Vagal Stimulation + Cognitive Behavioral Therapy for Indigestion
(CONVERGE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to manage indigestion by combining a sensory device with cognitive behavioral therapy (a type of talk therapy). The goal is to assess how this dual approach affects both the physical symptoms and personal experiences of individuals with functional dyspepsia, a chronic stomach disorder causing pain and discomfort. Participants will be divided into groups to test various combinations of device and therapy methods. Individuals with ongoing indigestion issues who have not previously undergone this type of therapy and are willing to engage in regular treatment sessions may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new treatment options.
Will I have to stop taking my current medications?
You may need to stop taking medications that affect gastrointestinal motility and products containing THC at least 7 days before the study and during the study. However, if you are on anti-depressants, you might be allowed to continue, but it will depend on the study team and Principal Investigator.
What prior data suggests that this dual intervention approach is safe for patients with functional dyspepsia?
Research has shown that Cognitive Behavioral Therapy (CBT) is safe and effective for improving mental health and reducing symptoms of functional dyspepsia, a type of indigestion. Studies have found that CBT aids in managing gut-brain disorders without causing serious side effects.
For Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), research indicates it is both effective and safe for treating functional dyspepsia. Studies have demonstrated that taVNS can relieve symptoms like indigestion without major safety concerns. Both treatments have been well-tolerated in past studies, making them promising options for those considering joining a clinical trial.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for indigestion because they combine cognitive behavioral therapy (CBT) with a unique approach called transcutaneous auricular vagus nerve stimulation (taVNS). Unlike standard treatments like dietary changes, medications, or even surgery, which primarily address symptoms, this approach targets the vagus nerve, a key player in digestion. By stimulating this nerve through the skin, combined with skills-building or health education, these treatments aim to not only alleviate symptoms but also address underlying psychological factors. This dual-action strategy could offer a more comprehensive solution to indigestion by potentially improving gut-brain communication and enhancing overall digestive health.
What evidence suggests that this trial's treatments could be effective for indigestion?
Research has shown that Cognitive Behavioral Therapy (CBT), one of the treatments in this trial, effectively reduces symptoms of functional dyspepsia, a type of indigestion. Studies indicate that CBT improves both stomach-related symptoms and mental health in individuals with digestive issues, with benefits observed in both the short and long term.
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), another treatment option in this trial, has also shown promise. Specifically, research found that taVNS significantly improved indigestion symptoms, quality of life, and mood compared to placebo treatments. Both treatments have a strong record of helping individuals with indigestion feel better.23567Are You a Good Fit for This Trial?
This trial is for individuals with stable indigestion treatment who can attend weekly video sessions, do daily taVNS at home, and avoid alcohol, nicotine, and caffeine before study visits. They must have a specific diagnosis of functional dyspepsia according to Rome IV criteria and be able to engage in English-language therapy.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 8 weeks of transcutaneous auricular vagus nerve stimulation (taVNS) and cognitive-behavioral therapy (CBT) to evaluate the synergistic impact on post-meal gut-brain communication
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on changes in gut-brain physiology and FD clinical outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Cognitive Behavioral Therapy
- Transcutaneous Auricular Vagus Nerve Stimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Spaulding Rehabilitation Hospital
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator