Background A substantial proportion of anorexia nervosa patients require intensive treatments, commonly inpatient or day-patient treatment. The relative merits of these treatments for adults with anorexia nervosa are unknown. Therefore, a trial investigating the clinical effectiveness and cost-effectiveness of inpatient treatment-as-usual versus a stepped-care day-patient approach in adults with anorexia nervosa (DAISIES) was commissioned. This trial terminated prematurely due to poor recruitment, mainly resulting from COVID-19’s impact on service provision. Objective We describe the rationale, methods and available outcomes of the DAISIES trial. Reasons behind the trial’s failure and implications for future research are investigated. Design A two-arm multicentre open-label parallel-group non-inferiority randomised controlled trial, evaluating the effectiveness, acceptability and cost-effectiveness of two intensive treatments for adults with severe anorexia nervosa. Setting Specialist eating-disorder services in the United Kingdom with inpatient and/or day-patient treatment facilities. Participants Adults (age 17 +) with severe anorexia nervosa (body mass index ≤ 16 kg/m 2 ) requiring intensive treatment and (optionally) their carers. Intended sample size: 386. Interventions Inpatient treatment-as-usual and a stepped-care day-patient treatment approach (with the option of initial inpatient treatment for medical stabilisation). Main outcome measures The primary outcome was body mass index at 12 months post randomisation. Qualitative interviews conducted during the trial included semistructured interviews to investigate patients’, families’ and clinicians’ views on treatments. Results During the 16-month recruitment period (November 2020 to March 2022), 53 patients were approached. Of these, 15 were enrolled and randomly allocated to the inpatient treatment-as-usual ( n = 7) or day-patient treatment ( n = 8) treatment arms. All participants were female with a mean (standard deviation) age of 24.8 (9.1) years and a mean (standard deviation) body mass index of 14.4 (1.6) kg/m 2 . Patients’ body mass indexes had increased similarly in both groups at 12 months. Participants perceived the stepped-care day-patient treatment approach to be more acceptable than inpatient treatment-as-usual. Qualitative interviews with patients, carers and clinicians suggested valued (e.g. multidisciplinary provision of care) and disliked (e.g. perceived over-focus on weight gain) aspects of treatment. Investigation of the reasons behind the trial’s failure revealed strong treatment preferences among patients as the most common reason for non-participation, alongside the impact of COVID-19 on service provision. Limitations The main trial questions could not be answered due to low participant numbers. Conclusions No conclusions can be drawn concerning the clinical and cost-effectiveness of inpatient treatment-as-usual or stepped-care day-patient treatment. The day-patient treatment approach was perceived more positively by patients and carers. Service-related (e.g. reduced clinician time for research), patient-related (e.g. treatment preferences) and wider systemic factors (e.g. reduced service capacity and patient throughput nationally during COVID-19) seem to have contributed to the failure of the DAISIES trial. Future work Despite the trial’s failure, the need to investigate the effectiveness and experience of intensive treatments of adult anorexia nervosa remains. Alternative trial designs incorporating patient preferences and investigating community-based intensive treatment options have potential to improve acceptability and recruitment. Funding This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number HTA 17/123/03.

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.

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.

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.

Background: Mindfulness Based Interventions (MBIs) for weight loss and overeating-related behaviours have recently gained popularity. Previous systematic reviews and meta-analyses included studies of variable quality, which hinders interpretation of results. This meta-analysis examined only randomised controlled trials (RCTs) comparing the efficacy of MBIs with control groups primarily encouraging either dietary or exercise-based behavioural change in individuals with overweight/obesity and/or binge eating disorder (BED). Methods: Using PRISMA guidelines, we systematically reviewed relevant articles in Medline, Psychinfo and EMBASE. Twelve eligible RCTs were identified, with three random-effects meta-analyses conducted on primary outcome measures of body mass (N = 11), mindfulness (N = 7) and BED symptoms (N = 3). Results: MBIs were more efficacious than control in increasing mindfulness scores and decreasing BED symptoms from pre-to post-treatment. However, they were no more efficacious than control in reducing body mass which may be attributed to variability in the duration of interventions. Based on intervention duration, exploratory cumulative meta-analyses revealed that while shorter interventions (i.e., 6 weeks) showed greater reductions in body mass compared to longer interventions (i.e., 24 weeks), longer interventions led to greater improvements in mindfulness scores and BED symptoms. Conclusions: These results highlight the potential of MBIs to improve obesity-related behaviours compared to lifestyle interventions, but their effects on short-term weight loss remain unclear. Future research with a rigorous methodology should consider long-term follow-ups including body mass and mindfulness-related outcome measures in order to establish the clinical potential of MBIs.

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.

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.

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.