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.

Evaluating a smartphone-based symptom self-monitoring app for psychosis in China (YouXin): A non-randomised validity and feasibility study with a mixed-methods design.

Background: Psychosis causes a significant burden globally, including in China, where limited mental health resources hinder access to care. Smartphone-based remote monitoring offers a promising solution. This study aimed to assess the validity, feasibility, acceptability, and safety of a symptom self-monitoring smartphone app, YouXin, for people with psychosis in China. Methods: A pre-registered non-randomised validity and feasibility study with a mixed-methods design. Participants with psychosis were recruited from a major tertiary psychiatric hospital in Beijing, China. Participants utilised the YouXin app to self-monitor psychosis and mood symptoms for four weeks. Feasibility outcomes were recruitment, retention and outcome measures completeness. Active symptom monitoring (ASM) validity was tested against corresponding clinical assessments (PANSS and CDS) using Spearman correlation. Ten participants completed qualitative interviews at study end to explore acceptability of the app and trial procedures. Results: Feasibility parameters were met. The target recruitment sample of 40 participants was met, with 82.5% completing outcome measures, 60% achieving acceptable ASM engagement (completing >33% of all prompts), and 33% recording sufficient passive monitoring data to extract mobility indicators. Five ASM domains (hallucinations, suspiciousness, guilt feelings, delusions, grandiosity) achieved moderate correlation with clinical assessment. Both quantitative and qualitative evaluation showed high acceptability of YouXin. Clinical measurements indicated no symptom and functional deterioration. No adverse events were reported, suggesting YouXin is safe to use in this clinical population. Conclusions: The trial feasibility, acceptability and safety parameters were met and a powered efficacy study is indicated. However, refinements are needed to improve ASM validity and increase passive monitoring data completeness.

Trauma-focused therapy in early psychosis: results of a feasibility randomized controlled trial of EMDR for psychosis (EMDRp) in early intervention settings.

BACKGROUND: Trauma is prevalent amongst early psychosis patients and associated with adverse outcomes. Past trials of trauma-focused therapy have focused on chronic patients with psychosis/schizophrenia and comorbid Post-Traumatic Stress Disorder (PTSD). We aimed to determine the feasibility of a large-scale randomized controlled trial (RCT) of an Eye Movement Desensitization and Reprocessing for psychosis (EMDRp) intervention for early psychosis service users. METHODS: A single-blind RCT comparing 16 sessions of EMDRp + TAU v. TAU only was conducted. Participants completed baseline, 6-month and 12-month post-randomization assessments. EMDRp and trial assessments were delivered both in-person and remotely due to COVID-19 restrictions. Feasibility outcomes were recruitment and retention, therapy attendance/engagement, adherence to EMDRp treatment protocol, and the 'promise of efficacy' of EMDRp on relevant clinical outcomes. RESULTS: Sixty participants (100% of the recruitment target) received TAU or EMDR + TAU. 83% completed at least one follow-up assessment, with 74% at 6-month and 70% at 12-month. 74% of EMDRp + TAU participants received at least eight therapy sessions and 97% rated therapy sessions demonstrated good treatment fidelity. At 6-month, there were signals of promise of efficacy of EMDRp + TAU v. TAU for total psychotic symptoms (PANSS), subjective recovery from psychosis, PTSD symptoms, depression, anxiety, and general health status. Signals of efficacy at 12-month were less pronounced but remained robust for PTSD symptoms and general health status. CONCLUSIONS: The trial feasibility criteria were fully met, and EMDRp was associated with promising signals of efficacy on a range of valuable clinical outcomes. A larger-scale, multi-center trial of EMDRp is feasible and warranted.

A Digital System (YouXin) to Facilitate Self-Management by People With Psychosis in China: Protocol for a Nonrandomized Validity and Feasibility Study With a Mixed Methods Design.

