risk of bias was assessed using the Risk of Bias in Systematic Reviews tool, in line with Cochrane recommendations. Results: The search identified 9138 records; 387 full text reports were assessed for eligibility, 42 of which matched the inclusion criteria. The majority, 83% (n=35), of reviews included data for studies with a duration of ≤12 weeks (ie, the acute phase of depression treatment). Of 39 reviews assessing efficacy, the majority (n=26) indicated that individual SSRIs and SSRI class demonstrated flat dose-response effects; standard doses were optimal for efficacy. Acceptability or tolerability were assessed in 28 reviews. Higher than standard daily doses were associated with higher dropout rates and a greater incidence of adverse drug effects (eg, nausea, sexual dysfunction, fatigue, anxiety). Despite a range of methods being reported, there was an overall consensus regarding SSRI dose related efficacy, dropouts, and adverse drug effects. Conclusion: Standard daily doses of SSRIs for the treatment of depression in adults provide a favourable balance between efficacy, acceptability, and tolerability. Patients are encouraged to talk to their prescriber or community pharmacist if they experience adverse effects or have any concerns about their drug treatments.

Discerning the adverse effects of psychological therapy: Consensus between experts by experience and therapists.

Measurement of adverse effects of psychological therapy is inconsistent due to ambiguity about the concept. The perspective of people undertaking psychological therapy (that is, experts by experience) has largely been overlooked. This study will investigate whether there is consensus between the opinions of professionals and experts by experience. The Delphi method was used. In Round 1 thematic analysis was used to analyse qualitative responses. Wilcoxon rank-sum tests were used to examine group differences in Rounds 2 and 3. The study protocol was prospectively registered, reference osf.io/f9wp7. Fifty-one professionals and 51 experts by experience generated 147 potential adverse effects in Round 1, across 9 themes; including 'therapy amplifies problem', 'emotional lability' and 'sense of self'. Each item was rated for overall consensus in Rounds 2 (n = 62) and 3 (n = 63). Thirty-eight items were rated as essential, very important or important to include on a list of potential adverse effects. A further 12 items were rated as important by the expert by experience group only. Professionals were more conservative in their ratings. There appeared to be consensus between professionals and experts by experience on what to include in a list of adverse effects of psychological therapy (the EDAPT), including novel adverse effects which have not been previously considered. Further research is required to understand which adverse effects are necessary, unnecessary, or indeed harmful to psychotherapy outcomes.

Peer-Delivery of a Gender-Specific Smoking Cessation Intervention for Women Living in Disadvantaged Communities in Ireland We Can Quit2 (WCQ2)-A Pilot Cluster Randomized Controlled Trial.

INTRODUCTION: We Can Quit" (WCQ) is community-based stop-smoking program delivered by trained community facilitators, based on the socio-ecological framework and developed using a Community-based Participatory Research approach, targeting women living in socioeconomically disadvantaged (SED) areas of Ireland. AIMS AND METHODS: The We Can Quit2 (WCQ2) pilot trial assessed the feasibility of WCQ. A pragmatic cluster randomized controlled trial with a process evaluation WCQ2, was conducted in four matched pairs of SED districts (8-10 000 women per district). Districts were independently randomized to WCQ (group support + nicotine replacement therapy), or to individual support delivered by health professionals. Participants were adult women smokers interested in quitting, who were living or working in trial districts. Recruitment of districts and 194 women in four waves (49 women per wave); retention at 12 weeks and 6 months; fidelity to intervention delivery and acceptability of trial-related processes were assessed. Validated smoking abstinence at 12-week and 6-month post-intervention was recorded, missing data assumed as continued smoking. RESULTS: Eight districts were recruited. 125/188 (66.5%) eligible women consented. The 49 women target was reached in wave4. Retention at 12 weeks was (Intervention [I]: 55.4%; Control [C]: 51.7%), at 6 months (I: 47.7%; C: 46.7%). Smoking abstinence at 12 weeks was (I: 23.1%, [95% CI: 14.5 to 34.7]; C: 13%, [95% CI: 6.9 to 24.1]). 83.8% of session activities were delivered. Trial-related processes were acceptable to facilitators. Low literacy was highlighted as a barrier for participants' acceptability. CONCLUSIONS: WCQ was feasible to deliver by trained facilitators and indicated a positive direction in abstinence rates. Low literacy will need to be addressed in a future trial design. IMPLICATIONS: This pilot trial showed that a stop-smoking intervention tailored to a group of women smokers living in SED areas which was delivered by trained local women within their local communities was feasible. Furthermore, although not formally compared, more WCQ women were abstinent from smoking at the end of treatment. The results are relevant to enhance the design of a fully powered effectiveness trial, and provide important evidence on the barriers to deliver a tailored smoking cessation service to SED women smokers in Ireland.

ICD-11 complex Post Traumatic Stress Disorder (CPTSD) in parents with perinatal bereavement: Implications for treatment and care.

