Preliminary clinical and cost effectiveness of augmented depression therapy versus cognitive behavioural therapy for the treatment of anhedonic depression (ADepT): a single-centre, open-label, parallel-group, pilot, randomised, controlled trial.

Background: Anhedonia (reduced interest/pleasure) symptoms and wellbeing deficits are core to depression and predict a poor prognosis. Current depression psychotherapies fail to target these features adequately, contributing to sub-optimal outcomes. Augmented Depression Therapy (ADepT) has been developed to target anhedonia and wellbeing. We aimed to establish clinical and economic proof of concept for ADepT and to examine feasibility of a future definitive trial comparing ADepT to Cognitive Behavioural Therapy (CBT). Methods: In this single-centre, open-label, parallel-group, pilot randomised controlled trial, adults meeting diagnostic criteria for a current major depressive episode, scoring ≥10 on the Patient Health Questionnaire (PHQ-9) and exhibiting anhedonic features (PHQ-9 item 1 ≥ 2) were recruited primarily from high intensity Improving Access to Psychological Therapy (IAPT) service waiting lists in Devon, UK. Participants were randomised to receive 20 sessions of CBT or ADepT, using a mimimisation algorithm to balance depression severity and antidepressant use between groups. Treatment was delivered in an out-patient university-based specialist mood disorder clinic. Researcher-blinded assessments were completed at intake and six, 12, and 18 months. Co-primary outcomes were depression (PHQ-9) and wellbeing (Warwick Edinburgh Mental Wellbeing Scale) at 6 months. Primary clinical proof-of-concept analyses were intention to treat. Feasibility (including safety) and health economic analyses used complete case data. This trial is registered at the ISRCTN registry, ISRCTN85278228. Findings: Between 3/29/2017 and 7/31/2018, 82 individuals were recruited (102% of target sample) and 41 individuals were allocated to each arm. A minimum adequate treatment dose was completed by 36/41 (88%) of CBT and 35/41 (85%) of ADepT participants. There were two serious adverse events in each arm (primarily suicide attempts; none of which were judged to be trial- or treatment-related), with no other evidence of harms. Intake and six-month primary outcome data was available for 37/41 (90%) CBT participants and 32/41 (78%) ADepT participants. Between-group effects favoured ADepT over CBT for depression (meanΔ = -1.35, 95% CI = -3.70, 1.00, d = 0.23) and wellbeing (meanΔ = 2.64, 95% CI = -1.71, 6.99, d = 0.27). At 18 months, the advantage of ADepT over CBT was preserved and ADepT had a >80% probability of cost-effectiveness. Interpretation: These findings provide proof of concept for ADepT and warrant continuation to definitive trial. Funding: NIHR Career Development Fellowship.

Evaluation of a complex intervention for prisoners with common mental health problems, near to and after release: the Engager randomised controlled trial.

BACKGROUND: Many male prisoners have significant mental health problems, including anxiety and depression. High proportions struggle with homelessness and substance misuse. AIMS: This study aims to evaluate whether the Engager intervention improves mental health outcomes following release. METHOD: The design is a parallel randomised superiority trial that was conducted in the North West and South West of England (ISRCTN11707331). Men serving a prison sentence of 2 years or less were individually allocated 1:1 to either the intervention (Engager plus usual care) or usual care alone. Engager included psychological and practical support in prison, on release and for 3-5 months in the community. The primary outcome was the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), 6 months after release. Primary analysis compared groups based on intention-to-treat (ITT). RESULTS: In total, 280 men were randomised out of the 396 who were potentially eligible and agreed to participate; 105 did not meet the mental health inclusion criteria. There was no mean difference in the ITT complete case analysis between groups (92 in each arm) for change in the CORE-OM score (1.1, 95% CI -1.1 to 3.2, P = 0.325) or secondary analyses. There were no consistent clinically significant between-group differences for secondary outcomes. Full delivery was not achieved, with 77% (108/140) receiving community-based contact. CONCLUSIONS: Engager is the first trial of a collaborative care intervention adapted for prison leavers. The intervention was not shown to be effective using standard outcome measures. Further testing of different support strategies for prison with mental health problems is needed.

Interrogating intervention delivery and participants' emotional states to improve engagement and implementation: A realist informed multiple case study evaluation of Engager.

BACKGROUND: 'Engager' is an innovative 'through-the-gate' complex care intervention for male prison-leavers with common mental health problems. In parallel to the randomised-controlled trial of Engager (Trial registration number: ISRCTN11707331), a set of process evaluation analyses were undertaken. This paper reports on the depth multiple case study analysis part of the process evaluation, exploring how a sub-sample of prison-leavers engaged and responded to the intervention offer of one-to-one support during their re-integration into the community. METHODS: To understand intervention delivery and what response it elicited in individuals, we used a realist-informed qualitative multiple 'case' studies approach. We scrutinised how intervention component delivery lead to outcomes by examining underlying causal pathways or 'mechanisms' that promoted or hindered progress towards personal outcomes. 'Cases' (n = 24) were prison-leavers from the intervention arm of the trial. We collected practitioner activity logs and conducted semi-structured interviews with prison-leavers and Engager/other service practitioners. We mapped data for each case against the intervention logic model and then used Bhaskar's (2016) 'DREIC' analytic process to categorise cases according to extent of intervention delivery, outcomes evidenced, and contributing factors behind engagement or disengagement and progress achieved. RESULTS: There were variations in the dose and session focus of the intervention delivery, and how different participants responded. Participants sustaining long-term engagement and sustained change reached a state of 'crises but coping'. We found evidence that several components of the intervention were key to achieving this: trusting relationships, therapeutic work delivered well and over time; and an in-depth shared understanding of needs, concerns, and goals between the practitioner and participants. Those who disengaged were in one of the following states: 'Crises and chaos', 'Resigned acceptance', 'Honeymoon' or 'Wilful withdrawal'. CONCLUSIONS: We demonstrate that the 'implementability' of an intervention can be explained by examining the delivery of core intervention components in relation to the responses elicited in the participants. Core delivery mechanisms often had to be 'triggered' numerous times to produce sustained change. The improvements achieved, sustained, and valued by participants were not always reflected in the quantitative measures recorded in the RCT. The compatibility between the practitioner, participant and setting were continually at risk of being undermined by implementation failure as well as changing external circumstances and participants' own weaknesses. TRIAL REGISTRATION NUMBER: ISRCTN11707331, Wales Research Ethics Committee, Registered 02-04-2016-Retrospectively registered https://doi.org/10.1186/ISRCTN11707331.

Psychological therapy for mood instability within bipolar spectrum disorder: a randomised, controlled feasibility trial of a dialectical behaviour therapy-informed approach (the ThrIVe-B programme).

BACKGROUND: A subgroup of those with bipolar spectrum disorders experience ongoing mood fluctuations outside of full episodes. We conducted a randomised, controlled feasibility study of a Dialectical Behavioural Therapy-informed approach for bipolar mood fluctuations (Therapy for Inter-episode mood Variability in Bipolar [ThrIVe-B]). Our study aimed to examine the feasibility and acceptability of a future definitive trial evaluating the clinical and cost effectiveness of the ThrIVe-B programme. Participants were required to meet diagnostic criteria for a bipolar spectrum disorder and report frequent mood swings outside of acute episodes. They were randomised to treatment as usual (control arm) or the ThrIVe-B intervention plus treatment as usual (intervention arm). Follow-up points were at 3, 6, 9 and 15 months after baseline, with 9 months as the primary end point. To evaluate feasibility and acceptability we examined recruitment and retention rates, completion rates for study measures, adverse events and feedback from participants on their experience of study participation and therapy. RESULTS: Of the target 48 participants, 43 were recruited (22 in the intervention arm; 21 in the control arm), with a recruitment rate of 3.9 participants per month. At 9 months 74% of participants engaged in research follow-up assessment, exceeding the pre-specified criterion of 60%. There were no serious concerns about the safety of the research procedures or the intervention. On one of the four candidate primary outcome measures, the 95% CI for the between-group mean difference score excluded the null effect and included the minimal clinically important difference, favouring the intervention arm, whilst on no measure was there evidence of deterioration in the intervention arm relative to the control arm. Attendance of the intervention (50% attending at least half of the mandatory sessions) was below the pre-specified continuation criterion of 60%, and qualitative feedback from participants indicated areas that may have hampered or facilitated engagement. CONCLUSIONS: It is broadly feasible to conduct a trial of this design within the population of people with frequent bipolar mood swings. Changes should be made to the therapy to increase uptake, such as simplifying content and considering individual rather than group delivery. Trial registration ISRCTN: ISRCTN54234300. Registered 14th July 2017, http://www.isrctn.com/ISRCTN54234300.

Using multiple case studies of health and justice services to inform the development of a new complex intervention for prison-leavers with common mental health problems (Engager).

BACKGROUND: People in the criminal justice system have complex needs but often do not make use of services outside of prison, in many cases due to poorly joined up working between health and criminal justice services. The 'Engager' programme aimed to develop a complex collaborative care intervention for people leaving prison with common mental health problems that could support their transition into the community and facilitate joined up working between health, justice and social services. To augment our core intervention theory, we wanted to learn from innovative and forward-thinking services providing interagency support and/or treatment for people experiencing common mental health problems within the criminal justice system. We wanted to identify key elements of interagency practice to understand what was and was not effective in engaging people, maintaining their contact and improving mental health and other aspects of their lives. METHOD: We used a multiple case study design with a focused ethnographic approach in four study sites. Data came from three sources (documents, field notes and semi-structured interviews) underwent a framework analysis. RESULTS: We identified seven main themes, namely: collaboration, client engagement, client motivation, supervision, therapeutic approach, peers and preparations for ending. Engaging and motivating clients was dependent on the relationship built with the professional. This relationship was developed through building trust and rapport, which required time and respectful, open and honest communication. Professionals were often unable to build this relationship effectively if they did not work in effective interagency collaborations, particularly those which included shared practices and were supported by effective supervision. CONCLUSIONS: The multiple case study design contributed insights as to how health and justice services work together. The main themes identified are well known factors in health and justice co-working. However, the novel insights were gleaned examining interdependence and interactions in complex, multifactorial phenomena and practice, in particular the importance of shared practice and supervision models. The approach of selecting a small number of cases representing identified knowledge gaps contributed a valuable addition to the program theory and delivery for an innovative complex intervention.

Measuring outcomes in trials of interventions for people who self-harm: qualitative study of service users' views.

BACKGROUND: Patients often have very different ideas from clinicians about what they want treatments to achieve. Their views on what outcomes are important are not always reflected in trials. AIMS: To elicit the views of people who self-harm on the most commonly used outcome measures and to identify the outcomes that matter to them. METHOD: We conducted in-depth interviews with 18 people with histories of self-harm, recruited from hospital and community settings. We conducted thematic analysis using a framework approach and used visual mapping to arrive at our final analysis and interpretation. RESULTS: Participants' accounts contained a number of challenges to the validity and meaningfulness of current trial outcome measures. Five broad issues emerged: (a) relationship between frequency and severity of self-harm; (b) behavioural substitution; (b) self-management skills; (d) the role of self-harm as survival tool and affect regulator, and (e) strategic self-presentation. We show how these affect the visibility and measurability of commonly used outcomes. The outcomes that mattered to participants focused on positive achievements in three domains: (a) general functioning and activities of everyday living; (b) social participation, and (c) engagement with services. Participants conceptualised these as both measures and means of sustained improvement. CONCLUSIONS: Our findings suggest that current self-harm trial science rests on flawed assumptions about the relationship between mental states and behaviours and about our ability to measure both. Greater understanding of the outcomes that matter to people who self-harm is needed to inform both intervention development and trial design.

Intervening to prevent a suicide in a public place: a qualitative study of effective interventions by lay people.

OBJECTIVES: Many suicides take place in public locations, usually involving jumping from high places or use of transport networks. Previous research has largely focused on the effectiveness of physical barriers at frequently used locations. There have been no studies of human intervention to prevent suicides in public places. The aim of this study was to identify the core components of an effective intervention by a member of the public. DESIGN AND METHODS: We conducted in-depth qualitative interviews with people who have either been prevented by a stranger from taking their own life in a public location (n=12) or intervened to prevent a stranger from taking their own life in a public location (n=21). Collectively, the two groups narrated 50 incidents of suicide rescue. We analysed interview transcripts using inductive thematic analysis. RESULTS: Suicidal people typically displayed no visible distress, describing themselves as being dissociated or 'in a bubble'. Intervention was seen to involve three main tasks: 'bursting the bubble' (reconnecting with self, others and everyday world); moving to a safer location, and summoning help. We show how interveners accomplished these tasks in a range of ways, using both verbal and non-verbal communication and different degrees of restraint. CONCLUSIONS: This is the first empirical study to examine the role of passing strangers in preventing suicides in public places. It shows that no specialist skills are needed. Interveners were ordinary people, distinguished only by a high level of social awareness, combined with a readiness for social action. The findings also suggest that people do not need a script and should not be afraid of saying 'the wrong thing.' What interveners said was much less important than how they made the suicidal person feel, namely safe, connected and validated ('I matter'). Interveners did this simply by being themselves, responding with authenticity, calmness and compassion. Members of the public need to be encouraged to recognise and reach out to those who may be at risk of suicide in public locations, but should be prepared for a prolonged and intense encounter that may leave them with troubling emotions.

Bringing light into darkness: A multiple baseline mixed methods case series evaluation of Augmented Depression Therapy (ADepT).

Two core features of depression are elevations in negative valence system (NVS) functioning and reductions in positive valence system (PVS) functioning. Existing psychological treatments have focused on the NVS and neglected the PVS, which may contribute to sub-optimal outcomes. The present mixed methods multiple randomised baseline case series preliminarily evaluates Augmented Depression Therapy (ADepT), a novel depression treatment targeting PVS and NVS disturbance, that aims both to reduce depression and enhance wellbeing. Eleven clinically depressed participants were recruited. Intensive time series analyses showed that 7/11 participants improved on both wellbeing and depression. Reliable and clinically significant improvement was observed for 9/11 participants on at least one of these outcomes (and also across a range of other PVS and NVS outcomes). Group level analyses showed significant pre to post change on all outcomes. Benchmarking analyses indicated these effect sizes were at least comparable (and for some PVS outcomes superior) to existing treatments. Gains were largely sustained over one-year follow-up. Qualitative interviews indicated ADepT was feasible and acceptable. These findings provide preliminary support for ADepT as a novel depression treatment. Further evaluation, directly comparing ADepT to existing treatments using randomised controlled trial designs, is now required.

Evaluating Augmented Depression Therapy (ADepT): study protocol for a pilot randomised controlled trial.

BACKGROUND: While existing psychological treatments for depression are effective for many, a significant proportion of depressed individuals do not respond to current approaches and few remain well over the long-term. Anhedonia (a loss of interest or pleasure) is a core symptom of depression which predicts a poor prognosis but has been neglected by existing treatments. Augmented Depression Therapy (ADepT) has been co-designed with service users to better target anhedonia alongside other features of depression. This mixed methods pilot trial aims to establish proof of concept for ADepT and to examine the feasibility and acceptability of a future definitive trial evaluating the clinical and cost-effectiveness of ADepT, compared to an evidence-based mainstream therapy (Cognitive Behavioural Therapy; CBT) in the acute treatment of depression, the prevention of subsequent depressive relapse, and the enhancement of wellbeing. METHODS: We aim to recruit 80 depressed participants and randomise them 1:1 to receive ADepT (15 weekly acute and 5 booster sessions in following year) or CBT (20 weekly acute sessions). Clinical and health economic assessments will take place at intake and at 6-, 12-, and 18-month follow-up. Reductions in PHQ-9 depression severity and increases in WEMWBS wellbeing at 6-month assessment (when acute treatment should be completed) are the co-primary outcomes. Quantitative and qualitative process evaluation will assess mechanism of action, implementation issues, and contextual moderating factors. To evaluate proof of concept, intake-post effect sizes and the proportion of individuals showing reliable and clinically significant change on outcome measures in each arm at each follow-up will be reported. To evaluate feasibility and acceptability, we will examine recruitment, retention, treatment completion, and data completeness rates and feedback from patients and therapists about their experience of study participation and therapy. Additionally, we will establish the cost of delivery of ADepT. DISCUSSION: We will proceed to definitive trial if any concerns about the safety, acceptability, feasibility, and proof of concept of ADepT and trial procedures can be rectified, and we recruit, retain, and collect follow-up data on at least 60% of the target sample. TRIAL REGISTRATION: ISCRTN85278228, registered 27/03/2017.

