[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629586":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":34,"centralContacts":39,"locations":48,"responsibleParty":63,"collaborators":65,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":23,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":23,"enrollmentInfo":80,"targetDuration":23,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":97,"whyStopped":23,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Catholic University of the Sacred Heart","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"CBT intervention","EXPERIMENTAL","Participants allocated to the CBT experimental group will be asked to complete one module per week (6 weeks), each based on the core principles of Cognitive Behavioral Therapy (CBT). The modules are designed to address the following domains: (1) introduction to the intervention framework and definition of individualized objectives; (2) identification and restructuring of negative automatic thoughts; (3) recognition and regulation of emotions, with specific focus on emotional eating; (4) stress management and development of assertive communication skills; and (5) enhancement of motivation, problem-solving abilities, and self-efficacy. An additional synchronous video-meeting (Module 6) is conducted to consolidate acquired skills, support relapse prevention, and promote long-term maintenance of treatment gains.",[13],"Behavioral: CBT Internet-based intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"BST intervention","Participants allocated to the CBT experimental group will be asked to complete one module per week (6 weeks), each based on the core principles of Brief Strategic Therapy (BST). The modules are designed to address the following domains: (1) introduction to the intervention framework and definition of individualized objectives; (2) identification and restructuring of negative automatic thoughts; (3) recognition and regulation of emotions, with specific focus on emotional eating; (4) stress management and development of assertive communication skills; and (5) enhancement of motivation, problem-solving abilities, and self-efficacy. An additional synchronous video-meeting (Module 6) is conducted to consolidate acquired skills, support relapse prevention, and promote long-term maintenance of treatment gains.",[18],"Behavioral: BST Internet-based intervention",{"label":20,"type":21,"description":22,"interventionNames":23},"Waiting List","NO_INTERVENTION","Participants allocated to the waiting list control group will not receive the intervention during the initial six-week study period. However, they will be granted full access to the treatment program after the six weeks have elapsed.",null,[25,30],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":23},"BEHAVIORAL","BST Internet-based intervention","Participants allocated to the experimental group will be asked to complete one module per week, each based on the core principles of Brief Strategic Therapy (BST). The program comprises five structured online self-help modules, designed to address the following domains: (1) introduction to the intervention framework and definition of individualized objectives; (2) identification and restructuring of negative automatic thoughts; (3) recognition and regulation of emotions, with specific focus on emotional eating; (4) stress management and development of assertive communication skills; and (5) enhancement of motivation, problem-solving abilities, and self-efficacy. An additional synchronous video-meeting (Module 6) is conducted to consolidate acquired skills, support relapse prevention, and promote long-term maintenance of treatment gains.",[15],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":23},"CBT Internet-based intervention","Participants allocated to the experimental group will be asked to complete one module per week, each based on the core principles of Cognitive Behavioral Therapy (CBT). The program comprises five structured online self-help modules, designed to address the following domains: (1) introduction to the intervention framework and definition of individualized objectives; (2) identification and restructuring of negative automatic thoughts; (3) recognition and regulation of emotions, with specific focus on emotional eating; (4) stress management and development of assertive communication skills; and (5) enhancement of motivation, problem-solving abilities, and self-efficacy. An additional synchronous video-meeting (Module 6) is conducted to consolidate acquired skills, support relapse prevention, and promote long-term maintenance of treatment gains.",[9],[35],{"name":36,"affiliation":37,"role":38},"Gianluca Castelnuovo","Catholic University of Sacred Heart of Milan","PRINCIPAL_INVESTIGATOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":23,"email":44},"Gloria Marchesi","CONTACT","+393337319707","gloria.marchesi@unicatt.it",{"name":46,"role":42,"phone":23,"phoneExt":23,"email":47},"Giada Pietrabissa","giada.pietrabissa@unicatt.it",[49],{"facility":50,"status":23,"city":51,"state":52,"zip":23,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Catholic University of Sacred Heart","Milan","Italy","IT",{"type":55,"coordinates":56},"Point",[57,58],12.59836,42.78235,{"lat":58,"lon":57},[61],{"name":36,"role":42,"phone":23,"phoneExt":23,"email":62},"gianluca.castelnuovo@unicatt.it",{"type":38,"investigatorFullName":36,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Professor",[66,69],{"name":67,"class":68},"Linkoeping University","OTHER_GOV",{"name":70,"class":6},"Istituto Auxologico Italiano","100629586","the-ob-well-project-a-randomized-controlled-trial-of-an-internet-based-self-help-system-for-psychological-support-in-obesity-100629586",false,"NCT07476599","The OB-WELL Project, a Randomized Controlled Trial of an Internet-Based Self-Help System for Psychological Support in Obesity","The OB-WELL Project: Study Protocol for a Three-Arm Randomized Controlled Trial of an Internet-Based Self-Help System for Psychological Support in Obesity","Inclusion Criteria:\n\n* Adults aged 18 years or older;\n* Body Mass Index (BMI) ≥ 30 kg\u002Fm²; 3. Internet access;\n* Sufficient computer and internet literacy;\n* Fluent knowledge of the Italian language;\n* Provision of informed consent via the digital platform;\n* Presence of mild or subthreshold psychological or eating-related symptoms, as identified by the Web Screening Questionnaire (WSQ);\n* Presence of a score \\\u003C 27 on the Binge Eating Scale (BES).\n\nExclusion Criteria:\n\n* Visual, auditory, or cognitive impairments that could limit effective interaction with the digital interface;\n* Diagnosis of severe psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);\n* Insufficient digital literacy or lack of stable internet connectivity;\n* Concurrent psychopharmacological treatment or ongoing psychological\u002Fpsychotherapeutic intervention during the study period.","ALL","18 Years",{"count":81,"type":82},224,"ESTIMATED","INTERVENTIONAL",[85],"NA","Objective: This study aims to evaluate the feasibility and effectiveness of the OB-WELL program, an internet-based self-help intervention grounded in the principles of Cognitive Behavioral Therapy (CBT) and Brief Strategic Therapy (BST), designed to promote psychological well-being among individuals with obesity from the general Italian population. Methods: A three-arm randomized controlled trial with individual-level random allocation will be conducted to compare two active intervention formats - CBT and BST - with a waiting list (WL) control condition. The intervention will last six weeks and will consist of five online self-help modules followed by one individual synchronous session. Selected psychological outcomes will be assessed at baseline and immediately post-intervention (after 6 weeks). Participants in the experimental groups will also complete follow-up assessments at 3, 6, and 12 months after treatment termination.\n\nExpected results and conclusions: Both active interventions are expected to show greater improvements immediately post-treatment compared to the waitlist (WL) condition, and these effects are anticipated to be maintained over time. It is further hypothesized that the BST condition will demonstrate greater stability of psychological outcomes at follow-up compared to CBT.",[88],"Obesity (BMI > 35)",[90,91,92,93,94,95,96],"Internet-based interventions","Obesity","Mental health","Cognitive Behavioral Therapy","Brief Strategic Therapy","Randomized controlled trial","Clinical psychology","NOT_YET_RECRUITING","2026-03-12",{"date":100,"type":101},"2026-03-17","ACTUAL",{"date":103,"type":82},"2026-06-15",{"date":105,"type":82},"2027-06-30",{"name":5,"class":6},1]