Actively Recruiting
A Randomized Controlled Trial of Exposure-Based Cognitive Behavioral Treatment for Avoidant/Restrictive Food Intake in Functional Dyspepsia
Led by Massachusetts General Hospital · Updated on 2025-09-25
50
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating a cognitive-behavioral treatment (CBT) compared to usual care in adults with functional dyspepsia who also meet criteria for avoidant/restrictive food intake disorder (ARFID) with weight loss. This randomized controlled trial aims to study the feasibility, acceptability, and clinical effects of this exposure-based behavioral treatment. The study is sponsored by Massachusetts General Hospital and targets adults with specific digestive and eating disorders.
CONDITIONS
Brief 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 GI series ruling out structural causes for functional dyspepsia
- Diagnosis of avoidant/restrictive food intake disorder (ARFID) by structured clinical interview
- At least 5% weight loss since onset of functional dyspepsia symptoms
- Stable enough for outpatient care
- No prior cognitive-behavioral therapy for functional dyspepsia or ARFID
- Access to computer and internet 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 other 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 other acute gastrointestinal processes
- Heartburn as predominant symptom
- History of peptic ulcer
- Symptom resolution with antisecretory therapy (except PPI use for other reasons)
- History of gastrointestinal surgery including gastrectomy, gastric bypass, or bowel resection
- History of serious medical conditions like cancer
- Use of narcotic pain medications more than three days per week
- Current pregnancy or breastfeeding within past 8 weeks
- Uncontrolled diabetes (HbA1c ≥7%)
- Intellectual disability
- Current substance or alcohol use disorder within past month
- Current or history of psychosis or mania within past year
- Active suicidal thoughts
- Psychiatric disorders requiring separate 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants in the CBT group receive eight 1-hour cognitive behavioral therapy sessions delivered weekly via a secure video platform. Participants in the usual care group continue their existing treatments during this time.
Weekly visits via secure video platform
Duration - 4 weeks
Participants are monitored for clinical outcomes and treatment acceptability after the treatment period ends.
1 visit
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
B
Blythe Peterson, BS
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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