Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

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

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Massachusetts General Hospital

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator