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 randomized controlled trial of the compuLsive Exercise Activity TheraPy (LEAP): A new approach to compulsive exercise in anorexia nervosa.

OBJECTIVE: To compare the efficacy of the compuLsive Exercise Activity theraPy (LEAP) programme integrated with manualized cognitive behavioral therapy for anorexia nervosa (CBT-AN) compared to CBT-AN alone. METHOD: Seventy-eight adults were randomized to CBT-AN, delivered with or without eight embedded sessions of LEAP, for a total of 34 individual outpatient sessions. Participants were assessed at baseline, the end of the first phase of CBT-AN (which included LEAP), mid-therapy, end of therapy, and at 3 and 6 months follow-up. Linear mixed effects modelling was used for comparing trajectories over time by group in primary outcomes of pathological exercise cognitions and secondary outcomes of exercise frequency, BMI, eating disorder (ED) symptoms, AN stage of change, anxiety/depression, and health related quality of life. RESULTS: There were significant improvements over time in all outcomes. There were no significant differences between treatment groups in primary outcome measures. Fidelity and end-of-treatment participant satisfaction were satisfactory across both conditions. DISCUSSION: CBT-AN and LEAP added to CBT-AN resulted in improved attitudes and beliefs toward exercise and general improvements in BMI and ED psychopathology in people with AN.

Validity of Exercise Measures in Adults with Anorexia Nervosa: The EDE, Compulsive Exercise Test and Other Self-Report Scales.

OBJECTIVE: Compulsive exercise is a prominent feature for the majority of patients with Anorexia Nervosa (AN), but there is a dearth of research evaluating assessment instruments. This study assessed the concurrent validity of the exercise items of the Eating Disorder Examination (EDE) and Eating Disorder Examination-Questionnaire (EDE-Q), with the Compulsive Exercise Test (CET) and other self-report exercise measures in patients with AN. We also aimed to perform validation of the CET in an adult clinical sample. METHODS: The sample consisted of 78 adults with AN, recruited for the randomized controlled trial "Taking a LEAP forward in the treatment of anorexia nervosa." At baseline, participants completed the EDE, EDE-Q, CET, Reasons for Exercise Inventory (REI), Commitment to Exercise Scale (CES) and Exercise Beliefs Questionnaire (EBQ). Correlational and regression analyses were performed. RESULTS: EDE exercise days and exercise time per day were positively correlated with each other and with all CET subscales (except Lack of exercise enjoyment), CES mean, EBQ total and REI total. Exercise time per day was associated with a higher EDE global score. The CET demonstrated good concurrent validity with the CES, the REI and the EBQ. Of the self-reports, the CET explained the greatest variance in eating disorder psychopathology and demonstrated good to excellent reliability in this sample. DISCUSSION: The EDE and EDE-Q demonstrated good concurrent validity with the CET. Further research is required to evaluate the CET's factor structure in a large clinical sample. However, the CET has demonstrated strong clinical utility in adult patients with AN. © 2016 Wiley Periodicals, Inc.(Int J Eat Disord 2017; 50:533-541).

Predictors of Positive Treatment Outcome in People With Anorexia Nervosa Treated in a Specialized Inpatient Unit: The Role of Early Response to Treatment.

OBJECTIVE: To investigate factors which predict positive treatment outcome in inpatients with anorexia nervosa (AN), particularly the role of early treatment response. METHOD: 102 patients entering specialist inpatient treatment were assessed for eating disorder history, psychopathology, and motivation to change. Predictive factors assessed were: early treatment response defined as weight increase of at least 0.5-1 kg/week during the first 6 weeks of treatment (n=87), admission body mass index (BMI), onset age, chronicity, motivation to change, diagnosis, and previous hospitalization for AN. Positive treatment outcome was defined as achieving a BMI of 17.5 kg/m(2) within an individual time frame. RESULTS: Logistic regression indicated that patients were 18 times more likely to reach positive treatment outcome if they met the National Institute for Health and Care Excellence weight guidelines within the first 6 weeks of hospitalization. Higher admission BMI was also found to predict positive treatment outcome. DISCUSSION: Higher entry BMI and early weight gain predict positive treatment outcome in individuals receiving specialist AN inpatient treatment. Copyright © 2016 John Wiley & Sons, Ltd and Eating Disorders Association.

Evaluation of a Motivation and Psycho-Educational Guided Self-Help Intervention for People with Eating Disorders (MOPED).

