Loading clinical trials...

Central and Peripheral Effects of Cognitive Behavioral Therapy on Brain-Gut Axis Signaling in Gastroparetic Patients | Clinical Trials | Clareo Health

RECRUITINGNANCT03531450

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

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 g...

Lead sponsor: Massachusetts General Hospital•1 U.S. locations•View source on ClinicalTrials.gov

Clareo plain-language summary

What this study is about

Generating AI summary...

Save this trial guide to your notes

Keep your clinical trial research organized — questions to ask, what to expect, and key details.

Contacts

Rebecca Karlson

CONTACT

617-726-0196 rkarlson@mgh.harvard.edu

Sponsors

Lead Sponsor

Massachusetts General Hospital

This randomized, controlled trial will examine the effects of cognitive behavioral therapy (CBT) on gastroparesis symptoms (including pain related brain circuitry). CBT reduces pain intensity, negative affect, and disability among patients with chronic pain, though there is a good deal of individual variability in treatment effects. Treatment gains following CBT are maintained or enhanced at 6 to 12-month follow-up. This study will examine the brain circuitry underlying these effects. In addition, as measures of gastroparesis symptoms and pain are correlated with other, more general, measures of negative affect (e.g., depression, anxiety), we will evaluate the specificity of the hypothesized effects by running the proposed statistical models both with and without inclusion of these conceptually overlapping factors. Based on pervious findings and published data, we expect that treatment-associated changes in pain and depression will likely share 10-20% of their variance. Treatment sessions will use active, structured techniques to alter distorted thoughts, with a focus on acquiring and practicing cognitive and emotional modulatory skills. CBT is based on a pain self-management paradigm, and involves the identification and reduction of maladaptive pain-related cognitions (i.e., catastrophizing) using techniques such as relaxation, thought-stopping, distraction, etc. CBT prominently emphasizes in-vivo practice during each session, and features home practice using written exercises. In particular, cognitive restructuring is used to help patients recognize the relationships between thoughts, feelings and behaviors. Patients learn to identify, evaluate, and challenge negative thoughts. In our protocol, each of the 8 weekly sessions will last for approximately 90 minutes and will be conducted or supervised by a trained psychologist. Following CBT, negative emotions are no longer closely linked to pain, suggesting that CBT provides patients with the skills to modulate and buffer their negative emotions such as catastrophizing. Subjects will undergo pre- and post-treatment testing through a variety of methods including brain MRI with associated physiological data, 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.

Related studies

RECRUITINGEARLY Phase 1

Growth Hormone for the Treatment of Gastroparesis

NCT06803589 · Gastroparesis

RECRUITING

Study of Gastric Motility in Eosinophilic Gastritis

NCT05229432 · Eosinophilic Gastritis, Gastroparesis, and more

RECRUITING

Gastroparesis Outcome Longitudinal Database Enrolled Numerically

NCT03876288 · Gastroparesis

RECRUITINGNA

To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.

NCT07287943 · Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I

RECRUITINGNA

The Use of Body Surface Gastric Mapping in Assessing the Clinical Success of G-POEM

NCT06493032 · Gastroparesis

View all related studies →

Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 26, 2024Terms

Trial snapshot

StatusRECRUITING

PhaseNA

Enrollment29

Start dateDec 2018

Last updatedJan 26, 2024

Condition

Gastroparesis

Locations shown

Massachusetts General Hospital

Boston, Massachusetts

For caregivers

Use Clareo to keep notes, questions, trial details, and next steps organized before and after appointments.

Start free trial →

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 26, 2024Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions