Development and evaluation of a de-escalation training intervention in adult acute and forensic units: the EDITION systematic review and feasibility trial.

Background: Containment (e.g. physical restraint and seclusion) is used frequently in mental health inpatient settings. Containment is associated with serious psychological and physical harms. De-escalation (psychosocial techniques to manage distress without containment) is recommended to manage aggression and other unsafe behaviours, for example self-harm. All National Health Service staff are trained in de-escalation but there is little to no evidence supporting training's effectiveness. Objectives: Objectives were to: (1) qualitatively investigate de-escalation and identify barriers and facilitators to use across the range of adult acute and forensic mental health inpatient settings; (2) co-produce with relevant stakeholders an intervention to enhance de-escalation across these settings; (3) evaluate the intervention's preliminary effect on rates of conflict (e.g. violence, self-harm) and containment (e.g. seclusion and physical restraint) and understand barriers and facilitators to intervention effects. Design: Intervention development informed by Experience-based Co-design and uncontrolled pre and post feasibility evaluation. Systematic reviews and qualitative interviews investigated contextual variation in use and effects of de-escalation. Synthesis of this evidence informed co-design of an intervention to enhance de-escalation. An uncontrolled feasibility trial of the intervention followed. Clinical outcome data were collected over 24 weeks including an 8-week pre-intervention phase, an 8-week embedding and an 8-week post-intervention phase. Setting: Ten inpatient wards (including acute, psychiatric intensive care, low, medium and high secure forensic) in two United Kingdom mental health trusts. Participants: In-patients, clinical staff, managers, carers/relatives and training staff in the target settings. Interventions: Enhancing de-escalation techniques in adult acute and forensic units: Development and evaluation of an evidence-based training intervention (EDITION) interventions included de-escalation training, two novel models of reflective practice, post-incident debriefing and feedback on clinical practice, collaborative prescribing and ward rounds, practice changes around admission, shift handovers and the social and physical environment, and sensory modulation and support planning to reduce patient distress. Main outcome measures: Outcomes measured related to feasibility (recruitment and retention, completion of outcome measures), training outcomes and clinical and safety outcomes. Conflict and containment rates were measured via the Patient-Staff Conflict Checklist. Clinical outcomes were measured using the Attitudes to Containment Measures Questionnaire, Attitudes to Personality Disorder Questionnaire, Violence Prevention Climate Scale, Capabilities, Opportunities, and Motivation Scale, Coercion Experience Scale and Perceived Expressed Emotion in Staff Scale. Results: Completion rates of the proposed primary outcome were very good at 68% overall (excluding remote data collection), which increased to 76% (excluding remote data collection) in the post-intervention period. Secondary outcomes had high completion rates for both staff and patient respondents. Regression analyses indicated that reductions in conflict and containment were both predicted by study phase (pre, embedding, post intervention). There were no adverse events or serious adverse events related to the intervention. Conclusions: Intervention and data-collection procedures were feasible, and there was a signal of an effect on the proposed primary outcome. Limitations: Uncontrolled design and self-selecting sample. Future work: Definitive trial determining intervention effects. Trial registration: This trial is registered as ISRCTN12826685 (closed to recruitment). Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/101/02) and is published in full in Health Technology Assessment; Vol. 28, No. 3. See the NIHR Funding and Awards website for further award information. Context: Conflict (a term used to describe a range of potentially unsafe events including violence, self-harm, rule-breaking, medication refusal, illicit drug and alcohol use and absconding) in mental health settings causes serious physical and psychological harm. Containment interventions which are intended to minimise harm from violence (and other conflict behaviours) such as restraint, seclusion and rapid tranquilisation can result in serious injuries to patients and, occasionally, death. Involvement in physical restraint is the most common cause of serious physical injury to National Health Service mental health staff in the United Kingdom. Violence to staff results in substantial costs to the health service in sickness and litigation payments. Containment interventions are also expensive (e.g. physical restraint costs mental health services £6.1 million and enhanced observations £88 million per annum). Despite these harms, recent findings indicate containment interventions such as seclusion and physical restraint continue to be used frequently in mental health settings. Clinical trials have demonstrated that interventions can reduce containment without increasing violence and other conflict behaviours (e.g. verbal aggression, self-harm). Substantial cost-savings result from reducing containment use. De-escalation, as an intervention to manage aggression and potential violence without restrictive practices, is a core intervention. 'De-escalation' is a collective term for a range of psychosocial techniques designed to reduce distress and anger without the need to use 'containment' interventions (measures to prevent harm through restricting a person's ability to act independently, such as physical restraint and seclusion). Evidence indicates that de-escalation involves ensuring conditions for safe intervention and effective communication are established, clarifying and attempting to resolve the patient's concern, conveyance of respect and empathy and regulating unhelpful emotions such as anxiety and anger. Despite featuring prominently in clinical guidelines and training policy domestically and internationally and being a component of mandatory National Health Service training, there is no evidence-based model on which to base training. A systematic review of de-escalation training effectiveness and acceptability conducted in 2015 concluded: (1) no model of training has demonstrated effectiveness in a sufficiently rigorous evaluation, (2) the theoretical underpinning of evaluated models was often unclear and (3) there has been inadequate investigation of the characteristics of training likely to enhance acceptability and uptake. Despite all National Health Service staff being trained in de-escalation there have been no high-quality trials evaluating the effectiveness and cost-effectiveness of training. Feasibility studies are needed to establish whether it is possible to conduct a definitive trial that can determine the clinical, safety and cost-effectiveness of this intervention.

