Actively Recruiting
Central and Peripheral Effects of Cognitive Behavioral Therapy on Brain-Gut Axis Signaling in Gastroparetic Patients
Led by Massachusetts General Hospital · Updated on 2024-01-26
29
Participants Needed
1
Research Sites
428 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Central and Peripheral Effects of Cognitive Behavioral Therapy on Brain-Gut Axis Signaling in Gastroparetic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged 18 - 65 years old (inclusive)
- Symptoms of gastroparesis lasting at least 12 weeks with nausea, vomiting, early satiety, or post-prandial fullness
- Idiopathic cause of gastroparesis
- Gastric emptying scintigraphy within 2 years showing abnormal 2 hour (>60% retention) and/or 4 hour (>10% retention) gastric emptying
- Body mass index (BMI) of 17.5 kg/m2 or higher
- No prior Cognitive Behavioral Therapy for chronic illness
- Access to a computer with internet
- Ability to speak, write, and understand English
- Stable medication doses for 30 days before study entry (except psychotropic, opioids, illicit drugs) and agreement to keep doses stable during study
You will not qualify if you...
- Unable to complete gastric emptying test or allergy to eggs
- Use of narcotic pain medicines more than three days per week
- Conditions that explain symptoms such as pyloric or intestinal obstruction, active inflammatory bowel disease, eosinophilic gastroenteritis or esophagitis, neurological conditions causing nausea/vomiting, acute liver or renal failure, chronic renal failure with creatinine >3 mg/dL or dialysis
- Prior gastric surgeries affecting function except certain fundoplications
- Current ulcers, diverticulitis, active GERD, infectious gastroenteritis, or other acute gastrointestinal conditions
- Any structural or metabolic causes or other conditions interfering with study
- Unable to provide informed consent
- BMI over 32 or weight above 235 lbs (MRI limits)
- Receiving enteral or parenteral feeding
- History of epilepsy or seizures
- Pregnant or nursing
- Psychotherapy started within last 8 weeks
- Contraindications to MRI including metallic implants, tattoos with metallic ink above nipple line, surgical clips, pacemakers, prosthetic valves, neurostimulators, implanted pumps, cochlear implants, metal rods/plates/screws, recent surgery, IUD, hearing aids, dentures causing artifacts, metal eye injuries, claustrophobia, suicidal thoughts
- Use of transdermal patches like nicotine or birth control
- Suicidal ideation indicated by HADS assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
R
Rebecca Karlson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here