Evaluation of perinatal anxiety assessment measures: a cognitive interview study.

BACKGROUND: Anxiety in pregnancy and postpartum is highly prevalent but under-recognised. To identify perinatal anxiety, assessment tools must be acceptable, relevant, and easy to use for women in the perinatal period. METHODS: To determine the acceptability and ease of use of anxiety measures to pregnant or postpartum women (n = 41) we examined five versions of four measures: the Generalised Anxiety Disorder scale (GAD) 2-item and 7-item versions; Whooley questions; Clinical Outcomes in Routine Evaluation (CORE-10); and Stirling Antenatal Anxiety Scale (SAAS). Cognitive interviews were used to examine ease of comprehension, judgement, retrieval and responding. RESULTS: All measures were acceptable. Some items were deemed less relevant to the perinatal period e.g., difficulties sleeping. Ease of comprehension, judgement, retrieval and responding varied, with all measures having strengths and weaknesses. The SAAS and CORE-10 had the lowest mean number of problematic components. The GAD had the highest mean number of problematic components​. Non-binary response options were preferred. Preferences for time frames (e.g. one week, one month) varied. Qualitative data provides in-depth information on responses to each measure. CONCLUSIONS: Findings can be used to inform clinical guidelines and research on acceptable anxiety assessment in pregnancy and after birth.

Women's experiences and views of routine assessment for anxiety in pregnancy and after birth: A qualitative study.

BACKGROUND: Anxiety in pregnancy and postnatally is highly prevalent but under-recognized. To identify perinatal anxiety, assessment tools must be acceptable to women who are pregnant or postnatal. METHODS: A qualitative study of women's experiences of anxiety and mental health assessment during pregnancy and after birth and views on the acceptability of perinatal anxiety assessment. Semi-structured interviews were conducted with 41 pregnant or postnatal women. Results were analysed using Sekhon et al.'s acceptability framework, as well as inductive coding of new or emergent themes. RESULTS: Women's perceptions of routine assessment for perinatal anxiety were generally favourable. Most participants thought assessment was needed and that the benefits outweighed potential negative impacts, such as unnecessary referrals to specialist services. Six themes were identified of: (1) Raising awareness; (2) Improving support; (3) Surveillance and stigma; (4) Gatekeeping; (5) Personalized care and (6) Trust. Assessment was seen as a tool for raising awareness about mental health during the perinatal period and a mechanism for normalizing discussions about mental health more generally. However, views on questionnaire assessments themselves were mixed, with some participants feeling they could become an administrative 'tick box' exercise that depersonalizes care and does not provide a space to discuss mental health problems. CONCLUSION: Routine assessment of perinatal anxiety was generally viewed as positive and acceptable; however, this was qualified by the extent to which it was informed and personalized as a process. Approaches to assessment should ideally be flexible, tailored across the perinatal period and embedded in continuity of care.

Barriers and facilitators to implementing workplace interventions to promote mental health: qualitative evidence synthesis.

BACKGROUND: Despite growing interest in workplace mental health interventions, evidence of their effectiveness is mixed. Implementation science offers a valuable lens to investigate the factors influencing successful implementation. However, evidence synthesis is lacking, especially for small-to-medium-sized enterprises (SMEs) and for specific work sectors. The objectives of this review are to establish the scope of research with explicit analysis of implementation aspects of workplace mental health interventions and to identify barriers and facilitators to implementation in general and within SMEs and selected sectors. METHODS: A systematic scoping review and meta-synthesis of mixed methods process evaluation research from 11 databases, with the evaluation of methodological quality (MMAT) and confidence in findings (CERQual), was conducted. We selected information-rich studies and synthesised them using domains within the Nielsen and Randall implementation framework: context, intervention activities, implementation; and mental models. RESULTS: We included 43 studies published between 2009 and 2022, of which 22 were rated as information-rich to be analysed for barriers and facilitators. Most studies were conducted in healthcare. Facilitators reflecting 'high confidence' included: relevant and tailored content, continuous and pro-active leadership buy-in and support, internal or external change agents/champions, assistance from managers and peers, resources, and senior-level experience and awareness of mental health issues. Healthcare sector-specific facilitators included: easy accessibility with time provided, fostering relationships, clear communication, and perceptions of the intervention. Stigma and confidentiality issues were reported as barriers overall. Due to the small number of studies within SMEs reported findings did not reach 'high confidence'. A lack of studies in construction and Information and Communication Technology meant separate analyses were not possible. CONCLUSIONS: There is dependable evidence of key factors for the implementation of workplace mental health interventions which should be used to improve implementation. However, there is a lack of studies in SMEs and in a larger variety of sectors. SYSTEMATIC REVIEW REGISTRATION: Research Registry ( reviewregistry897 ).

