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

Launched by MASSACHUSETTS GENERAL HOSPITAL · May 8, 2018

Keywords

ClinConnect Summary

This clinical trial is looking into how Cognitive Behavioral Therapy (CBT) can help patients with gastroparesis, a condition where the stomach takes too long to empty its contents. The study is being conducted at Massachusetts General Hospital and aims to see if CBT can improve not just stomach symptoms, like nausea and fullness, but also related issues such as pain, depression, and anxiety. Participants will undergo various tests before and after the therapy to understand how CBT affects both their symptoms and brain-gut communication.

To be eligible for this study, participants should be between 18 and 65 years old and have been experiencing gastroparesis symptoms for at least 12 weeks. They should also have a specific type of abnormal gastric emptying, as determined by a test done in the last two years. Participants must not have undergone CBT for chronic illness before and should have stable medication use for at least 30 days prior to joining. Throughout the study, individuals will receive CBT and complete tests to track any changes in their symptoms or overall health. This research could lead to better treatment options for those living with gastroparesis in the future.

Gender

ALL

Eligibility criteria

• 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.