Mapping the Autistic Advantage from the Accounts of Adults Diagnosed with Autism: A Qualitative Study.

Background: Autism has been associated with specific cognitive strengths. Strengths and weaknesses have traditionally been conceptualized as dichotomous. Methods: We conducted 28 semi-structured interviews with autistic adults. Maximum variation sampling was used to ensure diversity in relation to support needs. We asked which personal traits adults attributed to their autism, and how these have helped in the workplace, in relationships, and beyond. Data were collected in two stages. Responses were analyzed using content and thematic techniques. Results: The ability to hyperfocus, attention to detail, good memory, and creativity were the most frequently described traits. Participants also described specific qualities relating to social interaction, such as honesty, loyalty, and empathy for animals or for other autistic people. In thematic analysis we found that traits associated with autism could be experienced either as advantageous or disadvantageous dependent on moderating influences. Moderating influences included the social context in which behaviors occurred, the ability to control behaviors, and the extent to which traits were expressed. Conclusions: Separating autistic strengths from weaknesses may be a false dichotomy if traits cannot be isolated as separate constructs of strengths or deficits. If attempts to isolate problematic traits from advantageous traits are ill conceived, there may be implications for interventions that have reduction in autistic traits as a primary outcome measure. LAY SUMMARY: Why was this study done?: The study was done to find out what autistic adults could tell us about their own abilities. They told us about their abilities and how these abilities had helped them in their everyday lives: at work, in their relationships with other people, and at home.What was the purpose of this study?: To tell a story about what aspects of their autism adults thought were of benefit, when going about their daily lives.What did the researchers do?: The researchers interviewed 24 adults who had an autism diagnosis. Some lived in residential care and others lived alone in rented apartments. Some people were interviewed twice. Most people said they enjoyed the experience of being interviewed.Once the interviews were done, they were typed up and the researchers tried to figure out what were the common themes over all the stories they had heard. They thought about the themes, then did some more interviews with autistic adults to check they were on the right lines. After discussing them, they wrote the story.What were the results of the study?: Hyper focus, attention to detail, and the ability to remember were the abilities that autistic people said benefitted them most often. But autistic adults who were interviewed said although their autistic traits were sometimes helpful, at other times they hindered their progress. So the same trait might be useful in some circumstances and unhelpful in other situations. For example, hypersensitivity led one person to enjoy nature, but was difficult to cope with in crowded streets. The study highlights this interchangeability.What do these findings add to what was already known?: Before, autistic people were known to have both strengths and challenges, but studies tended to separate autistic strengths and weaknesses as different things. We theorize that some traits are expressed as behaviors that may serve to improve or hinder autistic people's progress, but this depends on their situation (context).What are potential weaknesses in the study?: Because the researchers used interviews, they did not include any nonverbal autistic people in the study.How will these findings help autistic adults now or in the future?: It could be useful to think about autism in a way that does not focus on deficits and this study will help us to do that. Plus, if an autistic trait can give people an advantage or a disadvantage, interventions aimed at reducing autistic behaviors might risk dampening advantageous traits as they seek to help with difficulties. That means, autistic adults and children might lose useful abilities when and if they are treated for traits that can also be problematic. The researchers hope their study will lead to more discussion about these types of ideas.

The clinical and cost effectiveness of adapted dialectical behaviour therapy (DBT) for bipolar mood instability in primary care (ThrIVe-B programme): a feasibility study.

