Therapeutic drug monitoring in adolescents with anorexia nervosa for safe treatment with adjunct olanzapine.

OBJECTIVE: Medication is commonly used in anorexia nervosa (AN) despite largely missing high grade evidence. Olanzapine (OLZ) is the best-evidenced substance used off-label in this group, with conflicting outcome regarding BMI, clinical and safety parameters. Therefore, it is important to strictly assure quality of treatment with OLZ in AN by using 'Therapeutic Drug Monitoring' according to AGNP-guidelines, including serum levels and adverse drug reactions (ADRs) to support safety for adolescents with AN and attempt to generate an initial age- and disorder-specific therapeutic reference range. METHOD: Sixty-five adolescents with AN (aged 10-18) treated with OLZ (98% female; 97.5% AN-restricting-type) were prospectively observed, ADRs reported, and correlations between dosage and serum levels measured at trough level were calculated, a preliminary therapeutic range defined. RESULTS: Mean dosage of OLZ was 8.15 (SD: 2.91) mg and 0.19 (SD: 0.07) mg/kg respectively, average concentration was 26.57 (SD: 13.46) ng/mL. Correlation between daily dosage/dosage per kg and serum level was 0.72 (**p < 0.001)/0.65 (**p < 0.001), respectively. ADRs with impairment were rare (6.3%). 75% improved clinically (CGI). BMI increased significantly by 1.5 kg/m2 (t = 10.6, p < 0.001). A preliminary therapeutic reference range is 11.9 and 39.9 ng/mL. CONCLUSIONS: OLZ in the hands of specialists is a well-tolerated and safe treatment adjunct for adolescents with AN.

An investigation of the factor structure of a German version of the Eating Disorder Symptom Impact Scale (EDSIS) among parents of adolescents and young adults with anorexia nervosa.

The aim of this study was to explore the factor structure, scale characteristics and convergent validity of a German version of the Eating Disorder Symptom Impact Scale (EDSIS). A total of 335 parents of adolescents and young adults with anorexia nervosa in inpatient or outpatient treatment completed the 24-item German translation of the EDSIS and other measures of caregiving burden and psychological distress. We tested a 4 vs. 6-factor model of the EDSIS using confirmatory factor analyses. The 6-factor model treating items as ordinal variables showed the best fit to the data (CFI = 0.949, RMSEA = 0.064). Strong invariance of this model was shown between the sample of mothers and fathers. Internal consistencies of the EDSIS scales were in the acceptable-to-good range. Bottom effects were observed for the 'Binge-Purge-Impacts' subscale only. Mothers had significantly higher EDSIS scores compared to fathers. The EDSIS total score and most of the subscores showed substantial positive correlations with caregivers' psychological distress, level of depression, anxiety and expressed emotion as well as negative associations with the level of perceived caregiving skills. The German version of the EDSIS is a useful tool to assess caregiving burden in mothers and fathers of patients with anorexia nervosa.

Exploring the link between eating disorders and persistent genital arousal disorder/genito-pelvic dysesthesia: first description and a systematic review of the literature.

BACKGROUND: Persistent Genital Arousal Disorder/Genito-Pelvic Dysesthesia (PGAD/GPD) characterized by recurrent physiological genital without corresponding psychological arousal is a poorly understood and researched condition. Based on the first two case descriptions of eating disorders directly linked to PGAD/GPD the aim of this paper was to systematically review the literature on possible associations between eating disorders and PGAD/GPD. METHOD: A systematic literature search on eating disorders and PGAD/GPD was conducted in PubMed, PsycINFO, and Scopus, complemented by Google Scholar. We included case reports, case series, cross-sectional studies and review articles published in peer-reviewed journals written in English or German-language. RESULTS: The included original papers described a total of 2078 cases with PGAD/GPD symptomatology. Of these, 892 participants fulfilled all five PGAD/GPD core criteria. The aetiology of PGAD/GPD is unknown. Multifactorial genesis of PGAD/GPD is presumed including neurological, pharmacological, hormonal, vascular and psychological causes. A high degree of psychological comorbidity is reported. No study was found that drew a direct link between eating disorders and PGAD/GPD. Although PGAD/GPD symptoms also occur in adolescents, there are no findings in this regard. However, we found a gap in data collection: eating disorders as potential psychiatric comorbidities were systematically recorded in only a few studies. CONCLUSION: The existing literature have not yet considered a possible link between eating disorders and PGAD/GPD so far. According to the authors' knowledge, this work is the first review to systematically explore the associations. We suspect underreporting of PGAD/GPD cases in eating disorders and particularly during adolescence. We argue that there are several common factors that appear to be important in the etiology, course, and treatment of both disorders (e.g. hormonal dysregulation or sensory sensitivity and avoidance), warranting future research on the possible comorbidity of these disorders.

