Cognitive Behavioral Therapy for Gastroparesis
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
You can continue taking your current medications if they have been stable for at least 30 days before the study and you agree not to change them during the study. However, you cannot take psychotropic drugs, opioids, or illicit drugs.
Is Cognitive Behavioral Therapy (CBT) safe for humans?
Cognitive Behavioral Therapy (CBT) and its variations, like Dialectical Behavior Therapy (DBT) and Mindfulness-Based Cognitive Therapy (MBCT), are generally considered safe for humans. They have been widely used and studied for various mental health conditions, and no significant safety concerns have been reported in the research.12345
How is Cognitive Behavioral Therapy different from other treatments for gastroparesis?
Cognitive Behavioral Therapy (CBT) is unique for gastroparesis as it focuses on changing thought patterns and behaviors to manage symptoms, unlike other treatments that primarily aim to improve gastric emptying or involve surgical interventions. This approach is novel because it addresses the psychological aspects of the condition, which are often overlooked in traditional medical or surgical treatments.678910
What data supports the effectiveness of this treatment for gastroparesis?
Cognitive Behavioral Therapy (CBT) has been shown to be effective in treating depression by helping people change negative thought patterns and behaviors. While this research focuses on depression, the techniques used in CBT, such as problem-solving and cognitive restructuring (changing unhelpful thinking), may also help people manage symptoms of gastroparesis by improving their ability to cope with the condition.12111213
Who Is on the Research Team?
Braden Kuo, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo an 8-week Cognitive Behavioral Therapy (CBT) trial with weekly sessions conducted via online videoconferencing
Post-Treatment Testing
Participants undergo post-treatment testing including brain MRI, autonomic function test (AFT), and nutrient drink test (NDT) to assess the impact of CBT
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments up to 12 weeks post-treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cognitive Behavioral Therapy
Cognitive Behavioral Therapy is already approved in European Union, United States, Canada for the following indications:
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
- Substance use disorders
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor