Serum Concentration-Dose Relationship and Modulation Factors in Children and Adolescents Treated with Fluvoxamine.

INTRODUCTION: Fluvoxamine is used in children and adolescents ('youths') for treating obsessive compulsive disorder (OCD) but also off-label for depressive and anxiety disorders. This study aimed to investigate the relationship between fluvoxamine dose and serum concentrations, independent correlates of fluvoxamine concentrations, and a preliminary therapeutic reference range (TRR) for youths with OCD and treatment response. METHODS: Multicenter naturalistic data of a therapeutic drug monitoring service, as well as prospective data of the 'TDM Vigil study' (EudraCT 2013-004881-33), were analyzed. Patient and treatment characteristics were assessed by standardized measures, including Clinical Global Impressions-Severity (CGI-S) and -Change (CGI-I), with CGI-I of much or very much improved defining treatment response and adverse drug reactions using the Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale. Multivariable regression analysis was used to evaluate the influence of sex, age, body weight, body mass index (BMI), and fluvoxamine dose on fluvoxamine serum concentrations. RESULTS: The study included 70 youths (age = 6.7-19.6 years, OCD = 78%, mean fluvoxamine dose = 140.4 (range = 25-300) mg/d). A weak positive correlation between daily dose and steady-state trough serum concentrations was found (rs = 0.34, p = 0.004), with dose variation explaining 16.2% of serum concentration variability. Multivariable correlates explaining 25.3% of the variance of fluvoxamine concentrations included higher fluvoxamine dose and lower BMI. Considering responders with OCD, the estimated TRR for youths was 55-371 ng/mL, exceeding the TRR for adults with depression of 60-230 ng/mL. DISCUSSION: These preliminary data contribute to the definition of a TRR in youth with OCD treated with fluvoxamine and identify higher BMI as a moderator of lower fluvoxamine concentrations.

Therapeutic Drug Monitoring in Children and Adolescents: Findings on Fluoxetine from the TDM-VIGIL Trial.

Fluoxetine is the recommended first-line antidepressant in many therapeutic guidelines for children and adolescents. However, little is known about the relationships between drug dose and serum level as well as the therapeutic serum reference range in this age group. Within a large naturalistic observational prospective multicenter clinical trial ("TDM-VIGIL"), a transdiagnostic sample of children and adolescents (n = 138; mean age, 15; range, 7-18 years; 24.6% males) was treated with fluoxetine (10-40 mg/day). Analyses of both the last timepoint and all timepoints (n = 292 observations), utilizing (multiple) linear regressions, linear mixed-effect models, and cumulative link (mixed) models, were used to test the associations between dose, serum concentration, outcome, and potential predictors. The receiver operating curve and first to third interquartile methods, respectively, were used to examine concentration cutoff and reference values for responders. A strong positive relationship was found between dose and serum concentration of fluoxetine and its metabolite. Higher body weight was associated with lower serum concentrations, and female sex was associated with lower therapeutic response. The preliminary reference ranges for the active moiety (fluoxetine+norfluoxetine) were 208-328 ng/mL (transdiagnostically) and 201.5-306 ng/mL (depression). Most patients showed marked (45.6%) or minimal (43.5%) improvements and reported no adverse effects (64.9%). This study demonstrated a clear linear dose-serum level relationship for fluoxetine in youth, with the identified reference range being within that established for adults.

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.

Auditing Practices of the Medical Service Regarding Hospitalizations of Patients With a Secondary Diagnosis of Obesity.

BACKGROUND: It has been observed that the Medical Service (Medizinischer Dienst, an auditing body of the German statutory health insurance system) is more likely to audit the bill for a hospitalization in a psychosomatic clinic if the patient carries a secondary diagnosis of obesity. METHODS: In an exploratory study, we retrospectively analyzed 771 datasets collected in 2019 as part of the standard documentation of acute psychosomatic hospitalizations. RESULTS: In 2019, the Medical Service audited bills for psychosomatic hospital - izations much more often in obese than in non-obese patients (odds ratio [OR] 2.499; 95% confidence interval [1.69; 3.69]). This was accounted for by a very high audit rate for patients with a secondary diagnosis of grade 3 obesity (OR = 3.972 [2.30; 6.86]). The audit categories "quality of coding" and "possible incorrect admission" were examined. CONCLUSION: Treatments of markedly obese inpatients that incurred greater expenses presumably led to a higher hospitalization audit rate as an automatic consequence of the auditing algorithms used. An unintentional statistical discrimination arose from the unjustified linkage of the audit category "quality of coding" of the secondary diagnosis (obesity) with the audit category "possible incorrect admission" with regard to the main diagnosis. Similar effects may be occurring with economically relevant secondary diagnoses in other areas of medicine as well.

