[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558504":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":42,"centralContacts":50,"locations":59,"responsibleParty":76,"collaborators":78,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":29,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":29,"enrollmentInfo":91,"targetDuration":29,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":102,"overallStatus":62,"whyStopped":29,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"University of Palermo","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Guided self-help plus IPT","EXPERIMENTAL","The participants will have access to self-help materials (workbook and videoclips), forum groups (interactional materials), online interpersonal group sessions for 8 weeks. Participants will use self-help materials through a mobile app and online platform. Regarding anorexic symptoms and behaviours, the self-help material will focus on the topics of the New Maudsley model. Further modules will cover the ED overeating problems and the interpersonal difficulties related to EDs.\n\nThe weekly online forum group is focused on interactional material that will be delivered weekly through a synchronous 1-hour mobile chat with a peer mentor (a recovered influencer). Each session lasts 60 minutes and is themed following the structure of the video-clips materials.\n\nFinally, 90-minute interpersonal group sessions will be led online by clinicians with an expertise in the treatment of eating disorders.",[13],"Behavioral: Guided self-help plus IPT",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment-as-usual","ACTIVE_COMPARATOR","Treatment as usual will vary between centres and this will impact the effect size of the intervention (Ayling et al., 2015). We will therefore conduct structured interviews with clinicians at each study site to clarify the nature of treatment as usual at each centre. We will also use an adapted form of the Client Service Receipt Inventory (a well-established tool used in health economics) to track the amount of treatment received over the year (Beecham \\& Knapp, 1992). The inventory will be administered at 8-week and 3-month, to measure patients' service usage.",[19],"Behavioral: TAU",{"label":21,"type":10,"description":22,"interventionNames":23},"Guided self-help","The participants will have access to self-help materials (workbook and videoclips), and forum groups (interactional materials). Participants will use self-help materials through a mobile app and online platform. Regarding anorexic symptoms and behaviours, the self-help material will focus on the topics of the New Maudsley model. Further modules will cover the ED overeating problems and the interpersonal difficulties related to EDs.\n\nThe weekly online forum group is focused on interactional material that will be delivered weekly through a synchronous 1-hour mobile chat with a peer mentor (a recovered influencer). Each session lasts 60 minutes and is themed following the structure of the video-clips materials.",[24],"Behavioral: Guided self-help",{"label":26,"type":27,"description":28,"interventionNames":29},"No treatment","NO_INTERVENTION","The no-treatment control condition includes participants with sub-threshold eating symptoms who attend regular visits with their own primary care physician. In this context, it is important that participants, interested to take part to the study, offered number or contact of the own primary care physician in case of an illness worsening.",null,[31,35,38],{"type":32,"name":9,"description":33,"armGroupLabels":34,"otherNames":29},"BEHAVIORAL","The participants allocated in the intervention GSH arm will have access to self-help materials (workbook and videoclips), forum groups (interactional materials), online interpersonal group sessions for 8 weeks. The proposed online GSH will be adapted from two online interventions developed and tested with people with eating disorders by the Eating Disorders Research Unit team at King's College London, with a cooperation of the University of Palermo research team (Cardi et al., 2020). The GSH will include self-help materials, i.e. a written workbook and a library of 74 brief video-clips with the goal of providing psychoeducation about eating disorders and interpersonal difficulties and describing and modelling the use of helpful strategies to reverse abnormal eating behaviours. Participants will also attend a weekly online forum with interactional materials, and an online interpersonal group session.",[9],{"type":32,"name":21,"description":36,"armGroupLabels":37,"otherNames":29},"The participants allocated in the intervention GSH arm will have access to self-help materials (workbook and videoclips), forum groups (interactional materials), online interpersonal group sessions for 8 weeks. The proposed online GSH will be adapted from two online interventions developed and tested with people with eating disorders by the Eating Disorders Research Unit team at King's College London, with a cooperation of the University of Palermo research team (Cardi et al., 2020). The GSH will include self-help materials, i.e. a written workbook and a library of 74 brief video-clips with the goal of providing psychoeducation about eating disorders and interpersonal difficulties and describing and modelling the use of helpful strategies to reverse abnormal eating behaviours.",[21],{"type":32,"name":39,"description":40,"armGroupLabels":41,"otherNames":29},"TAU","The