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

Официальное название

Multimodal Phenotyping of Functional Dyspepsia: Controlled Trial on Response to Cognitive-Behavioral Therapy in Subtypes of Epigastric Pain Syndrome and Postprandial Discomfort Syndrome

Обзор

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

Подробное описание

Functional Dyspepsia is a chronic disorder of gut-brain interaction characterized by persistent upper gastrointestinal symptoms in the absence of structural disease. It is commonly classified into Epigastric Pain Syndrome and Postprandial Distress Syndrome, which may reflect partially distinct underlying mechanisms. Standard medical treatments often provide incomplete symptom relief, and growing evidence supports a role for psychological factors and gut-brain axis dysregulation in symptom generation and persistence.

This randomized controlled trial investigates the effectiveness of adding a manualized Cognitive Behavioral Therapy program to optimized standard medical treatment in adults with Functional Dyspepsia. Participants are stratified by dyspepsia subtype and randomly assigned in a 1:1 ratio to receive either optimized standard treatment alone or optimized standard treatment combined with Cognitive Behavioral Therapy. Outcome assessors are blinded to treatment allocation.

The Cognitive Behavioral Therapy intervention is delivered individually by trained therapists and focuses on psychoeducation, cognitive restructuring, stress management, coping strategies, and behavioral and interoceptive exposure. The intervention is designed to target symptom-related cognitions, emotional responses, and behavioral patterns that may contribute to symptom persistence.

In addition to evaluating clinical efficacy, the study adopts a multimodal approach to characterize biological, psychological, and clinical factors associated with treatment response. Data collection includes clinical and psychological assessments and the collection of biological samples to explore markers related to inflammation, stress regulation, gut barrier function, and gut microbiota composition and activity. Measurements are obtained at baseline and during follow-up to assess changes over time and their relationship with symptom improvement.

The study aims to identify predictors of response to Cognitive Behavioral Therapy and to explore differences between Epigastric Pain Syndrome and Postprandial Distress Syndrome. By integrating clinical, psychological, and biological data, the trial seeks to support a more personalized treatment approach for Functional Dyspepsia and to improve the targeting of psychological interventions in clinical practice.

Вмешательства

• Препарат Optimized Standard Treatment (OPT)
  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.
• Поведенческое Cognitive Behavioral Therapy + Optimized Standard Treatment (CBT + OPT)
  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.

Первичные конечные точки

• Reduction in gastrointestinal symptom severity as assessed by the Leeds Dyspepsia Questionnaire - Short Form (LDQ-SF) [Срок оценки: Baseline (T0), 3 months (T1 - end of intervention), 6 months (T2 - intermediate follow-up), 12 months (T3 - final follow-up)]

Вторичные конечные точки (12)

• Anxiety and Depression - Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)]
• Perceived Stress - Perceived Stress Scale (PSS) [Срок оценки: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)]
• Somatic Symptom Burden - Patient Health Questionnaire (PHQ-15) [Срок оценки: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)]
• Patient Global Impression of Change (PGIC) [Срок оценки: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)]
• Visceral Anxiety - Visceral Sensitivity Index (VSI) [Срок оценки: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)]
• Serum Interleukin-6 (IL-6) [Срок оценки: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)]
• Serum Interleukin-8 (IL-8) [Срок оценки: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)]
• Serum Interleukin-10 (IL-10) [Срок оценки: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)]
• Serum Tumor Necrosis Factor-alpha (TNF-α) [Срок оценки: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)]
• High-sensitivity C-Reactive Protein (hs-CRP) [Срок оценки: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)]
• Diurnal Salivary Cortisol Profile [Срок оценки: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)]
• Plasma Ghrelin [Срок оценки: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07577089 · RC2026-22

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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