Mental health hospitals are stressful places for patients and staff. Patients are often detained against their will, in places that are noisy, unfamiliar and frightening. Violence and self-injury happen quite frequently. Sometimes staff physically restrain patients or isolate patients in locked rooms (called seclusion). While these measures might sometimes be necessary to maintain safety, they are psychologically and physically harmful. To help reduce the use of these unsafe measures, staff are trained in communication skills designed to reduce anger and distress without using physical force. Professionals call these skills 'de-escalation'. Although training in de-escalation is mandatory, there is no good evidence to say whether it works or not, or what specific techniques staff should be trained in. The Enhancing de-escalation techniques in adult acute and forensic units: Development and evaluation of an evidence-based training intervention (EDITION) project aimed to develop and evaluate a de-escalation training programme informed by research evidence. We interviewed over one hundred people who either worked in or received treatment in a mental health hospital. These people were clear that the training should target key sources of interpersonal and environmental stress that prevent de-escalation from working. We also reviewed all the scientific studies on de-escalation and training, aiming to identify the elements of training that are most likely to increase use of de-escalation. Then, in partnership with current mental health service users and clinical staff, we developed the training programme. Training was delivered to more than 270 staff working in 10 different wards in mental health hospitals. We measured rates of violence, self-injury and use of physical restraint and seclusion 8 weeks before staff received training and 16 weeks after they received training (24 weeks of data collection in total). Analysis of these data showed that these unsafe events were occurring significantly less frequently after training than they were before training, which raised the possibility that the training was helping to reduce harm.

Behavioural activation to mitigate the psychological impacts of COVID-19 restrictions on older people in England and Wales (BASIL+): a pragmatic randomised controlled trial.

BACKGROUND: Older adults were more likely to be socially isolated during the COVID-19 pandemic, with increased risk of depression and loneliness. We aimed to investigate whether a behavioural activation intervention delivered via telephone could mitigate depression and loneliness in at-risk older people during the COVID-19 pandemic. METHODS: BASIL+ (Behavioural Activation in Social Isolation) was a pragmatic randomised controlled trial conducted among patients recruited from general practices in England and Wales, and was designed to assess the effectiveness of behavioural activation in mitigating depression and loneliness among older people during the COVID-19 pandemic. Eligible participants were aged 65 years and older, socially isolated, with a score of 5 or higher on the Patient Health Questionnaire-9 (PHQ-9), and had multiple long-term conditions. Participants were allocated in a 1:1 ratio to the intervention (behavioural activation) or control groups by use of simple randomisation without stratification. Behavioural activation was delivered by telephone; participants were offered up to eight weekly sessions with trained BASIL+ Support Workers. Behavioural activation was adapted to maintain social connections and encourage socially reinforcing activities. Participants in the control group received usual care with existing COVID-19 wellbeing resources. The primary clinical outcome was self-reported depression severity, assessed by the PHQ-9, at 3 months. Outcomes were assessed masked to allocation and analysis was by treatment allocation. This trial is registered with the ISRCTN registry (ISRCTN63034289). FINDINGS: Between Feb 8, 2021, and Feb 28, 2022, 449 eligible participants were identified and 435 from 26 general practices were recruited and randomly assigned (1:1) to the behavioural activation intervention (n=218) or to the control group (usual care with signposting; n=217). The mean age of participants was 75·7 years (SD 6·7); 270 (62·1%) of 435 participants were female, and 418 (96·1%) were White. Participants in the intervention group attended an average of 5·2 (SD 2·9) of eight remote behavioural activation sessions. The adjusted mean difference in PHQ-9 scores between the control and intervention groups at 3 months was -1·65 (95% CI -2·54 to -0·75, p=0·0003). No adverse events were reported that were attributable to the behavioural activation intervention. INTERPRETATION: Behavioural activation is an effective and potentially scalable intervention that can reduce symptoms of depression and emotional loneliness in at-risk groups in the short term. The findings of this trial add to the range of strategies to improve the mental health of older adults with multiple long-term conditions. These results can be helpful to policy makers beyond the pandemic in reducing the global burden of depression and addressing the health impacts of loneliness, particularly in at-risk groups. FUNDING: UK National Institute for Health and Care Research.

Stakeholder perspectives of family interventions for schizophrenia in Indonesia: a qualitative study.

Mental illnesses comprise the single largest source of health-related economic burden globally and low-and middle-income countries (LMICs) are disproportionately affected. Many individuals with schizophrenia do not receive evidence-based, psychosocial interventions as these are largely unavailable, undeveloped, and under-researched in LMICs. Involving service-users and carers in the design of interventions is crucial to ensure stakeholder needs are adequately addressed by the intervention and to aid successful implementation. We aimed to explore the views and perspectives of different stakeholder groups about the delivery, format, and content of family interventions for people living with schizophrenia in Indonesia as a first step towards developing evidence-based, acceptable family interventions. This study used a qualitative design comprising single stakeholder focus groups. Data were analysed separately using the framework approach incorporating deductive and inductive coding within an existing heuristic framework. 51 participants consented to take part in this study comprising six stakeholder consultation groups including service-users (n = 15), caregivers (n = 15) and healthcare professionals (n = 21). Service users were diagnosed with schizophrenia. Caregivers comprised parents (n = 10, 67%), brothers (n = 2, 13%), sister (n = 1, 7%) and husbands (n = 2, 13%). Healthcare professionals were working as nurses (n = 6, 29%), doctors (n = 5, 23%) or cadre's (n = 10, 48%). Caregiver and service-user respondents had limited knowledge or experience of structured family interventions. There was strong support for such interventions, however, for effective delivery a number of challenges exist in terms of widespread stigmatised views, low expectations for involvement in sharing decisions about care and treatment, views that healthcare professionals are expert and have the authority to delegate tasks to families such as responsibility for ensuring medication adherence and understanding the need to balance the needs of both service-users and families when there are conflicting agendas for treatment. These findings can support the development of evidence-based family interventions for families of those with schizophrenia in Indonesia, as user-informed interventions enhance engagement, satisfaction, and adherence to family interventions.

Exploring access and engagement with Improving Access to Psychological Therapies (IAPT) services, before, during, and after the COVID-19 lockdown: A service evaluation in the Northwest of England.

The purpose of this study was to compare clients' prevalence and explore the characteristics that predicted access and engagement with IAPT treatment before, during, and after Lockdown.We conducted a retrospective observational service evaluation, using routinely collected IAPT data from n = 13,019 clients who entered treatment between March and September in 2019, 2020, and 2021. Chi-square and multiple logistic regression were used to explore associations and potential predictors of access and engagement with IAPT treatment.The number of people accessing and engaging with IAPT treatment was significantly higher after lockdown compared to before. Unemployed clients were less likely to access treatment during and after lockdown. Yet, perinatal clients and people from a black ethnic background were more likely to access treatment during lockdown. Being young and being unemployed were predictors of treatment disengagement across all three time points, whereas perinatal clients were less likely to engage only before and during lockdown. Clients who were not prescribed medication and clients with a long-term condition were more likely to engage during lockdown.The demonstrated changes in access and engagement with IAPT treatment after the introduction of remote therapy urges the services to further consider the individual needs of specific client groups.

Using digital technology to promote physical health in mental healthcare: A sequential mixed-methods study of clinicians' views.

AIM: Recent years have seen innovation in 'mHealth' tools and health apps for the management/promotion of physical health and fitness across the general population. However, there is limited research on how this could be applied to mental healthcare. Therefore, we examined mental healthcare professionals' current uses and perceived roles of digital lifestyle interventions for promoting healthy lifestyles, physical health and fitness in youth mental healthcare. METHODS: A sequential, mixed-methods design was used, consisting of a quantitative online survey, followed by qualitative in-depth interviews. RESULTS: A total of 127 mental healthcare professionals participated in the online survey. Participants had limited mHealth experience, and the majority agreed that further training would be beneficial. Thirteen mental healthcare professionals were interviewed. Five themes were generated (i) digital technology's ability to enhance the physical healthcare; (ii) Conditions for the acceptability of apps; (iii) Limitations on staff capability and time; (iv) Motivation as the principal barrier; and (v) Practicalities around receiving lifestyle data. Systematic integration of data produced novel insights around: (i) staff involvement and needs; (ii) ideal focus and content of digital lifestyle interventions; and (iii) barriers towards implementation (including mental healthcare professionals own limited experience using digital lifestyle interventions, which aligned with the appeal of formal training). CONCLUSIONS: Overall, digital lifestyle interventions were positively received by mental healthcare professionals, particularly for health behaviour-tracking and mHealth support for exercise and nutrition. Practical suggestions for facilitating their uptake/implementation to improve availability of physical health interventions in mental healthcare are presented.

An exploration of women's lived experiences of care and support following perinatal death in South-Western Nigeria: A hermeneutic phenomenological study.

BACKGROUND: Perinatal death results in long-lasting intense grief for bereaved mothers with a potential to negatively impact on their short- and long-term outcomes and quality of life if inadequately supported in coping with and managing their experience. AIM: This study aimed at exploring the lived experience of women, of care and support following perinatal death in South-Western, Nigeria. METHODS: A qualitative methodology using Heideggerian phenomenology was used. Fourteen women who had experienced perinatal death in South-Western Nigeria within the last (5) five years were interviewed, and Van Manen's approach to hermeneutic phenomenology was used in data analysis. FINDINGS: Four main themes were identified: "they did not tell me the baby died", "response of health care professionals after the baby died", "moving on from hospital", and "support from family". The physical health status of mothers determined how they were informed of perinatal death. Health care professionals were distant, rude, nonempathetic and did not offer emotional support, in some cases. Mothers were given opportunity to see and hold their babies. There was no routine follow-up support in the community, besides a postnatal check-up appointment offered to all mothers regardless of their birth outcome. Family provided emotional support for mothers on discharge. CONCLUSION: This study was the first to explore the lived experience of women of the care and support following perinatal death in South-Western, Nigeria. There is a need for healthcare systems to review bereavement care and support provisions for women who experience perinatal death.

Pragmatic randomised controlled trial of guided self-help versus individual cognitive behavioural therapy with a trauma focus for post-traumatic stress disorder (RAPID).

Background: Guided self-help has been shown to be effective for other mental conditions and, if effective for post-traumatic stress disorder, would offer a time-efficient and accessible treatment option, with the potential to reduce waiting times and costs. Objective: To determine if trauma-focused guided self-help is non-inferior to individual, face-to-face cognitive-behavioural therapy with a trauma focus for mild to moderate post-traumatic stress disorder to a single traumatic event. Design: Multicentre pragmatic randomised controlled non-inferiority trial with economic evaluation to determine cost-effectiveness and nested process evaluation to assess fidelity and adherence, dose and factors that influence outcome (including context, acceptability, facilitators and barriers, measured qualitatively). Participants were randomised in a 1 : 1 ratio. The primary analysis was intention to treat using multilevel analysis of covariance. Setting: Primary and secondary mental health settings across the United Kingdom's National Health Service. Participants: One hundred and ninety-six adults with a primary diagnosis of mild to moderate post-traumatic stress disorder were randomised with 82% retention at 16 weeks and 71% at 52 weeks. Nineteen participants and ten therapists were interviewed for the process evaluation. Interventions: Up to 12 face-to-face, manualised, individual cognitive-behavioural therapy with a trauma focus sessions, each lasting 60-90 minutes, or to guided self-help using Spring, an eight-step online guided self-help programme based on cognitive-behavioural therapy with a trauma focus, with up to five face-to-face meetings of up to 3 hours in total and four brief telephone calls or e-mail contacts between sessions. Main outcome measures: Primary outcome: the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, at 16 weeks post-randomisation. Secondary outcomes: included severity of post-traumatic stress disorder symptoms at 52 weeks, and functioning, symptoms of depression, symptoms of anxiety, alcohol use and perceived social support at both 16 and 52 weeks post-randomisation. Those assessing outcomes were blinded to group assignment. Results: Non-inferiority was demonstrated at the primary end point of 16 weeks on the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [mean difference 1.01 (one-sided 95% CI -∞ to 3.90, non-inferiority p = 0.012)]. Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, score improvements of over 60% in both groups were maintained at 52 weeks but the non-inferiority results were inconclusive in favour of cognitive-behavioural therapy with a trauma focus at this timepoint [mean difference 3.20 (one-sided 95% confidence interval -∞ to 6.00, non-inferiority p = 0.15)]. Guided self-help using Spring was not shown to be more cost-effective than face-to-face cognitive-behavioural therapy with a trauma focus although there was no significant difference in accruing quality-adjusted life-years, incremental quality-adjusted life-years -0.04 (95% confidence interval -0.10 to 0.01) and guided self-help using Spring was significantly cheaper to deliver [£277 (95% confidence interval £253 to £301) vs. £729 (95% CI £671 to £788)]. Guided self-help using Spring appeared to be acceptable and well tolerated by participants. No important adverse events or side effects were identified. Limitations: The results are not generalisable to people with post-traumatic stress disorder to more than one traumatic event. Conclusions: Guided self-help using Spring for mild to moderate post-traumatic stress disorder to a single traumatic event appears to be non-inferior to individual face-to-face cognitive-behavioural therapy with a trauma focus and the results suggest it should be considered a first-line treatment for people with this condition. Future work: Work is now needed to determine how best to effectively disseminate and implement guided self-help using Spring at scale. Trial registration: This trial is registered as ISRCTN13697710. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/192/97) and is published in full in Health Technology Assessment; Vol. 27, No. 26. See the NIHR Funding and Awards website for further award information.

Post-traumatic stress disorder is a common, disabling condition that can occur following major traumatic events. Typical symptoms include distressing reliving, avoidance of reminders and feeling a current sense of threat. First-choice treatments for post-traumatic stress disorder are individual, face-to-face talking treatments, of 12­16 hours duration, including cognitive behavioural therapy with a trauma focus. If equally effective treatments could be developed that take less time and can be largely undertaken in a flexible manner at home, this would improve accessibility, reduce waiting times and hence the burden of disease. RAPID was a randomised controlled trial using a web-based programme called Spring. The aim was to determine if trauma-focused guided self-help provided a faster and cheaper treatment for post-traumatic stress disorder than first-choice face-to-face therapy, while being equally effective. Guided self-help using Spring is delivered through eight steps. A therapist provides a 1-hour introductory meeting followed by four further, fortnightly sessions of 30 minutes each and four brief (around 5 minutes) telephone calls or e-mail contacts between sessions. At each session, the therapist reviews progress and guides the client through the programme, offering continued support, monitoring, motivation and problem-solving. One hundred and ninety-six people with post-traumatic stress disorder to a single traumatic event took part in the study. Guided self-help using Spring was found to be equally effective to first-choice face-to-face therapy at reducing post-traumatic stress disorder symptoms at 16 weeks. Very noticeable improvements were maintained at 52 weeks post-randomisation in both groups, when most results were inconclusive but in favour of face-to-face therapy. Guided self-help using Spring was significantly cheaper to deliver and appeared to be well-tolerated. It is noteworthy that not everyone benefitted from guided self-help using Spring, highlighting the importance of considering it on a person-by-person basis, and personalising interventions. But, the RAPID trial has demonstrated that guided self-help using Spring provides a low-intensity treatment option for people with post-traumatic stress disorder that is ready to be implemented in the National Health Service.

Exploratory RCT of a group psychological intervention for postnatal depression in British mothers of South Asian origin - ROSHNI-D.

