Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07838324

A Pilot Investigation of Pain Reprocessing Therapy for Functional Dyspepsia

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Functional Dyspepsia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Average Gastroparesis Cardinal Symptom Index Score

    Time frame: Baseline, Week 7

    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.

Secondary outcomes

  1. Change in Maximum Tolerated Volume During Nutrient Drink Test

    Time frame: Baseline, Week 7

    Change in maximum tolerated volume consumed during the nutrient drink test will be assessed. Maximum tolerated volume is the total volume of nutrient drink consumed before the participant reaches the protocol-defined stopping point.

  2. Change in Symptom Ratings During Nutrient Drink Test

    Time frame: Baseline, Week 7

    Change in standardized symptom ratings collected during the nutrient drink test will be assessed. Symptoms may include fullness, nausea, bloating, and abdominal pain, with higher scores indicating greater symptom severity.

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

    Time frame: Baseline, Week 7

    Change in Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life score will be assessed. The questionnaire measures disease-specific quality of life in participants with upper gastrointestinal disorders; higher scores indicate better quality of life.

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

    Time frame: Baseline, Week 7

    Gastrointestinal-specific pain catastrophizing will be assessed using the Pain Catastrophizing subscale of the Gastrointestinal Unhelpful Thinking Scale. Mean scores will be calculated at baseline and following completion of treatment. A negative change from baseline indicates improvement in gastrointestinal-specific pain catastrophizing.

  5. Mean Change From Baseline in Visceral Sensitivity Index Score

    Time frame: Baseline, Week 7

    Gastrointestinal-specific anxiety will be assessed using the Visceral Sensitivity Index. Mean scores will be calculated at baseline and following completion of treatment. A negative change from baseline indicates improvement in gastrointestinal-specific anxiety.

  6. Mean Change From Baseline in Fear of Food Questionnaire Score

    Time frame: Baseline, Week 7

    Food-related fear and avoidance will be assessed using the Fear of Food Questionnaire. Mean scores will be calculated at baseline and following completion of treatment. A negative change from baseline indicates improvement in food-related fear and avoidance.

  7. Mean Change From Baseline in Nine Item ARFID Screen Fear Subscale Score

    Time frame: Baseline, Week 7

    Restrictive eating behaviors related to fear of aversive consequences will be assessed using the fear subscale of the Nine Item ARFID Screen. Mean scores will be calculated at baseline and following completion of treatment. A negative change from baseline indicates improvement in fear-related restrictive eating behaviors.

  8. Mean Change From Baseline in PROMIS Physical Function Score

    Time frame: Baseline, Week 7

    General physical function will be assessed using the PROMIS Physical Function scale. Mean scores will be calculated at baseline and following completion of treatment. A positive change from baseline indicates improvement in physical function.

  9. Mean Change From Baseline in PROMIS Anxiety Score

    Time frame: Baseline, Week 7

    Anxiety will be assessed using the PROMIS Anxiety scale. Mean scores will be calculated at baseline and following completion of treatment. A negative change from baseline indicates improvement in anxiety.

  10. Mean Change From Baseline in PROMIS Depression Score

    Time frame: Baseline, Week 7

    Depression will be assessed using the PROMIS Depression scale. Mean scores will be calculated at baseline and following completion of treatment. A negative change from baseline indicates improvement in depression.

  11. Mean Change From Baseline in PROMIS Fatigue Score

    Time frame: Baseline, Week 7

    Fatigue will be assessed using the PROMIS Fatigue scale. Mean scores will be calculated at baseline and following completion of treatment. A negative change from baseline indicates improvement in fatigue.

  12. Mean Change From Baseline in PROMIS Sleep Disturbance Score

    Time frame: Baseline, Week 7

    Sleep disturbance will be assessed using the PROMIS Sleep Disturbance scale. Mean scores will be calculated at baseline and following completion of treatment. A negative change from baseline indicates improvement in sleep disturbance.

  13. Mean Change From Baseline in PROMIS Ability to Participate in Social Roles and Activities Score

    Time frame: Baseline, Week 7

    Ability to participate in social roles and activities will be assessed using the PROMIS Ability to Participate in Social Roles and Activities scale. Mean scores will be calculated at baseline and following completion of treatment. A positive change from baseline indicates improvement in social participation.

  14. Mean Change From Baseline in PROMIS Pain Interference Score

    Time frame: Baseline, Week 7

    Pain interference will be assessed using the PROMIS Pain Interference scale. Mean scores will be calculated at baseline and following completion of treatment. A negative change from baseline indicates improvement in pain interference.

  15. Mean Change From Baseline in PROMIS Pain Intensity Score

    Time frame: Baseline, Week 7

    Pain intensity will be assessed using the PROMIS Pain Intensity numerical rating scale. Mean scores will be calculated at baseline and following completion of treatment. A negative change from baseline indicates improvement in pain intensity.

  16. Mean Change From Baseline in PROMIS Anger Score

    Time frame: Baseline, Week 7

    Anger will be assessed using the PROMIS Anger scale. Mean scores will be calculated at baseline and following completion of treatment. A negative change from baseline indicates improvement in anger.

  17. Percentage of Participants Who Complete the Pain Reprocessing Therapy Intervention

    Time frame: Baseline, Week 7

    The percentage of enrolled participants who complete all 8 planned pain reprocessing therapy sessions will be reported.

  18. Percentage of Participants Who Report Satisfaction With Pain Reprocessing Therapy

    Time frame: Week 7

    The percentage of participants who rate satisfaction with services as "mostly satisfied" or "very satisfied" on the Client Satisfaction Questionnaire-4 will be reported.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.