Childhood adversity and mental health admission patterns prior to young person suicide (CHASE): a case-control 36 year linked hospital data study, Scotland UK 1981-2017.

BACKGROUND: Childhood adversity is associated with increased later mental health problems and suicidal behaviour. Opportunities for earlier healthcare identification and intervention are needed. AIM: To determine associations between hospital admissions for childhood adversity and mental health in children who later die by suicide. METHOD: Population-based longitudinal case-control study. Scottish in-patient general and psychiatric records were summarised for individuals born 1981 or later who died by suicide between 1991 and 2017 (cases), and matched controls (1:10), for childhood adversity and mental health (broadly defined as psychiatric diagnoses and general hospital admissions for self-harm and substance use). RESULTS: Records were extracted for 2477 'cases' and 24 777 'controls'; 2106 cases (85%) and 13 589 controls (55%) had lifespan hospitalisations. Mean age at death was 23.7; 75.9% were male. Maltreatment or violence-related childhood adversity codes were recorded for 7.6% cases aged 10-17 (160/2106) versus 2.7% controls (371/13 589), odds ratio = 2.9 (95% CI, 2.4-3.6); mental health-related admissions were recorded for 21.7% cases (458/2106), versus 4.1% controls (560/13 589), odds ratio = 6.5 (95% CI, 5.7-7.4); 80% of mental health admissions were in general hospitals. Using conditional logistic models, we found a dose-response effect of mental health admissions <18y, with highest adjusted odds ratio (aOR) for three or more mental health admissions: aORmale = 8.17 (95% CI, 5.02-13.29), aORfemale = 15.08 (95% CI, 8.07-28.17). We estimated that each type of childhood adversity multiplied odds of suicide by aORmale = 1.90 (95% CI, 1.64-2.21), aORfemale = 2.65 (95% CI, 1.94-3.62), and each mental health admission by aORmale = 2.06 (95% CI, 1.81-2.34), aORfemale = 1.78 (95% CI, 1.50-2.10). CONCLUSIONS: Our lifespan study found that experiencing childhood adversity (primarily maltreatment or violence-related admissions) or mental health admissions increased odds of young person suicide, with highest odds for those experiencing both. Healthcare practitioners should identify and flag potential 'at-risk' adolescents to prevent future suicidal acts, especially those in general hospitals.

The effects of different types of organisational workplace mental health interventions on mental health and wellbeing in healthcare workers: a systematic review.

OBJECTIVE: To determine if and which types of organisational interventions conducted in small and medium size enterprises (SMEs) in healthcare are effective on mental health and wellbeing. METHODS: Following PRISMA guidelines, we searched six scientific databases, assessed the methodological quality of eligible studies using QATQS and grouped them into six organisational intervention types for narrative synthesis. Only controlled studies with at least one follow-up were eligible. RESULTS: We identified 22 studies (23 articles) mainly conducted in hospitals with 16 studies rated of strong or moderate methodological quality. More than two thirds (68%) of the studies reported improvements in at least one primary outcome (mental wellbeing, burnout, stress, symptoms of depression or anxiety), most consistently in burnout with eleven out of thirteen studies. We found a strong level of evidence for the intervention type "Job and task modifications" and a moderate level of evidence for the types "Flexible work and scheduling" and "Changes in the physical work environment". For all other types, the level of evidence was insufficient. We found no studies conducted with an independent SME, however five studies with SMEs attached to a larger organisational structure. The effectiveness of workplace mental health interventions in these SMEs was mixed. CONCLUSION: Organisational interventions in healthcare workers can be effective in improving mental health, especially in reducing burnout. Intervention types where the change in the work environment constitutes the intervention had the highest level of evidence. More research is needed for SMEs and for healthcare workers other than hospital-based physicians and nurses.

