A Pilot Investigation of Pain Reprocessing Therapy for Functional Dyspepsia

NCT07838324 | Recruiting

• 1 other identifier: 26-003631
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to test whether pain processing therapy, a novel psychological intervention that emphasizes exposure-based techniques, can reduce digestive symptom severity and improve functioning in people with functional dyspepsia.

Conditions

Functional Dyspepsia

Keywords

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

• Change in Average Gastroparesis Cardinal Symptom Index Score

  Change in average Gastroparesis Cardinal Symptom Index score from the Patient Assessment of Upper Gastrointestinal Disorders Symptoms Questionnaire will be assessed. The Gastroparesis Cardinal Symptom Index assesses upper gastrointestinal symptom severity; higher scores indicate greater symptom severity.

  Baseline, Week 7

Secondary Outcomes (18)

• Change in Maximum Tolerated Volume During Nutrient Drink Test

  Baseline, Week 7

• Change in Symptom Ratings During Nutrient Drink Test

  Baseline, Week 7

• Change in Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life Score

  Baseline, Week 7

• Mean Change From Baseline in Gastrointestinal Unhelpful Thinking Scale Pain Catastrophizing Subscale Score

  Baseline, Week 7

• Mean Change From Baseline in Visceral Sensitivity Index Score

  Baseline, Week 7

Study Arms (1)

Pain Reprocessing Therapy

EXPERIMENTAL

Participants will receive eight weekly pain reprocessing therapy sessions. Session 1 will occur at Week 0, and sessions will continue weekly through Session 8 at Week 7. The first and last sessions will be delivered in person when possible to coordinate with baseline and post-treatment physiologic testing, and interim sessions will be completed via telehealth.

Behavioral: Pain Reprocessing Therapy

Interventions

Pain Reprocessing Therapy BEHAVIORAL

Pain reprocessing therapy is a psychological intervention designed to help patients reconceptualize chronic symptoms in functional dyspepsia as related to changes in brain-gut communication. Treatment includes education about the neuroscience of chronic symptoms, development of a personalized understanding of symptom mechanisms, interoceptive exposure using mindfulness and safety reappraisal, approaches to reduce symptom-related fear and avoidance, techniques for addressing psychosocial threat factors, and strategies to increase positive emotional experiences.

Pain Reprocessing Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Study Officials

• Megan Petrick, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonah Pedelty

CONTACT

507-538-7774; Pedelty.Jonah@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 24, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 3, 2028
• Study Completion (Estimated): April 3, 2028
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)