← Back to Search

Behavioral Intervention

Cognitive Behavioral Therapy for Gastroparesis

N/A

Recruiting

Led By Braden Kuo, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

On stable doses of any medication for 30 days prior to entering the study and agrees not to change medications or dosages during the study period

Symptoms of gastroparesis of at least 12 weeks duration with varying degrees of nausea, vomiting, early satiety, and/or post-prandial fullness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks

Awards & highlights

Study Summary

This trial will help researchers understand how CBT impacts symptoms of gastroparesis as well as other conditions like pain, depression, anxiety, and catastrophizing.

Who is the study for?

This trial is for adults aged 18-65 with gastroparesis, a condition causing delayed stomach emptying. Participants must have had symptoms for at least 12 weeks and not received CBT for chronic illness before. They need internet access, speak English, be on stable medication doses, and have specific BMI and gastric emptying study results. Exclusions include MRI contraindications like metal implants or claustrophobia, certain medications use, other conditions that could cause similar symptoms or inability to comply with the study.Check my eligibility

What is being tested?

The trial tests Cognitive Behavioral Therapy's (CBT) effects on gastroparesis by assessing changes in brain-gut signaling. Patients will undergo pre- and post-CBT evaluations using brain MRI scans, autonomic function tests, gastric emptying studies among others to see if CBT can improve symptoms of pain, depression, anxiety related to their condition.See study design

What are the potential side effects?

Since this trial involves Cognitive Behavioral Therapy which is a non-pharmacological treatment involving talking therapy sessions aimed at changing thought patterns and behaviors there are no direct side effects as seen with medication; however participants may experience emotional discomfort discussing sensitive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I've been on the same medication dose for 30 days and won't change it during the study.

Select...

I have had symptoms like nausea or feeling full quickly for at least 12 weeks.

Select...

I have never had cognitive behavioral therapy for a chronic illness.

Select...

My condition has an unknown cause.

Select...

I am between 18 and 65 years old.

Select...

My stomach empties slowly, confirmed by a test in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM)

Secondary outcome measures

Abdominal Quantitative Sensory Testing (QST)

Autonomic Function Testing (AFT)

Electrocardiogram acquired during MRI scans

+19 more

Side effects data

From 2021 Phase 4 trial • 12 Patients • NCT04135937

irritability

100%

80%

60%

40%

20%

Study treatment Arm

MESH

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cognitive Behavioral TherapyExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Behavioral Therapy

2016

Completed Phase 4

~3120

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,935 Previous Clinical Trials

13,198,612 Total Patients Enrolled

7 Trials studying Gastroparesis

1,186 Patients Enrolled for Gastroparesis

Braden Kuo, MDPrincipal InvestigatorMassachusetts General Hospital

7 Previous Clinical Trials

887 Total Patients Enrolled

5 Trials studying Gastroparesis

789 Patients Enrolled for Gastroparesis

Media Library

Cognitive Behavioral Therapy (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03531450 — N/A

Gastroparesis Research Study Groups: Cognitive Behavioral Therapy

Gastroparesis Clinical Trial 2023: Cognitive Behavioral Therapy Highlights & Side Effects. Trial Name: NCT03531450 — N/A

Cognitive Behavioral Therapy (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03531450 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the target age range of this research venture exceeding 45 years?

"This clinical trial stipulates an age limit between 18 and 65, meaning all patients wanting to participate must fall within this range."

Answered by AI

Could I be a viable candidate for this clinical investigation?

"To be considered for this research study, potential participants must suffer from gastroparesis and lie within the age brackets of 18-65. Currently, there are 17 openings in the trial."

Answered by AI

Is enrollment open for the experiment at this point in time?

"This medical research is actively recruiting participants, with the initial post made on December 7th 2018 and the latest edit being June 1st 2023."

Answered by AI

How many individuals are involved in this clinical investigation?

"Affirmative. Data hosted on clinicaltrials.gov indicates that this medical investigation, which was initially posted on December 7th 2018, is actively seeking participants. Approximately 17 individuals need to be enrolled from 1 clinical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Braden Kuo 2018. "Central and Peripheral Effects of Cognitive Behavioral Therapy on Brain-Gut Axis Signaling in Gastroparetic Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03531450.

All > Diabetic Gastroparesis > Gastroparesis