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

NCT07577089 | Not Yet Recruiting

• 1 other identifier: RC2026-22
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Functional Dyspepsia; Epigastric Pain Syndrome; Postprandial Distress Syndrome

Keywords

Functional Dyspepsia; Cognitive Behavioral Therapy; Epigastric Pain Syndrome; Postprandial Distress Syndrome; Gut-Brain Axis; Microbiota; Randomized Controlled Trial; Disorders of Gut-Brain Interaction; Gastrointestinal Symptoms; Inflammation; Biomarkers; Precision Medicine

Outcome Measures

Primary Outcomes (1)

• Reduction in gastrointestinal symptom severity as assessed by the Leeds Dyspepsia Questionnaire - Short Form (LDQ-SF)

  The primary outcome is a statistically significant reduction in total LDQ-SF score in patients treated with CBT + optimized pharmacological treatment (OPT) compared to OPT alone, with an expected greater benefit in the Postprandial Distress Syndrome (PDS) subtype compared to the Epigastric Pain Syndrome (EPS) subtype. The LDQ-SF assesses the frequency and severity of dyspeptic symptoms (epigastric pain, heartburn, nausea, vomiting, early satiety, bloating, regurgitation, postprandial discomfort); scores range from 0 to 32, with higher scores indicating greater symptom severity. Responder status is defined as a ≥30-50% reduction in total LDQ-SF score from baseline.

  Baseline (T0), 3 months (T1 - end of intervention), 6 months (T2 - intermediate follow-up), 12 months (T3 - final follow-up)

Secondary Outcomes (32)

• Anxiety and Depression - Hospital Anxiety and Depression Scale (HADS)

  Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)

• Perceived Stress - Perceived Stress Scale (PSS)

  Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)

• Somatic Symptom Burden - Patient Health Questionnaire (PHQ-15)

  Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)

• Patient Global Impression of Change (PGIC)

  Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)

• Visceral Anxiety - Visceral Sensitivity Index (VSI)

  Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)

Other Outcomes (6)

• Weekly Symptom Diary - Frequency and Intensity of Gastrointestinal Symptoms

  Weekly from baseline through 12 months (T3)

• CBT Adherence Rate

  3 months (T1) and 6 months (T2 - booster session)

• CBT Drop-out Rate

  3 months (T1) and 6 months (T2 - booster session)

Study Arms (2)

Optimized Standard Treatment (OPT)

EXPERIMENTAL

Participants receive standard medical treatment for Functional Dyspepsia, including proton pump inhibitors, antiacids, and prokinetics at standard doses, according to clinical guidelines. No additional psychological intervention is provided.

Drug: Optimized Standard Treatment (OPT)

Cognitive Behavioral Therapy + Optimized Standard Treatment (CBT + OPT)

EXPERIMENTAL

Participants receive the same optimized standard medical treatment as the OPT arm, plus a manualized Cognitive Behavioral Therapy program. CBT consists of 10 individual sessions (60 minutes each) over 12 weeks, with a 6-month booster session. Sessions include psychoeducation, cognitive restructuring, stress management, coping strategies, interoceptive and behavioral exposure, relaxation, and nutritional integration. Adherence and engagement are monitored throughout the study.

Drug: Optimized Standard Treatment (OPT); Behavioral: Cognitive Behavioral Therapy + Optimized Standard Treatment (CBT + OPT)

Interventions

Optimized Standard Treatment (OPT) DRUG

Participants receive guideline-based standard medical treatment for Functional Dyspepsia, including proton pump inhibitors, antiacids, and prokinetics at recommended doses. This intervention does not include any psychological or behavioral therapy.

Cognitive Behavioral Therapy + Optimized Standard Treatment (CBT + OPT); Optimized Standard Treatment (OPT)

Cognitive Behavioral Therapy + Optimized Standard Treatment (CBT + OPT) BEHAVIORAL

Participants receive the same optimized standard medical treatment as the OPT arm, plus a manualized Cognitive Behavioral Therapy program. CBT consists of 10 individual sessions (60 minutes each) over 12 weeks, with a 6-month booster session. Sessions cover psychoeducation, cognitive restructuring, stress management, coping strategies, interoceptive/behavioral exposure, relaxation, and nutritional integration.

Cognitive Behavioral Therapy + Optimized Standard Treatment (CBT + OPT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• Diagnosis of Functional Dyspepsia according to Rome IV criteria
• Classification as Epigastric Pain Syndrome (EPS) or Postprandial Distress Syndrome (PDS)
• Active symptoms within the last month
• Willingness to participate in Cognitive Behavioral Therapy and provide biological samples for research
• Ability to provide written informed consent

You may not qualify if:

• Presence of structural gastrointestinal disease (e.g., peptic ulcer, malignancy)
• History of major abdominal surgery affecting the stomach or small intestine
• Severe psychiatric disorders (e.g., psychosis, bipolar disorder) interfering with participation
• Current participation in other interventional clinical trials
• Use of medications that may confound study outcomes (e.g., chronic corticosteroids, immunosuppressants)
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead

Related Publications (6)

• Huang Q, You F, Liang F, Ma C. Dietary microbes and functional dyspepsia: modulating the gut microecology for therapeutic benefit. Front Nutr. 2025 Aug 19;12:1625987. doi: 10.3389/fnut.2025.1625987. eCollection 2025.

  PMID: 40904772 BACKGROUND

• Cheng M, Zhou XE, Xu YC, Dou HM. The efficacy of cognitive behavior stress management on functional dyspepsia: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2022 May 13;101(19):e29157. doi: 10.1097/MD.0000000000029157.

  PMID: 35583527 BACKGROUND

• Sun E, Zhang X, Zhao Y, Li J, Sun J, Mu Z, Wang R. Beverages containing Lactobacillus paracasei LC-37 improved functional dyspepsia through regulation of the intestinal microbiota and their metabolites. J Dairy Sci. 2021 Jun;104(6):6389-6398. doi: 10.3168/jds.2020-19882. Epub 2021 Mar 11.

  PMID: 33714585 BACKGROUND

• Singh V, Lee G, Son H, Koh H, Kim ES, Unno T, Shin JH. Butyrate producers, "The Sentinel of Gut": Their intestinal significance with and beyond butyrate, and prospective use as microbial therapeutics. Front Microbiol. 2023 Jan 12;13:1103836. doi: 10.3389/fmicb.2022.1103836. eCollection 2022.

  PMID: 36713166 BACKGROUND

• Brown G, Hoedt EC, Keely S, Shah A, Walker MM, Holtmann G, Talley NJ. Role of the duodenal microbiota in functional dyspepsia. Neurogastroenterol Motil. 2022 Nov;34(11):e14372. doi: 10.1111/nmo.14372. Epub 2022 Apr 11.

  PMID: 35403776 BACKGROUND

• Wei Z, Xing X, Tantai X, Xiao C, Yang Q, Jiang X, Hao Y, Liu N, Wang Y, Wang J. The Effects of Psychological Interventions on Symptoms and Psychology of Functional Dyspepsia: A Systematic Review and Meta-Analysis. Front Psychol. 2022 Apr 8;13:827220. doi: 10.3389/fpsyg.2022.827220. eCollection 2022.

  PMID: 35465581 BACKGROUND

MeSH Terms

Conditions

Inflammation

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Laura Prospero, Psychologist

CONTACT

+390804994274; laura.prospero@irccsdebellis.it

Francesco Russo, MD

CONTACT

+390804994129; francesco.russo@irccsdebellis.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: May 11, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share