The clinical effectiveness and cost-effectiveness of a ‘stepping into day treatment’ approach versus inpatient treatment as usual for anorexia nervosa in adult specialist eating disorder services (DAISIES trial): a study protocol of a randomised controlled multi-centre open-label parallel group non-inferiority trial

BACKGROUND: Anorexia nervosa (AN) is a serious and disabling mental disorder with a high disease burden. In a proportion of cases, intensive hospital-based treatments, i.e. inpatient or day patient treatment, are required, with day patient treatment often being used as a 'step-down' treatment after a period of inpatient treatment. Demand for such treatment approaches has seen a sharp rise. Despite this, the relative merits of these approaches for patients, their families, and the NHS and wider society are relatively unknown. This paper describes the rationale for, and protocol of, a two-arm multi-centre open-label parallel group non-inferiority randomised controlled trial, evaluating the effectiveness and cost-effectiveness of these two intensive treatments for adults with severe AN: inpatient treatment as usual and a stepped care day patient approach (the combination of day patient treatment with the option of initial inpatient treatment for medical stabilisation). The main aim of this trial is to establish whether, in adults with severe AN, a stepped care day patient approach is non-inferior to inpatient treatment as usual in relation to improving body mass index (BMI) at 12 months post-randomisation. METHODS: 386 patients with a Diagnostic and Statistical Manual 5th edition diagnosis of severe AN or related disorder, with a BMI of ≤16 kg/m2 and in need of intensive treatment will be randomly allocated to either inpatient treatment as usual or a stepped care day patient approach. Patients in both groups will receive treatment until they reach a healthy weight or get as close to this point as possible. Assessments will be conducted at baseline (prior to randomisation), and at 6 and 12 months post-randomisation, with additional monthly symptom monitoring. The primary outcome will be BMI at the 12-month post-randomisation assessment. Other outcomes will include psychosocial adjustment; treatment motivation, expectations and experiences; cost-effectiveness; and carer burden. DISCUSSION: The results of this study will provide a rigorous evaluation of two intensive treatment approaches which will inform future national and international treatment guidelines and service provision

An investigation of hypothalamic pituitary adrenal axis hyperactivity in anorexia nervosa

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A pragmatic randomised multi-centre trial of multifamily and single family therapy for adolescent anorexia nervosa

BACKGROUND: Considerable progress has been made in recent years in developing effective treatments for child and adolescent anorexia nervosa, with a general consensus in the field that eating disorders focussed family therapy (often referred to as Maudsley Family Therapy or Family Based Treatment) currently offers the most promising outcomes. Nevertheless, a significant number do not respond well and additional treatment developments are needed to improve outcomes. Multifamily therapy is a promising treatment that has attracted considerable interest and we report the results of the first randomised controlled trial of multifamily therapy for adolescent anorexia nervosa. METHODS: The study was a pragmatic multicentre randomised controlled superiority trial comparing two outpatient eating disorder focussed family interventions - multifamily therapy (MFT-AN) and single family therapy (FT-AN). A total of 169 adolescents with a DSM-IV diagnosis of anorexia nervosa or eating disorder not otherwise specified (restricting type) were randomised to the two treatments using computer generated blocks of random sizes to ensure balanced numbers in the trial arms. Independent assessors, blind to the allocation, completed evaluations at baseline, 3 months, 12 months (end of treatment) and 18 months. RESULTS: Both treatment groups showed clinically significant improvements with just under 60% achieving a good or intermediate outcome (on the Morgan-Russell scales) at the end of treatment in the FT-AN group and more than 75% in the MFT-AN group - a statistically significant benefit in favour of the multifamily intervention (OR = 2.55 95%; CI 1.17, 5.52; p = 0.019). At follow-up (18 months post baseline) there was relatively little change compared to end of treatment although the difference in primary outcome between the treatments was no longer statistically significant. Clinically significant gains in weight were accompanied by improvements in mood and eating disorder psychopathology. Approximately half the patients in FT-AN and nearly 60% of those in MFT-AN had started menstruating. CONCLUSIONS: This study confirms previous research findings demonstrating the effectiveness of eating disorder focused family therapy and highlights the additional benefits of bringing together groups of families that maximises the use of family resources and mutual support leading to improved outcomes. TRIAL REGISTRATION: Current Controlled Trials ISRCTN11275465; Registered 29 January 2007 (retrospectively registered

A multi-centre cohort study of short term outcomes of hospital treatment for anorexia nervosa in the UK

BACKGROUND: Individual, family and service level characteristics and outcomes are described for adult and adolescent patients receiving specialist inpatient or day patient treatment for anorexia nervosa (AN). Potential predictors of treatment outcome are explored. METHOD: Admission and discharge data were collected from patients admitted at 14 UK hospital treatment units for AN over a period of three years (adult units N = 12; adolescent N = 2) (patients N = 177). RESULTS: One hundred and seventy-seven patients with a severe and enduring illness with wide functional impairment took part in the study. Following inpatient care, physical improvement was moderate/good with a large increase in BMI, although most patients continued to have a clinical level of eating disorder symptoms at discharge. The potentially modifiable predictors of outcome included confidence to change, social functioning and carer expressed emotion and control. CONCLUSIONS: Overall, the response to inpatient treatment was modest particularly in the group with a severe enduring form of illness. Adolescents had a better response. Although inpatient treatment produces an improvement in physical health there was less improvement in other eating disorder and mood symptoms. As predicted by the carer interpersonal maintenance model, carer behaviour may influence the response to inpatient care, as may improved social functioning and confidence to change

Exploring the use of individualised patient-reported outcome measures in eating disorders:Validation of the Psychological Outcome Profiles