High dropout rates and poor levels of engagement are well documented for patients with eating disorders. Utilising motivational techniques and providing psycho-education have been suggested as ways to reduce treatment disengagement. This study aimed to evaluate the effect of a newly developed motivational and psycho-educational (MOPED) guided self-help intervention for people with eating disorders on engagement and retention in therapy. Patients who received MOPED pre-treatment (n = 79) were compared with a diagnosis-matched group of patients receiving treatment as usual (TAU; n = 79). The study found that patients receiving MOPED had a higher engagement rate than those within the TAU group. Specifically, patients in the anorexic spectrum were found to present with both higher rates of engagement and completion of therapy when issued with MOPED in comparison with TAU. Self-help packages using motivational style could be a valuable and cost-effective intervention for patients with eating disorders.

Treatment outcome of patients with comorbid type 1 diabetes and eating disorders.

BACKGROUND: Co-morbidity between Type 1 Diabetes Mellitus (T1DM) and eating disorders (ED) has been previously described; however the effect of this illness on the outcomes for conventional ED treatments has not been previously investigated. This study aims to compare clinical, psychopathological and personality features between two samples of ED individuals: those with comorbid T1DM and those without (No-DM); and to identify differences in treatment outcomes between the groups. METHODS: This study compares treatment outcome, dropouts, ED psychopathology and personality characteristics for 20 individuals with ED and T1DM and 20 ED patients without diabetes, matched for diagnostic and treatment type. RESULTS: The study found higher dropout rates from therapy in individuals with T1DM and worse treatment outcome in spite of having no significant differences in eating disorder psychopathology, although individuals with T1DM report misusing insulin. CONCLUSIONS: The low levels of motivation to change, and insulin abuse in T1DM patients, may suggest that treatment for patients with ED and T1DM should consider the individual's personality and role of insulin abuse when determining the appropriate intervention.

Anorexia nervosa and low weight EDNOS: a 10-year study of service consumption and outcome in a local specialised service for adults.

A 10-year retrospective case note study of adults with eating disorders at low weight examined levels of service consumption and the outcome in terms of body mass index. Records of 202 such patients, referred to a specialist secondary service, were studied. Just over one quarter of the patients failed to engage in treatment, attending five or fewer appointments. Of those who did engage, most were treated as out-patients and had an average contact with the service of almost 2.5 years and 46 sessions. Only about one in six patients was admitted as an in-patient at any time. These results suggest that most adults with eating disorder at low weight can be managed as out-patients. However, service providers should expect prolonged contact and high service consumption.

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. TRIAL REGISTRATION: ISRCTN ISRCTN10166784 . Registered 28 February 2020. ISRCTN is a primary registry of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) network and includes all items from the WHO Trial Registration Data Set.

The Compulsive Exercise Test: confirmatory factor analysis and links with eating psychopathology among women with clinical eating disorders.

BACKGROUND: This study aimed to determine the psychometric properties of the Compulsive Exercise Test (CET) among an adult sample of patients with eating disorders. METHOD: Three hundred and fifty six patients and 360 non-clinical control women completed the CET and the Eating Disorders Examination questionnaire (EDE-Q). RESULTS: A confirmatory factor analysis revealed that the clinical data showed a moderate fit to the previously published five factor model derived from a community sample (Taranis L, Touyz S, Meyer C, Eur Eat Disord Rev 19:256-268, 2011). The clinical group scored significantly higher than the non-clinical group on four of the five CET subscales, and logistic regression analysis revealed that the CET could successfully discriminate between the two groups. A Receiver Operating Curve analysis revealed that a cut-off score of 15 on the CET resulted in acceptable values of both sensitivity and specificity. CONCLUSIONS: The CET appears to have a factor structure that is acceptable for use with an adult sample of patients with eating disorders. It can identify compulsive exercise among patients with eating disorders and a cut-off score of 15 is acceptable as indicating an appropriate cut-off point.

Mortality rates in patients with anorexia nervosa and other eating disorders. A meta-analysis of 36 studies.