BACKGROUND: Psychosis is one of the most disabling mental health conditions and causes significant personal, social, and economic burden. Accurate and timely symptom monitoring is critical to offering prompt and time-sensitive clinical services. Digital health is a promising solution for the barriers encountered by conventional symptom monitoring approaches, including accessibility, the ecological validity of assessments, and recall bias. However, to date, there has been no digital health technology developed to support self-management for people with psychosis in China. OBJECTIVE: We report the study protocol to evaluate the validity, feasibility, acceptability, usability, and safety of a symptom self-monitoring smartphone app (YouXin; Chinese name ) for people with psychosis in China. METHODS: This is a nonrandomized validity and feasibility study with a mixed methods design. The study was approved by the University of Manchester and Beijing Anding Hospital Research Ethics Committee. YouXin is a smartphone app designed to facilitate symptom self-monitoring for people with psychosis. YouXin has 2 core functions: active monitoring of symptoms (ie, smartphone survey) and passive monitoring of behavioral activity (ie, passive data collection via embedded smartphone sensors). The development process of YouXin utilized a systematic coproduction approach. A series of coproduction consultation meetings was conducted by the principal researcher with service users and clinicians to maximize the usability and acceptability of the app for end users. Participants with psychosis aged 16 years to 65 years were recruited from Beijing Anding Hospital, Beijing, China. All participants were invited to use the YouXin app to self-monitor symptoms for 4 weeks. At the end of the 4-week follow-up, we invited participants to take part in a qualitative interview to explore the acceptability of the app and trial procedures postintervention. RESULTS: Recruitment to the study was initiated in August 2022. Of the 47 participants who were approached for the study from August 2022 to October 2022, 41 participants agreed to take part in the study. We excluded 1 of the 41 participants for not meeting the inclusion criteria, leaving a total of 40 participants who began the study. As of December 2022, 40 participants had completed the study, and the recruitment was complete. CONCLUSIONS: This study is the first to develop and test a symptom self-monitoring app specifically designed for people with psychosis in China. If the study shows the feasibility of YouXin, a potential future direction is to integrate the app into clinical workflows to facilitate digital mental health care for people with psychosis in China. This study will inform improvements to the app, trial procedures, and implementation strategies with this population. Moreover, the findings of this trial could lead to optimization of digital health technologies designed for people with psychosis in China. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45170.

Clinical Effects of the 'Crisis Toolbox' (CTB): A Brief, Skills Based, Intervention Delivered in a Crisis Resolution and Home Treatment Team.

Access to psychological interventions for people under Crisis Resolution and Home Treatment Teams (CRHTTs) is limited. The Crisis Toolbox (CTB) is a skills-based intervention designed to increase access using flexible methods of delivery. This study aimed to evaluate the clinical effects of the CTB. A retrospective service evaluation of 399 participants who accessed the CTB between November 2020 and February 2021 was employed. Sessional measures comprising the Patient Health Questionnaire (PHQ-9) and Generalised Anxiety Scale (GAD-7) were recorded across three time points. Overall, there were significantly decreasing trends in PHQ-9 (ß = - 1.6, p < 0.001) and GAD-7 scores (ß = - 1.5, p < 0.001) in participants who accessed the CTB. The magnitude and direction of specific trends differed according to age, diagnosis, and neurodiversity. The CTB could help reduce depression and anxiety in people experiencing crisis. Randomised controlled trials are now required to test its acceptability, feasibility, and effectiveness.

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.

Using an objective computer task (QbTest) to aid the identification of attention deficit hyperactivity disorder (ADHD) in the Children and Young People Secure Estate (CYPSE): a feasibility randomised controlled trial.

OBJECTIVES: QbTest has been shown to improve time to decision/diagnosis for young people with attention deficit hyperactivity disorder (ADHD). The aim was to assess the feasibility of QbTest for young people in prison. DESIGN: Single-centre feasibility randomised controlled trial (RCT), with 1:1 allocation. Concealed random allocation using an online pseudorandom list with random permuted blocks of varying sizes. SETTING: One Young Offenders Institution in England. PARTICIPANTS: 355 young people aged 15-18 years displaying possible symptoms of ADHD were assessed for eligibility, 69 were eligible to take part and 60 were randomised. INTERVENTION: QbTest-a computer task measuring attention, activity and impulsivity. MAIN OUTCOME MEASURES: Eligibility, recruitment and retention rates and acceptability of randomisation and trial participation. RESULTS: Of the 355 young people assessed for eligibility, 69 were eligible and 60 were randomised (n=30 QbTest plus usual care; n=30 usual care alone). The study achieved the specified recruitment target. Trial participation and randomisation were deemed acceptable by the majority of participants. 78% of young people were followed up at 3 months, but only 32% at 6 months, although this was also affected by COVID-19 restrictions. Secondary outcomes were mixed. Participants including clinical staff were mostly supportive of the study and QbTest; however, some young people found QbTest hard and there were issues with implementation of the ADHD care pathway. There were no serious adverse events secondary to the study or intervention and no one was withdrawn from the study due to an adverse event. CONCLUSIONS: With adaptations, a fully powered RCT may be achievable to evaluate the effectiveness of QbTest in the assessment of ADHD in the Children and Young People Secure Estate, with time to decision (days) as the primary outcome measure. However, further programme developmental work is required to address some of the challenges highlighted prior to a larger trial. TRIAL REGISTRATION NUMBER: ISRCTN17402196.