INTRODUCTION: The 11th revision of the WHO International Classification of Diseases (ICD-11) has identified Complex PTSD (CPTSD) as a new condition. AIM: To explore whether the new diagnosis of CPTSD (ICD11) is relevant to women who have experienced perinatal bereavement and to advance knowledge about the acceptability, feasibility and perceived impact of delivering an innovative flexible Compassionate Focused Therapy (CFT) informed treatment package to alleviate symptoms of this condition. METHODS: A mixed methods study using survey and interviews was conducted. Participants first completed the International Trauma Questionnaire (ITQ) to assess if they met the criteria for PTSD or CPTSD (n=72), and subsequent semi-structured interviews (n=12) identified participants' views about different treatment approaches. PARTICIPANTS: A convenience sample of women who had experienced perinatal bereavement were recruited from one geographical region in Scotland. DATA COLLECTION: Information was gathered about trauma experiences related to perinatal bereavement; participants' levels of PTSD or CPTSD using the ITQ; and views regarding the features of treatment options. In-depth interviews with women (n=12) and a focus group with staff (n=5) were also conducted. FINDINGS: Of 74 participants (n=74) who fully completed the ITQ, 10.8% (n=8) met the criteria for PTSD and 29.7% (n=22) for CPTSD, equating to a total of 40.5% of participants experiencing traumatic stress. Results suggest that CPTSD is a more common condition than PTSD in people with perinatal bereavement, with qualitative data suggesting that CFT and EMDR can be useful and acceptable interventions for this population group. CONCLUSION: A feasibility study is recommended next to evaluate acceptability of trial processes in preparation for a definitive randomised controlled trial of a new flexible CFT informed treatment package to address PTSD and CPTSD in people with perinatal bereavement. RECOMMENDATIONS FOR PRACTICE: Routine assessment of ICD-11 CPTSD is recommended in this population group.

A network meta-analysis of psychological interventions for schizophrenia and psychosis: Impact on symptoms.

BACKGROUND: Evidence for the effectiveness of psychological interventions for schizophrenia/psychosis is growing, however there is no consensus on the psychological intervention most likely to reduce symptoms. METHODS: A network meta-analysis was conducted to identify all randomised controlled trials (RCTs) of psychological interventions for adults with schizophrenia/psychosis. A systematic review of the literature using MEDLINE, PsycINFO, EMBASE and CENTRAL led to an analysis of 90 RCTs with 8440 randomised participants across 24 psychological intervention, and control groups. Psychological interventions were categorised and rated for treatment fidelity and risk of bias. Data for total symptoms were extracted and network meta-analysis, using a frequentist approach, was undertaken using Stata SE v15 to compare the direct and indirect evidence for the effectiveness of each psychological intervention. FINDINGS: Psychological interventions were more likely to reduce symptoms than control groups, and one intervention, mindfulness-based psychoeducation, was consistently ranked as most likely to reduce total symptoms. Subgroup analyses identified differential effectiveness in different settings and for different subgroups. INTERPRETATION: Mindfulness-based psychoeducation was consistently ranked as most likely to reduce symptoms; however all studies were based in China. More RCTs in a variety of cultural contexts would help to elucidate whether these findings generalise internationally. A number of psychological interventions could potentially be more effective than interventions recommended by NICE guidelines, such as CBT and family therapy, and additional RCTs and meta-analyses are needed to generate more conclusive evidence in this regard.

Co-creation of five key research priorities across law enforcement and public health: A methodological example and outcomes.

WHAT IS KNOWN ON THE SUBJECT?: Between policing and health, there are many shared issues. Mental health distress and crises and caring for people who may be vulnerable are priority areas. Working together in partnership is challenging, and fragmented systems and processes are the result. This leads to poor experiences for the police, health professions and the public. WHAT THE PAPER ADDS TO EXISTING KNOWLEDGE?: This paper describes an event that brought together 26 stakeholders involved in law enforcement and public health. The aim of this work was to identify the biggest shared challenges that they experience in their day to day jobs. The five key priorities were as follows: vulnerability; mental health crisis; decision-making around assessment and triage across professional groups and professional roles; peer support and organizational well-being; and information and data sharing. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: This paper demonstrates the strength of bringing partners together throughout law enforcement and public health, making proper time to actually discuss the "big issues" which affect them, how they each experience these issues, and how they might have overcome these within their own professions. Only through working together as partners and having everyone on the same page with the shared priorities can we really start to make a difference in the areas and with the people who matter. The focus on "vulnerability" and "mental health crisis" demonstrates the complexity of the issues between the professions, and that they need to find effective ways to work together to support people. No one professional group can solve inter-professional challenges alone. ABSTRACT: Introduction Law enforcement professions now assume more responsibility for tackling mental health issues alongside public health colleagues than ever before. The term "vulnerability" is frequently used within Law Enforcement and Public Health (LEPH) to identify those requiring emergency mental health care. However, there are ongoing challenges within LEPH to determine whose responsibility this is. Aim To co-create the most important priorities for LEPH research in Scotland. Method The paper describes a collaborative workshop which brought together an Expert Advisory Group (EAG) of 26 senior stakeholders, from academia, policing, mental health nursing, psychiatry, paramedics, emergency medicine, people with lived experience, policy makers and third sector. Results The five key priorities included: vulnerability; mental health crisis; decision-making around assessment and triage across professional groups and professional roles; peer support and organizational well-being; and information and data sharing. Discussion The paper discusses the EAG group event as a co-production process, focusing on how key LEPH research priorities were derived. Implications for practice This paper demonstrates the inextricable link between co-production and co-creation of value via EAG group consensus on LEPH research priorities. Shared vision and professional will are not enough to ensure progress: there must also be shared policy, knowledge and access.

