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.
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)
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)
Parallel
Cognitive Behavioral Therapy
BehavioralEight 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.
Enrollment
At the end of the study, we will calculate the percentage of participants who consent to initiate the study from the total who are offered.
Assessment completion
At the end of the study, we will calculate the percentage of participants who complete all assessments in each CBT and usual care groups.
Retention
At the end of the study, we will calculate the percentage of participants who complete at least 6 of the 8 CBT sessions.
Interventionist Fidelity ratings
At the end of the study, we will calculate fidelity, which measures the percentage of sessions that 100% of the CBT content was delivered.
Short Form Nepean Dyspepsia Inventory (SF-NDI)
The Short Form Nepean Dyspepsia Inventory (SF-NDI) includes a 15 item symptoms checklist to assess functional dyspepsia symptom severity. It also includes 10 items scored on a 5-point Likert scale measuring functional dyspepsia-related quality of life; subscales include interference with daily activities, knowledge/control, tension, work/study, and eating/drinking.
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Massachusetts General Hospital
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