BACKGROUND: Postnatal depression (PND) is a global public health problem. There is a high prevalence of PND amongst ethnic minority women and major ethnic inequalities in mental health care in the U.K. Language and cultural barriers pose a significant challenge for access to timely treatment and interventions for British South Asian (BSA) women with PND. METHODS: The study, carried out in Manchester and Lancashire, England, was a two-arm single-blind exploratory randomised controlled trial. BSA women (N = 83) having a baby <12 months were randomised either to the group receiving the culturally adapted Positive Health Programme (PHP) (n = 42) or to the group receiving treatment as usual (TAU) (n = 41). Follow-up assessments were at 3 months (end of intervention) and 6 months after randomisation. RESULTS: Using an intention to treat analysis, there was no significant difference between PHP intervention and TAU groups in depression measured using Hamilton Depression Rating Scale both at 3 and 6 months follow up. Using modified intention to treat analysis, women who attended four or more sessions showed significant reduction in depression in the PHP group compared to the TAU group and the greater number of sessions attended was associated with greater reductions in depression scores. LIMITATIONS: The sample was relatively small and the study was conducted in one geographical area in Northwest England; hence, these results may not be generalizable to other regions and populations. CONCLUSION: The recruitment and trial retention figures highlighted the ability of the research team to engage with BSA women, having implications in planning services for this group. TRIAL REGISTRATION: Clinicaltrials.govNCT01838889.

Narrative Matters: Hidden LIVE - Adam's story - a mental health theatre production as an example of participatory principles and practices.

This article presents the co-production principles underpinning the co-creation of a multimedia theatre production on young people's mental health.

Exploring the use of social network interventions for adults with mental health difficulties: a systematic review and narrative synthesis.

BACKGROUND: People with mental health difficulties often experience social isolation. The importance of interventions to enhance social networks and reduce this isolation is increasingly being recognised. However, the literature has not yet been systematically reviewed with regards to how these are best used. This narrative synthesis aimed to investigate the role of social network interventions for people with mental health difficulties and identify barriers and facilitators to effective delivery. This was undertaken with a view to understanding how social network interventions might work best in the mental health field. METHODS: Systematic searches using combinations of synonyms for mental health difficulties and social network interventions were undertaken across 7 databases (MEDLINE, Embase, PsycINFO, CINAHL, Cochrane Library, Web of Science) and 2 grey literature databases (EThoS and OpenGrey) from their inception to October 2021. We included studies reporting primary qualitative and quantitative data from all study types relating to the use of social network interventions for people with mental health difficulties. The quality of included studies was assessed using the Mixed Methods Appraisal Tool. Data were extracted and synthesised narratively. RESULTS: The review included 54 studies, reporting data from 6,249 participants. Social network interventions were generally beneficial for people with mental health difficulties but heterogeneity in intervention type, implementation and evaluation made it difficult to draw definitive conclusions. Interventions worked best when they (1) were personalised to individual needs, interests and health, (2) were delivered outside formal health services and (3) provided the opportunity to engage in authentic valued activities. Several barriers to access were identified which, without careful consideration could exacerbate existing health inequalities. Further research is required to fully understand condition-specific barriers which may limit access to, and efficacy of, interventions. CONCLUSIONS: Strategies for improving social networks for people with mental health difficulties should focus on supporting engagement with personalised and supported social activities outside of formal mental health services. To optimise access and uptake, accessibility barriers should be carefully considered within implementation contexts and equality, diversity and inclusion should be prioritised in intervention design, delivery and evaluation and in future research.

Enhancing the quality of psychological interventions delivered by telephone in mental health services: increasing the likelihood of successful implementation using a theory of change.

BACKGROUND: The implementation of new and complex interventions in mental health settings can be challenging. This paper explores the use of a Theory of Change (ToC) for intervention design and evaluation to increase the likelihood of complex interventions being effective, sustainable, and scalable. Our intervention was developed to enhance the quality of psychological interventions delivered by telephone in primary care mental health services. METHODS: A ToC represents how our designed quality improvement intervention targeting changes at service, practitioner, and patient levels was expected to improve engagement in, and the quality of, telephone-delivered psychological therapies. The intervention was evaluated following implementation in a feasibility study within three NHS Talking Therapies services through a qualitative research design incorporating semi-structured interviews and a focus group with key stakeholders (patients, practitioners, and service leads) (N = 15). Data were analysed using the Consolidated Framework for Implementation Research (CFIR) and the ToC was examined and modified accordingly following the findings. RESULTS: CFIR analysis highlighted a set of challenges encountered during the implementation of our service quality improvement telephone intervention that appeared to have weakened the contribution to the change mechanisms set out by the initial ToC. Findings informed changes to the intervention and refinement of the ToC and are expected to increase the likelihood of successful future implementation in a randomised controlled trial. CONCLUSIONS: Four key recommendations that could help to optimise implementation of a complex intervention involving different key stakeholder groups in any setting were identified. These include: 1-developing a good understanding of the intervention and its value among those receiving the intervention; 2-maximising engagement from key stakeholders; 3-ensuring clear planning and communication of implementation goals; and 4-encouraging the use of strategies to monitor implementation progress.

Evaluating a prototype digital mental health literacy intervention for children and young people aged 11-15 in Java, Indonesia: a mixed methods, multi-site case study evaluation.