Fluctuations in proximity seeking and paranoia.

OBJECTIVES: This study aimed to investigate associations between proximity seeking, stress and paranoia in the context of daily life, and whether these relationships are moderated by trait attachment styles. METHODS: Sixty non-clinical participants completed 3423 assessments of state stress, proximity seeking and paranoia over a 6-day period using an experience sampling method. Multilevel linear regression was performed to evaluate relationships between variables. RESULTS: The post-hoc analysis showed antecedent events subjectively appraised as very unpleasant or very pleasant predicted greater levels of momentary proximity seeking at the subsequent timepoint. Greater stress predicted greater subsequent shifts or variability in proximity seeking. Changes in proximity seeking were not associated with momentary paranoia. However, for individuals with an avoidant attachment style, greater shifts in proximity seeking resulted in greater subsequent reports of paranoia. CONCLUSIONS: These findings suggest that, in daily life, the attachment system may become active in response to stress. For those with an avoidant attachment style, an active attachment system may exacerbate paranoid thoughts possibly due to the activation of attachment-related beliefs that one should be fearful of unavailable others and instead rely on one's autonomy to regulate affect. These findings highlight the need to consider attachment in the assessment and formulation of paranoia.

Self-injury in young bisexual people: A microlongitudinal investigation (SIBL) of thwarted belongingness and self-esteem on non-suicidal self-injury.

BACKGROUND: Bisexual people are at an elevated risk for non-suicidal self-injury (NSSI). Psychological factors including self-esteem and thwarted belongingness may help explain this risk. The aim of the current study was to investigate associations between self-esteem, thwarted belongingness and NSSI urges and behavior in young bisexual people. METHODS: Participants aged 16-25 from 25 countries took part in this microlongitudinal online survey study (N = 207). Mixed-effects linear and logistic regression were used for analysis, given the nested structure of data. Analysis examined the relationship between self-esteem and thwarted belongingness on NSSI urges and behavior at the same point in time, and lagged by one week. RESULTS: At the same timepoint, self-esteem and thwarted belongingness both had significant between- and within-person associations with NSSI urges and behavior. For lagged models, self-esteem had significant between-person effects on urges, and thwarted belongingness had significant within-person effects. For NSSI behavior, both variables were only associated with between-person effects. CONCLUSION: Findings support previous research suggesting the importance of self-esteem in explaining NSSI among sexual minorities. Preventative and intervention strategies to improve self-esteem may help reduce NSSI risk. Future studies should focus upon the experiences of bisexual people with intersecting identities and ensure that studies are statistically powered from inception to detect effects.

A Cross-Sectional Study Investigating the Relationship Between Alexithymia and Suicide, Violence, and Dual Harm in Male Prisoners.

Background: Suicide and violence are common within male prisoners. One suggested risk factor for both behaviors is alexithymia. Alexithymia describes a deficit in identifying and describing feelings and is also related to externally oriented thinking. This study aimed to explore the relationship between alexithymia, suicide, violence and dual harm in male prisoners. Methods: Eighty male prisoners were recruited from three prisons. Participants were asked to complete a battery of questionnaires including measures of alexithymia (TAS-20), suicide ideation (ASIQ), suicide behavior, violence ideation (SIV), violence behavior, depression (BDI-II), hopelessness (BHS), impulsivity (DII) and anger (NAS-PI). Regression analyses and ANOVAS were conducted to assess the association between alexithymia (and its subcomponents) with six outcomes; suicide ideation, suicide behavior, violence ideation, violence behavior, dual harm ideation and dual harm behavior. Results: Alexithymia was a univariate predictor of suicide ideation, though was not a significant predictor when considered in a multivariate model. Alexithymia was a significant multivariate predictor of suicide behavior. Alexithymia was not a significant multivariate predictor of violence ideation or behavior. There were no significant differences in alexithymia or subscales between those with suicide ideation/behavior alone, violence ideation/behavior alone and those with dual harm ideation/behavior. Conclusion: In male prisoners, alexithymia appears an important univariate predictor of suicide and violence, though the current study suggests no significant contribution above other well-known correlates of suicide and violence.

Investigating expressed emotion in individuals at-risk of developing psychosis and their families over 12 months.

High levels of expressed emotion (EE) are present in families of individuals with an at-risk mental state (ARMS) of psychosis and can negatively impact on service users' functioning and symptoms, as well as relatives' psychological wellbeing. OBJECTIVES: This is the first longitudinal study to assess EE from the family/carers' perspective, as well as the service users' perceptions of the family/carers' EE. We explored the effects of EE on transition risk and outcomes of depression, worry, and anxiety. METHODS: Questionnaires were completed by 70 ARMS individuals and 70 family/carers at three time points: baseline, 6 and 12 months. All participants completed measures of anxiety, depression, and worry, plus a version of the Family Questionnaire to assess EE. RESULTS: EE scores reduced over time for both service users and family/carers. High EE perceived by service users at 6 months was associated with higher transition to psychosis at 12 months. High-EE levels at baseline were associated with higher levels of service user depression and family/carer anxiety at 12 months. Higher family/carer total EE scores were associated with less contact with the service user and higher levels of worry. CONCLUSIONS: Novel implications suggest that interventions to reduce high EE in families of people with ARMS would benefit service users by protecting them from higher levels of depression and transition to psychosis. Reducing high-EE attitudes would also benefit the family/carers by reducing levels of anxiety and worry. Family interventions focussing on multiple perceptions of the home environment could help to direct services and prevent negative psychological outcomes for all family members.

Eye movement desensitization and reprocessing therapy for psychosis (EMDRp): Protocol of a feasibility randomized controlled trial with early intervention service users.

AIM: Traumatic events are involved in the development and maintenance of psychotic symptoms. There are few trials exploring trauma-focused treatments as interventions for psychotic symptoms, especially in individuals with early psychosis. This trial will evaluate the feasibility and acceptability of conducting a definitive trial of Eye Movement Desensitization and Reprocessing for psychosis (EMDRp) in people with early psychosis. METHODS: Sixty participants with first episode psychosis and a history of a traumatic/adverse life event(s)will be recruited from early intervention services in the North West of England and randomized to receive16 sessions of EMDRp + Treatment as Usual (TAU) or TAU alone. Participants will be assessed at baseline, 6 and 12 months post-randomization using several measures of psychotic symptoms, trauma symptoms, anxiety, depression, functioning, service-user defined recovery, health economics indicators and quality of life. Two nested qualitative studies to assess participant feedback of therapy and views of professional stakeholders on the implementation of EMDRp into services will also be conducted. The feasibility of a future definitive efficacy and cost-effectiveness evaluation of EMDRp will be tested against several outcomes, including ability to recruit and randomize participants, trial retention at 6- and 12-month follow-up assessments, treatment engagement and treatment fidelity. CONCLUSIONS: If it is feasible to deliver a multi-site trial of this intervention, it will be possible to evaluate whether EMDRp represents a beneficial treatment to augment existing evidence-based care of individuals with early psychosis supported by early intervention services.

Development of a measure for patients preparing to start dialysis and their partners: The Starting Dialysis Questionnaire (SDQ).

BACKGROUND: The transition onto dialysis is a stressful time that affects both patients and their partners. Research suggests that psychological and interpersonal characteristics within the couple are related to how well they adapt to dialysis. The aim of this multi-phase, mixed methods study was to develop a measure, the Starting Dialysis Questionnaire (SDQ), that is applicable to both patients and their partners and assesses their own thoughts and feelings about these constructs. METHODS: Data from semi-structured interviews with patients and their partners (n = 22 couples) were analysed using theoretical thematic analysis to identify and define constructs related to quality of life (QOL). Next, items addressing these constructs were derived from the interviews. Then, cognitive interviews were conducted with patients with chronic kidney disease and their partners (n = 5 couples) to assess the face validity and comprehensibility of the items. Lastly, preliminary psychometric properties were evaluated in a sample of patients preparing to start dialysis and their partners (n = 83 couples). RESULTS: Three themes related to QOL were identified, namely dialysis expectations, accepting dialysis and dyadic relationship characteristics. The cognitive interviews refined the SDQ and established its face validity. Psychometric assessments indicated that overall the items performed well and did not show significant floor or ceiling effects. Good internal consistency was found within the three domains, and items correlated within the domains. CONCLUSIONS: The SDQ is a measure (34 items) that assesses key psychological and interpersonal factors in patients and their partners as they start dialysis. It shows good preliminary psychometric properties; however, a large-scale field trial is needed to establish its validity. Once validated, it could offer a clinically useful tool to assist clinicians in preparing patients and partners for dialysis.

An intervention to improve the quality of life in children of parents with serious mental illness: the Young SMILES feasibility RCT.

BACKGROUND: Quality of life for children and adolescents living with serious parental mental illness can be impaired, but evidence-based interventions to improve it are scarce. OBJECTIVE: Co-production of a child-centred intervention [called Young Simplifying Mental Illness plus Life Enhancement Skills (SMILES)] to improve the health-related quality of life of children and adolescents living with serious parental mental illness, and evaluating its acceptability and feasibility for delivery in NHS and community settings. DESIGN: Qualitative and co-production methods informed the development of the intervention (Phase I). A feasibility randomised controlled trial was designed to compare Young SMILES with treatment as usual (Phase II). Semistructured qualitative interviews were used to explore acceptability among children and adolescents living with their parents, who had serious mental illness, and their parents. A mixture of semistructured qualitative interviews and focus group research was used to examine feasibility among Young SMILES facilitators and referrers/non-referrers. SETTING: Randomisation was conducted after baseline measures were collected by the study co-ordinator, ensuring that the blinding of the statistician and research team was maintained to reduce detection bias. PARTICIPANTS: Phase I: 14 children and adolescents living with serious parental mental illness, seven parents and 31 practitioners from social, educational and health-related sectors. Phase II: 40 children and adolescents living with serious parental mental illness, 33 parents, five referrers/non-referrers and 16 Young SMILES facilitators. INTERVENTION: Young SMILES was delivered at two sites: (1) Warrington, supported by the National Society for the Prevention of Cruelty to Children (NSPCC), and (2) Newcastle, supported by the NHS and Barnardo's. An eight-session weekly group programme was delivered, with four to six children and adolescents living with serious parental mental illness per age-appropriate group (6-11 and 12-16 years). At week 4, a five-session parallel weekly programme was offered to the parents/carers. Sessions lasted 2 hours each and focused on improving mental health literacy, child-parent communication and children's problem-solving skills. MAIN OUTCOME MEASURES: Phase ll children and parents completed questionnaires at randomisation and then again at 4 and 6 months post randomisation. Quality of life was self-reported by children and proxy-reported by parents using the Paediatric Quality of Life questionnaire and KIDSCREEN. Semistructured interviews with parents (n = 14) and children (n = 17) who participated in the Young SMILES groups gathered information about their motivation to sign up to the study, their experiences of participating in the group sessions, and their perceived changes in themselves and their family members following intervention. Further interviews with individual referrers (n = 5) gathered information about challenges to recruitment and randomisation. Two focus groups (n = 16) with practitioners who facilitated the intervention explored their views of the format and content of the Young SMILES manual and their suggestions for changes. RESULTS: A total of 35 families were recruited: 20 were randomly allocated to Young SMILES group and 15 to treatment as usual. Of those, 28 families [15/20 (75%) in the intervention group and 13/15 (87%) in the control group] gave follow-up data at the primary end point (4 months post baseline). Participating children had high adherence to the intervention and high completion rates of the questionnaires. Children and adolescents living with their parents, who had serious mental illness, and their parents were mainly very positive and enthusiastic about Young SMILES, both of whom invoked the benefits of peer support and insight into parental difficulties. Although facilitators regarded Young SMILES as a meaningful and distinctive intervention having great potential, referrers identified several barriers to referring families to the study. One harm was reported by a parent, which was dealt with by the research team and the NSPCC in accordance with the standard operating procedures. LIMITATIONS: The findings from our feasibility study are not sufficient to recommend a fully powered trial of Young SMILES in the near future. Although it was feasible to randomise children and adolescents living with serious parental mental illness of different ages to standardised, time-limited groups in both NHS and non-NHS settings, an intervention like Young SMILES is unlikely to address underlying core components of the vulnerability that children and adolescents living with serious parental mental illness express as a population over time. CONCLUSIONS: Young SMILES was widely valued as unique in filling a recognised gap in need. Outcome measures in future studies of interventions for children and adolescents living with serious parental mental illness are more likely to capture change in individual risk factors for reduced quality of life by considering their unmet need, rather than on an aggregate construct of health-related quality of life overall, which may not reflect these young people's needs. FUTURE WORK: A public health approach to intervention might be best. Most children and adolescents living with serious parental mental illness remain well most of the time, so, although their absolute risks are low across outcomes (and most will remain resilient most of the time), consistent population estimates find their relative risk to be high compared with unexposed children. A public health approach to intervention needs to be both tailored to the particular needs of children and adolescents living with serious parental mental illness and agile to these needs so that it can respond to fluctuations over time. TRIAL REGISTRATION: Current Controlled Trials ISRCTN36865046. FUNDING: This project was funded by the National Institute of Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 59. See the NIHR Journals Library website for further project information.