CONTEXT: Morbidity and mortality rates in patients with eating disorders are thought to be high, but exact rates remain to be clarified. OBJECTIVE: To systematically compile and analyze the mortality rates in individuals with anorexia nervosa (AN), bulimia nervosa (BN), and eating disorder not otherwise specified (EDNOS). DATA SOURCES: A systematic literature search, appraisal, and meta-analysis were conducted of the MEDLINE/PubMed, PsycINFO, and Embase databases and 4 full-text collections (ie, ScienceDirect, Ingenta Select, Ovid, and Wiley-Blackwell Interscience). STUDY SELECTION: English-language, peer-reviewed articles published between January 1, 1966, and September 30, 2010, that reported mortality rates in patients with eating disorders. DATA EXTRACTION: Primary data were extracted as raw numbers or confidence intervals and corrected for years of observation and sample size (ie, person-years of observation). Weighted proportion meta-analysis was used to adjust for study size using the DerSimonian-Laird model to allow for heterogeneity inclusion in the analysis. DATA SYNTHESIS: From 143 potentially relevant articles, we found 36 quantitative studies with sufficient data for extraction. The studies reported outcomes of AN during 166 642 person-years, BN during 32 798 person-years, and EDNOS during 22 644 person-years. The weighted mortality rates (ie, deaths per 1000 person-years) were 5.1 for AN, 1.7 for BN, and 3.3 for EDNOS. The standardized mortality ratios were 5.86 for AN, 1.93 for BN, and 1.92 for EDNOS. One in 5 individuals with AN who died had committed suicide. CONCLUSIONS: Individuals with eating disorders have significantly elevated mortality rates, with the highest rates occurring in those with AN. The mortality rates for BN and EDNOS are similar. The study found age at assessment to be a significant predictor of mortality for patients with AN. Further research is needed to identify predictors of mortality in patients with BN and EDNOS.

Changes in alcohol intake in response to transdiagnostic cognitive behaviour therapy for eating disorders.

OBJECTIVE: The aim of this study was to examine how alcohol intake changes during and after transdiagnostic cognitive behaviour therapy for eating disorders (CBT-E). Additionally, the paper considers the relationship between alcohol consumption, eating disorder diagnosis and current major depressive episode at the time of first assessment. METHOD: One hundred and forty nine outpatients with an eating disorder (body mass index over 17.5) were divided into high or low alcohol intake groups (HIG and LIG) according to their intake at pre-treatment assessment. Their alcohol intake and eating disorder psychopathology were examined over the course of treatment and follow-up. RESULTS: There was no difference between the groups on response of the eating disorder to treatment. The HIG significantly reduced their alcohol intake following treatment whilst the intake of the LIG remained stable over the course of treatment and follow-up. There were no group differences in major depression and overall severity of eating disorder at baseline. CONCLUSIONS: The response to CBT-E was not influenced by baseline level of alcohol use. The mean alcohol intake of the heavy drinking subjects decreased without being specifically addressed by the treatment.

Can treatment trial samples be representative?

A catchment area-based sample of patients recruited for an eating disorder treatment trial was compared with patients from the same geographical area seen in the 12 months before and after the trial. The three samples were very similar. The research sample was representative of the usual clinic sample from which it had been selected and thus the results could be extrapolated with some confidence to other similar clinical settings. It is concluded that whilst treatment trials, by their very nature, have explicit and implicit inclusion and exclusion criteria with appropriate designs they can be usefully representative.

Transdiagnostic cognitive-behavioral therapy for patients with eating disorders: a two-site trial with 60-week follow-up.

OBJECTIVE: The aim of this study was to compare two cognitive-behavioral treatments for outpatients with eating disorders, one focusing solely on eating disorder features and the other a more complex treatment that also addresses mood intolerance, clinical perfectionism, low self-esteem, or interpersonal difficulties. METHOD: A total of 154 patients who had a DSM-IV eating disorder but were not markedly underweight (body mass index over 17.5), were enrolled in a two-site randomized controlled trial involving 20 weeks of treatment and a 60-week closed period of follow-up. The control condition was an 8-week waiting list period preceding treatment. Outcomes were measured by independent assessors who were blind to treatment condition. RESULTS: Patients in the waiting list control condition exhibited little change in symptom severity, whereas those in the two treatment conditions exhibited substantial and equivalent change, which was well maintained during follow-up. At the 60-week follow-up assessment, 51.3% of the sample had a level of eating disorder features less than one standard deviation above the community mean. Treatment outcome did not depend on eating disorder diagnosis. Patients with marked mood intolerance, clinical perfectionism, low self-esteem, or interpersonal difficulties appeared to respond better to the more complex treatment, with the reverse pattern evident among the remaining patients. CONCLUSIONS: These two transdiagnostic treatments appear to be suitable for the majority of outpatients with an eating disorder. The simpler treatment may best be viewed as the default version, with the more complex treatment reserved for patients with marked additional psychopathology of the type targeted by the treatment.