Mind over stomach: could CBT ease gastroparesis symptoms?
NCT ID NCT03531450
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether cognitive behavioral therapy (CBT) can reduce symptoms of gastroparesis, a condition where the stomach empties slowly, causing nausea, bloating, and pain. Twenty-seven adults with idiopathic gastroparesis received CBT sessions and were assessed before and after with brain scans, stomach tests, and symptom surveys. The goal was to see if changing thought patterns could improve gut symptoms and quality of life.
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 drug-free way to manage gastroparesis symptoms and improve quality of life.
- What could go wrong
- This is a very small pilot study with only 27 people, so results may not apply to everyone. CBT requires time and effort, and not all patients may benefit.
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
-
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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27 people
The number who actually took part.
- Started
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Dec 2018
- Finished
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Dec 2025
- 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 to 65 years
- 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: 1. Male and female patients aged 18 - 65 years old (inclusive) 2. Symptoms of gastroparesis of at least 12 weeks duration (do not have to be continuous) with varying degrees of nausea, vomiting, early satiety, and/or post-prandial fullness 3. An idiopathic etiology 4. GES of solids using 4 hours Egg Beaters® protocol within the last 2 years with either: \- Abnormal gastric emptying rate defined as an abnormal 2 hour (\>60% retention) and/or 4 hour (\>10% retention) result based on a 4 hour scintigraphic low fat Egg Beaters® gastric emptying study. 5. Body mass index (BMI) ≥ 17.5 kg/m2 6. Have not previously received CBT for coping with chronic illness 7. Have access to a computer with internet access 8. Speak, write, and understand English 9. On stable doses of any medication for 30 days prior to entering the study (exceptions are psychotropic, opioids, and/or illicit drugs) and agrees not to change medications or dosages during the study period. Exclusion Criteria: 1. Inability to comply with or complete GES test (including allergy to eggs) 2. Use of narcotic analgesics greater than three days per week 3. Presence of other conditions that could explain the patient's symptoms: * Pyloric or intestinal obstruction as determined by endoscopy, upper GI series or abdominal CT scan * Active inflammatory bowel disease * Known eosinophilic gastroenteritis or eosinophilic esophagitis * Primary neurological conditions that could cause nausea and/or vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions * Acute liver failure * Acute renal failure * Chronic renal failure (serum creatinine \>3 mg/dL) and/or on hemodialysis or peritoneal dialysis * Prior gastric surgery to restore function or relieve GI symptoms including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, or gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy. Note: patients with prior (Nissen, Dor, or Toupet) fundoplication will be eligible for enrollment. * Subject has current evidence of duodenal ulcer, gastric ulcer, diverticulitis, active GERD or infectious gastroenteritis. * Any acute gastrointestinal process. * Any other plausible structural or metabolic cause * Any condition, which in the opinion of the investigator, would interfere with study requirements 4. Inability to provide informed consent 5. BMI more than 32 and/or weight \> 235 lbs. (limits of the MRI table) 6. Enteral or parenteral feeding 7. Epilepsy or a prior history of seizures 8. Pregnancy or nursing 9. Psychotherapy initiated in the last 8 weeks 10. Contraindications for MRI: High magnetic fields may pose a serious health hazard to subjects with implanted ferromagnetic objects. Every subject in this study will be carefully screened before entering the high magnetic field shielded room to collect a precise outline of the subject's medical history. Subjects with the following characteristics/disease will not be eligible to participate in the study: * History of Head Trauma * Any metallic implants (e.g. braces or permanent retainers) * Tattoos with metallic ink above the nipple line * Surgical Aneurysm Clips * Cardiac Pacemaker * Prosthetic Heart Valve * Neurostimulator * Implanted pumps * Cochlear Implants * Metal rods, Plates * Screws * Recent Previous Surgery * IUD * Hearing Aid * Dentures (which might create NMR artifacts) * Metal Injury to eyes * Pregnancy or plans to become pregnant * Breast Feeding * Meniere's Disease * Transdermal (skin) patches such as NicoDerm (nicotine for tobacco dependence), Transderm Scop, or Ortho Evra (birth control) * Claustrophobia * Suicidal ideation as indicated from the HADS All concomitant medications taken during the study will be recorded in the case report form, along with dosage information and start and stop dates. Patients requiring excluded drugs will be discontinued from the study.
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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.
Contacts and locations
Locations
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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