BACKGROUND: In bipolar spectrum disorder, some individuals experience ongoing, frequent fluctuations in mood outside of affective episodes. There are currently no evidence-based psychological interventions designed to address this. This feasibility study is a phase II evaluation of a dialectical behavioural therapy-informed approach (Therapy for Inter-episode mood Variability in Bipolar [ThrIVe-B]). It seeks to examine the feasibility and acceptability of a future definitive trial evaluating the clinical and cost effectiveness of the ThrIVe-B programme. METHODS/DESIGN: Patients will be randomised 1:1 to either treatment as usual only (control arm) or the ThrIVe-B intervention plus treatment as usual (intervention arm). Follow-up points will be at 3, 6, 9 and 15 months after baseline, with 9 months as the primary end point for the candidate primary outcome measures. We aim to recruit 48 individuals meeting diagnostic criteria for a bipolar spectrum disorder and reporting frequent mood swings outside of acute episodes, through primary and secondary care services and self-referral. To evaluate feasibility and acceptability, we will examine recruitment and retention rates, completion rates for study measures and feedback from participants on their experience of study participation and therapy. DISCUSSION: Proceeding to a definitive trial will be indicated if the following criteria are met: (1) trial participation does not lead to serious negative consequences for our participants; (2) any serious concerns about the acceptability and feasibility of the trial procedures can be rectified prior to a definitive trial; (3) follow-up data at 9 months are available for at least 60% of participants; (4) at least 60% of patients in the ThrIVe-B arm complete treatment. TRIAL REGISTRATION: ISRCTN, ISRCTN54234300 . Registered on 20 July 2017.

Engaging Without Exposing: Use of a Fictional Character to Facilitate Mental Health Talk in Focus Groups With Men Who Have Been Subject to the Criminal Justice System.

In an effort to encourage men with experience of being subject to the criminal justice system to contribute to focus group discussions on the sensitive topic of mental health, while also doing our utmost to protect them from discomfort or risk of exploitation, we used a novel technique involving the creation of a fictional character, supplemented by an audio-recorded vignette. We studied the role played by this technique in achieving our stated aims of "engaging without exposing." In this article, we report on the use of this technique in three focus groups, showing how in very different ways it shaped the interaction between participants and generated crucial insights into the lives and service needs of each group. We conclude that the technique may lend itself to being used in focus groups with other marginalized or seldom-heard populations.

Evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: study protocol for a randomised controlled trial.

INTRODUCTION: The 'Engager' programme is a 'through-the-gate' intervention designed to support prisoners with common mental health problems as they transition from prison back into the community. The trial will evaluate the clinical and cost-effectiveness of the Engager intervention. METHODS AND ANALYSIS: The study is a parallel two-group randomised controlled trial with 1:1 individual allocation to either: (a) the Engager intervention plus standard care (intervention group) or (b) standard care alone (control group) across two investigation centres (South West and North West of England). Two hundred and eighty prisoners meeting eligibility criteria will take part. Engager is a person-centred complex intervention delivered by practitioners and aimed at addressing offenders' mental health and social care needs. It comprises one-to-one support for participants prior to release from prison and for up to 20 weeks postrelease. The primary outcome is change in psychological distress measured by the Clinical Outcomes in Routine Evaluation-Outcome Measure at 6 months postrelease. Secondary outcomes include: assessment of subjective met/unmet need, drug and alcohol use, health-related quality of life and well-being-related quality of life measured at 3, 6 and 12 months postrelease; change in objective social domains, drug and alcohol dependence, service utilisation and perceived helpfulness of services and change in psychological constructs related to desistence at 6 and 12 months postrelease; and recidivism at 12 months postrelease. A process evaluation will assess fidelity of intervention delivery, test hypothesised mechanisms of action and look for unintended consequences. An economic evaluation will estimate the cost-effectiveness. ETHICS AND DISSEMINATION: This study has been approved by the Wales Research Ethics Committee 3 (ref: 15/WA/0314) and the National Offender Management Service (ref: 2015-283). Findings will be disseminated to commissioners, clinicians and service users via papers and presentations. TRIAL REGISTRATION NUMBER: ISRCTN11707331; Pre-results.

General practitioner contributions to achieving sustained healthcare for offenders: a qualitative study.

BACKGROUND: Offenders frequently have substantial healthcare needs and, like many other socially marginalised groups, often receive healthcare in inverse proportion to their needs. Improved continuity of healthcare over time could contribute to addressing these needs. General Practitioners need to be able to support people with complex social and medical problems, even in systems that are not specifically designed to manage individuals with such degrees of complexity. We aimed to examine offenders' perspectives on factors that contributed to, or worked against, creating and sustaining their access to healthcare. METHODS: From a sample of 200 participants serving community or prison sentences in South West (SW) and South East (SE) England, who were interviewed about their health care experiences as part of the Care for Offenders: Continuity of Access (COCOA) study, we purposively sampled 22 participants for this sub-study, based on service use. These interviews were transcribed verbatim. A thematic analytic approach initially applied 5 a priori codes based on access and different components of continuity. Data were then examined for factors that contributed to achieving and disrupting access and continuity. RESULTS: Participants described how their own life situations and behaviours contributed to their problems in accessing healthcare and also identified barriers created by existing access arrangements. They also highlighted how some General Practitioners used their initiative and skills to 'workaround' the system, and build positive relationships with them; feeling listened to and building trust were particularly valued, as was clear communication. Limitations faced by General Practitioners included a lack of appropriate services to refer people to, where the offender patients would meet the access criteria, and disagreements regarding medication prescriptions. CONCLUSIONS: General Practitioners can make a positive contribution to supporting access to healthcare for an under-served population by facilitating more flexible and less formal access arrangements, by using their relationship skills, and by problem-solving. General Practitioners should recognise their potential to transform people's experience of healthcare whilst working in imperfect systems, particularly with vulnerable and marginalised groups who have complex medical and social needs.

How people come to recognise a problem and seek medical help for a person showing early signs of dementia: A systematic review and meta-ethnography.

Evidence suggests that there is usually a long delay between noticing first signs of dementia and seeking medical help. We conducted a systematic review of what people experience and how they make decisions during this time, and used a meta-ethnographic approach to synthesise the findings. Screening and quality assessment resulted in nine studies eligible for inclusion. People with dementia mainly report experiencing memory lapses, while carers focus on more subtle changes in personality. People respond to these changes in one of three ways: 1) they discount them as normal; 2) they reserve judgement as to their cause and significance, or 3) they misattribute them. Pivotal events can finally trigger help seeking. Active reflection and seeking of further evidence may lead to earlier recognition of the possibility of dementia and the need to seek help; it also reduces the risk of a pivotal event. Public education should aim to improve recognition of more subtle signs and to encourage repeated evaluation and reflection.

Development and evaluation of a leaflet for concerned family members and friends: 'It's safe to talk about suicide'.

OBJECTIVES: Significant others can play a key role in suicide prevention, but little attention has been given to the resources they may need in order to do so effectively. Based on previous qualitative research and working in partnership with suicide prevention charities, we developed a simple educational leaflet to help family members and friends recognise and respond to a possible suicidal crisis. We disseminated 15,000 copies through a wide range of community agencies within one English local authority. This paper describes the development, distribution and evaluation of the leaflet. The aim of the evaluation was to assess how the distribution strategy was working, whether the leaflet was regarded as useful and acceptable, how it was being used and whether there were any concerns about its content. DESIGN: Interview study. METHODS: We conducted two rounds of semi-structured telephone interviews with every agency on the distribution list and in-depth qualitative interviews with a purposefully selected sub-sample. RESULTS: The leaflet was seen as filling an important gap. It was eagerly embraced by staff in frontline agencies, who passed it on to clients, used it for their own personal/professional development and to support clients or colleagues, or used it as a teaching aid. No concerns were raised about its content. CONCLUSION: Findings reveal a deep-seated fear of talking about suicide among frontline staff. They were using the leaflet in ways we had not anticipated, demonstrating lateral thinking and a real commitment to suicide prevention in agencies that are not typically associated with it.

Lived Lives: A Pavee Perspective. An arts-science community intervention around suicide in an indigenous ethnic minority.

Background: Suicide is a significant public health concern, which impacts on health outcomes. Few suicide research studies have been interdisciplinary. We combined a psychobiographical autopsy with a visual arts autopsy, in which families donated stories, images and objects associated with the lived life of a loved one lost to suicide. From this interdisciplinary research platform, a mediated exhibition was created (Lived Lives) with artist, scientist and families, co-curated by communities, facilitating dialogue, response and public action around suicide prevention. Indigenous ethnic minorities (IEMs) bear a significant increased risk for suicide. Irish Travellers are an IEM with social and cultural parallels with IEMs internationally, experiencing racism, discrimination, and poor health outcomes including elevated suicide rates (SMR 6.6). Methods: An adjusted Lived Lives exhibition, Lived Lives: A Pavee Perspective manifested in Pavee Point, the national Traveller and Roma Centre. The project was evaluated by the Travelling Community as to how it related to suicide in their community, how it has shaped their understanding of suicide and its impacts, and its relevance to other socio-cultural contexts, nationally and internationally. The project also obtained feedback from all relevant stakeholders. Evaluation was carried out by an international visual arts research advisor and an independent observer from the field of suicide research. Results: Outputs included an arts-science mediated exhibition with reference to elevated Irish Traveller suicide rates. Digital online learning materials about suicide and its aftermath among Irish Travellers were also produced. The project reached its target audience, with a high level of engagement from members of the Travelling Community. Discussion: The Lived Lives methodology navigated the societal barriers of stigma and silence to foster communication and engagement, working with cultural values, consistent with an adapted intervention. Feedback from this project can inform awareness, health promotion, education and interventions around suicide and its aftermath in IEMs.

Implementation of a text-messaging intervention for adolescents who self-harm (TeenTEXT): a feasibility study using normalisation process theory.

BACKGROUND: There are few interventions that directly address self-harming behaviour among adolescents. At the request of clinicians in Child and Adolescent Mental Health Services (CAMHS) in England and working with them, we redeveloped an adult SMS text-messaging intervention to meet the needs of adolescents under the care of CAMHS who self-harm. METHODS: We used normalisation process theory (NPT) to assess the feasibility of delivering it through CAMHS. We planned to recruit 27 young people who self-harm and their clinicians, working as dyads and using the intervention (TeenTEXT) for 6 months. RESULTS: Despite strong engagement in principle from CAMHS teams, in practice we were able to recruit only three clinician/client dyads. Of these, two dropped out because the clients were too unwell. We identified a number of barriers to implementation. These included: a context of CAMHS in crisis, with heavy workloads and high stress levels; organisational gatekeeping practices, which limited the extent to which clinicians could engage with the intervention; perceived burdensomeness and technophobia on the part of clinicians, and a belief by many clinicians that CAMHS may be the wrong delivery setting and that the intervention may have better fit with schools and universal youth services. CONCLUSIONS: User-centred design principles and the use of participatory methods in intervention development are no guarantee of implementability. Barriers to implementation cannot always be foreseen, and early clinical champions may overestimate the readiness of colleagues to embrace new ideas and technologies. NPT studies have an important role to play in identifying whether or not interventions are likely to receive widespread clinical support. This study of a text-messaging intervention to support adolescents who self-harm (TeenTEXT) showed that further work is needed to identify the right delivery setting, before testing the efficacy of the intervention.

Needs and fears of young people presenting at accident and emergency department following an act of self-harm: secondary analysis of qualitative data.

BACKGROUND: Presentation at an accident and emergency (A&E) department is a key opportunity to engage with a young person who self-harms. The needs of this vulnerable group and their fears about presenting to healthcare services, including A&E, are poorly understood. AIMS: To examine young people's perceptions of A&E treatment following self-harm and their views on what constitutes a positive clinical encounter. METHOD: Secondary analysis of qualitative data from an experimental online discussion forum. Threads selected for secondary analysis represent the views of 31 young people aged 16-25 with experience of self-harm. RESULTS: Participants reported avoiding A&E whenever possible, based on their own and others' previous poor experiences. When forced to seek emergency care, they did so with feelings of shame and unworthiness. These feelings were reinforced when they received what they perceived as punitive treatment from A&E staff, perpetuating a cycle of shame, avoidance and further self-harm. Positive encounters were those in which they received 'treatment as usual', i.e. non-discriminatory care, delivered with kindness, which had the potential to challenge negative self-evaluation and break the cycle. CONCLUSIONS: The clinical needs of young people who self-harm continue to demand urgent attention. Further hypothesis testing and trials of different models of care delivery for this vulnerable group are warranted.