A mixed methods systematic literature review of barriers and facilitators to help-seeking among women with stigmatised pelvic health symptoms.

BACKGROUND: Women's pelvic health is a globally important subject, included in international and United Kingdom health policies, emphasising the importance of improving information and access to pelvic health services. Consequences of pelvic symptoms are intimate, personal, and varied, often causing embarrassment and shame, affecting women's quality of life and wellbeing. AIM: To understand the experience of seeking healthcare for stigmatised pelvic health symptoms by synthesising all types of published primary research and mapping the results to behavioural theory, to identify potential targets for intervention. METHODS: Systematic search of MEDLINE, CINAHL, PsycINFO, SocINDEX, PubMED databases, CDSR and CENTRAL registers, from inception to May 2023 for all types of research capturing women's views and experiences of seeking help with stigmatised urogenital and bowel symptoms. Studies only reporting prevalence, predictors of help-seeking, non-health related help-seeking, or written in languages other than English, German, French, Spanish and Swedish were excluded. Reference checking and forward citation searching for all included studies was performed. A results-based synthesis approach was used to integrate quantitative and qualitative data. Themes were mapped to the Common-Sense model and Candidacy framework. The Mixed Methods Appraisal Tool was used for critical appraisal. Grading of Recommendations Assessment, Development and Evaluation - Confidence in Evidence from Reviews of Qualitative research for assessing certainty of review findings. RESULTS: 86 studies representing over 20,000 women from 24 high income countries were included. Confidence was high that barriers to help-seeking were similar across all study types and pelvic symptoms: stigma, lack of knowledge, women's perception that clinicians dismissed their symptoms, and associated normalising and deprioritising of low bother symptoms. Supportive clinicians and increased knowledge were key facilitators. CONCLUSIONS: Using the Common-Sense Model to explore women's help-seeking behaviour with stigmatised pelvic symptoms reveals problems with cognitive representation of symptom identity, emotional representations of embarrassment and shame, and a subjective norm that women believe their symptoms will be trivialised by clinicians. Together these barriers frustrate women's identification of their candidacy for healthcare. Addressing these issues through behavioural change interventions for women and clinicians, will help to achieve universal access to pelvic healthcare services (United Nations Sustainable Development Goal 3.7). SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021256956.

When is the best time to screen for perinatal anxiety? A longitudinal cohort study.

BACKGROUND: For screening for anxiety during pregnancy and after birth to be efficient and effective it is important to know the optimal time to screen in order to identify women who might benefit from treatment. AIMS: To determine the optimal time to screen for perinatal anxiety to identify women with anxiety disorders and those who want treatment. A secondary aim was to examine the stability and course of perinatal anxiety over time. METHODS: Prospective longitudinal cohort study of 2243 women who completed five screening questionnaires of anxiety and mental health symptoms in early pregnancy (11 weeks), mid-pregnancy (23 weeks), late pregnancy (32 weeks) and postnatally (8 weeks). Anxiety and mental health questionnaires were the GAD7, GAD2, SAAS, CORE-10 and Whooley questions. To establish presence of anxiety disorders diagnostic interviews were conducted with a subsample of 403 participants. RESULTS: Early pregnancy was the optimal time to screen for anxiety to identify women with anxiety disorders and women wanting treatment at any time during pregnancy or postnatally. These findings were consistent across all five questionnaires of anxiety and mental health. Receiving treatment for perinatal mental health problems was most strongly associated with late pregnancy and/or postnatal assessments. Anxiety symptoms were highest in early pregnancy and decreased over time. CONCLUSION: Findings show that screening in early pregnancy is optimal for identifying women who have, or develop, anxiety disorders and who want treatment. This has clear implications for practice and policy for anxiety screening during the perinatal period.

Assessment of perinatal anxiety: diagnostic accuracy of five measures.

BACKGROUND: Anxiety in pregnancy and after giving birth (the perinatal period) is highly prevalent but under-recognised. Robust methods of assessing perinatal anxiety are essential for services to identify and treat women appropriately. AIMS: To determine which assessment measures are most psychometrically robust and effective at identifying women with perinatal anxiety (primary objective) and depression (secondary objective). METHOD: We conducted a prospective longitudinal cohort study of 2243 women who completed five measures of anxiety and depression (Generalized Anxiety Disorder scale (GAD) two- and seven-item versions; Whooley questions; Clinical Outcomes in Routine Evaluation (CORE-10); and Stirling Antenatal Anxiety Scale (SAAS)) during pregnancy (15 weeks, 22 weeks and 31 weeks) and after birth (6 weeks). To assess diagnostic accuracy a sample of 403 participants completed modules of the Mini-International Neuropsychiatric Interview (MINI). RESULTS: The best diagnostic accuracy for anxiety was shown by the CORE-10 and SAAS. The best diagnostic accuracy for depression was shown by the CORE-10, SAAS and Whooley questions, although the SAAS had lower specificity. The same cut-off scores for each measure were optimal for identifying anxiety or depression (SAAS ≥9; CORE-10 ≥9; Whooley ≥1). All measures were psychometrically robust, with good internal consistency, convergent validity and unidimensional factor structure. CONCLUSIONS: This study identified robust and effective methods of assessing perinatal anxiety and depression. We recommend using the CORE-10 or SAAS to assess perinatal anxiety and the CORE-10 or Whooley questions to assess depression. The GAD-2 and GAD-7 did not perform as well as other measures and optimal cut-offs were lower than currently recommended.

Improving the mental health of farmers: what types of remote support are acceptable, feasible, and improve outcomes? A feasibility RCT.

BACKGROUND: The farming community have high rates of poor mental health, and are relatively 'hard to reach' with mental health services. The aim of this study was therefore to undertake a feasibility RCT, based on two mental health interventions. These were (1) CBT based 'Living Life to the Full for Farming Communities' (LLTTF-F; www.llttf.com ), and (2) a holistic social and emotional support service delivered by the Royal Scottish Agricultural Benevolent Institution (RSABI). The feasibility was supplemented by process evaluation. METHODS: This feasibility study aimed to recruit 40 individuals from the farming community who were experiencing a common health problem defined as a score of > = 8 on PHQ-9. A snowball approach was used to recruit interested individuals who had an association with farming. An initial telephone call screened for eligibility and obtained consent to randomisation to the two specified interventions, or to a thirdly group receiving a combination of both LLTTF-F and 'Social and emotional support'. Participants were permitted to override the randomised option if they expressed a strong preference before the interventions began. RESULTS: Thirty-two participants provided baseline and three-month data. All three interventions showed positive improvements on PHQ-9 scores as follows: the 'combined intervention' mean baseline score was 18.1 compared to 12.0 at 3-month follow-up (mean change 6.1). 'Social and emotional support' mean baseline score was 11.3 compared to 6.7 at 3-month follow-up (mean change 4.6). 'LLTTF-F CBT-based intervention only' mean baseline score was 11.8 compared to 4.5 at 3-month follow-up (mean change 7.3). The retention rate was 81% at three months. In a sub-group of the LLTTF-F CBT-based intervention online materials were supplemented by telephone guided support. This approach received very positive feedback. CONCLUSIONS: Recruitment from the farming community required intense effort, and good engagement can then be retained for at least three months. There is evidence that the interventions used were feasible, and tentative evidence that they had a demonstrable effect on mental wellbeing, with the LLTTFF providing the largest effect on PHQ-9 scores. Trial Registration Number ISRCTN27173711, submitted 25/08/2023, confirmed 22/092023.

Scoping review: mapping clinical guidelines and policy documents that address the needs of women who are dependent on drugs during the perinatal period.

