What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy (CBT) for Gastroparesis primarily aims to modify thought patterns and behaviors to alleviate symptoms. Known side effects of CBT are generally minimal and may include temporary discomfort from confronting distressing thoughts and emotions, mild anxiety, or fatigue after sessions. Compared to pharmacological treatments, which can have side effects such as nausea, diarrhea, or abdominal pain, CBT is considered a safer alternative with fewer physical side effects.

What prior FDA approvals exist?

Cognitive Behavioral Therapy (CBT) is being studied as a non-pharmacological intervention for gastroparesis, aiming to modify thought patterns and behaviors to alleviate symptoms. While the context does not provide specific FDA approvals for gastroparesis treatments, it highlights ongoing research into the efficacy of CBT for managing symptoms and improving quality of life in patients with gastroparesis.

What other types of research exist?

Promising, novel alternatives to CBT for Gastroparesis patients include Mindfulness-Based Cognitive Therapy (MBCT) and relaxation techniques such as yoga and hypnosis. These therapies have shown potential in improving symptoms and overall well-being in various clinical settings.

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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

Must not have

Presence of duodenal ulcer, gastric ulcer, diverticulitis, active GERD or infectious gastroenteritis

Enteral or parenteral feeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if Cognitive Behavioral Therapy (CBT) can help people with gastroparesis by reducing their pain and negative emotions. CBT involves talking through problems and practicing new ways to think and act. The study will measure changes in symptoms over time to see how effective it is.

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.

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.

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

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

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

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

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My condition has an unknown cause.

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I am between 18 and 65 years old.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a stomach or intestinal ulcer, diverticulitis, severe acid reflux, or an infectious stomach bug.

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I am receiving nutrition through a tube or IV.

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My BMI is over 32 or my weight is more than 235 lbs.

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I have had surgery on my stomach to improve its function or relieve symptoms.

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I am currently experiencing an acute stomach or intestinal issue.

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I have epilepsy or have had seizures before.

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I started psychotherapy within the last 8 weeks.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Abdominal Quantitative Sensory Testing (QST)

Autonomic Function Testing (AFT)

Gastrointestinal symptom assessment via Brief Pain Inventory

+6 more

Side effects data

From 2021 Phase 4 trial • 12 Patients • NCT04135937

irritability

100%

80%

60%

40%

20%

Study treatment Arm

MESH

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive Behavioral Therapy (CBT) for gastroparesis focuses on modifying negative thought patterns and behaviors that exacerbate symptoms like nausea, vomiting, and abdominal pain. By reducing stress and anxiety, which can worsen gastroparesis, CBT offers a holistic and side-effect-free approach to symptom management. This is particularly important for patients seeking non-pharmacological treatment options to improve their quality of life.

Rumination and vomiting in the developmentally disabled: a critical review of the behavioral, medical, and psychiatric treatment research.Severe vomiting in a diabetic woman. Psychological considerations.The etiology and management of rumination and psychogenic vomiting: a review.