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      Using internet-based self-help to bridge waiting time for face-to-face outpatient treatment for Bulimia Nervosa, Binge Eating Disorder and related disorders: Study protocol of a randomized controlled trial

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          Abstract

          Background

          Eating disorders are serious conditions associated with an impaired health-related quality of life and increased healthcare utilization and costs. Despite the existence of evidence-based treatments, access to treatment is often delayed due to insufficient health care resources. Internet-based self-help interventions may have the potential to successfully bridge waiting time for face-to-face outpatient treatment and, thus, contribute to overcoming treatment gaps. However, little is known about the feasibility of implementing such interventions into routine healthcare. The aim of this study is to analyze the effects and feasibility of an Internet-based self-help intervention (everyBody Plus) specifically designed for patients with Bulimia Nervosa, Binge Eating Disorder and other specified feeding and eating disorders (OSFED) on a waiting list for outpatient face-to-face treatment. The aim of this paper is to describe the study protocol.

          Methods

          A multi-country randomized controlled trial will be conducted in Germany and the UK. N = 275 female patients awaiting outpatient treatment will be randomly allocated either to the guided online self-help intervention “everyBody Plus” or a waitlist control group condition without access to the intervention. everyBody Plus comprises eight weekly sessions that cover topics related to eating and exercise patterns, coping with negative emotions and stress as well as improving body image. Participants will receive weekly individualized feedback based on their self-monitoring and journal entries. Assessments will take place at baseline, post-intervention as well as at 6- and 12-months follow up. In addition, all participants will be asked to monitor core eating disorder symptoms weekly to provide data on the primary outcome. The primary outcome will be number of weeks after randomization until a patient achieves a clinically relevant improvement in core symptoms (BMI, binge eating, compensatory behaviors) for the first time. Secondary outcomes include frequency of core symptoms and eating disorder related attitudes and behaviors, as well as associated psychopathology. Additional secondary outcomes will be the participating therapists' confidence in treating eating disorders as well as perceived benefits of everyBody Plus for patients.

          Discussion

          To the best of our knowledge, this is the first randomized controlled trial examining the effects of Internet-based self-help for outpatients with eating disorders awaiting face-to-face outpatient treatment. If proven to be effective and successfully implemented, Internet-based self-help programs might be used as a first step of treatment within a stepped-care approach, thus reducing burden and cost for both patients and health care providers.

          Highlights

          • Patients with eating disorders are often confronted with long and stressful waiting times.

          • Internet-based self-help interventions used as a first step of treatment may have the potential to overcome treatment gaps.

          • We will evaluate an Internet-based self-help intervention used to bridge waiting times in a randomized controlled trial.

          • We hope to reduce the time until a patient achieves a clinically relevant improvement in core symptoms for the first time.

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          Most cited references41

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          The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials.

          To comprehend the results of a randomized, controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Con solidated S tandards o f R eporting T rials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, that are included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.
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            Twelve-month prevalence, comorbidity and correlates of mental disorders in Germany: the Mental Health Module of the German Health Interview and Examination Survey for Adults (DEGS1-MH).

            This paper provides up to date prevalence estimates of mental disorders in Germany derived from a national survey (German Health Interview and Examination Survey for Adults, Mental Health Module [DEGS1-MH]). A nationally representative sample (N = 5318) of the adult (18-79) population was examined by clinically trained interviewers with a modified version of the Composite International Diagnostic Interview (DEGS-CIDI) to assess symptoms, syndromes and diagnoses according to DSM-IV-TR (25 diagnoses covered). Of the participants 27.7% met criteria for at least one mental disorder during the past 12 months, among them 44% with more than one disorder and 22% with three or more diagnoses. Most frequent were anxiety (15.3%), mood (9.3%) and substance use disorders (5.7%). Overall rates for mental disorders were substantially higher in women (33% versus 22% in men), younger age group (18-34: 37% versus 20% in age group 65-79), when living without a partner (37% versus 26% with partnership) or with low (38%) versus high socio-economic status (22%). High degree of urbanization (> 500,000 inhabitants versus < 20,000) was associated with elevated rates of psychotic (5.2% versus 2.5%) and mood disorders (13.9% versus 7.8%). The findings confirm that almost one third of the general population is affected by mental disorders and inform about subsets in the population who are particularly affected.
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              • Article: not found

              Weight concerns influence the development of eating disorders: a 4-year prospective study.

              The authors examined factors prospectively associated with age of onset of partial syndrome eating disorders over a 4-year interval in a community sample (N = 877) of high school-age adolescent girls. Four percent developed a partial syndrome eating disorder over the interval. A measure of weight concerns was significantly associated with onset in a multivariate Cox proportional hazard analysis (p < .001). Girls scoring in the highest quartile on the measure of weight concerns had the highest incidence (10%) of partial syndrome onset, whereas none of the girls in the lowest quartile developed eating disorder symptoms. This finding is consistent with both theoretical and clinical perspectives and may represent a useful step toward the establishment of a rational basis for the choice of a prevention intervention target.
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                Author and article information

                Contributors
                Journal
                Internet Interv
                Internet Interv
                Internet Interventions
                Elsevier
                2214-7829
                26 February 2018
                April 2019
                26 February 2018
                : 16
                : 26-34
                Affiliations
                [a ]Technische Universität Dresden, Institut für Klinische Psychologie und Psychotherapie, Chemnitzer Str. 46, D-01187 Dresden, Germany
                [b ]King's College London, Institute of Psychiatry, Psychology and Neuroscience, Box P059, De Crespigny Park, London SE5 8AF, UK
                [c ]Westfälische Wilhelms-Universität Münster, Institute of Biostatistics and Clinical Research, Schmeddingstraße 56, Münster, Germany
                [d ]South London and Maudsley NHS Foundation Trust, Eating Disorders Outpatient Unit, The Maudsley Hospital, Denmark Hill, London SE5 8AF, UK
                Author notes
                [* ]Corresponding author. Bianka.Vollert@ 123456tu-dresden.de
                Article
                S2214-7829(17)30123-9
                10.1016/j.invent.2018.02.010
                6364326
                30775262
                af299d03-4801-4339-ae23-17c36461658d
                © 2018 The Authors

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                : 20 December 2017
                : 19 February 2018
                Categories
                Article

                eating disorders,internet-based interventions,guided self-help,bridging waiting time,outpatients,randomized controlled trial

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