Infra-Low Frequency Neurofeedback in the Treatment of Patients With Chronic Eating Disorder and Comorbid Post-Traumatic Stress Disorder.

The treatment of patients suffering from an eating disorder and a comorbid post-traumatic stress disorder is challenging and often leads to poor outcomes. In a randomized control trial, we evaluated to what extent adding Infra-Low Frequency (ILF) neurofeedback could improve symptom reduction within an established inpatient treatment program. In a randomized two-group design, patients suffering from an eating disorder (anorexia nervosa, bulimia nervosa, or binge eating disorder) and comorbid post-traumatic stress disorder (N = 36) were examined while attending an inpatient treatment program in a clinic for psychosomatic disorders. The intervention group received ILF neurofeedback in addition to regular therapy, while the control group received "media-supported relaxation" as a placebo intervention. At the beginning and at the end of their treatment, all participants completed the Eating Disorder Examination-Questionnaire (EDE-Q) as a measure of eating disorder psychopathology and the Impact of Event Scale-Revised (IES-R) in order to assess symptoms of post-traumatic stress. Changes in EDE-Q and IES-R scores over time served as primary outcomes as well as an increase in body mass index in underweight patients. Secondary outcomes were the perceived benefit of the received intervention, global assessment of psychological treatment success, and complications in the course of treatment. Statistical evaluation was carried out with repeated measurement analysis of variance for the primary outcomes and with t-tests and Fisher's exact test for the secondary outcomes. Our results indicate better treatment outcomes in the ILF neurofeedback group with regard to trauma-associated avoidance as well as with regard to restraint eating and increase in body weight. Furthermore, patients who had received ILF neurofeedback rated the intervention they received and, in tendency, their overall treatment more positively and they experienced fewer complications in the course of treatment. ILF neurofeedback is very well accepted by patients and seems to provide a relevant additional benefit in some aspects of symptom reduction. Findings confirm the feasibility of embedding this treatment approach in an inpatient setting and support the case for a larger study for greater statistical power. Clinical Trial Registration: "Infra-Low Frequency Neurofeedback training in the treatment of patients with eating disorder and comorbid post-traumatic stress disorder"; German Clinical Trials Registry (https://www.drks.de; Identifier: DRKS00027826).

Therapeutic drug monitoring of sertraline in children and adolescents: A naturalistic study with insights into the clinical response and treatment of obsessive-compulsive disorder.

BACKGROUND: Sertraline is a selective serotonin reuptake inhibitor with specific indications in child and adolescent psychiatry. Notwithstanding its frequent use and clinical benefits, the relationship between pharmacokinetics, pharmacodynamics, efficacy, and tolerability of sertraline across indications, particularly in non-adult patients, is not fully understood. METHOD: This naturalistic therapeutic drug monitoring (TDM) study was conducted in a transdiagnostic sample of children and adolescents treated with sertraline (n = 78; mean age, 14.22 ± 2.39; range, 7-18 years) within the prospective multicenter "TDM-VIGIL" project. Associations between dose, serum concentration, and medication-specific therapeutic and side effects based on the Clinical Global Impression scale were examined. Tolerability was measured qualitatively with the 56-item Pediatric Adverse Event Rating Scale. RESULTS: A strong linear positive dose-serum concentration relationship (with dose explaining 45% of the variance in concentration) and significant effects of weight and co-medication were found. Neither dose nor serum concentration were associated with side effects. An overall mild-to-moderate tolerability profile of sertraline was observed. In contrast with the transdiagnostic analysis that did not indicate an effect of concentration, when split into depression (MDD) and obsessive-compulsive disorder (OCD) diagnoses, the probability of clinical improvement significantly increased as both dose and concentration increased for OCD, but not for MDD. CONCLUSIONS: This TDM-flexible-dose study revealed a significant diagnosis-specific effect between sertraline serum concentration and clinical efficacy for pediatric OCD. While TDM already guides clinical decision-making regarding compliance, dose calibration, and drug-drug interactions, combining TDM with other methods, such as pharmacogenetics, may facilitate a personalized medicine approach in psychiatry.

Ascertaining minimal clinically meaningful changes in symptoms of depression rated by the 15-item Centre for Epidemiologic Studies Depression Scale.

RATIONALE, AIMS AND OBJECTIVES: In clinical practise and in clinical studies on depression it is important to estimate whether changes in symptomatology measured by self-rating instruments are, in fact, clinically relevant. Therefore, the aim of the study was to estimate the clinical relevance of changes on the 15-item version of the Centre for Epidemiologic Studies Depression Scale (CES-D-15) based on the concept of the minimal clinically important difference (MCID). METHODS: Data was acquired from 4781 patients with depression symptoms from a German psychosomatic hospital who have been assessed using the CES-D-15 before and after treatment. Threshold values representing the MCID were estimated on the basis of mean change scores and sensitivity/specificity analyses. Patients' global impression of change, clinical (therapists') global impression of change and change in impairment severity were used as external anchor criteria. RESULTS: On average, the MCID was represented by a reduction of approximately 11 points in the CES-D-15, irrespective of age, gender, type of treatment and first or secondary diagnosis. However, higher baseline scores in the CES-D-15 required larger changes of raw values to represent a clinically important difference. CONCLUSIONS: Anchor-based values are suggested here as an estimation of the clinical relevance of changes in the CES-D-15. Thus, instead of relying solely on effect sizes, the evaluation of treatment outcomes should be supplemented by reporting the percentage of patients who have reached the MCID. Further examinations to verify our results in other patient populations and with other types of anchor criteria will be needed.

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.

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.

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.

[Barriers and Resources in Inpatient Psychosomatic Rehabilitative Care of Migrant Patients]. / Barrieren und Ressourcen in der Behandlung von Patient/innen mit Migrationshintergrund in der psychosomatischen Rehabilitation.

Patients from migrant descent access inpatient psychosomatic rehabilitative care less and achieve less treatment success than patients from the host populations. They are confronted with different process barriers in the healthcare system which combined with individual barriers can inhibit successful treatment. Studies have shown that working with migrant patients may also be challenging for healthcare providers.This study aims to assess and compare barriers and resources faced by migrant and non-migrant patients during their treatment in inpatient psychosomatic rehabilitative care. Also, the aim is to assess and compare barriers and resources faced by healthcare providers in treating migrant and non-migrant patients in order to identify barriers and resources specific to working with migrant patients.A total of 77 semi-structured interviews were conducted (20 migrant and 19 non-migrant patients as well as 14 migrant and 24 non-migrant healthcare providers). Data were transcribed and analyzed applying the method of qualitative content analysis (Mayring) with inductive categories.Migrant and non-migrant patients stated that they profit from the treatment in inpatient psychosomatic rehabilitative care. The greatest barriers for both migrant patients and healthcare providers are language barriers, cultural differences, differences in expectations regarding the treatment and limited organizational cultural competences. As far as organizational cultural competences are implemented, they are profitable for migrant patients and non-migrant healthcare providers. However, migrant healthcare workers seem responsible for implementing culturally competent care and suffer from increased workload.

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.

[Effective factors in multifamily therapy in patients with eating disorders : Critical appraisal and implications for practice]. / Wirkfaktoren in der Multifamilientherapie bei Patienten mit Essstörungen : Kritische Würdigung und Folgerungen für die Praxis.

Multifamily therapy (MFT), the treatment of several families simultaneously, is an established method of psychotherapy used in a wide range of diagnoses. However, there is limited knowledge about the exact factors of action of this treatment method. The development of MFT as a separate form of therapy is presented, as are its previous applications in the treatment of patients with eating disorders. Known factors of change are critically evaluated, new factors of change are discussed and the practical application in MFT in the context of inpatient treatment of adolescents with eating disorders is demonstrated.Processes in the large group that have not yet been considered, such as emotional contagion, exaltation of emotion and subgroup formation and work with the meta-family, are described for the first time in the context of MFT and possibly represent mediators in the therapeutic process.The model of affect and process resonance in Plassmann's individual therapy can be applied well to the processes in the MFT and possibly represents its own effect factor through the production of episodes of secure attachment. Further research on the factors of change in the MFT is of practical relevance.

