[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484368":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":52,"collaborators":55,"id":59,"slug":18,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":18,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":18,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":18,"overallStatus":36,"whyStopped":18,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cognitive Behavioral Therapy","EXPERIMENTAL","Subjects will receive cognitive behavioral therapy for functional dyspepsia with avoidant restrictive food intake disorder.",[13],"Behavioral: Cognitive Behavioral Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","NO_INTERVENTION","In the usual care condition, participants will be allowed to continue with treatment they are already receiving at the time of randomization, and we will collect detailed data on the nature of these interventions. Participants will be allowed to pursue non study treatments in this condition.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","Eight 1-hour sessions delivered weekly via the MGH-approved secure video platform Enterprise Zoom. Skills include: education about gut-brain regulation and weight loss, and regularizing eating to improve hunger and satiety cues; techniques to facilitate weight gain with targets of increased food volume and variety; and plan for maintenance of treatment gains.",[9],[25],{"name":26,"affiliation":5,"role":27},"Helen Burton Murray, PhD","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},"Blythe Peterson, BS","CONTACT","617-643-7884","GIbehavioralresearch@mgh.harvard.edu",[35],{"facility":5,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-71.05977,42.35843,{"lat":46,"lon":45},[49,50,51],{"name":26,"role":31,"phone":32,"phoneExt":18,"email":33},{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},{"name":26,"role":27,"phone":18,"phoneExt":18,"email":18},{"type":27,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Helen B. Murray, PHD","Principal Investigator",[56],{"name":57,"class":58},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100484368",false,"NCT05587127","Exposure-Based CBT for Avoidant\u002FRestrictive Food Intake in Functional Dyspepsia","A Randomized Controlled Trial of Exposure-Based Cognitive Behavioral Treatment for Avoidant\u002FRestrictive Food Intake in Functional Dyspepsia","Inclusion Criteria\n\n* Age at least 18 years at screening visit\n* Rome IV Functional Dyspepsia post-prandial distress type (with or without epigastric pain syndrome)\n* Negative upper endoscopy or upper radiographic GI series to rule out structural\u002Forganic cause for FD\n* Avoidant\u002FRestrictive Food Intake Disorder (ARFID) diagnosis (by the Structured Clinical Interview for DSM-5; SCID-5 at Screening visit)\n* ≥5% weight loss from weight after functional dyspepsia symptom onset (at Screening visit)\n* Stable for outpatient care (based on the American Psychiatric Association Practice Guideline for the Treatment of Patients with Eating Disorders)\n* No previous history of CBT for functional dyspepsia or ARFID\n* Computer\u002Finternet webcam access\n* Fluency in English\n* Stable dose for 30 days if on any medication\n\nExclusion Criteria\n\n* Inability to provide informed consent\n* Presence of other conditions that could explain the patient's symptoms by chart:\n\nPyloric or intestinal obstruction (by EGD, UGI, or Abdominal CT) Active H.pylori infection (by CLO test or stool antigen test) Active inflammatory bowel disease Eosinophilic gastroenteritis or eosinophilic esophagitis Acute renal failure Chronic renal failure (serum creatinine \\>3 mg\u002FdL) and\u002For on hemodialysis or peritoneal dialysis Acute liver failure Any acute gastrointestinal process Any plausible structural or metabolic causes Heartburn as predominant symptom History of peptic ulcer\n\n* Symptom resolution with antisecretory therapy (PPI use for other reasons that did not resolve FD symptoms will be allowed)\n* History of gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection)\n* History of any serious medical condition (e.g., cancer)\n* Use of narcotic analgesics greater than three days per week\n* Current pregnancy or breastfeeding within the last 8 weeks\n* Uncontrolled diabetes (indicated by HbA1c ≥7%) by chart\n* Intellectual disability by history\n* Current substance\u002Falcohol use disorder within the past month\n* Current\u002Fhistory of psychosis (by Mini-International Neuropsychiatric Interview (MINI-Screen)\n* Current mania (by Mini-International Neuropsychiatric Interview (MINI-Screen) (defined as any manic episodes within the past 12 months)\n* Active suicidal ideation (by MINI-Screen)\n* Psychiatric disorder that would warrant independent attention (by Mini-International - Neuropsychiatric Interview (MINI-Screen))\n* Current enteral or parenteral feeding\n* Plans to initiate another psychotherapy or pregnancy in the concurrent study period","ALL","18 Years",{"count":68,"type":69},50,"ESTIMATED","INTERVENTIONAL",[72],"NA","Randomized controlled trial of an exposure-based behavioral treatment (CBT) in adults with functional dyspepsia who meet criteria for avoidant\u002Frestrictive food intake disorder (ARFID) with weight loss.",[75,76,77,9,78,79,80,81],"Avoidant\u002FRestrictive Food Intake Disorder","Dyspepsia","Feeding and Eating Disorders","Appetite Regulation","Functional Dyspepsia","Post-prandial Distress Syndrome","Behavioral Medicine","2025-09-22",{"date":84,"type":85},"2025-09-25","ACTUAL",{"date":87,"type":85},"2022-11-30",{"date":89,"type":69},"2027-05",{"name":5,"class":6},1]