BACKGROUND: The Improving Mental Health Literacy Among Children and Young People in Indonesia (IMPeTUs) intervention is a co-produced, evidence-based digital intervention designed to improve anxiety and depression focused mental health literacy and self-management among people aged 11-15 in Java, Indonesia. This study aimed to evaluate the usability, feasibility and preliminary impact of our intervention. METHODS: Mixed methods, multi-site case studies based on a theory of change. Pre-and post-assessments of a range of outcomes and qualitative interviews/focus groups with children and young people (CYP), parents and facilitators. The intervention was implemented in 8 health, school and community sites across Java, Indonesia (Megelang, Jakarta and Bogor). Quantitative data designed to understand the impact of and feasibility of evaluating the intervention collected from 78 CYP who used the intervention were analysed descriptively. Qualitative data from interviews and focus groups collected from 56 CYP, 49 parents/caregivers and 18 facilitators were analysed using framework analysis. RESULTS: Qualitative data analysis indicated high levels of usability and acceptability for the interface aesthetic, personalisation, message presentation and navigation. Participants reported minimal burden and no negative outcomes associated with the intervention. CYP, parents and facilitators identified a range of direct and spill over effects of interventions engagement, some of which were not anticipated at study outset. Quantitative data highlighted the feasibility of intervention evaluation, with high levels of recruitment and retention across study time points. Minimal changes were identified in outcomes pre-to-post intervention, which may in part be due to a lack of scale relevance and/or sensitivity to the intervention mechanisms indicated in the qualitative data. CONCLUSIONS: Digital mental health literacy applications are potentially an acceptable and feasible way to prevent burdens of common mental health problems amongst CYP in Indonesia. Our intervention and evaluative processes will be further refined prior to definitive evaluation.

What is the efficacy and effectiveness of telemedicine intervention for deaf signing populations in comparison to face-to-face interventions? A systematic review.

BACKGROUND: Deaf signing populations face inequality in both access to health services and health outcomes. Telemedicine intervention might offer a potential solution to address these inequalities in mental health and health related services, therefore a systematic review was carried out. The review question was: "What is the efficacy and effectiveness of telemedicine intervention for Deaf signing populations in comparison to face-to-face interventions?". METHODS: The PICO framework was applied to identify the components of the review question for this study. The inclusion criteria were: Deaf signing populations; any intervention that includes the delivery of telemedicine therapy and/or the delivery of assessment (e.g. psychological assessments) using telemedicine; and any evidence for the benefits, efficacy and effectiveness of telemedicine intervention with Deaf people whether in health and/or mental health services. The databases PsycINFO, PubMed, Web of Science, CINAHL, and Medline were searched up to August 2021. RESULTS: Following the search strategy, and after the duplicates were removed, 247 records were identified. Following screening, 232 were removed as they did not meet the inclusion criteria. The remaining 15 full-text articles were assessed for eligibility. Only two met the criteria to be included in the review (both concerned telemedicine and mental health interventions). However, they did not fully answer the review's research question. Therefore, the evidence gap remains regarding the effectiveness of telemedicine intervention for Deaf people. CONCLUSIONS: The review has identified a gap in the knowledge on the efficacy and effectiveness of telemedicine intervention for Deaf people when compared with face-to-face interventions.

The ongoing importance of the routine enquiry into trauma and abuse and trauma-informed care within mental health trusts in England.

WHAT IS KNOWN ON THE SUBJECT?: A significant number of people with mental health diagnoses have also experienced some form of trauma. In 2008, it was recommended that MHTs in England provide training to MHPs to support them in how to ask their service users about trauma and abuse. It has been identified that staff are not consistently enquiring about trauma and abuse in mental health services. WHAT THE PAPER ADDS TO EXISTING KNOWLEDGE?: A description of how many MHTs in England are providing training for staff to ensure that they enquire about trauma and abuse. The current gaps in the resources available for mental health practitioners and staff. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: Much more work and development of trauma-informed care and accessibility of training is needed for MHPs working in MHTs. Most MHTs still need to take the first step of implementing training in trauma-informed care. This should involve ways to ask about trauma and abuse and advice on how to respond to any disclosures made. ABSTRACT: INTRODUCTION: Trauma, abuse and adversities are extremely prevalent for those who access secondary mental health services. Health policy guidance recommends that mental health professionals (MHPs) should routinely enquire about trauma and abuse. Staff training is required to adopt trauma-informed approaches, as research has identified a clear gap in practice. This study provides a baseline measure of the current provision of trauma-informed training in English mental health trusts (MHTs). QUESTION: What trauma-informed training is currently available for MHPs in England? METHOD: A freedom of information request was submitted to 52 MHTs in England to explore the current training available for MHPs in trauma-informed care, routine enquiry into abuse and responding to disclosures. RESULTS: The results showed 70% of respondents reported no available training in trauma-informed care. DISCUSSION: Many MHTs in England do not provide any trauma-informed training (despite existing recommendations from 2008). Does this contribute to the re-traumatisation of patients? IMPLICATIONS FOR PRACTICE: MHTs in England require a responsible and active approach to training MHPs in sensitive routine enquiry into trauma and abuse as a first step to becoming trauma responsive.

Understanding the support needs of parents of children with obsessive-compulsive disorder: a qualitative descriptive study in the UK.

INTRODUCTION: Caring for a child with obsessive-compulsive disorder (OCD) can be extremely difficult, yet evidence-based support strategies for parents/carers are limited. A detailed understanding of parent support needs is an important first step in intervention development and qualitative research with this focus is currently lacking. In this study, the viewpoints of parents and professionals were used to understand support needs and preferences when caring for a child with OCD. This qualitative descriptive study formed part of a wider UK-based project aimed at developing better support for parents of children with OCD. METHOD: Individual semi-structured interviews (and an optional one-week journal) with a purposive sample of parents of children and young people (CYP) with OCD, aged 8-18, and focus groups (or individual interviews where preferred) with a purposive sample of professionals supporting CYP with OCD. Data comprised transcripts of audio-recorded interviews and focus groups, and text from journals. Analysis was informed by the Framework approach involving inductive and deductive coding, supported by NVivo 12.0 software. Co-production methods were adopted throughout the research process, including the involvement of a parent co-researcher and charity collaborators. RESULTS: Interviews were undertaken with 20 parents, of which 16 completed a journal. Twenty-five professionals took part in a focus group or interview. Five key themes relating to parent support challenges and support needs/preferences were identified (1) Coping with the impact of OCD; (2) Getting help for my child; (3) Understanding parents' role; (4) Making sense of OCD; (5) Joined-up care. CONCLUSION: Parents caring for children with OCD have clear caregiver support needs which are currently not being met. Through triangulation of parent and professional accounts, this study has identified parent support challenges (e.g., emotional impact of OCD, visibility of caring role, misunderstanding about OCD) and support needs/ preferences (e.g., headspace/respite, compassion/sensitivity, guidance on accommodation) to lay the vital foundations for the development of effective parent support interventions. There is now an urgent need to develop and test an intervention to support parents in their caregiving role, with the aim of preventing and/or reducing their levels of burden and distress and ultimately, improving their quality of life.

Cost-effectiveness of cognitive behavioural and personalized exercise interventions for reducing fatigue in inflammatory rheumatic diseases.

OBJECTIVES: To estimate the cost-effectiveness of a cognitive behavioural approach (CBA) or a personalized exercise programme (PEP), alongside usual care (UC), in patients with inflammatory rheumatic diseases who report chronic, moderate to severe fatigue. METHODS: A within-trial cost-utility analysis was conducted using individual patient data collected within a multicentre, three-arm randomized controlled trial over a 56-week period. The primary economic analysis was conducted from the UK National Health Service (NHS) perspective. Uncertainty was explored using cost-effectiveness acceptability curves and sensitivity analysis. RESULTS: Complete-case analysis showed that, compared with UC, both PEP and CBA were more expensive [adjusted mean cost difference: PEP £569 (95% CI: £464, £665); CBA £845 (95% CI: £717, £993)] and, in the case of PEP, significantly more effective [adjusted mean quality-adjusted life year (QALY) difference: PEP 0.043 (95% CI: 0.019, 0.068); CBA 0.001 (95% CI: -0.022, 0.022)]. These led to an incremental cost-effectiveness ratio (ICER) of £13 159 for PEP vs UC, and £793 777 for CBA vs UC. Non-parametric bootstrapping showed that, at a threshold value of £20 000 per QALY gained, PEP had a probability of 88% of being cost-effective. In multiple imputation analysis, PEP was associated with significant incremental costs of £428 (95% CI: £324, £511) and a non-significant QALY gain of 0.016 (95% CI: -0.003, 0.035), leading to an ICER of £26 822 vs UC. The estimates from sensitivity analyses were consistent with these results. CONCLUSION: The addition of a PEP alongside UC is likely to provide a cost-effective use of health care resources.

Culturally adapted family intervention for people with schizophrenia in Indonesia (FUSION): a development and feasibility study protocol.

BACKGROUND: Mental illnesses comprise the single largest source of health-related economic burden globally, and low- and middle-income countries are disproportionately affected. The majority of people with schizophrenia who need treatment do not receive it and are often wholly reliant on family caregivers for daily care and support. Family interventions have an exceptionally robust evidence base for their efficacy in high-resource settings, but it is unknown whether they can produce equivalent effects in some low-resource settings where cultural beliefs, explanatory models of illness and contextual socio-economic issues differ. METHODS: This protocol describes the methods for a randomised controlled trial to determine the feasibility of testing culturally adapt and refine an evidence-based, family intervention for relatives and caregivers of people with schizophrenia in Indonesia. The feasibility and acceptability of implementing our adapted, co-produced intervention via task shifting in primary care settings will be evaluated using the Medical Research Council framework for complex interventions. We will recruit 60 carer-service-user dyads and randomise them in a 1:1 ratio either to receive our manualised intervention or continue to receive treatment as usual. Healthcare workers in primary care settings will be trained to deliver family interventions using our manualised intervention by a family intervention specialist. Participants will complete the ECI, IEQ, KAST and GHQ. Service-user symptom level and relapse status will be measured using the PANSS at baseline, post-intervention and 3 months later by trained researchers. Fidelity to the intervention model will be measured using the FIPAS. Qualitative evaluation will further assist with refining the intervention, evaluating trial processes and evaluating acceptability. DISCUSSION: National healthcare policy in Indonesia supports the delivery of mental health services in a complex network of primary care centres. This study will provide important information on the feasibility of delivering family interventions for people with schizophrenia via task shifting in primary care settings in Indonesia and allow further refinement of the intervention and trial processes.

