Health TrialsbyHealthPanel

A Pilot Investigation of Pain Reprocessing Therapy for Functional Dyspepsia

ConditionFunctional Dyspepsia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Pain Reprocessing TherapyExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Baseline, Week 7

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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