About this trial
Randomized controlled trial of an exposure-based behavioral treatment (CBT) in adults with functional dyspepsia who meet criteria for avoidant/restrictive food intake disorder (ARFID) with weight loss.
Eligibility criteria
Qualifiers
Age at least 18 years at screening visit
Rome IV Functional Dyspepsia post-prandial distress type (with or without epigastric pain syndrome)
Negative upper endoscopy or upper radiographic GI series to rule out structural/organic cause for FD
Avoidant/Restrictive Food Intake Disorder (ARFID) diagnosis (by the Structured Clinical Interview for DSM-5; SCID-5 at Screening visit)
Disqualifiers
Inability to provide informed consent
Symptom resolution with antisecretory therapy (PPI use for other reasons that did not resolve FD symptoms will be allowed)
History of gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection)
History of any serious medical condition (e.g., cancer)
Trial design
Treatments tested in this trial
- Cognitive Behavioral Therapy
Treatment groups
Sponsors and collaborators
Massachusetts General Hospital
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator