Autopsy of a failed trial part 2: Outcomes, challenges, and lessons learnt from the DAISIES trial.

OBJECTIVE: The relative merits of inpatient or day-treatment for adults with anorexia nervosa (AN) are unknown. The DAISIES trial aimed to establish the non-inferiority of a stepped-care day patient treatment (DPT) approach versus inpatient treatment as usual (IP-TAU) for improving body mass index (BMI) at 12 months in adults with AN. The trial was terminated due to poor recruitment. This paper presents outcomes and investigates the reasons behind the trial's failure. METHOD: Fifteen patients with AN (of 53 approached) participated and were followed-up to 6 or 12 months. Summary statistics were calculated due to low sample size, and qualitative data concerning treatment experiences were analysed using thematic analysis. RESULTS: At baseline, participants in both trial arms rated stepped-care DPT as more acceptable. At 12 months, participants' BMIs had increased in both trial arms. Qualitative analysis highlighted valued and challenging aspects of care across settings. Only 6/12 sites opened for recruitment. Among patients approached, the most common reason for declining participation was their treatment preference (n = 12/38). CONCLUSIONS: No conclusions can be drawn concerning the effectiveness of IP-TAU and stepped-care DPT, but the latter was perceived more positively. Patient-related, service-related and systemic factors (COVID-19) contributed to the trial's failure. Lessons learnt can inform future studies.

A randomised controlled feasibility study of food-related computerised attention training versus mindfulness training and waiting-list control for adults with overweight or obesity: the FOCUS study.

BACKGROUND: In a feasibility randomised controlled trial in people with overweight/obesity with and without binge eating disorder (BED) symptoms, we assessed eight weekly sessions of attention bias modification training (ABMT) and mindfulness training (MT) versus waiting list (WL) and explored potential mechanisms. METHODS: 45 participants were randomly allocated to one of three trial arms. Primary outcomes were recruitment, retention and treatment adherence rates. Secondary outcomes included measures of eating behaviour, mood, attention and treatment acceptability. Assessments were conducted at baseline, post-intervention (week 8), and follow-up (week 12). RESULTS: Participant retention at follow-up was 84.5% across groups. Session completion rates in the laboratory were 87% for ABMT and 94% for MT, but home practice was much poorer for ABMT. Changes in BMI and body composition were small between groups and there was a medium size BMI reduction in the MT group at follow-up. Effect sizes of eating disorder symptom changes were not greater for either intervention group compared to WL, but favoured ABMT compared to MT. Hedonic hunger and mindful eating scores favoured MT compared to ABMT and WL. ABMT reduced attention biases towards high-calorie food cues, which correlated with lower objective binge eating days at post-intervention. No significant changes were observed in the MT, or WL conditions. CONCLUSIONS: Both ABMT and MT have potential value as adjuncts in the treatment of obesity and BED, and a larger clinical trial appears feasible and indicated. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN15745838. Registered on 22 May 2018.

In this small research study, people who were classified as overweight or living with obesity (with or without symptoms of binge eating disorder) received either a mindfulness intervention, a "subconscious" attention-based intervention called attention bias modification training (ABMT) or were put on a waiting list for 8 weeks. People in the mindfulness group experienced improvements in emotional eating, mindful eating, and "impulsive" eating. Those who received the attention-based training paid less attention to highly caloric food after the intervention which correlated with fewer binge eating episodes. Results from this study suggest that both types of interventions have potential as add-on treatments for obesity and binge eating disorder, but larger studies are necessary to assess their clinical impact.

Autopsy of a failed trial part 1: A qualitative investigation of clinician's views on and experiences of the implementation of the DAISIES trial in UK-based intensive eating disorder services.