Persistent genital arousal disorder/genito-pelvic dysesthesia (PGAD/GPD) is characterized by recurrent physiological genital arousal without corresponding psychological arousal. PGAD/GPD is a poorly understood and researched disorder. It is often associated with significant psychological impairment and distress.Eating disorders are severe psychological illnesses that predominantly affect the female sex. They have a high psychological comorbidity and are often associated with severe physical consequences.We treated two female patients in whom there was a direct association between PGAD/GPD and eating disorder. In our systematic review of the literature, we found no study that further investigated the co-occurrence between PGADPGAD/GPD and eating disorders. This paper is the first to describe and investigate a relationship between PGAD/GPD and eating disorders.In previous literature, several factors have been hypothesized for the development of PGAD/GPD but also eating disorders. We argue that there are several common factors that appear to be important in the etiology, course, and treatment of both disorders (e.g. hormonal dysregulation or sensory sensitivity and avoidance), warranting future research on the possible comorbidity of these disorders.

Does a Skills Intervention for Parents Have a Positive Impact on Adolescents' Anorexia Nervosa Outcome? Answers from a Quasi-Randomised Feasibility Trial of SUCCEAT.

Skills trainings for caregivers of patients with anorexia nervosa (AN) have been proven to be effective in improving caregiver skills and reducing caregivers' psychopathology. The effects on patients, especially adolescents, are largely unknown. The aim of this study was to evaluate the effectiveness of a caregivers' skills training program (Supporting Carers of Children and Adolescents with Eating Disorders in Austria, SUCCEAT, workshop or online version) on adolescents with AN delivered as workshops (WS) or online (ONL). Outcomes are Body-Mass-Index (BMI) percentile, eating psychopathology (Eating Disorder Examination, EDE), attitudinal and behavioural dimensions of eating disorders (Eating Disorder Inventory-2), motivation to change (AN Stages of Change Questionnaire), emotional and behavioural problems (Youth Self-Report) and quality of life (KINDL). All outcome variables significantly improved across both SUCCEAT groups (WS and ONL) and were sustained at 12-month follow-up. The online and workshop delivery of SUCCEAT were equally effective. Most effect sizes were in the medium-to-high range. Full or partial remission was observed in 72% (WS) and 87% (ONL) of patients. Caregiver skills trainings, either delivered as workshops or online modules, are highly recommended to complement treatment as usual.

Impact of COVID-19 Lockdown in Eating Disorders: A Multicentre Collaborative International Study.

BACKGROUND: The COVID-19 lockdown has had a significant impact on mental health. Patients with eating disorders (ED) have been particularly vulnerable. AIMS: (1) To explore changes in eating-related symptoms and general psychopathology during lockdown in patients with an ED from various European and Asian countries; and (2) to assess differences related to diagnostic ED subtypes, age, and geography. METHODS: The sample comprised 829 participants, diagnosed with an ED according to DSM-5 criteria from specialized ED units in Europe and Asia. Participants were assessed using the COVID-19 Isolation Scale (CIES). RESULTS: Patients with binge eating disorder (BED) experienced the highest impact on weight and ED symptoms in comparison with other ED subtypes during lockdown, whereas individuals with other specified feeding and eating disorders (OFSED) had greater deterioration in general psychological functioning than subjects with other ED subtypes. Finally, Asian and younger individuals appeared to be more resilient. CONCLUSIONS: The psychopathological changes in ED patients during the COVID-19 lockdown varied by cultural context and individual variation in age and ED diagnosis. Clinical services may need to target preventive measures and adapt therapeutic approaches for the most vulnerable patients.

A German version of the Caregiver Skills scale for caregivers of patients with anorexia nervosa.

OBJECTIVE: To investigate acceptance, reliability, convergent validity, factor structure and sensitivity to change of a German translation of the Caregiver Skills (CASK) scale measuring skills related to caring for patients with eating disorders. METHODS: Two hundred and thirty-three parents (76% female) of adolescent patients (mean age 15.1) with anorexia nervosa (AN) completed the 27 items of the CASK. We calculated item/scale characteristics, internal consistencies and bivariate correlations with other measures of caregiving burden. We evaluated goodness-of-fit of the 6-factor model using confirmatory factors analysis and explored the sensitivity to change following two skills-based trainings. RESULTS: The fit of the 6-factor model was acceptable (Root Mean Square Error of Approximation: 0.077, Standard Root Mean Square Residual: 0.080). Cronbach's alpha was excellent for the total (.94) and acceptable for all subscales (0.73-0.85). The total CASK score was 68.04 (max. 100) showing relatively high self-rated caregiver skills. Non-completion rates of most items were low (<3%) indicating high acceptance. Convergent validity was found with measures of psychological distress, depression, anxiety and expressed emotion. The total score significantly increased following an 8-week workshop/online skills training (d = 0.70) and a 2-day multi-family intervention (d = 0.47). DISCUSSION: The German CASK version is a useful instrument to assess caregiver skills in parents of patients with AN and to evaluate outcomes of skills-based trainings.

