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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Rebecca Karlson
rkarlson@mgh.harvard.edu
617-726-0196
Time Frame
Start Date: 2018-12-07
Estimated Completion Date: 2027-02-25
Participants
Target number of participants: 29
Treatments
Experimental: Cognitive Behavioral Therapy
Patients in the cognitive behavioral therapy group will be asked to undergo a 8-week CBT trial. An online videoconferencing link will be used to deliver CBT virtual sessions that will be approximately 60 minutes in length. Each session will be conducted by a clinical psychology doctoral student, supervised by a licensed psychologist. Patients will also undergo careful phenotyping pre- and post intervention with brain MRI, AFT, and NDT.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov