An interventional study of Pain Reprocessing Therapy in Functional Dyspepsia, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
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.
372 studies on the registry are indexed under Dyspepsia; 67 are open to participants now.
This study's planned enrollment of 15 is below the median of 89 across 302 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Time frame: Baseline, Week 7
Change in Maximum Tolerated Volume During Nutrient Drink Test
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.
Time frame: Baseline, Week 7
Change in Symptom Ratings During Nutrient Drink Test
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.
Time frame: Baseline, Week 7
Change in Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life Score
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.
Time frame: Baseline, Week 7
Mean Change From Baseline in Gastrointestinal Unhelpful Thinking Scale Pain Catastrophizing Subscale Score
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.
Time frame: Baseline, Week 7
Mean Change From Baseline in Visceral Sensitivity Index Score
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.
Time frame: Baseline, Week 7
Mean Change From Baseline in Fear of Food Questionnaire Score
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.
Time frame: Baseline, Week 7
Mean Change From Baseline in Nine Item ARFID Screen Fear Subscale Score
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.
Time frame: Baseline, Week 7
Mean Change From Baseline in PROMIS Physical Function Score
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.
Time frame: Baseline, Week 7
Mean Change From Baseline in PROMIS Anxiety Score
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.
Time frame: Baseline, Week 7
Mean Change From Baseline in PROMIS Depression Score
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.
Time frame: Baseline, Week 7
Mean Change From Baseline in PROMIS Fatigue Score
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.
Time frame: Baseline, Week 7
Mean Change From Baseline in PROMIS Sleep Disturbance Score
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.
Time frame: Baseline, Week 7
Mean Change From Baseline in PROMIS Ability to Participate in Social Roles and Activities Score
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.
Time frame: Baseline, Week 7
Mean Change From Baseline in PROMIS Pain Interference Score
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.
Time frame: Baseline, Week 7
Mean Change From Baseline in PROMIS Pain Intensity Score
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.
Time frame: Baseline, Week 7
Mean Change From Baseline in PROMIS Anger Score
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.
Time frame: Baseline, Week 7
Percentage of Participants Who Complete the Pain Reprocessing Therapy Intervention
The percentage of enrolled participants who complete all 8 planned pain reprocessing therapy sessions will be reported.
Time frame: Baseline, Week 7
Percentage of Participants Who Report Satisfaction With Pain Reprocessing Therapy
The percentage of participants who rate satisfaction with services as "mostly satisfied" or "very satisfied" on the Client Satisfaction Questionnaire-4 will be reported.
Time frame: Week 7
Plan to share: No
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