BACKGROUND: Women who use or are in treatment for drug use during the perinatal period often have complex needs and presenting comorbidity. Women who use opioids during pregnancy, and their infants, experience poor outcomes. Drug use by women during pregnancy is a public health priority. This scoping review aimed to (1) map clinical guidelines, treatment protocols and good practice guidance across the UK for women who use or are in treatment for drug use during the perinatal period, (2) identify recommended best practice across health and social care for optimising outcomes and reducing inequalities for these women and (3) identify potential gaps within guidance. METHODS: We followed the Joanna Briggs International (JBI) guidance on scoping reviews and PRISMA Scr extension. A registered protocol, containing a clear search strategy, inclusion, and exclusion criteria was adhered to. Reviewers double screened 25%, discussing disagreements. Data were extracted using a predefined template and charted in tables. Recommendations for best practice were organised around agreed categories. RESULTS: Of 968 documents screened, 111 met the inclusion criteria. The documents included UK-wide, national, regional, and organisational policy documents. They varied in the degree they were relevant to women who use or are in treatment for drug use during the perinatal period, the settings to which they applied, and their intended users. Most were created without patient or public involvement and lacked any clear evidence base. Overall, documents recommended an integrated model of care with a lead professional, clear referral pathways and information sharing between agencies. Guidance suggested referrals should be made to specialist midwives, drug, and social care services. A holistic assessment, inclusive of fathers / partners was suggested. Recent documents advocated a trauma-informed care approach. Opioid substitution therapy (OST) was recommended throughout pregnancy where required. Potential gaps were identified around provision of support for women postnatally, especially when their baby is removed from their care. CONCLUSIONS: This synthesis of recommended practice provides key information for practitioners, service providers and policy makers. It also highlights the need for guidelines to be evidence-based, informed by the experiences of women who use or are in treatment for drug use during the perinatal period, and to address the support needs of postnatal women who have their babies removed from their care.

Implementing a complex mental health intervention in occupational settings: process evaluation of the MENTUPP pilot study.

BACKGROUND: According to the Medical Research Council (MRC) framework, the theorisation of how multilevel, multicomponent interventions work and the understanding of their interaction with their implementation context are necessary to be able to evaluate them beyond their complexity. More research is needed to provide good examples following this approach in order to produce evidence-based information on implementation practices. OBJECTIVES: This article reports on the results of the process evaluation of a complex mental health intervention in small and medium enterprises (SMEs) tested through a pilot study. The overarching aim is to contribute to the evidence base related to the recruitment, engagement and implementation strategies of applied mental health interventions in the workplace. METHOD: The Mental Health Promotion and Intervention in Occupational Settings (MENTUPP) intervention was pilot tested in 25 SMEs in three work sectors and nine countries. The evaluation strategy of the pilot test relied on a mixed-methods approach combining qualitative and quantitative research methods. The process evaluation was inspired by the RE-AIM framework and the taxonomy of implementation outcomes suggested by Proctor and colleagues and focused on seven dimensions: reach, adoption, implementation, acceptability, appropriateness, feasibility and maintenance. RESULTS: Factors facilitating implementation included the variety of the provided materials, the support provided by the research officers (ROs) and the existence of a structured plan for implementation, among others. Main barriers to implementation were the difficulty of talking about mental health, familiarisation with technology, difficulty in fitting the intervention into the daily routine and restrictions caused by COVID-19. CONCLUSIONS: The results will be used to optimise the MENTUPP intervention and the theoretical framework that we developed to evaluate the causal mechanisms underlying MENTUPP. Conducting this systematic and comprehensive process evaluation contributes to the enhancement of the evidence base related to mental health interventions in the workplace and it can be used as a guide to overcome their contextual complexity. TRIAL REGISTRATION NUMBER: ISRCTN14582090.

Understanding capacity for implementing new interventions: A qualitative study of speech and language therapy services for children with speech sound disorder.

