A phase II randomised controlled trial of intranasal oxytocin in anorexia nervosa.

BACKGROUND: Anorexia nervosa (AN) is an eating disorder (ED) with high mortality rates and limited response to existing treatments, prompting the need to identify effective agents and adjuncts. There is evidence for an emerging role for the neuropeptide oxytocin (OT) in the pathophysiology of AN, with studies showing a perturbed oxytocinergic system in patients with AN. Preliminary evidence has demonstrated that intranasal OT (IN-OT) can produce anxiolytic effects in AN, as well as reducing concern about eating, and dysfunctional attentional biases related to the disorder. IN-OT is a non-invasive treatment option for AN that requires investigation as an adjunct to nutritional rehabilitation. METHODS: This multi-site study (Trial Registration:ACTRN1261000897460) sought to replicate and extend a previous randomised placebo-controlled pilot trial of repeated dose IN-OT in patients with AN hospitalised for nutritional rehabilitation. Patients with AN (N=61) received daily IN-OT (18 IU twice per day) or placebo for four weeks, whilst undergoing inpatient hospital treatment. Outcome measures included ED psychopathology (primary) as measured by the Eating Disorder Examination (EDE) and Body Mass Index (BMI; secondary). Participants were assessed pre- and post-treatment, and at six months following the intervention. The effects of the first and last doses of IN-OT on responses (anxiety ratings and salivary cortisol) to a high-energy snack were also examined. RESULTS: Sixty-one female inpatients (Mage=24.36,SD=7.87) with an average BMI of 16.24 (range: 11.43-18.55), were recruited into the study. No significant differences were found between placebo and OT groups at any of the time points on the outcomes of interest, but significant improvements in almost all psychological parameters in both groups were evident over time. IN-OT did not significantly reduce anxiety nor salivary cortisol in response to a high-calorie snack. CONCLUSION: This is the largest randomised placebo-controlled trial of repeated dose intranasal OT in people with AN, during refeeding. The therapeutically promising findings of the pilot study were not replicated. Limitations and reasons for the non-replication included relatively large variance, baseline psychopathology scores being higher in this patient group, potential ceiling effects in BMI and ED psychopathology as well as differing comorbidities.

A randomised controlled trial of clinician supported vs self-help delivery of online cognitive behaviour therapy for Bulimia Nervosa.

High dropout rates and poor adherence associated with digital interventions have prompted research into modifications of these treatments to improve engagement and completion rates. This trial aimed to investigate the added benefit of clinician support when paired alongside a ten-session, online cognitive behaviour therapy (CBT) self-help intervention for bulimia nervosa (BN). As part of a three-arm, phase II randomised controlled trial, 114 participants (16 years or over) with full or subthreshold BN were randomly assigned to complete the intervention in a self-help mode (with administrative researcher contact; n = 38), with adjunct clinician support (weekly 30-minute videoconferencing sessions; n = 37), or a no-treatment waitlist control (WLC; n = 39). Baseline to post-treatment (12-weeks) decreases in objective binge episode frequency were significantly greater for clinician-supported participants as compared to WLC, but not for self-help when compared to WLC. However, due to continued improvements for self-help across follow-up (24-weeks), both arms outperformed WLC when analysed as an overall rate of change across three timepoints. Clinician-supported participants outperformed self-help in regards to laxative use and dietary restraint. Our results demonstrate that good clinical outcomes can be achieved with a relatively brief online CBT-based program even in the absence of structured clinical support, indicating a possible overreliance upon clinician support as a primary adherence-facilitating mechanism.

The acceptability, feasibility, and preliminary efficacy of a supported online self-help treatment program for binge-eating disorder.

