RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-12-07

Study Completion:2027-02-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03531450

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: 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.	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

Inclusion Criteria

Exclusion 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:
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.

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

Contacts and Locations

Study Contact

Rebecca Karlson

CONTACT

617-726-0196

rkarlson@mgh.harvard.edu

Principal Investigator

Braden Kuo, MD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Braden Kuo, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-12-07

Study Completion Date2027-02-25

Study Record Updates

Study Start Date2018-12-07

Study Completion Date2027-02-25

Terms related to this study

Keywords Provided by Researchers

Gastroparesis

Additional Relevant MeSH Terms

Gastroparesis