BACKGROUND: Many speech sound disorder (SSD) interventions with a long-term evidence base are 'new' to clinical practice, and the role of services in supporting or constraining capacity for practice change is underexplored. Innovations from implementation science may offer solutions to this research-practice gap but have not previously been applied to SSD. AIM: To explain variation in speech and language therapy service capacity to implement new SSD interventions. METHODS & PROCEDURES: We conducted an intensive, case-based qualitative study with 42 speech and language therapists (SLTs) in three NHS services (n = 39) and private practice (n = 3) in Scotland. We explored therapists' diverse experiences of SSD practice change through individual interviews (n = 28) or self-generated paired (n = 2) or focus groups (n = 3). A theoretical framework (Normalization Process Theory) helped us understand how the service context contributed to the way therapists engaged with different practice changes. OUTCOMES & RESULTS: We identified six types ('cases') of practice change, two of which involved the new SSD interventions. We focus on these two cases ('Transforming' and 'Venturing') and use Normalization Process Theory's Cognitive participation construct to explain implementation (or not) of new SSD interventions in routine practice. Therapists were becoming aware of the new interventions through knowledge brokers, professional networks and an intervention database. In the Transforming case, new SSD interventions for selected children were becoming part of local routine practice. Transforming was the result of a favourable service structure, a sustained and supported 'push' that made implementation of the new interventions a service priority, and considerable collective time to think about doing it. 'Venturing' happened where the new SSD interventions were not a service priority. It involved individual or informal groups of therapists trying out or using one or more of the new interventions with selected children within the constraints of their service context. CONCLUSIONS & IMPLICATIONS: New, evidence-based SSD interventions may be challenging to implement in routine practice because they have in common a need for therapists who understand applied linguistics and can be flexible with service delivery. Appreciating what it really takes to do routine intervention differently is vital for managers and services who have to make decisions about priorities for implementation, along with realistic plans for resourcing and supporting it. WHAT THIS PAPER ADDS: What is already known on the subject Many SSD interventions have an evidence base but are not widely adopted into routine clinical practice. Addressing this is not just about individual therapists or education/training, as workplace pressures and service delivery models make it difficult to change practice. What this paper adds to the existing knowledge This paper applies innovations from implementation science to help explain how what is going on in services can support or constrain capacity for implementing evidence-based SSD interventions. What are the potential or actual clinical implications of this work? Service managers and therapists will have a clearer idea of the time and support they may realistically have to invest for new SSD interventions to be used routinely.

Mapping factors that may influence attrition and retention of midwives: a scoping review protocol.

INTRODUCTION: An appropriately staffed midwifery workforce is essential for the provision of safe and high-quality maternity care. However, there is a global and national shortage of midwives. Understaffed maternity services are frequently identified as contributing to unsafe care provision and adverse outcomes for mothers and babies. While there is a need to recruit midwives through pre-registration midwifery programmes, this has significant resource implications, and is counteracted to a large extent by the high number of midwives leaving the workforce. It is increasingly recognised that there is a critical need to attend to retention in midwifery in order to develop and maintain safe staffing levels. The objective of this review is to collate and map factors that have been found to influence attrition and retention in midwifery. METHODS AND ANALYSIS: Joanna Briggs Institute guidance for scoping reviews and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews will be used to guide the review process and reporting of the review. CINAHL, MEDLINE, PsycINFO and Scopus databases will be searched for relevant literature from date of inception to 21 July 2023. Research from high-income countries that explores factors that influence leaving intentions for midwives will be included. Literature from low-income and middle-income countries, and studies where nursing and midwifery data cannot be disaggregated will be excluded. Two reviewers will screen 20% of retrieved citations in duplicate, the first author will screen the remaining results. Data will be extracted using a preformed data extraction tool by the first author. Findings will be presented in narrative, tabular and graphical formats. ETHICS AND DISSEMINATION: The review will collate data from existing research, therefore ethics approval is not required. Findings will be published in journals, presented at conferences and will be translated into infographics and other formats for online dissemination.

Implementation and evaluation of a multi-level mental health promotion intervention for the workplace (MENTUPP): study protocol for a cluster randomised controlled trial.

BACKGROUND: Well-organised and managed workplaces can be a source of wellbeing. The construction, healthcare and information and communication technology sectors are characterised by work-related stressors (e.g. high workloads, tight deadlines) which are associated with poorer mental health and wellbeing. The MENTUPP intervention is a flexibly delivered, multi-level approach to supporting small- and medium-sized enterprises (SMEs) in creating mentally healthy workplaces. The online intervention is tailored to each sector and designed to support employees and leaders dealing with mental health difficulties (e.g. stress), clinical level anxiety and depression, and combatting mental health-related stigma. This paper presents the protocol for the cluster randomised controlled trial (cRCT) of the MENTUPP intervention in eight European countries and Australia. METHODS: Each intervention country will aim to recruit at least two SMEs in each of the three sectors. The design of the cRCT is based on the experiences of a pilot study and guided by a Theory of Change process that describes how the intervention is assumed to work. SMEs will be randomly assigned to the intervention or control conditions. The aim of the cRCT is to assess whether the MENTUPP intervention is effective in improving mental health and wellbeing (primary outcome) and reducing stigma, depression and suicidal behaviour (secondary outcome) in employees. The study will also involve a process and economic evaluation. CONCLUSIONS: At present, there is no known multi-level, tailored, flexible and accessible workplace-based intervention for the prevention of non-clinical and clinical symptoms of depression, anxiety and burnout, and the promotion of mental wellbeing. The results of this study will provide a comprehensive overview of the implementation and effectiveness of such an intervention in a variety of contexts, languages and cultures leading to the overall goal of delivering an evidence-based intervention for mental health in the workplace. TRIAL REGISTRATION: Please refer to Item 2a and registration ISRCTN14104664. Registered on 12th July 2022.

