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



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 65
Updated:3/8/2019
Start Date:December 7, 2018
End Date:December 2019
Contact:April Mendez
Email:amendez5@mgh.harvard.edu
Phone:617-726-0196

Use our guide to learn which trials are right for you!

This is a single-center, randomized 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. A subset of the CBT trial patients will
undergo careful phenotyping pre- and post- intervention with brain MRI, autonomic function
test (AFT), gastric emptying scintigraphy (GES), wireless motility capsule test (WMC), and
nutrient drink test (NDT) to determine the impact of CBT on these metrics in patients with
gastroparesis. Patients randomly assigned to a standard medical treatment (SMT) group will be
treated by the standard of care. Characterization of these relationships or lack thereof can
help guide future development of more targeted approaches and optimize treatment strategies
for gastroparesis.


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 6 months 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.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Braden Kuo, M.D.
?
mi
from
Boston, MA
Click here to add this to my saved trials