Actively Recruiting
Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia
Led by Massachusetts General Hospital · Updated on 2025-09-25
50
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age at least 18 years at screening visit
- Diagnosis of Rome IV Functional Dyspepsia post-prandial distress type (with or without epigastric pain syndrome)
- Negative upper endoscopy or upper radiographic gastrointestinal series to exclude structural or organic causes for functional dyspepsia
- Diagnosis of avoidant/restrictive food intake disorder (ARFID) confirmed by Structured Clinical Interview for DSM-5 (SCID-5) at screening visit
- At least 5% weight loss from weight after onset of functional dyspepsia symptoms
- Stable for outpatient care based on American Psychiatric Association guidelines for eating disorders
- No previous cognitive-behavioral therapy for functional dyspepsia or ARFID
- Access to a computer with internet and webcam
- Fluency in English
- Stable medication dose for at least 30 days if on any medication
You will not qualify if you...
- Unable to provide informed consent
- Presence of conditions explaining symptoms such as pyloric or intestinal obstruction, active H. pylori infection, inflammatory bowel disease, eosinophilic gastroenteritis or esophagitis, acute or chronic renal failure, acute liver failure, or any acute gastrointestinal process
- Structural or metabolic causes for symptoms
- Heartburn as predominant symptom
- History of peptic ulcer
- Symptom resolution with antisecretory therapy (except when PPI used for other reasons without symptom resolution)
- History of gastrointestinal surgery including gastrectomy, gastric bypass, or bowel resection
- History of serious medical conditions such as cancer
- Use of narcotic analgesics more than three days per week
- Current pregnancy or breastfeeding within the last 8 weeks
- Uncontrolled diabetes with HbA1c equal to or above 7%
- Intellectual disability
- Current substance or alcohol use disorder within past month
- Current or past psychosis
- Current mania episode within past 12 months
- Active suicidal ideation
- Psychiatric disorders requiring independent attention
- Current enteral or parenteral feeding
- Plans to start another psychotherapy or pregnancy during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
B
Blythe Peterson, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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