Developing a framework for evaluation: a Theory of Change for complex workplace mental health interventions.

BACKGROUND: There is a gap between the necessity of effective mental health interventions in the workplace and the availability of evidence-based information on how to evaluate them. The available evidence outlines that mental health interventions should follow integrated approaches combining multiple components related to different levels of change. However, there is a lack of robust studies on how to evaluate multicomponent workplace interventions which target a variety of outcomes at different levels taking into account the influence of different implementation contexts. METHOD: We use the MENTUPP project as a research context to develop a theory-driven approach to facilitate the evaluation of complex mental health interventions in occupational settings and to provide a comprehensive rationale of how these types of interventions are expected to achieve change. We used a participatory approach to develop a ToC involving a large number of the project team representing multiple academic backgrounds exploiting in tandem the knowledge from six systematic reviews and results from a survey among practitioners and academic experts in the field of mental health in SMEs. RESULTS: The ToC revealed four long-term outcomes that we assume MENTUPP can achieve in the workplace: 1) improved mental wellbeing and reduced burnout, 2) reduced mental illness, 3) reduced mental illness-related stigma, and 4) reduced productivity losses. They are assumed to be reached through six proximate and four intermediate outcomes according to a specific chronological order. The intervention consists of 23 components that were chosen based on specific rationales to achieve change on four levels (employee, team, leader, and organization). CONCLUSIONS: The ToC map provides a theory of how MENTUPP is expected to achieve its anticipated long-term outcomes through intermediate and proximate outcomes assessing alongside contextual factors which will facilitate the testing of hypotheses. Moreover, it allows for a structured approach to informing the future selection of outcomes and related evaluation measures in either subsequent iterations of complex interventions or other similarly structured programs. Hence, the resulting ToC can be employed by future research as an example for the development of a theoretical framework to evaluate complex mental health interventions in the workplace.

Engaging the agricultural community in the development of mental health interventions: a qualitative research study.

BACKGROUND: Farmers and those involved in the wider agricultural industry have a high suicide rate. They are also a 'hard to reach' group who make less than average use of mental health services. There is therefore a need to understand how best to develop interventions that meet their needs. The aims of this study were to develop a deeper understanding of the farming context and target population and to engage farmers in the shaping of two potential mental health interventions that could be incorporated in a pilot RCT. METHODS: The study was informed throughout by a reference group, who assisted in co-production of the research materials. A snowball approach was used to recruit interested individuals who had an association with farming. Twenty one telephone interviews were undertaken and analysed using the six phases of thematic analysis proposed by Braun and Clarke. RESULTS: Key themes (and sub-themes shown in brackets) related to the study aims were: everyday life (work-life balance; isolation and loneliness); farm management (technology and social media; production, people management, learning and teaching; external pressures; livestock and farm production; financial aspects); demographics (effects of aging); engagement (appropriate wording when talking about mental health; recognising need for help; religion; normalising mental health issues; approaching the conversation); training (mental health training for supporters of the farming community; health & safety and the inclusion of mental health training); and personal stories and experiences, which was an emerging theme. CONCLUSIONS: Recruiting farmers into research studies is best done by meeting farmers where they are found, for example, farmers marts. Accessibility of content, tailoring to the farming community, and guided support are key to effective recruitment and retention.

Women's experiences of care and treatment preferences for perinatal depression: a systematic review.

Understanding women's experiences of care, and treatment preferences, is vital for delivering acceptable and useful services to women with perinatal depression. This systematic review synthesises evidence on care and treatment preferences of women with perinatal depression. This qualitative evidence synthesis uses systematic review methodology. Medline, PsychINFO, CINAHL and EMBASE were searched from January 2011 to October 2021. Search terms fell into five categories: depression, the perinatal period, treatment preferences, experiences of care and qualitative research. Study quality was assessed and thematic analysis was used to synthesise findings. Thirteen papers met the inclusion criteria. Quality of included papers was of moderate to high quality. Five key themes were identified: women prioritise family needs; perinatal-specific care; when care falls short; professional empathy; and tailored care. Clinicians need to enable mothers to prioritise their own well-being. Service providers should ensure that treatment is tailored to the specifics of the perinatal period, providing specialist advice around medication, and therapy that fits with the demands of caring for a new baby.

Challenges in implementing GP clusters in Scotland: a qualitative study comparing the views of senior primary care stakeholders in 2016 with those in 2021.

BACKGROUND: Formation of GP clusters began in Scotland in April 2016 as part of a new Scottish GP contract. They aim to improve the care quality for local populations (intrinsic role) and the integration of health and social care (extrinsic role). AIM: To compare predicted challenges of cluster implementation in 2016 with reported challenges in 2021. DESIGN & SETTING: Qualitative study of senior national stakeholders in primary care in Scotland. METHOD: Qualitative analysis of semi-structured interviews with 12 senior primary care national stakeholders in 2016 (n = 6) and 2021 (n = 6). RESULTS: Predicted challenges in 2016 included balancing intrinsic and extrinsic roles, providing sufficient support, maintaining motivation and direction, and avoiding variation between clusters. Progress of clusters in 2021 was perceived as suboptimal and was reported to vary significantly across the country, reflecting differences in local infrastructure. Practical facilitation (data, administrative support, training, project improvement support, and funded time) and strategic guidance from the Scottish Government was felt to be lacking. GP engagement with clusters was felt to be hindered by the significant time and workforce pressures facing primary care. These barriers were considered as collectively contributing to cluster lead 'burnout' and loss of momentum, exacerbated by inadequate opportunities for shared learning between clusters across Scotland. Such barriers preceded, but were perpetuated by, the impact of the COVID-19 pandemic. CONCLUSION: Apart from the COVID-19 pandemic, many of the challenges reported by stakeholders in 2021 were predicted in 2016. Accelerating progress in cluster working will require renewed investment and support applied consistently across the country.

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.

Long-term effects and costs of pelvic floor muscle training for prolapse: trial follow-up record-linkage study.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse affects around 40% of women aged over 50 years. A multicentre parallel group randomised trial (the Pelvic Organ Prolapse PhysiotherapY (POPPY) trial) demonstrated that pelvic floor muscle training (PFMT) was effective in reducing prolapse symptoms compared with no treatment. However, insight into the long-term impact of PFMT on health outcomes and health-service utilisation is scarce. METHODS: This study utilised linkage of Scottish administrative health records to follow-up POPPY trial participants resident in Scotland over 11 years. Mixed effects logistic regression determined the likelihood of receiving further prolapse treatment for those in the PFMT and control groups. Analyses were adjusted for age group, prolapse stage, baseline symptom severity and attitude towards surgery. A cost assessment estimated longitudinal costs to the UK National Health Service (in Scotland) of accessing further prolapse treatment for each trial group. RESULTS: Two hundred and ninety-three women, aged 25 to 79 years, were followed up. One hundred and forty-one women (48.1%) had received further prolapse treatment: 65 (of 149; 43.6%) in the PFMT group compared with 76 (of 144; 52.8%) in the control group. PFMT was associated with a reduction in the odds of any prolapse treatment during follow-up (AOR 0.61; 95% CI 0.37 to 0.99). Total cost of secondary care was £154,544 (GBP) in the PFMT group and £172,549 (GBP) in the control group. CONCLUSIONS: Although PFMT did not lead to significant differences in total costs for further prolapse treatment over a post-intervention period of more than 10 years, it reduced the overall long-term risk of requiring hospital-based treatment for pelvic floor disorders.