Clinical Trial

Cognitive Behavioral Therapy for Functional Dyspepsia (Epigastric Pain Syndrome and Postprandial Distress Syndrome Subtypes)

Study acronym: FD-CBT
Not Yet Recruiting
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Summary
The goal of this clinical trial is to learn whether adding Cognitive Behavioral Therapy (CBT) to standard medical treatment can improve symptoms in adults with Functional Dyspepsia. The study includes adults aged 18 to 65 years diagnosed with Functional Dyspepsia, classified as Epigastric Pain Syndrome or Postprandial Distress Syndrome. The main questions it aims to answer are: Does Cognitive Behavioral Therapy added to standard treatment reduce gastrointestinal symptoms compared with standard treatment alone? Do patients with Postprandial Distress Syndrome and Epigastric Pain Syndrome respond differently to Cognitive Behavioral Therapy? Researchers will compare optimized standard medical treatment alone to optimized standard treatment combined with Cognitive Behavioral Therapy to see if the addition of CBT leads to greater symptom improvement and better quality of life. Participants will: Be randomly assigned to receive either standard medical treatment alone or standard treatment plus Cognitive Behavioral Therapy Take part in clinical visits and complete questionnaires about gastrointestinal symptoms, psychological well-being, and quality of life Provide blood, saliva, and stool samples at several time points over a 12-month follow-up period
Trial Details
NCT Number NCT07577089
Lead Sponsor Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Conditions Functional Dyspepsia, Epigastric Pain Syndrome, Postprandial Distress Syndrome
Enrollment 90 participants
Start Date 2026-04
Primary Completion 2027-02 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-11