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.

Acceptability of Specialist Psychotherapy with Emotion for Anorexia in Kent and Sussex (SPEAKS): A novel intervention for anorexia nervosa.

OBJECTIVE: Investigate the acceptability of Specialist Psychotherapy with Emotion for Anorexia in Kent and Sussex (SPEAKS), a novel intervention for anorexia nervosa (AN), conducted as a feasibility trial to provide an initial test of the intervention. METHODS: SPEAKS therapy lasting 9-12 months was provided to 34 people with AN or atypical AN by eight specialist eating disorder therapists trained in the model across two NHS Trusts in the UK (Kent and Sussex) during a feasibility trial. All participants were offered a post-therapy interview; sixteen patients and six therapists agreed. All patient participants were adult females. Interviews were semi-structured and asked questions around individuals' experience of SPEAKS, the acceptability of the intervention and of the research methods. Interviews were analyzed using thematic analysis. RESULTS: Key areas explored in line with research questions led to 5 overarching themes and 14 subthemes: (1) shift in treatment focus and experience, (2) balancing resources and treatment outcomes, (3) navigating the online treatment environment, (4) therapist adaptation and professional development, and (5) research processes. DISCUSSION: SPEAKS was found to be an acceptable intervention for treating AN from the perspective of patients and therapists. The findings provide strong support for delivery of a larger scale randomized control trial. Recommendations for future improvements, particularly pertaining to therapist understanding of the treatment model are detailed, alongside broader clinical implications. PUBLIC SIGNIFICANCE: We aimed to evaluate the acceptability of a new anorexia nervosa treatment called SPEAKS. Interviews were conducted with patients and therapists involved in the pilot study and responses were analyzed. Results showed that both patients and therapists found SPEAKS to be an acceptable treatment for anorexia nervosa. The study suggests that SPEAKS meets the criteria for moving forward with a larger trial to assess its effectiveness.

Corrigendum: "Beyond laughter": a systematic review to understand how interventions utilise comedy for individuals experiencing mental health problems.

[This corrects the article DOI: 10.3389/fpsyg.2023.1161703.].

Co-producing principles to guide health research: an illustrative case study from an eating disorder research clinic.

BACKGROUND: There is significant value in co-produced health research, however power-imbalances within research teams can pose a barrier to people with lived experience of an illness determining the direction of research in that area. This is especially true in eating disorder research, where the inclusion of co-production approaches lags other research areas. Appealing to principles or values can serve to ground collaborative working. Despite this, there has not been any prior attempt to co-produce principles to guide the work of a research group and serve as a basis for developing future projects. METHODS: The aim of this piece of work was to co-produce a set of principles to guide the conduct of research within our lived experience led research clinic, and to offer an illustrative case for the value of this as a novel co-production methodology. A lived experience panel were recruited to our eating disorder research group. Through an iterative series of workshops with the members of our research clinic (composed of a lived experience panel, clinicians, and researchers) we developed a set of principles which we agreed were important in ensuring both the direction of our research, and the way in which we wanted to work together. RESULTS: Six key principles were developed using this process. They were that research should aim to be: 1) real world-offering a clear and concrete benefit to people with eating disorders, 2) tailored-suitable for marginalised groups and people with atypical diagnoses, 3) hopeful-ensuring that hope for recovery was centred in treatment, 4) experiential-privileging the 'voice' of people with eating disorders, 5) broad-encompassing non-standard therapeutic treatments and 6) democratic-co-produced by people with lived experience of eating disorders. CONCLUSIONS: We reflect on some of the positives as well as limitations of the process, highlighting the importance of adequate funding for longer-term co-production approaches to be taken, and issues around ensuring representation of minority groups. We hope that other health research groups will see the value in co-producing principles to guide research in their own fields, and will adapt, develop, and refine this novel methodology.

It important that when researchers are trying to understand illnesses they do this together with people who have experienced them. This can be difficult, because researchers often take over­even if everyone is meant to be working as a team. We are a group of people trying to understand eating disorders and help people who have them get better. In our group there are some people that have experienced an eating disorder, health workers and researchers.We thought it might be helpful if we could start by working out what things were most important to us as a group, and then try to stick by them. We talked a lot together to come up with a list of principles.The six principles we thought were the most important were that research should make a difference to people's lives, see people as individuals, be hopeful, make sure that people have a voice, look at things that aren't traditional therapies, and always work together as equals.There are some issues with what we did; we found it hard to get a good mix of people in our group, and we were lucky in having enough money to pay people to do what we wanted to do, which is not always true. Despite this, we still hope that other teams might look at what we have done, and see if they could build on it, or change it, so it would work for them.

"Beyond laughter": a systematic review to understand how interventions utilise comedy for individuals experiencing mental health problems.

Introduction: There is evidence for the impact of comedy and humour for mental health and wellbeing. Existing systematic reviews have concluded laughter has a positive impact on wellbeing, however other potential benefits of comedy interventions have remained under explored. The aim of the current study was to synthesise current evidence for comedy/humour interventions and evaluate mechanisms through which comedy interventions may impact upon the recovery of those experiencing psychological distress, using the Connectedness, Hope, Identity, Meaning and Purpose and Empowerment (CHIME) framework. Methods: Five electronic databases were searched for studies exploring the impact of interventions using comedy on wellbeing and mental health recovery, from earliest record until January 2023. Grey literature was obtained via contacting experts in comedy interventions for mental health and supplemented by an internet search for comedy interventions. To be eligible for inclusion, studies had to include primary data, published in English or German, and explore a population of adults, with self-reported distress or a self-reported/diagnosed mental health condition. Studies included only explored interventions which utilised comedy as the main intervention and aimed to induce 'simulated' laughter, in response to a stimulus. 17 studies were included in the review. Results: Studies were found to have positive impact on mental health symptoms and several mechanisms of the CHIME framework for recovery, including connectedness, hope, identity and empowerment. Potential theorised mechanisms for change included confidence in new skills, promotion of social skills, opportunities for social interaction, laughter, vulnerability, and cognitive flexibility. The current review found that comedy/humour interventions are beneficial for mental health recovery and wellbeing and found preliminary evidence for a range of mechanisms through which comedy may have positive impact. Discussion: Further research should focus on qualitative exploration of the mechanisms by which comedy interventions may have impact on wellbeing and mental health recovery for specific populations and within different settings. It is concluded that there is a need for transdisciplinary collaboration in research on comedy interventions, which brings together the expertise of comedians delivering/developing interventions, those with lived experience of mental health issues and researchers from both health sciences and humanities disciplines.

Participant retention in paediatric randomised controlled trials published in six major journals 2015-2019: systematic review and meta-analysis.

BACKGROUND: The factors which influence participant retention in paediatric randomised controlled trials are under-researched. Retention may be more challenging due to child developmental stages, involving additional participants, and proxy-reporting of outcomes. This systematic review and meta-analysis explores the factors which may influence retention in paediatric trials. METHODS: Using the MEDLINE database, paediatric randomised controlled trials published between 2015 and 2019 were identified from six general and specialist high-impact factor medical journals. The review outcome was participant retention for each reviewed trial's primary outcome. Context (e.g. population, disease) and design (e.g. length of trial) factors were extracted. Retention was examined for each context and design factor in turn, with evidence for an association being determined by a univariate random-effects meta-regression analysis. RESULTS: Ninety-four trials were included, and the median total retention was 0.92 (inter-quartile range 0.83 to 0.98). Higher estimates of retention were seen for trials with five or more follow-up assessments before the primary outcome, those less than 6 months between randomisation and primary outcome, and those that used an inactive data collection method. Trials involving children aged 11 and over had the higher estimated retention compared with those involving younger children. Those trials which did not involve other participants also had higher retention, than those where they were involved. There was also evidence that a trial which used an active or placebo control treatment had higher estimated retention, than treatment-as-usual. Retention increased if at least one engagement method was used. Unlike reviews of trials including all ages of participants, we did not find any association between retention and the number of treatment groups, size of trial, or type of treatment. CONCLUSIONS: Published paediatric RCTs rarely report the use of specific modifiable factors that improve retention. Including multiple, regular follow-ups with participants before the primary outcome may reduce attrition. Retention may be highest when the primary outcome is collected up to 6 months after a participant is recruited. Our findings suggest that qualitative research into improving retention when trials involve multiple participants such as young people, and their caregivers or teachers would be worthwhile. Those designing paediatric trials also need to consider the use of appropriate engagement methods. RESEARCH ON RESEARCH (ROR) REGISTRY: https://ror-hub.org/study/2561.

Adapting the ADVANCE group program for digitally-supported delivery to reduce intimate partner violence by men in substance use treatment: a feasibility study.