Introduction: Studies in transdiagnostic eating disorder (ED) samples suggest supported online self-help programs (eTherapies) are effective and may improve access to treatment; however, their evaluation in those with binge-eating disorder (BED) is limited. Given BED's high prevalence and low levels of treatment uptake, further eTherapy evaluation is needed to broaden access to effective, evidence-based treatment options. The aim of this study was to investigate the acceptability, feasibility, and preliminary efficacy of a supported eTherapy for those with BED or subthreshold BED, and to examine symptom change across the duration of therapy. Method: Nineteen women with BED completed a supported, 10-session Cognitive Behavioural Therapy-based eTherapy in an uncontrolled, pre-post, and 3 months follow up intervention study. Key outcomes were assessed by the Eating Disorder Examination Questionnaire (EDE-Q): objective binge episode (OBE) frequency and ED psychopathology. Feasibility was evaluated via program adherence and dropout, whilst acceptability was assessed through participant feedback post-treatment. Weekly symptom change (ED psychopathology) during treatment was assessed by the Eating Disorder Examination - Questionnaire Short (EDE-QS). Results: Generalised estimating equations showed statistically and clinically significant reductions in OBEs and ED psychopathology (large effects) post-treatment, with these decreases maintained at follow up. Across weekly assessment, a marked slowing in the rate of change in ED psychopathology was observed after four sessions of the program. Program feasibility was high (i.e., 84% of content completed), as was program acceptability (i.e., 93% of participants expressed high levels of satisfaction). Discussion: These results support the acceptability, feasibility, and preliminary efficacy of a supported eTherapy program for those with BED and suggest the variability of symptom change across the duration of therapy. Future research should further investigate findings in an adequately powered randomised controlled trial.

Using health administrative data to model associations and predict hospital admissions and length of stay for people with eating disorders.

BACKGROUND: Eating disorders are serious mental illnesses requiring a whole of health approach. Routinely collected health administrative data has clinical utility in describing associations and predicting health outcome measures. This study aims to develop models to assess the clinical utility of health administrative data in adult eating disorder emergency presentations and length of stay. METHODS: Retrospective cohort study on health administrative data in adults with eating disorders from 2014 to 2020 in Sydney Local Health District. Emergency and admitted patient data were collected with all clinically important variables available. Multivariable regression models were analysed to explore associations and to predict admissions and length of stay. RESULTS: Emergency department modelling describes some clinically important associations such as decreased odds of admission for patients with Bulimia Nervosa compared to Anorexia Nervosa (Odds Ratio [OR] 0.31, 95% Confidence Interval [95%CI] 0.10 to 0.95; p = 0.04). Admitted data included more predictors and therefore further significant associations including an average of 0.96 days increase in length of stay for each additional count of diagnosis/comorbidities (95% Confidence Interval [95% CI] 0.37 to 1.55; p = 0.001) with a valid prediction model (R2 = 0.56). CONCLUSIONS: Health administrative data has clinical utility in adult eating disorders with valid exploratory and predictive models describing associations and predicting admissions and length of stay. Utilising health administrative data this way is an efficient process for assessing impacts of multiple factors on patient care and predicting health care outcomes.

The impact of the COVID-19 pandemic and associated public health response on people with eating disorder symptomatology: an Australian study.

OBJECTIVE: People with lived experience of eating disorders (ED) may be particularly vulnerable to the COVID-19 pandemic and associated public health response due to exasperating situations such as social isolation, presence of other mental and physical health conditions, disruptions to treatment, etc. This study investigates the association of the pandemic with ED symptomatology to consider impact and identify risk factors for clinical consideration. METHODS: Participants with self-reported ED diagnosis and/or symptomatology over 16 years were invited to complete an online survey during the first months of the pandemic in Australia. Questions included history of ED, occurrence of co-occurring mental health conditions, change in ED symptoms since the start of the pandemic, and validated measures of ED illness, state mental health and loneliness. RESULTS: Of 1723 participants (mode age 24.9 years, 91.6% identifying as female, EDE-Q Global Score x = 4.08, SD = 1.18, 79.0% reporting co-occurring mental health condition, predominantly obsessive-compulsive disorder and/or anxiety), 88.0% reported an increase in body image concerns, 74.1% in food restriction, 66.2% binge eating and 46.8% driven exercise during the pandemic. Increased ED symptomatology was associated with poorer state mental health (i.e., depression, anxiety, and stress) and loneliness across the ED symptom profile. Most participants were negatively impacted by various aspects of the public health response, more so for those with more acute ED illness as measured by the Eating Disorder Examination Questionnaire (EDE-Q). CONCLUSIONS: Associated with the COVID-19 pandemic is a mental health crisis, particularly for those with a lived experience of an eating disorder. With 40.5% of participants not having sought formal diagnostic assessment and less than half in treatment, this study provides evidence for the detrimental impact of the pandemic on people with a lived experience of an eating disorder, especially for those not yet supported by the health care system.