We Can Quit2 (WCQ2): a community-based intervention on smoking cessation for women living in disadvantaged areas of Ireland-study protocol for a pilot cluster randomised controlled trial.

BACKGROUND: Tobacco use is the leading cause of preventable death in Ireland with almost 6000 smokers dying each year from smoking-related diseases. The 'We Can Quit2' (WCQ2) study is a pilot pragmatic two-arm, parallel-group, cluster randomised trial that aims to explore the feasibility and acceptability of trial processes including recruitment and to estimate parameters to inform sample size estimates needed for an effectiveness trial. This future trial will assess the effectiveness of a community-based smoking cessation intervention for women living in disadvantaged areas on short- and medium-term cessation rates. METHODS/DESIGN: Four matched pairs of districts (eight clusters) selected by area level of deprivation, geographical proximity, and eligibility for free medical services will be randomised to receive either WCQ (behavioural support + access to Nicotine Replacement Therapy (NRT)) delivered over 12 weeks by trained Community Facilitators (CFs) or to a form of usual care, a one-to-one smoking cessation service delivered by Smoking Cessation Officers from Ireland's national health service, the Health Service Executive (HSE). Within each cluster, 24-25 women will be recruited (97 per arm; 194 in total) in 4 phases with consent obtained prior to cluster randomisation. The outcome measures will assess feasibility and acceptability of trial processes, including randomisation. Outcome data for a future definitive intervention (biochemically validated smoking abstinence) will be collected at end of programme (12 weeks) and at 6 months. WCQ2 has an embedded process evaluation using both qualitative and quantitative methods. This will be conducted (semi-structured client and CF interviews, intervention delivery checklist, and diary) to explore acceptability of trial processes, intervention fidelity, trial context, and implementation. Trial processes will be assessed against domains of the PRECIS-2 wheel to inform a future definitive trial design. DISCUSSION: Data from this pilot trial will inform the design and sample size for a full cluster randomised trial to determine the effectiveness of an intervention tailored to disadvantaged women in improving smoking cessation rates. It will provide transferable learning on the systems and implementation strategies needed to support effective design of future pragmatic community-based trials which address health promotion interventions for women in disadvantaged communities. TRIAL REGISTRATION: Concurrent to publication. Controlled trials ISRCTN74721694.

Understanding the attitudes and acceptability of extra-genital Chlamydia testing in young women: evaluation of a feasibility study.

BACKGROUND: Chlamydia trachomatis (C. trachomatis) is the most common bacterial sexually transmitted infection in the UK. Recent studies suggest that in addition to the genital tract, C. trachomatis is found in the throat and rectum, suggesting the number of infections is under-reported. There is an urgent need to study the impact of extending diagnosis to include extra-genital samples; however, there is a lack of evidence on the acceptability of asking young women to provide these samples. METHOD: A mixed methods single group feasibility study explored the acceptability of combined genital and extra-genital testing in young women aged 16-25 years consecutively attending a sexual health centre in Edinburgh, Scotland. Young women were asked to complete a self- administered anonymous questionnaire whether they would be willing to give self-taken throat and ano-rectal samples. Interviews with women (n = 20) willing to self-sample were conducted before and after self-sampling, and these explored the underlying reasons behind their decision, and feelings about the tests. RESULTS: Of 500 women recruited to the study, 422 (84.4%) women provided sufficient data for analysis. From completed questionnaires, 86.3% of respondents reported willingness to self-sample from the throat. Willingness of ano-rectal self-sampling was lower (59.1%), particularly in women under 20 (< 20 years: 44.4%; ≥20 years, 68.2%). Willingness of ano-rectal self-sampling was higher in women who had more sexual partners in the last 6 months (0 partners, 48.3%, n = 14, 3 or more partners, 67.4%, n = 60) and in those who have previous experience of a positive test for a sexually transmitted infection (STI) (positive: 64.5%; negative: 57%). Interviewed women suggested that a lack of knowledge of STIs, embarrassment and lack of confidence in the ability to carry out the sampling were barriers towards acceptability. CONCLUSIONS: In this study, self-sampling of throat samples is largely acceptable; however, the acceptability of taking an ano-rectal sample for C. trachomatis testing in young women was lower in younger women. The study suggests further research to investigate the acceptability of extra-genital testing as an addition to routine C. trachomatis testing, and whether this increases detection and prevents infective sequelae for women.