NCT05587127 · Massachusetts General Hospital
Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia
What this study is about
randomly assigned 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
- ≥5% weight loss from weight after functional dyspepsia symptom onset (at Screening visit)
- Stable for outpatient care (based on the American Psychiatric Association Practice Guideline for the Treatment of Patients with Eating Disorders)
- No previous history of CBT for functional dyspepsia or ARFID
- Computer/internet webcam access
- Fluency in English
- Stable dose for 30 days if on any medication
Exclusion criteria
- Inability to provide informed consent
- Presence of other conditions that could explain the patient's symptoms by chart: Pyloric or intestinal obstruction (by EGD, UGI, or Abdominal CT) Active H.pylori infection (by CLO test or stool antigen test) Active inflammatory bowel disease Eosinophilic gastroenteritis or eosinophilic esophagitis Acute renal failure Chronic renal failure (serum creatinine \>3 mg/dL) and/or on hemodialysis or peritoneal dialysis Acute liver failure Any acute gastrointestinal process Any plausible structural or metabolic causes Heartburn as predominant symptom History of peptic ulcer
- 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)
- Use of narcotic analgesics greater than three days per week
- Current pregnancy or breastfeeding within the last 8 weeks
- Uncontrolled diabetes (indicated by HbA1c ≥7%) by chart
- Intellectual disability by history
- Current substance/alcohol use disorder within the past month
- Current/history of psychosis (by Mini-International Neuropsychiatric Interview (MINI-Screen)
- Current mania (by Mini-International Neuropsychiatric Interview (MINI-Screen) (defined as any manic episodes within the past 12 months)
- Active suicidal ideation (by MINI-Screen)
- Psychiatric disorder that would warrant independent attention (by Mini-International - Neuropsychiatric Interview (MINI-Screen))
- Current enteral or parenteral feeding
- Plans to initiate another psychotherapy or pregnancy in the concurrent study period
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 25, 2025 · Source of record for eligibility and locations