Introduction: COVID-19 restrictions created barriers to "business as usual" in healthcare but also opened the door to innovation driven by necessity. This manuscript (1) describes how ADVANCE, an in-person group perpetrator program to reduce intimate partner violence (IPV) against female (ex)partners by men in substance use treatment, was adapted for digitally-supported delivery (ADVANCE-D), and (2) explores the feasibility and acceptability of delivering ADVANCE-D to men receiving substance use treatment. Methods: Firstly, the person-based approach and mHealth development framework were used to iteratively adapt ADVANCE for digitally-supported delivery including conceptualization, formative research, and pre-testing. Then, a non-randomized feasibility study was conducted to assess male participants' eligibility, recruitment, and attendance rates and uptake of support offered to their (ex)partners. Exploratory analyses on reductions in IPV perpetration (assessed using the Abusive Behavior Inventory; ABI) and victimization (using the revised ABI; ABI-R) at the end of the program were performed. Longitudinal qualitative interviews with participants, their (ex)partners, and staff provided an understanding of the program's implementation, acceptability, and outcomes. Results: The adapted ADVANCE-D program includes one goal-setting session, seven online groups, 12 self-directed website sessions, and 12 coaching calls. ADVANCE-D includes enhanced risk management and support for (ex)partners. Forty-five participants who had perpetrated IPV in the past 12 months were recruited, forty of whom were offered ADVANCE-D, attending 11.4 (SD 9.1) sessions on average. Twenty-one (ex)partners were recruited, 13 of whom accepted specialist support. Reductions in some IPV perpetration and victimization outcome measures were reported by the 25 participants and 11 (ex)partners interviewed pre and post-program, respectively. Twenty-two participants, 11 (ex)partners, 12 facilitators, and 7 integrated support service workers were interviewed at least once about their experiences of participation. Overall, the program content was well-received. Some participants and facilitators believed digital sessions offered increased accessibility. Conclusion: The digitally-supported delivery of ADVANCE-D was feasible and acceptable. Remote delivery has applicability post-pandemic, providing greater flexibility and access. Given the small sample size and study design, we do not know if reductions in IPV were due to ADVANCE-D, time, participant factors, or chance. More research is needed before conclusions can be made about the efficacy of ADVANCE-D.

Enhancing member engagement in a Tier 3 personality disorder service during COVID-19: evaluation of a virtual group programme.

BACKGROUND: Drop-out rates from evidence-based interventions for people with a diagnosis of personality disorder (PD) are high. The COVID-19 pandemic has likely exacerbated barriers to engagement with the introduction of virtual working. Virtual therapy has a good evidence-base for Axis I disorders, but limited research for Axis II disorders. AIMS: To investigate facilitators and barriers to engagement in a Tier 3 PD service virtual group programme. METHOD: A virtual group programme was developed in collaboration with service members, and analysed members' attendance rates over a 5-month period pre- and post-COVID-19. Thematic analysis of semi-structured telephone interviews with 38 members is reported, describing their experience of the virtual group programme. RESULTS: Attendance rates were significantly higher pre-COVID (72%) than post-COVID (50%). Thematic analysis highlighted key barriers to attendance were: practical issues, low motivation, challenges of working in a group online and feeling triggered at home. Main promoters of engagement were: feeling valued, continued sense of connection and maintaining focus on recovery. DISCUSSION: The results suggest that the pandemic has exacerbated relational and practical barriers to engagement in a Tier 3 PD service. Ways of enhancing engagement are discussed, as well as preliminary recommendation for services offering virtual therapy to people with a diagnosis of PD.

Barriers and facilitators to the effective de-escalation of conflict behaviours in forensic high-secure settings: a qualitative study.

BACKGROUND: Violent and aggressive incidents are common within mental health settings and are often managed using high-risk physical interventions such as restraint and seclusion. De-escalation is a first-line technique to manage conflict behaviours and prevent violence and aggression. There is limited research into the use of de-escalation in high-secure settings. This study investigated staff, patient and carer perspectives on the barriers and facilitators to using de-escalation for conflict behaviours. METHODS: Semi-structured individual interviews (n = 12) and focus groups (n = 3) were conducted with eight patients, four carers and 25 staff members in a high-secure hospital in England. Interviews and focus groups were informed by the theoretical domains framework and were digitally recorded, transcribed verbatim and analysed using framework analysis and the COM-B behaviour change model. RESULTS: Four themes and 15 sub-themes (barriers and facilitators) were identified. Themes related to capabilities (building relationships: knowing the patient and knowing yourself), opportunities (filling the void: challenges within the high-security environment; dynamic relationships) and motivation (keeping everyone safe). Strong staff-patient therapeutic relationships underpinned by trust, fairness, consistency and an awareness of the trauma-aggression link were considered key to successful de-escalation. Specific psychological and interpersonal skills including empathy, respect, reassurance, sincerity, genuine concern and validation of the patient perspective are needed to achieve this. Barriers related to the physical environment; organisational resources, practices and systems; staff traumatisation; hierarchical and punitive attitudes towards patient care, and an insufficient understanding of psychiatric diagnoses, especially personality disorder. It was apparent across themes that fear, which was experienced by both staff and patients, was a driver for many behaviours. CONCLUSIONS: This work has identified organizational and behaviour change targets for interventions seeking to reduce violence and restrictive practices through the use of de-escalation in high-secure hospitals. The potential for, and occurrence of, violence in such settings is high and leads to fear in patients and staff. The factors which promote fear in each group should be addressed in de-escalation training.