OBJECTIVE: The DAISIES trial, comparing inpatient and stepped-care day patient treatment for adults with severe anorexia nervosa was prematurely terminated in March 2022 due to poor recruitment. This qualitative study seeks to understand the difficulties faced during the trial by investigating stakeholders' views on and experiences of its implementation. METHOD: Semi-structured interview and focus group transcripts, and trial management and oversight group meeting minutes from May 2020-June 2022 were analysed using thematic analysis. Participants were 47 clinicians and co-investigators involved with the DAISIES trial. The Non-Adoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework was applied to the interpretive themes to classify barriers and facilitators to implementation. RESULTS: Five themes were identified: incompatible participation interests; changing standard practice; concerns around clinical management; systemic capacity and capability issues; and Covid-19 disrupting implementation. Applying the NASSS framework indicated the greatest implementation challenges to arise with the adopters (e.g. patients, clinicians), the organisational systems (e.g. service capacity), and the wider socio-political context (e.g. Covid-19 closing services). CONCLUSIONS: Our findings emphasise the top-down impact of systemic-level research implementation challenges. The impact of the Covid-19 pandemic accentuated pre-existing organisational barriers to trial implementation within intensive eating disorder services, further limiting the capacity for research.

Clinicians' perspectives on supporting individuals with severe anorexia nervosa in specialist eating disorder intensive treatment settings during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic has significantly affected intensive treatment settings (i.e., inpatient [IP] and day patient [DP]) in specialist eating disorder services. However, the impact on clinicians working in these services is largely unknown. We therefore explored the perspectives of those supporting individuals with severe anorexia nervosa (AN) in intensive treatment settings during the pandemic. METHODS: Between May 2020 and June 2021, we interviewed clinicians (n = 21) who delivered IP and/or DP treatment to patients with severe AN in four specialist eating disorder services in the United Kingdom. Data relating to experiences during COVID-19 were analysed using reflexive thematic analysis. RESULTS: We identified six themes: Disruptions to Routine Treatment; Introduction of Virtual Treatment; Separation from Treatment, Others and the World; Impact on Recovery; Impact on Staff; and Pressure on Referral Pathways. COVID-19 posed significant challenges to IP and DP services: forcing closures, operating with restrictions and virtual treatment, and impacting delivery of essential treatment components, referral pathways, clinician wellbeing, risk management, and patient isolation and recovery trajectories. Opportunities arose, in particular in DP services offering virtual support. CONCLUSIONS: COVID-19 challenged the continuation of multidisciplinary treatment. The findings underline the necessity for medical, psychological, practical, and nutritional support, as well as carer involvement and fostering social connections to remain at the forefront of intensive treatment for severe AN. They also emphasise the uncertainty surrounding which intensive treatment may be best suited to which patient when, particularly within the context of virtual DP support.

The COVID-19 pandemic has significantly affected eating disorder inpatient and day patient treatment. However, the impact of the pandemic on clinicians working in these settings is largely unknown. We interviewed twenty-one clinicians working in specialist inpatient and day patient eating disorder services to explore their views on supporting people with severe anorexia nervosa during the pandemic. We analysed the transcripts using thematic analysis. We identified that COVID-19 posed significant challenges for intensive treatment settings, forcing the closure or merging of eating disorder services, the delivery of treatment under restrictions, and the introduction of virtual treatment. These changes challenged the delivery of multidisciplinary treatment for people with severe anorexia nervosa and impacted referral pathways, clinicians' wellbeing, risk management, and patients' isolation and recovery trajectories. We also identified some opportunities as a result of the pandemic, in particular in day patient services offering virtual support. These opportunities included more accessible treatment for patients and their families, more individualised treatment, and the chance for treatment innovation and creativity.

Clinicians' perspectives on supporting individuals with severe anorexia nervosa in specialist eating disorder intensive treatment settings.

BACKGROUND: Admissions to intensive treatment (i.e., inpatient [IP] and/or day patient [DP]) for individuals with severe anorexia nervosa (AN) are common. Growing literature indicates potential risks and benefits of each intensive treatment approach; however, existing research has focused on patient and carer perspectives of these treatments. Also, there is scant empirical evidence available for guiding the parameters of intensive treatments for AN. We therefore explored clinicians' perspectives and experience of supporting adults with severe AN in intensive settings. METHODS: We conducted twenty one semi-structured interviews with clinicians who deliver intensive treatments (i.e., IP and/or DP) for individuals with severe AN across four specialist Eating Disorder Services in the United Kingdom between May 2020 and June 2021. We asked clinicians about their views and experiences of supporting individuals with severe AN in intensive treatment settings and the challenges and opportunities associated with IP and DP treatment. Data were analysed using reflexive thematic analysis supported by NVivo software. RESULTS: Five broad and interrelated themes were identified: (1) Intensive Support; (2) The Severity of Patients' Illnesses; (3) Hope and Recovery; (4) Which Treatment When; (5) Limited Resources; and (6) Carer Burden. We identified various similarities between the two intensive treatment approaches, including the value of intensive and multidisciplinary support and carer involvement, and the challenge of managing complex and unique needs in resource-limited intensive settings. We also found differences in the relationship of treatment to patients' home environments, the necessity of patient motivation, and the management of risk. CONCLUSIONS: Both intensive treatment settings are valued by clinicians; however, there are unique challenges and opportunities for supporting individuals with severe AN within each. Our findings suggest DP treatment may be used as an alternative to IP treatment for individuals with severe AN. However, clear questions remain over which intensive treatment setting is best suited to which patient when and should be the focus of future research.

Some people with anorexia nervosa will need intensive treatment (e.g., inpatient and day patient treatment) during the course of their illness. We interviewed twenty-one clinicians working in Specialist Eating Disorder Services to explore their views on supporting people with severe anorexia nervosa in inpatient and day patient services and about the perceived advantages and disadvantages of these. We analysed the transcripts of these interviews using thematic analysis. We identified similarities between the two intensive treatment approaches. These included the value of intensive and multidisciplinary support, the importance of carer involvement, and the challenge of managing patient's complex and unique needs in services with limited resources. We also found differences between inpatient and day patient treatment. These included how treatment relates to patients' home environments, the importance of patient motivation, and managing risk. Day patient treatment may be an alternative to inpatient treatment for people with severe anorexia nervosa. Future research should investigate which intensive treatment setting is best suited to which patient and when.

Food related attention bias modification training for anorexia nervosa and its potential underpinning mechanisms.

Treatment outcomes in anorexia nervosa (AN) remain suboptimal, evidencing the need for better and more targeted treatments. Whilst the aetiology of AN is complex, cognitive processes such as attention bias (AB) have been proposed to contribute to maintaining food restriction behaviour. Attention bias modification raining (ABMT) has been investigated in other eating disorders (EDs) such as binge eating disorder (BED) as a means of modifying AB for food and of changing eating behaviour. Promising findings have been reported, but the mechanisms underlying ABMT are poorly understood. We hypothesise that in AN, ABMT has the potential to modify maladaptive eating behaviours related to anxiety around food and eating and propose two mechanistic models; (1) ABMT increases general attentional control (which will improve control over disorder-relevant thoughts) or (2) ABMT promotes stimulus re-evaluation. In this second case, the effects of ABMT might arise via changes in the subjective value of food stimuli (i.e. reward processing) or via habituation, with both resulting in a reduced threat response. Investigating the clinical potential of ABMT in AN holds the promise of a novel, evidence-based adjunctive treatment approach. Importantly, understanding ABMT's underlying mechanisms will help tailor treatment protocols and improve understanding of the cognitive characteristics of AN and other EDs.

Study protocol of a randomised controlled feasibility study of food-related computerised attention training versus mindfulness training and waiting-list control for adults with overweight or obesity.