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.

[Anchor-based ascertaining of meaningful changes in depressive symptoms using the example of the German short form of the CES-D]. / Ankerbasierte Ermittlung klinisch relevanter Veränderung depressiver Symptomatik am Beispiel der Kurzform der CES-D.

BACKGROUND AND OBJECTIVES: Depression is frequently measured on the 15 item version of the Center for Epidemiological Studies Depression Scale (CES-D-15). Up to now, there are no data based estimates for minimal clinically important differences (MCID) in depression scales. METHODS: Data on 5241 subjects with depressive symptoms from a German psychosomatic hospital were used. The changes in the CES-D-15 from admission to discharge were compared to the clinically global impression of change (CGIC), i. e., the therapists' perception. Categories of "slightly improved" and "much improved" were used as indicators of a clinically important difference. The relation between these ratings and the CES-D-15 was explored using mean change scores and sensitivity/specificity analyses. RESULTS: On average, a reduction of approximately nine points or 30 percent in the CES-D-15 or an individual effect size of 0.9 represented a minimal clinically important difference. A consistent relationship between the changes in the CES-D-15 and the CGIC was demonstrated irrespective of age, gender, education level, type of treatment, or first diagnosis. However, higher baseline scores in CES-D-15 required larger changes of raw values to represent a clinically important difference. CONCLUSIONS: Our results show anchor-based values for change in CES-D-15 that best represent a minimal clinically important difference. Reporting the percentage of patients who have reached the MCID improves the evaluation of therapeutical processes. The estimated MCID could also be used as an indicator for relevant changes in clinical practice. A further examination in other patient populations will be needed.

[Quality management in weight restitution in Anorexia nervosa--pathophysiology, evidence-based practice and prevention of the refeeding syndrome]. / Zur Qualitätssicherung der Gewichtsrestitution bei Magersucht--Pathophysiologie, evidenzbasierte Praxis und Vermeidung des Refeeding-Syndroms.

During refeeding syndrome-a well-known and dreaded complication of weight-restauration in anorexia nervosa-a shift of electrolytes and fluid can occur in malnourished patients and might therefore lead to-potentially fatal-cardiovascular, respiratory and neurological symptoms. Causes of this are metabolic and hormonal changes during re-establishment of a carbohydrate-rich diet. This syndrome is most commonly associated with hypophosphatemia, which can however be accompanied by other chemical laboratory abnormalities. Standardized guidelines for the prevention and management of the refeeding syndrome have not yet been established. In case and cohort studies different low- and high-calorie diet protocols led to comparable results with similar complication rates. A focus should be placed on prevention of serious complications by careful monitoring. The pathophysiology, the main constituents in the development of the refeeding syndrome, recommendations for risk assessment and treatment, and current evidence are discussed.

Predictors for good therapeutic outcome and drop-out in technology assisted guided self-help in the treatment of bulimia nervosa and bulimia like phenotype.

OBJECTIVE: Technology assisted guided self-help has been proven to be effective in the treatment of bulimia nervosa (BN). The aim of this study was to determine predictors of good long-term outcome as well as drop-out, in order to identify patients for whom these interventions are most suitable. METHODS: One hundred and fifty six patients with BN were assigned to either 7 months internet-based guided self-help (INT-GSH) or to conventional guided bibliotherapy (BIB-GSH), both guided by e-mail support. Evaluations were taken at baseline, after 4, 7, and 18 months. As potential predictors, psychiatric comorbidity, personality features, and eating disorder psychopathology were considered. RESULTS: Higher motivation, lower frequency of binge eating, and lower body dissatisfaction at baseline predicted good outcome after the end of treatment. Lower frequency of binge eating predicted good outcome at long-term follow-up. Factors prediciting drop-out were higher depression and lower self-directedness at baseline. CONCLUSION: Technology assisted self-help can be recommended for patients with a high motivation to change, lower binge-eating frequency and lower depression scores.