Central and Peripheral Effects of Cognitive Behavioral Therapy on Brain-Gut Axis Signaling in Gastroparetic Patients

Completed · Not applicable

Conditions studied: Gastroparesis

In brief

This is a single-center pilot study to be conducted at Massachusetts General Hospital. The purpose of this study is to examine the non-pharmacological impact of Cognitive Behavioral Therapy (CBT) on gastroparesis symptoms and other clinical co-comorbidities such as pain, depression, anxiety, and catastrophizing. CBT trial patients will undergo careful phenotyping pre- and post- intervention with brain MRI, autonomic function test (AFT), gastric emptying scintigraphy (GES), and nutrient drink test (NDT) to determine the impact of CBT on these metrics in patients with gastroparesis. Characterization of these relationships or lack thereof can help guide future development of more targeted approaches and optimize treatment strategies for gastroparesis.

Key facts

Study ID: NCT03531450
Run by: Massachusetts General Hospital
People needed: 27
Starts: 2018-12-07
Expected to finish: 2025-12-11
Last updated by the study team: 2026-06-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male and female patients aged 18 - 65 years old (inclusive)
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
An idiopathic etiology
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.
Body mass index (BMI) ≥ 17.5 kg/m2
Have not previously received CBT for coping with chronic illness
Have access to a computer with internet access
Speak, write, and understand English
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.

You may not qualify if…

Inability to comply with or complete GES test (including allergy to eggs)
Use of narcotic analgesics greater than three days per week
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
Inability to provide informed consent
BMI more than 32 and/or weight > 235 lbs. (limits of the MRI table)
Enteral or parenteral feeding
Epilepsy or a prior history of seizures
Pregnancy or nursing
Psychotherapy initiated in the last 8 weeks
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

Where it is running

Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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