RATIONALE: Psychotherapies for eating disorders (EDs) are routinely assessed using standardised patient-reported outcome measures (PROMs). PROMs have been criticised for their lack of patient centeredness and clinical utility. The Psychological Outcome Profiles (PSYCHLOPS) is an individualised PROM that allows patients to specify their own outcomes. AIMS: (1) To validate the use of the PSYCHLOPS in ED treatment, and (2) to identify patient concerns beyond those measured by common ED PROMs. METHODS: Two hundred and seventy-eight emerging adult patients, presenting with a first-episode ED (aged 16-25, illness duration <3 years) completed the PSYCHLOPS and two standardised ED PROMs (the EatingDisorder Examination Questionnaire [EDE-Q] and the Clinical Impairment Assessment Questionnaire [CIA]) at four time points across 12 months. Psychometrics of the PSYCHLOPS were assessed quantitatively against the EDE-Q and CIA. Content analysis assessed unique patient concerns identified by PSYCHLOPS. RESULTS: The PSYCHLOPS had adequate to good psychometric properties. A total of 53.3% of participants reported a concern not addressed by the EDE-Q or the CIA, the most common being depression/anxiety, academic problems, treatment concerns and disturbed sleep. DISCUSSION: PROMs can be complemented by the PSYCHLOPS to identify problems specific to an individual's context. As ED patients are typically ambivalent about change, understanding their concerns is vital in building motivation for change

"I'm truly free from my eating disorder": Emerging adults' experiences of FREED, an early intervention service model and care pathway for eating disorders

BACKGROUND: Eating disorders (EDs) typically start during adolescence or emerging adulthood, periods of intense biopsychosocial development. FREED (First Episode Rapid Early Intervention for EDs) is a service model and care pathway providing rapid access to developmentally-informed care for emerging adults with EDs. FREED is associated with reduced duration of untreated eating disorder and improved clinical outcomes, but patients' experiences of treatment have yet to be assessed. OBJECTIVE: This study aimed to assess emerging adults' experiences of receiving treatment through FREED. METHOD: This study triangulated qualitative data on participants' experiences of FREED treatment from questionnaires and semi-structured interviews. Participants were 106 emerging adults (aged 16-25; illness duration < 3 yrs) (questionnaire only = 92; interview only = 6; both = 8). Data were analysed thematically. RESULTS: Most participants reported psychological and behavioural changes over the course of treatment (e.g. reduction in symptoms; increased acceptance and understanding of difficulties). Participants identified five beneficial characteristics of FREED treatment: i) rapid access to treatment; ii) knowledgeable and concerned clinicians; iii) focusing on life beyond the eating disorder; iv) building a support network; v) becoming your own therapist. CONCLUSION: This study provides further supports for the implementation of early intervention and developmentally-informed care for EDs. Future service model development should include efforts to increase early help-seeking

Confirmatory factor analysis for two questionnaires of caregiving in eating disorders

Objective: Caring for someone diagnosed with an eating disorder (ED) is associated with a high level of burden and psychological distress which can inadvertently contribute to the maintenance of the illness. The Eating Disorders Symptom Impact Scale (EDSIS) and Accommodation and Enabling Scale for Eating Disorders (AESED) are self-report scales to assess elements of caregiving theorised to contribute to the maintenance of an ED. Further validation and confirmation of the factor structures for these scales are necessary for rigorous evaluation of complex interventions which target these modifiable elements of caregiving. Method: EDSIS and AESED data from 268 carers of people with anorexia nervosa (AN), recruited from consecutive admissions to 15 UK inpatient or day patient hospital units, were subjected to confirmatory factor analysis to test model fit by applying the existing factor structures: (a) four-factor structure for the EDSIS and (b) five-factor structure for the AESED. Results: Confirmatory factor analytic results support the existing four-factor and five-factor structures for the EDSIS and the AESED, respectively. Discussion: The present findings provide further validation of the EDSIS and the AESED as tools to assess modifiable elements of caregiving for someone with an ED

The effects of stress on body weight : Biological and psychological predictors of change in BMI

Objective: To investigate individual differences in the effects of stress on BMI. Research Methods and Procedures: Participants were 71 healthy women volunteers enrolled in a university-based nurse practitioner program. Predictors of change in BMI were hypothesized to be cortisol secretion, dietary restraint, bingeing, mastery, mood, and eating attitudes. Measures were made at the beginning of the academic semester and 12 weeks later during the participants' examination period. Results: The women were of normal weight (BMI 25.2 +/- 4.3) for their age [43; standard deviation (SD), 7]. By the examination period, 40 had gained weight (mean, 5.5 pounds; SD, 2.2), 19 lost weight (mean, 2.5 pounds; SD, 1.5), and 12 had stable weight. BMI, salivary cortisol secretion, bingeing behavior, depression, and anxiety increased significantly, whereas scores on dietary restraint, weight, shape, and eating concerns, and mastery decreased significantly. Regression analysis showed that change in daily cortisol secretion significantly predicted change in BMI and that mastery significantly moderated this relationship. However, a reduction in dietary restraint was a perfect mediator of this relationship. Change in cortisol secretion also significantly predicted change in dietary restraint, and this was moderated by dietary restraint at the beginning of the academic semester. Reduction in dietary restraint was also predicted by a reduction in mastery and weight concern. Discussion: We identified individual differences that confer vulnerability to weight gain during stressful life events (dietary restraint and mastery). Given that women are exposed to daily stressors and use cognitive strategies to restrain their dietary intake, increasing awareness of the role of stress on eating behavior and weight is an important goal.Peer reviewe