[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640497":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":24,"responsibleParty":39,"collaborators":24,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":24,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":73,"whyStopped":24,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":24},{"fullName":5,"class":6},"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Optimized Standard Treatment (OPT)","EXPERIMENTAL","Participants receive standard medical treatment for Functional Dyspepsia, including proton pump inhibitors, antiacids, and prokinetics at standard doses, according to clinical guidelines. No additional psychological intervention is provided.",[13],"Drug: Optimized Standard Treatment (OPT)",{"label":15,"type":10,"description":16,"interventionNames":17},"Cognitive Behavioral Therapy + Optimized Standard Treatment (CBT + OPT)","Participants receive the same optimized standard medical treatment as the OPT arm, plus a manualized Cognitive Behavioral Therapy program. CBT consists of 10 individual sessions (60 minutes each) over 12 weeks, with a 6-month booster session. Sessions include psychoeducation, cognitive restructuring, stress management, coping strategies, interoceptive and behavioral exposure, relaxation, and nutritional integration. Adherence and engagement are monitored throughout the study.",[13,18],"Behavioral: Cognitive Behavioral Therapy + Optimized Standard Treatment (CBT + OPT)",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Participants receive guideline-based standard medical treatment for Functional Dyspepsia, including proton pump inhibitors, antiacids, and prokinetics at recommended doses. This intervention does not include any psychological or behavioral therapy.",[15,9],null,{"type":26,"name":15,"description":27,"armGroupLabels":28,"otherNames":24},"BEHAVIORAL","Participants receive the same optimized standard medical treatment as the OPT arm, plus a manualized Cognitive Behavioral Therapy program. CBT consists of 10 individual sessions (60 minutes each) over 12 weeks, with a 6-month booster session. Sessions cover psychoeducation, cognitive restructuring, stress management, coping strategies, interoceptive\u002Fbehavioral exposure, relaxation, and nutritional integration.",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Laura Prospero, Psychologist","CONTACT","+390804994274","laura.prospero@irccsdebellis.it",{"name":36,"role":32,"phone":37,"phoneExt":24,"email":38},"Francesco Russo, MD","+390804994129","francesco.russo@irccsdebellis.it",{"type":40,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100640497","cognitive-behavioral-therapy-for-functional-dyspepsia-epigastric-pain-syndrome-and-postprandial-distress-syndrome-subtypes-100640497",false,"NCT07577089","Cognitive Behavioral Therapy for Functional Dyspepsia (Epigastric Pain Syndrome and Postprandial Distress Syndrome Subtypes)","Multimodal Phenotyping of Functional Dyspepsia: Controlled Trial on Response to Cognitive-Behavioral Therapy in Subtypes of Epigastric Pain Syndrome and Postprandial Discomfort Syndrome","FD-CBT","Inclusion Criteria:\n\n* Age 18-65 years\n* Diagnosis of Functional Dyspepsia according to Rome IV criteria\n* Classification as Epigastric Pain Syndrome (EPS) or Postprandial Distress Syndrome (PDS)\n* Active symptoms within the last month\n* Willingness to participate in Cognitive Behavioral Therapy and provide biological samples for research\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Presence of structural gastrointestinal disease (e.g., peptic ulcer, malignancy)\n* History of major abdominal surgery affecting the stomach or small intestine\n* Severe psychiatric disorders (e.g., psychosis, bipolar disorder) interfering with participation\n* Current participation in other interventional clinical trials\n* Use of medications that may confound study outcomes (e.g., chronic corticosteroids, immunosuppressants)\n* Pregnancy or breastfeeding","ALL","18 Years","65 Years",{"count":53,"type":54},90,"ESTIMATED","INTERVENTIONAL",[57],"NA","The goal of this clinical trial is to learn whether adding Cognitive Behavioral Therapy (CBT) to standard medical treatment can improve symptoms in adults with Functional Dyspepsia. The study includes adults aged 18 to 65 years diagnosed with Functional Dyspepsia, classified as Epigastric Pain Syndrome or Postprandial Distress Syndrome.\n\nThe main questions it aims to answer are:\n\nDoes Cognitive Behavioral Therapy added to standard treatment reduce gastrointestinal symptoms compared with standard treatment alone? Do patients with Postprandial Distress Syndrome and Epigastric Pain Syndrome respond differently to Cognitive Behavioral Therapy? Researchers will compare optimized standard medical treatment alone to optimized standard treatment combined with Cognitive Behavioral Therapy to see if the addition of CBT leads to greater symptom improvement and better quality of life.\n\nParticipants will:\n\nBe randomly assigned to receive either standard medical treatment alone or standard treatment plus Cognitive Behavioral Therapy Take part in clinical visits and complete questionnaires about gastrointestinal symptoms, psychological well-being, and quality of life Provide blood, saliva, and stool samples at several time points over a 12-month follow-up period",[60,61,62],"Functional Dyspepsia","Epigastric Pain Syndrome","Postprandial Distress Syndrome",[60,64,61,62,65,66,67,68,69,70,71,72],"Cognitive Behavioral Therapy","Gut-Brain Axis","Microbiota","Randomized Controlled Trial","Disorders of Gut-Brain Interaction","Gastrointestinal Symptoms","Inflammation","Biomarkers","Precision Medicine","NOT_YET_RECRUITING","2026-05-05",{"date":76,"type":77},"2026-05-11","ACTUAL",{"date":79,"type":54},"2026-04",{"date":81,"type":54},"2028-12",{"name":5,"class":6}]