BACKGROUND: Obesity is a highly prevalent condition with multiple adverse health consequences. Widely available first-line treatments for obesity, such as dietary and other lifestyle interventions, typically have only short-term effects. Thus, new treatment approaches are needed. Novel interventions such as Attention Bias Modification Training (ABMT) and mindfulness-based interventions focus on modifying different maladaptive cognitive patterns typically present in people with obesity (e.g. attention bias to food cues); however, their mechanisms of action remain largely unknown. We describe the theoretical basis and the rationale for a study protocol of a feasibility randomised controlled trial (RCT) comparing two attention trainings (ABMT vs Mindfulness Training [MT]) in people with overweight or obesity. The aim of this study is to inform the development of a large-scale RCT in relation to acceptability and attendance rates and to identify preliminary evidence for the interventions' clinical efficacy and potential underlying mechanisms. DESIGN: Forty-five adults who are either overweight or obese (minimum body mass index of 25 kg/m2) will be randomly allocated to receive eight sessions over eight weeks of either computerised ABMT or MT or be on a waiting list. Clinical and cognitive outcomes will be assessed at baseline, post-treatment (8 weeks) and follow-up (12 weeks post-randomisation). These include mood, body composition and attention biases. Credibility and acceptability of the trainings will be assessed using questionnaires, and recruitment and retention rates will be recorded. DISCUSSION: Findings will inform the feasibility of developing a large-scale RCT that takes into consideration effect sizes for primary outcome measures and the acceptability of the design. The study will also provide preliminary evidence on the clinical efficacy of two different attention trainings for people with obesity and associated underlying mechanisms. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN15745838. Registered on 22 May 2018.

Same, same but different: Attention bias for food cues in adults and adolescents with anorexia nervosa.

OBJECTIVE: Attention processing for food may be biased in people with Anorexia Nervosa (AN). However, previous studies have had inconsistent results. This is likely to be due to indirect assessment of attention, which does not inform on the underlying attention processes, and/or the heterogeneity of participants across studies, testing either adults or adolescents with AN, that is, people at very different developmental and illness stages. METHOD: Eye-tracking was employed as a direct assessment of attention during a visual probe task with food versus non-food pictures. Attention bias for food was measured in 39 adults and 34 adolescents with AN and in 53 adults and 31 adolescents without AN. RESULTS: All participants had a direction bias for food, specifically for high-calorie food. However, adults with AN subsequently avoided maintaining attention on food versus non-food cues, compared to adults without AN. Adolescents with or without AN demonstrated increased attention maintenance on food versus non-food cues, and, contrary to our hypothesis, did not differ in their attention bias for food cues. Accordingly, adults with AN differed significantly from adolescents with AN in attention maintenance for food cues: while adolescents with AN showed significantly increased attention maintenance on food stimuli, adults avoided maintaining attention on food cues. DISCUSSION: Adults with AN may apply attention strategies to facilitate restrictive eating. This strategy is absent in adolescents with AN. This difference in food-related attention bias between adolescents and adults with AN suggests that attention biases develop over time as the illness progresses.

Obturación única con compuesto de trióxido mineral en diente avulsionado con reabsorción radicular: informe de un caso / Single obturation with mineral trioxide aggregate in an avulsed tooth with root resorption: report of a case

Objetivo: informar el tratamiento de un diente avulsionado con reabsorción radicular y obturado únicamente con compuesto de mineral trióxido (MTA, Angelus, Londrina, Brasil). Caso clínico: en un paciente de 17 años que presentó avulsión del 11, con tiemop extraoral mayor a 60 minutos, 6 meses después se observó reabsorción radicular externa inflamatoria comunicante con ligamento periodontal, pérdida de cresta ósea, tracto sinuoso y movilidad dental. A pesar de no haber buen pronóstico, se realizó el tratamiento de la reabsorción con medicación con hidróxido de calcio y obturación única del conducto con MTA. Se efectuó un control con tomografía de cono a los 2 años y 10 meses, el cual mostró la no continuación de la reabsorción de cresta ósea. Conclusión: el tratamiento adecuado y la obturación con MTA ofrecen la oportunidad de lograr una buena cicatrización de los tejidos perirradiculares y preservar dientes comprometidos.