Functional DyspepsiaNCT07838324
A Pilot Investigation of Pain Reprocessing Therapy for Functional Dyspepsia
A study testing Pain Reprocessing Therapy in people with Functional Dyspepsia, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Pain Reprocessing Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 3 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Jonah Pedelty, 507-538-7774
About this study
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
- Being tested
- Pain Reprocessing Therapy
- Keywords
- Functional Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Reprocessing TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Pain Reprocessing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 7
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion3 Apr 2028 (estimated)
- Study completion3 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Petrik, Mayo Clinic
- Investigators
- Megan Petrick, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838324
- Sponsor's protocol ID
- 26-003631
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Investigation of Pain Reprocessing Therapy for Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT07838324
- Acronym / sponsor ID
- 26-003631
- Conditions
- Functional Dyspepsia
- Keywords
- Functional Dyspepsia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 3 Apr 2028 (estimated)
- Study completion
- 3 Apr 2028 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain Reprocessing Therapy | Experimental | Behavioral: Pain Reprocessing TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Reprocessing TherapyPain 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. | Behavioural | Pain Reprocessing Therapy |
Primary outcome
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.
18 secondary outcomes
Change in Maximum Tolerated Volume During Nutrient Drink Test
Time frame: Baseline, Week 7
Change in Symptom Ratings During Nutrient Drink Test
Time frame: Baseline, Week 7
Change in Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life Score
Time frame: Baseline, Week 7
Mean Change From Baseline in Gastrointestinal Unhelpful Thinking Scale Pain Catastrophizing Subscale Score
Time frame: Baseline, Week 7
Mean Change From Baseline in Visceral Sensitivity Index Score
Time frame: Baseline, Week 7
Mean Change From Baseline in Fear of Food Questionnaire Score
Time frame: Baseline, Week 7
Mean Change From Baseline in Nine Item ARFID Screen Fear Subscale Score
Time frame: Baseline, Week 7
Mean Change From Baseline in PROMIS Physical Function Score
Time frame: Baseline, Week 7
Mean Change From Baseline in PROMIS Anxiety Score
Time frame: Baseline, Week 7
Mean Change From Baseline in PROMIS Depression Score
Time frame: Baseline, Week 7
Mean Change From Baseline in PROMIS Fatigue Score
Time frame: Baseline, Week 7
Mean Change From Baseline in PROMIS Sleep Disturbance Score
Time frame: Baseline, Week 7
Mean Change From Baseline in PROMIS Ability to Participate in Social Roles and Activities Score
Time frame: Baseline, Week 7
Mean Change From Baseline in PROMIS Pain Interference Score
Time frame: Baseline, Week 7
Mean Change From Baseline in PROMIS Pain Intensity Score
Time frame: Baseline, Week 7
Mean Change From Baseline in PROMIS Anger Score
Time frame: Baseline, Week 7
Percentage of Participants Who Complete the Pain Reprocessing Therapy Intervention
Time frame: Baseline, Week 7
Percentage of Participants Who Report Satisfaction With Pain Reprocessing Therapy
Time frame: Week 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Functional Dyspepsia
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
RecruitingPhase 4
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Functional Dyspepsia, Probiotics
RecruitingPhase 2
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Functional Gastrointestinal Disorders
Not yet recruitingObservational study
Interactive Effects of Early-Life Stress, Diet, and Metabolism on Gastrointestinal Dysfunction With Neuropsychiatric Symptoms
Irritable Bowel Syndrome (IBS), Functional Dyspepsia
Active, not recruitingObservational study
Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis
Irritable Bowel Syndrome, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Megan Petrick, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Reprocessing Therapy in people with Functional Dyspepsia, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonah Pedelty (507-538-7774, Pedelty.Jonah@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Average Gastroparesis Cardinal Symptom Index Score (time frame: Baseline, Week 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.