Establishing evidence to inform culturally competent mental health services: A mixed methods study protocol.

BACKGROUND: COVID-19 has exacerbated the significant and longstanding mental health inequalities for ethnic minorities, who were less likely to access mental health support in primary care but more likely to end up in crisis care compared to the majority ethnic group. Services were poorly offered and accessed to respond to the increased mental health challenges. AIM: To 1) establish evidence on which changes to mental health services provided in response to COVID-19 are beneficial for ethnic minorities who experience mental health difficulties in the North of England, and 2) to inform what and how culturally competent mental health services should be routinely provided. METHODS: A mixed methods approach comprising 1) a rapid review to map services and models of care designed or adjusted for mental health during the pandemic, 2) an observational study of retrospective routine data to assess changes to mental health services and associated outcomes, 3) qualitative interviews to understand experiences of seeking care and factors associated with high-quality service provision, and 4) a Delphi study to establish consensus on key features of culturally competent services. From the selected areas in the North of England, adults from ethnic minorities who experience mental health difficulties will be identified from the primary, community and secondary care services and local ethnic minority communities. DISCUSSION: This study will identify ways to tackle health inequalities and contribute to mental health service recovery post pandemic by providing practice recommendations on equitable and effective services to ensure culturally competent and high-quality care. A list of services and features on what and how mental health services will be provided. Working with study collaborators and public and patient involvement partners, the study findings will be widely disseminated through presentations, conferences and publications and will inform the subsequent funding application for intervention development and evaluation.

A brief transdiagnostic group (the take control course) compared to individual low-intensity CBT for depression and anxiety: a randomized non-inferiority trial.

Few studies have examined brief transdiagnostic groups. The Take Control Course (TCC) was developed for patients with mild to moderate common mental health problems. We examined whether TCC is non-inferior to individual low-intensity cognitive behaviour therapy (CBT) in a single-blind individually randomised parallel non-inferiority trial. The primary outcomes were depression (PHQ9) and anxiety (GAD7) at 6-month follow-up (primary outcome point) and 12-month follow-up. The non-inferiority margin that we set, based on previous trials, corresponds to approximately 3 points on the PHQ9 and approximately 2.5 points on the GAD7. Intention-to-treat (ITT) and per-protocol (PP) analyses of 6-month data of 156 randomised patients indicated that TCC was non-inferior to individual low-intensity CBT on anxiety (ITT Coefficient = 0.24; 95% CI: -1.45 to 1.92; d = 0.04; p = .79), and depression (ITT Coefficient = 0.82; 95% CI: -1.06 to 2.69; d = 0.14; p = .39) outcomes, and functioning (ITT Coefficient = 0.69; 95% CI: -2.56 to 3.94; d = 0.08; p = .68). The findings at 12 months were inconclusive and require further testing. This randomised trial provides preliminary support that TCC is not less effective than short-term individual CBT within Improving Access to Psychological Therapies (IAPT) services.

One session treatment (OST) is equivalent to multi-session cognitive behavioral therapy (CBT) in children with specific phobias (ASPECT): results from a national non-inferiority randomized controlled trial.

BACKGROUND: 5%-10% children and young people (CYP) experience specific phobias that impact daily functioning. Cognitive Behaviour Therapy (CBT) is recommended but has limitations. One Session Treatment (OST), a briefer alternative incorporating CBT principles, has demonstrated efficacy. The Alleviating Specific Phobias Experienced by Children Trial (ASPECT) investigated the non-inferiority of OST compared to multi-session CBT for treating specific phobias in CYP. METHODS: ASPECT was a pragmatic, multi-center, non-inferiority randomized controlled trial in 26 CAMHS sites, three voluntary agency services, and one university-based CYP well-being service. CYP aged 7-16 years with specific phobia were randomized to receive OST or CBT. Clinical non-inferiority and a nested cost-effectiveness evaluation was assessed 6-months post-randomization using the Behavioural Avoidance Task (BAT). Secondary outcome measures included the Anxiety Disorder Interview Schedule, Child Anxiety Impact Scale, Revised Children's Anxiety Depression Scale, goal-based outcome measure, and EQ-5DY and CHU-9D, collected blind at baseline and six-months. RESULTS: 268 CYPs were randomized to OST (n = 134) or CBT (n = 134). Mean BAT scores at 6 months were similar across groups in both intention-to-treat (ITT) and per-protocol (PP) populations (CBT: 7.1 (ITT, n = 76), 7.4 (PP, n = 57), OST: 7.4 (ITT, n = 73), 7.6 (PP, n = 56), on the standardized scale-adjusted mean difference for CBT compared to OST -0.123, 95% CI -0.449 to 0.202 (ITT), mean difference -0.204, 95% CI -0.579 to 0.171 (PP)). These findings were wholly below the standardized non-inferiority limit of 0.4, suggesting that OST is non-inferior to CBT. No between-group differences were found on secondary outcomes. OST marginally decreased mean service use costs and maintained similar mean Quality Adjusted Life Years compared to CBT. CONCLUSIONS: One Session Treatment has similar clinical effectiveness to CBT for specific phobias in CYP and may be a cost-saving alternative.