Treatment as Usual is the usual or routine care provided to participants in the outpatient setting.",[15],[43,46],{"name":44,"affiliation":5,"role":45},"Gianluca Lo Coco","PRINCIPAL_INVESTIGATOR",{"name":47,"affiliation":48,"role":49},"Cristina Segura-Garcia","University of Catanzaro","STUDY_DIRECTOR",[51,55],{"name":44,"role":52,"phone":53,"phoneExt":29,"email":54},"CONTACT","+39 09123897725","gianluca.lococo@unipa.it",{"name":56,"role":52,"phone":57,"phoneExt":29,"email":58},"Cristina Segura Garcia","+39 0961712408","segura@unicz.it",[60],{"facility":61,"status":62,"city":63,"state":29,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Outpatient Unit for Clinical research and Treatment of Eating Disorders. University Hospital Mater Domini","RECRUITING","Catanzaro","88100","Italy","IT",{"type":68,"coordinates":69},"Point",[70,71],16.60086,38.88247,{"lat":71,"lon":70},[74],{"name":75,"role":52,"phone":57,"phoneExt":29,"email":58},"Cristina Segura-Garcia, MD",{"type":45,"investigatorFullName":44,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Professor",[79,80],{"name":48,"class":6},{"name":81,"class":6},"University of Padova","100558504","interconnect-eds-a-guided-self-help-mobile-app-to-improve-outcome-in-eating-disorders-100558504",false,"NCT06551974","INTERconNEcT-Eds: a Guided Self-help Mobile App to Improve Outcome in Eating Disorders","Development of a Guided Self-help Mobile App to Improve Treatment Outcome for Individuals Suffering From Eating Disorders","Inclusion Criteria:\n\nThe inclusion criteria for study 1 are: (1) \\>18 years, (2) with a clinician-formulated diagnosis of eating disorder (i.e., anorexia nervosa, bulimia nervosa, binge eating disorder) or Other Specified Feeding or Eating Disorder based on the criteria of the DSM-5-TR, (3) having started TAU within 12 months; (4) with access to Internet connection through a mobile device, (5) Italian speaking.\n\nThe inclusion criteria for study 2 are: (1) \\>18 years, (2) a score \\> 2.77 on the Eating Disorders Examination Questionnaire, (3) attending no treatment for eating disorder symptoms but reporting a regular monitoring by their own primary care physician (GP), 4) with access to Internet connection through a mobile device, (4) Italian speaking.\n\nExclusion Criteria:\n\nFor both study 1and 2: acute psychosis, clinical depression or suicidal ideation, pregnancy, use of medication that might influence eating behavior, neurological and visual impairment and Intellectual disability.","ALL","18 Years",{"count":92,"type":93},242,"ESTIMATED","INTERVENTIONAL",[96],"NA","Eating disorders (EDs) are psychiatric illnesses characterised by pathological eating behaviours, ranging from protracted undereating to recurrent loss of control over eating. Based on the transdiagnostic approach, EDs are triggered and maintained by interpersonal distress and difficulties to manage negative emotions. Thus, interpersonal skills have been implicated as important targets for change in the treatment. In this project, we will adopt digital technologies to improve treatment adherence and outcome of individuals with EDs, by testing the effectiveness of an online self-help program delivered through a mobile app. Specifically, this project aims to establish if an online personalized self-help approach is feasible and effective in ameliorating eating disorder symptoms and distress. We planned to conduct two randomised controlled trials to test the effectiveness of online guided self-help (GSH) in two different settings: (1) the community, and (2) the outpatient setting. This is to establish at which stage of treatment this approach is most helpful. Across studies, we will recruit 242 individuals aged ≥18 years with ED symptoms and\u002For a proper diagnosis of EDs (DSM-5). During eight weeks period, GSH will be available to participants both on a website and a new-developed smartphone app and consists of written materials and brief video-clips, a weekly chat based forum group and an online interpersonal group session. Guidance in forum groups will be facilitated by non-specialist help-care providers (i.e., peer mentors); whereas experienced mental health providers will lead the online group sessions. Participant's interpersonal distress will be assessed at intake to personalize guidance in the group, by addressing dysfunctional interpersonal characteristics which can be associated with ED symptoms. Participants will also complete a weekly working alliance measure to examine whether the quality of relationship with mentor predicts clients' level of clinical change.\n\nRegarding the outpatient setting, the first aim is to assess if GSH intervention is effective to improve the following primary outcome for patients with ED diagnosis: 1) overall psychological distress. In the community setting, the study aims to examine if GSH is effective to improve the following primary outcomes for individuals with self-reported ED symptoms: 1) overall psychological distress; 2) first contact with clinical services to manage their dysfunctional eating behaviors.",[99,100,101],"Eating Disorder Symptom","Eating Disorders","Eating Behavior",[103,104,105,106,107,108,109],"eating disorders","guided self-help","online intervention","peer mentoring","tailored interventions","interpersonal group","therapeutic alliance","2024-12-09",{"date":112,"type":113},"2024-12-13","ACTUAL",{"date":115,"type":113},"2024-11-15",{"date":117,"type":93},"2025-10-31",{"name":5,"class":6},1]