Reduction of High Expressed Emotion and Treatment Outcomes in Anorexia Nervosa-Caregivers' and Adolescents' Perspective.

High expressed emotion (EE) is common in caregivers of patients with anorexia nervosa (AN) and associated with poorer outcome for patients. In this study, we examined the prevalence of high EE in caregivers of adolescents with AN and analyzed predictors for EE using multivariate linear regression models. We further analyzed whether EE is reduced by the "Supporting Carers of Children and Adolescents with Eating Disorders in Austria" (SUCCEAT) intervention using general linear mixed models and whether a reduction of EE predicts patients' outcomes. Caregivers were randomly allocated to the SUCCEAT workshop (N = 50) or online intervention (N = 50) and compared to a comparison group (N = 49). EE and patients' outcomes were assessed at the baseline, post-intervention, and at the 12-month follow-up. Up to 47% of caregivers showed high EE. Lower caregiver skills, higher AN symptom impact, higher levels of depression and motivation to change in caregivers were significant predictors for high EE. EE significantly decreased in the SUCCEAT groups and the comparison group according to the caregivers', but not the patients' perspective. The level of reduction could partially predict subjective improvement and improvement in clinically assessed AN symptoms and body mass index of patients. Implementing interventions for caregivers addressing EE in the treatment of adolescents with AN is strongly recommended.

Long-Term Efficacy of the Workshop Vs. Online SUCCEAT (Supporting Carers of Children and Adolescents with Eating Disorders) Intervention for Parents: A Quasi-Randomised Feasibility Trial.

Interventions for main carers of adult patients with anorexia nervosa (AN) can reduce the caregiving burden and increase caregiver skills. However, the effectiveness and feasibility for carers of adolescent patients, the optimal form of the intervention and long-term outcomes are largely unknown. We evaluated the efficacy and feasibility of the "Supporting Carers of Children and Adolescents with Eating Disorders in Austria" (SUCCEAT) workshop vs. online intervention. Main caregivers (parents) of adolescent patients with AN were randomly allocated to a workshop (n = 50) or online version (n = 50). Participants were compared to a non-randomised comparison group (n = 49) receiving multi-family or systemic family therapy. Primary (General Health Questionnaire) and secondary outcomes were obtained at baseline, three-month and 12-month follow-up. Adherence was high for workshop and online participants (6.2 and 6.7 sessions completed out of 8). Intention-to-treat analyses revealed significant pre-post reductions in the primary outcome for the workshop (d = 0.87 (95%conficence interval (CI): 0.48; 1.26)) and online (d = 0.65 (95%CI: 0.31; 0.98)) intervention that were sustained at the 12-month follow-up. There was no significant group difference (p = 0.473). Parental psychopathology and burden decreased and caregiver skills increased in all groups; the improvement of caregiver skills was significantly higher in SUCCEAT participants than in the comparison group. Online interventions for parents of adolescents with AN were equally effective as workshops. The improvements remained stable over time.

Supporting Carers of Children and Adolescents with Eating Disorders in Austria (SUCCEAT): Study protocol for a randomised controlled trial.

Supporting Carers of Children and Adolescents with Eating Disorders in Austria (SUCCEAT) is an intervention for carers of children and adolescents with anorexia nervosa and atypical anorexia nervosa. This paper describes the study protocol for a randomised controlled trial including the process and economic evaluation. Carers are randomly allocated to one of the 2 SUCCEAT intervention formats, either 8 weekly 2-hr workshop sessions (n = 48) or web-based modules (n = 48), and compared with a nonrandomised control group (n = 48). SUCCEAT includes the cognitive-interpersonal model, cognitive behavioural elements, and motivational interviewing. The goal is to provide support for carers to improve their own well-being and to support their children. Outcome measures include carers' distress, anxiety, depression, expressed emotions, needs, motivation to change, experiences of caregiving, and skills. Further outcome measures are the patients' eating disorder symptoms, emotional problems, behavioural problems, quality of life, motivation to change, and perceived expressed emotions. These are measured before and after the intervention, and 1-year follow-up.