This study investigates the impact of the COVID-19 pandemic and associated public health response on people with a self-reported lived experience of eating disorders across Australia. A nation-wide online survey of 1723 participants aged 16­80 years indicated eating disorders symptoms increased globally including body image concern (for 88% of participants), food restriction (74%) and binge eating (66%), especially for those reporting more acute eating disorder illness, poorer mental health (including depression, anxiety, and stress) and experience of loneliness. Albeit necessary, several pandemic experiences were identified as being particularly associated with more acute eating disorder illness such as changes in daily routine, social media reactions, restricted access to support people, and changes to treatment. As less than half of the participants were in treatment at assessment and over 40% had never sought formal diagnosis or treatment, this study highlights the prevalence of unidentified and unsupported people in the community experiencing increase eating disorder symptoms during this pandemic and the need for clinical awareness in general medical and mental health practice.

Supported online cognitive behavioural therapy for bulimia nervosa: a study protocol of a randomised controlled trial.

BACKGROUND: Despite the availability of effective treatments for bulimia nervosa (BN), a number of barriers to accessibility exist. Examples include access to trained clinicians, the expense of treatment, geographical limitations, and personal limitations such as stigma regarding help seeking. Self-help interventions, delivered via a digital platform, have the potential to overcome treatment gaps by providing patients with standardised, evidence-based treatments that are easily accessible, cost-effective, and require minimal clinician support. Equally, it is important to examine the shortcomings of digital interventions when compared to traditional to face-to-face delivery (e.g., high dropout rates) in order to maximise the therapeutic effectiveness of online, self-help interventions. METHODS: A three-arm, multisite randomised controlled trial will be conducted in Australia examining the effectiveness and cost-effectiveness of a newly developed online self-help intervention, Binge Eating eTherapy (BEeT), in a sample of patients with full or sub-threshold BN. The BEeT program consists of 10, multimedia sessions delivering the core components of cognitive behaviour therapy. Eligible participants will be randomised to one of three groups: independent completion of BEeT as a purely self-help program, completion of BEeT alongside clinician support (in the form of weekly telemedicine sessions), or waitlist control. Assessments will take place at baseline, weekly, post-intervention, and three-month follow up. The primary outcome is frequency of objective binge episodes. Secondary outcomes include frequency of other core eating disorder behavioural symptoms and beliefs, psychological distress, and quality of life. Statistical analyses will examine treatment effectiveness, feasibility, acceptability and cost effectiveness. DISCUSSION: There is limited capacity within the mental health workforce in Australia to meet the demand of people seeking treatment for eating disorders. This imbalance has only worsened following outbreak of the COVID-19 pandemic. Further research is required into innovative digital modes of treatment delivery with the capacity to service mental health needs in an accessible and affordable manner. Self-help programs may also appeal to individuals who are more reluctant to engage in traditional face-to-face treatment formats. This study will provide rigorous evidence on how to diversify treatment options for individuals with BN, ensuring more people with the illness can access evidence-based treatment. The study has been registered with the Australia New Zealand Clinical Trials Registry (ANZCTR Registration Number: ACTRN12619000123145p). Registered 22 January 2019, https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12619000123145 .

Assessing nutritional status in a cohort of liver cirrhosis outpatients: A prospective cross-sectional study.

BACKGROUND: Malnutrition impairs prognosis in patients with liver cirrhosis (LC). There is limited research exploring the prevalence of malnutrition in patients with LC in an Australian population and in outpatient settings. AIMS: One aim of this study was to investigate the prevalence of malnutrition in patients with LC in an outpatient liver clinic at a tertiary metropolitan hospital in Sydney, Australia, and explore other factors that may be associated with malnutrition. The second aim was to compare different versions of Subjective Global Assessment (SGA). METHODS: This cross-sectional study evaluated the nutritional status of 42 prospectively recruited participants by SGA, SGA modified for liver disease (SGA-LD) and patient-generated SGA (PG-SGA). Anthropometric measures and handgrip strength (HGS) were also measured for comparison. Clinical and demographic data were compared with nutritional status. RESULTS: SGA, SGA-LD and PG-SGA yielded the same prevalence of malnutrition of 40% with very good agreement (kappa value = 1.00). Malnourished patients had a lower median HGS% of normal than those who were well-nourished. Malnourished patients also had anthropometric measurements trending towards the lower percentiles of a healthy population. Nutritional status was significantly associated with ethnicity (p = 0.02) and PG-SGA score (p < 0.0001). CONCLUSION: The present study showed that nearly half of our study population were malnourished (40%). Thus, nutrition intervention in terms of nutrition support could improve patient outcomes. It appears that the standard SGA is suitable to assess nutritional status in patients in the early stages of LC compared to more time-consuming SGA versions.