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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: Recruiting NA study of Gastroparesis, sponsored by Massachusetts General Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
One of the primary endpoints will be change in gastroparesis symptom severity by the Gastroparesis Cardinal Symptom Inventory (GCSI). The GCSI is comprised of three subscales: post-prandial fullness/early satiety, nausea/vomiting, and bloating. A one-point decrease in the GCSI has been validated to indicate clinically significant improvement.
Conditions Studied
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2018-12-07 |
| Est. Completion | 2027-02-25 |
| Phase | NA |
What NCT03531450 shows while recruiting
NCT03531450 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 302-participant average among 44 other Gastroparesis trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03531450's enrollment target sits among peer trials
29 31st of 44 higher than 14 of 44 other Gastroparesis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroparesis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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