Recruiting

Pain Processing Therapy

Sponsor:

Mayo Clinic

Code:

NCT07838324

Conditions

Functional Dyspepsia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pain Reprocessing Therapy

Study Details

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

Study ID

NCT07838324

Start date

Oct 1, 2026

Status verified date

Sep, 2026

Completion date

Apr 3, 2028

Anticipated

Primary completion date

Apr 3, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pain Reprocessing Therapy

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.

Interventions

Pain Reprocessing Therapy

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.

Primary outcome measure

  • Change in Average Gastroparesis Cardinal Symptom Index Score [ Time Frame: Baseline, Week 7 ]

Central Contacts and Locations

Central contacts

Jonah Pedelty

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

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Jonah Pedelty

507-538-7774

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Keywords

  • Functional Dyspepsia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.