Children and adolescents living with serious parental mental illness are at increased risk of poorer mental, physical and emotional health but few services are available to them. We worked with young people, parents and professionals to co-develop a community-based intervention called Young Simplifying Mental Illness plus Life Enhancement Skills (SMILES). This involves eight children's sessions over 8 weeks in two age groups (6­11 and 12­16 years) and five separate parent sessions. Each session includes activities designed to improve understanding of mental illness, communication between children and parents, and problem-solving. To assess the feasibility and how acceptable Young SMILES is to those who received (and delivered) the intervention, we recruited 35 families: 20 were offered Young SMILES and 15 continued to receive their usual care. Children and parents completed questionnaires when they entered the research and then after 4 and 6 months. Children and adolescents living with serious parental mental illness assigned to either Young SMILES or usual-care groups reported that their quality of life, mental health, day-to-day functioning and knowledge of mental illness was similar to that of their population peers. Answers to parental questionnaires suggested that overall our participants' parenting style was positive and their levels of stress were as expected for parents in general. Across questionnaires, parents underestimated their children's quality of life and overestimated their difficulties. Children and adolescents living with serious parental mental illness and parents were mainly very positive and enthusiastic about Young SMILES. They liked getting together to discuss their experiences with others in similar situations, but some parents felt unprepared to do this. Children liked having something that focused on their own needs separately from those of their parents; they liked the fun activities and valued the time away from their parents, but also wanted their parents to have support. Facilitators and referrers saw great value in Young SMILES. The needs of children with mentally ill parents remain unmet in the current system; a future evaluation of Young SMILES needs to reconsider the primary outcome and start with a pilot trial with clear criteria for progression to a full trial.

The relationship between sleep disturbance, symptoms and daytime functioning in psoriasis: a prospective study integrating actigraphy and experience sampling methodology.

OBJECTIVE/BACKGROUND: Sleep disturbance is common in individuals with psoriasis and appears to be related to both physical and psychological factors. We sought to examine whether psoriasis symptoms, night-time arousal and low mood predicted subsequent objective and self-reported sleep; and whether objective and self-reported sleep predicted next-day psoriasis symptoms and day-time functioning. PARTICIPANTS/METHODS: A total of 19 individuals (Female: 11 [57.9%], median age: 39 years) with chronic plaque psoriasis and poor sleep quality (mean Pittsburgh Sleep Quality Index, PSQI = 9.11) participated. Momentary assessments of psoriasis symptoms, mood and daytime functioning were completed at five pseudo-random intervals each day for 15 days using time-stamped digital diary entry. Objective sleep was estimated using wrist-worn actigraphy. Self-reported sleep and night-time arousal were assessed each morning using validated measures. RESULTS AND CONCLUSIONS: Two-level random intercept models showed that increased night-time arousal was associated with poorer diary-reported sleep. Neither self-reported nor objective sleep parameters were associated with daytime psoriasis symptoms in bi-directional analyses. Diary-reported sleep predicted next-day functioning, specifically sleepiness, concentration, and fatigue. Actigraphy-defined total sleep time predicted next-day fatigue. Night-time arousal is associated with poorer self-reported sleep in people with psoriasis, and sleep predicts next-day functioning. Contrary to our hypothesis, sleep disturbance does not appear to be associated with momentary assessments of psoriasis symptoms.

Correction to: Quality of life improved for patients after starting dialysis but is impaired, initially, for their partners: a multi-centre, longitudinal study.

An amendment to this paper has been published and can be accessed via the original article.

Quality of life improved for patients after starting dialysis but is impaired, initially, for their partners: a multi-centre, longitudinal study.

BACKGROUND: Quality of life (QOL) is important to patients with end stage renal disease and their partners. Despite the first 12 weeks being a critical time in the treatment pathway, limited research exists which examines how the transition onto dialysis impacts QOL. In this study we measured QOL in patients and their partners at pre-dialysis and over the first 12 weeks on dialysis to investigate QOL during this crucial period. METHODS: Patients and their partners, recruited from 10 renal units in England, completed questionnaires at pre-dialysis (n = 166 participants, 83 couples), 6 weeks (n = 90 participants, 45 couples) and 12 weeks (n = 78, 39 couples) after starting dialysis. On each occasion participants completed a QOL questionnaire (WHOQOL-BREF). Multilevel modelling accommodated the nested structure of couples with repeated measures within participants. Three-level random intercept models estimated changes in WHOQOL general QOL and its four domains (Physical, Psychological, Social and Environment). Two-level random intercept models assessed the relationship between baseline clinical and socio-demographic variables with changes in general QOL. RESULTS: Patients reported positive changes in general QOL from pre-dialysis to 6 weeks (ß = 0.42, p < 0.001, 95% CI 0.19, 0.65) and from pre-dialysis to 12 weeks (ß = 0.47, p < 0.001, 95% CI 0.24, 0.71). Partners' general QOL decreased significantly from pre-dialysis to 6 weeks (ß = - 0.24, p = 0.04, 95% CI -0.47, - 0.01) but returned to its original level at 12 weeks. Patients reported improvements in the physical domain between pre-dialysis and 12 weeks (ß = 6.56, p < 0.004, 95% CI 2.10, 11.03). No other domains changed significantly in patients or partners. Only in patients were there significant associations between moderator variables and general QOL. High comorbidity risk level and diabetes were associated with poorer QOL at pre-dialysis whereas being female and having an arteriovenous fistula were linked with improvements in general QOL. CONCLUSIONS: Patients reported significant improvements in their general and physical QOL after starting dialysis. Partners' general QOL worsened after patients started dialysis but improved by 12 weeks. Both patients and partners may benefit from additional educational and counselling services in the lead up to, and immediately after starting dialysis, which could facilitate the transition onto dialysis and improve QOL in both. STUDY REGISTRATION: This study was adopted on the NIHR Clinical Research Network (UK). The details of this study are registered on the Research Registry website (www.researchregistry.com). The identifier for this study is researchregistry2574.

FACT: a randomised controlled trial to assess the feasibility of QbTest in the assessment process of attention deficit hyperactivity disorder (ADHD) for young people in prison-a feasibility trial protocol.

INTRODUCTION: The prevalence of attention deficit hyperactivity disorder (ADHD) within the Children and Young People Secure Estate (CYPSE) is much higher than seen in the general population. To make a diagnosis of ADHD, clinicians draw on information from multiple sources, including parents and teachers. However, obtaining these is particularly difficult for young people in the secure estate. There is increasing evidence in the community that QbTest is able to assist in the accurate and earlier diagnosis of ADHD. The objective of this study is to assess the feasibility and acceptability of QbTest in the assessment of ADHD within the CYPSE. METHODS AND ANALYSIS: A single-centre parallel group feasibility randomised controlled trial will be conducted. Sixty young people within the CYPSE identified as displaying possible symptoms of ADHD will be randomised to the intervention arm (n=30; QbTest plus usual care) or control arm (n=30; usual care). Primary analyses will be descriptive and a process evaluation will be conducted to assess the contexts involved in implementing the intervention. Interviews will be conducted to explore acceptability and thematic analysis will be used to analyse the data. ETHICS AND DISSEMINATION: This study was approved by National Health Service Wales research ethics committee 3 (18/WA/0347) on 15 February 2019. The findings will be published in peer-reviewed journals, presented at relevant conferences and disseminated to the public via summaries cocreated with our patient and public involvement group. TRIAL REGISTRATION NUMBER: ISRCTN17402196.

