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NCT03531450 · ClinicalTrials.gov registry record · NA

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

A NA study of Gastroparesis, sponsored by Massachusetts General Hospital.

Recruiting
Registry status
NA
Development phase
29
Enrollment target
1
Study location

NCT03531450 is a NA study of Gastroparesis that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 29 participants, below the 302-participant average among 44 other Gastroparesis trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03531450, a NA study of Gastroparesis, is actively recruiting participants, sponsored by Massachusetts General Hospital.

RECRUITING
Registry status
NA
Development phase
29 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • BEHAVIORAL Cognitive Behavioral Therapy

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2018-12-07
Est. Completion 2027-02-25
Phase NA

Sponsor

Massachusetts General Hospital

2,032 total trials

What the Registry Record Tells You About NCT03531450

The ClinicalTrials.gov registry entry for NCT03531450 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 302-participant average among 44 other Gastroparesis trials with a reported enrollment target (90% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Gastroparesis appearing as the primary indexed condition, and to 1 intervention - of which Cognitive Behavioral Therapy is the first listed.

NCT03531450 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT03531450 about?

NCT03531450 is a clinical study titled "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 gastroparesis symptoms and other clinical co-comorbidities such as pain, depression, anxiety, and cat...

What is the current status of trial NCT03531450?

This trial is currently recruiting. It is a NA study. The enrollment target is 29 participants. The study started on 2018-12-07. Estimated completion is 2027-02-25.

What conditions does trial NCT03531450 study?

This clinical trial studies the following conditions: Gastroparesis.

What interventions are being tested in trial NCT03531450?

The interventions under investigation include: Cognitive Behavioral Therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT03531450?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03531450 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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