Can therapy help you eat again when your stomach hurts?
NCT ID NCT05587127
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a type of talking therapy called exposure-based cognitive behavioral therapy (CBT) for adults who have both functional dyspepsia (a stomach condition causing pain and fullness) and avoidant/restrictive food intake disorder (ARFID), leading to weight loss. Fifty participants will receive eight weekly therapy sessions online or continue usual care. The goal is to see if the therapy helps them eat more variety and volume, improve symptoms, and gain weight.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cognitive behavioral therapy (CBT)
- What this could lead to
- If it works, this could offer a structured therapy to help people with functional dyspepsia overcome food avoidance and regain weight.
- What could go wrong
- This is a small, early-stage trial with only 50 participants, so results may not apply widely. The therapy requires weekly sessions and may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2022
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
Contact Email: •••••@•••••
Contact Email: •••••@•••••
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