Parkinson's-adapted cognitive stimulation therapy: a pilot randomized controlled clinical trial.

Cognitive stimulation therapy (CST) is widely used with people with dementia, but there is no evidence of its efficacy in mild cognitive impairment or dementia in Parkinson's disease (PD-MCI; PDD) or dementia with Lewy bodies (DLB). We aimed to explore the impact of 'CST-PD', which is home-based, individualized CST adapted for this population. In a single-blind, randomized controlled exploratory pilot trial (RCT), we randomized 76 participant-dyads [PD-MCI (n = 15), PDD (n = 40), DLB (n = 21) and their care partners] to CST-PD or treatment as usual (TAU). CST-PD involves home-based cognitively stimulating and engaging activities delivered by a trained care partner. Exploratory outcomes at 12 weeks included cognition (Addenbrooke's Cognitive Evaluation; ACE-III), neuropsychiatric symptoms and function. In care partners, we assessed burden, stress and general health status. Relationship quality and quality of life were assessed in both dyad members. At 12 weeks, the ACE-III showed a nonstatistically significant improvement in the CST-PD group compared with the TAU group, although neuropsychiatric symptoms increased significantly in the former. In contrast, care partners' quality of life (d = 0.16) and relationship quality ('satisfaction', d = 0.01; 'positive interaction', d = 0.55) improved significantly in the CST-PD group, and care burden (d = 0.16) and stress (d = 0.05) were significantly lower. Qualitative findings in the CST-PD recipients revealed positive 'in the moment' responses to the intervention, supporting the quantitative results. In conclusion, care-partner-delivered CST-PD may improve a range of care-partner outcomes that are important in supporting home-based care. A full-scale follow-up RCT to evaluate clinical and cost effectiveness is warranted.

Parkinson's-adapted cognitive stimulation therapy: feasibility and acceptability in Lewy body spectrum disorders.

BACKGROUND: Drug-based therapeutic approaches for Parkinson's disease dementia (PDD) and dementia with Lewy bodies (DLB) are moderately effective and not always tolerated. Tailoring psychosocial approaches in PDD and DLB may offer additional support and improve outcomes. We adapted home-based, care partner-delivered Cognitive Stimulation Therapy (CST) for individuals with PDD or DLB and their care partners (CST-PD). OBJECTIVES: To evaluate the feasibility, acceptability, and tolerability of CST-PD. METHODS: This randomised controlled trial used mixed methods, including a process evaluation. People with PDD, DLB or mild cognitive impairment in PD (PD-MCI) and their care partners were randomised to 12 weeks of treatment as usual (TAU) or CST-PD. Outcomes were feasibility of the study conduct (i.e., recruitment, retention rate) and acceptability and tolerability of the intervention. Measures included rating scales, researcher field notes, therapy diaries, and exploratory clinical and care partner efficacy measures. RESULTS: The recruitment target was met with 76 consenting participant-dyads. Retention in both arms was high at over 70%. More than 90% of dyads undertook discrete sessions greater than 20 min duration, but the average number of sessions completed was lower than the recommended dose. Acceptability ratings (i.e., interest, motivation and sense of achievement) of the intervention were high. Participants reported no serious adverse events related to the intervention. CONCLUSIONS: The field of psychosocial interventions for PDD and DLB is newly emerging, and we demonstrated that this type of intervention is acceptable and well tolerated. Evaluating its clinical effectiveness in a full-scale randomized controlled clinical trial is warranted. TRIAL REGISTRATION NUMBER: The trial is a psychosocial intervention with an allocated ISRCTN number 11455062.