Pain Reprocessing Therapy for Functional Dyspepsia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study tests Pain Reprocessing Therapy, a psychological intervention focused on how pain is perceived, for individuals with functional dyspepsia. Participants must meet Rome V criteria for postprandial distress syndrome, report moderate or higher symptom severity, and have normal gastric emptying with no organic GI disease. The approach uses exposure-based techniques to modulate pain processing and may improve symptom burden and functioning. The trial is conducted at Mayo Clinic in Rochester, MN, led by Mayo Clinic, with no listed collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Fulfilled Rome V diagnostic criteria for functional dyspepsia postprandial distress syndrome subtype, with or without epigastric pain syndrome.
* A total score of at least 3 on the Gastroparesis Cardinal Symptom Index (GCSI) indicating symptom severity to be moderate or higher.
* Normal gastric emptying as confirmed by standard gastric emptying testing (if such a testing was clinically done).
* Upper endoscopy negative to rule out structural or organic etiologies for GI symptoms (within last 1 year).
* Fluent in English language.
* Able to provide informed consent and comply with study procedures.

Exclusion Criteria:

* Evidence of organic gastrointestinal disease or surgical history that could explain participant symptoms (e.g., peptic ulcer disease, celiac disease, inflammatory bowel disease, eosinophilic gastritis or eosinophilic esophagitis, malignancy).
* Current or recent (within the past 12 months) eating disorder such as anorexia nervosa or bulimia nervosa. Historical eating disorder diagnosis may also be exclusionary if residual disordered eating patterns, fear of weight gain, or food-related body image concerns are judged by the investigator to potentially confound symptom interpretation or participation.
* Underweight BMI (\<17 kg/m²) or evidence of clinically significant unintentional weight loss (\>25% body weight in 6 months).
* Current use of enteral or parenteral nutrition for \>50% of caloric needs and/or participant unwillingness to reduce use of enteral or parenteral nutrition at the time of study enrollment.
* History of developmental or intellectual disability, current cognitive impairment that would preclude participation, or other neurological illness impairing cognitive functioning.
* Active suicidal ideation, suicide attempt within the past 12 months, severe psychiatric illness, severe depressive symptomatology, acute distress, or other symptomatology that, in the investigator's judgment, would necessitate a different level of psychiatric care and/or prevent full engagement in psychological intervention sessions or adherence to study procedures.
* Medical disability or any unstable systemic illness (e.g., decompensated hepatic, cardiac, renal, or neurological disease) that could interfere with participation, comprehension, or safety in psychological intervention sessions.
* Current daily cannabis use (inhaled, edible, or medical). Other substance use or misuse of prescription medications may also be exclusionary if substance use patterns are judged by the investigator to potentially confound symptom interpretation or participation.
* Current pregnancy or lactation.
* Inability or unwillingness of individual to give informed consent.
* Non-fluent in English, or any condition that would limit compliance or follow-up.

Where it's running

• Mayo Clinic
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Megan Petrick, PhD — Mayo Clinic
• Study coordinator: Jonah Pedelty
• Email: Pedelty.Jonah@mayo.edu
• Phone: 507-538-7774

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.