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

5 maggio 2026 aggiornato da: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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

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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

90

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

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Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Optimized Standard Treatment (OPT)
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.
Droga: 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.
Sperimentale: 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 include psychoeducation, cognitive restructuring, stress management, coping strategies, interoceptive and behavioral exposure, relaxation, and nutritional integration. Adherence and engagement are monitored throughout the study.
Droga: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Reduction in gastrointestinal symptom severity as assessed by the Leeds Dyspepsia Questionnaire - Short Form (LDQ-SF)
Lasso di tempo: Baseline (T0), 3 months (T1 - end of intervention), 6 months (T2 - intermediate follow-up), 12 months (T3 - final follow-up)
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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Anxiety and Depression - Hospital Anxiety and Depression Scale (HADS)
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
Change from baseline in HADS total score and subscales (anxiety and depression) in CBT + OPT vs OPT alone. The HADS consists of 14 items divided into two subscales (anxiety and depression, 7 items each); each subscale ranges from 0 to 21, with higher scores indicating greater psychological distress. The total score ranges from 0 to 42.
Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
Perceived Stress - Perceived Stress Scale (PSS)
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
Change from baseline in perceived stress levels in CBT + OPT vs OPT alone. The PSS-10 consists of 10 items; scores range from 0 to 40, with higher scores indicating greater perceived stress.
Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
Somatic Symptom Burden - Patient Health Questionnaire (PHQ-15)
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
A 15-item measure of somatic symptom severity (range: 0-30). Higher scores indicate greater somatic symptom burden.
Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
Patient Global Impression of Change (PGIC)
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
Patient-reported subjective perception of overall improvement at each follow-up time point. A 7-point Likert scale assessing the patient's overall perception of improvement (range: 1-7). Higher scores indicate greater perceived improvement.
Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
Visceral Anxiety - Visceral Sensitivity Index (VSI)
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
A 15-item scale assessing gastrointestinal-specific anxiety (range: 0-75). Higher scores indicate greater anxiety and hypervigilance toward gastrointestinal sensations.
Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
Serum Interleukin-6 (IL-6)
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
Change from baseline in serum IL-6 levels (pg/mL) in CBT + OPT vs. OPT alone, as a marker of systemic inflammation.
Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
Serum Interleukin-8 (IL-8)
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Change from baseline in serum IL-8 levels (pg/mL) in CBT + OPT vs. OPT alone, as a marker of systemic inflammation.
Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Serum Interleukin-10 (IL-10)
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Change from baseline in serum IL-10 levels (pg/mL) in CBT + OPT vs. OPT alone, as a marker of anti-inflammatory response.
Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Serum Tumor Necrosis Factor-alpha (TNF-α)
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
Change from baseline in serum TNF-α levels (pg/mL) in CBT + OPT vs. OPT alone, as a marker of systemic inflammation.
Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
High-sensitivity C-Reactive Protein (hs-CRP)
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
Change from baseline in serum hs-CRP levels (mg/L) in CBT + OPT vs. OPT alone, as a marker of systemic low-grade inflammation.
Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
Diurnal Salivary Cortisol Profile
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Change from baseline in diurnal salivary cortisol levels (nmol/L), measured at 4 time points across the day, in CBT + OPT vs. OPT alone, as a marker of hypothalamic-pituitary-adrenal (HPA) axis activity and stress regulation.
Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Plasma Ghrelin
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Change from baseline in plasma ghrelin levels (pg/mL) in CBT + OPT vs. OPT alone, as a marker of appetite regulation and gut-brain axis signaling.
Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Plasma Cholecystokinin (CCK)
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Change from baseline in plasma CCK levels (pg/mL) in CBT + OPT vs. OPT alone, as a marker of postprandial satiety signaling and gastrointestinal motility.
Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Plasma Glucagon-Like Peptide-2 (GLP-2)
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Change from baseline in plasma GLP-2 levels (pg/mL) in CBT + OPT vs. OPT alone, as a marker of intestinal barrier integrity and mucosal growth.
Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Plasma Peptide YY (PYY)
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Change from baseline in plasma PYY levels (pg/mL) in CBT + OPT vs. OPT alone, as a marker of postprandial satiety and gut motility regulation.
Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Plasma Gastrin
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Change from baseline in plasma gastrin levels (pg/mL) in CBT + OPT vs. OPT alone, as a marker of gastric acid secretion and mucosal function.
Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Plasma Motilin
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Change from baseline in plasma motilin levels (pg/mL) in CBT + OPT vs. OPT alone, as a marker of gastric motility and interdigestive motor activity.
Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Plasma Leptin
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Change from baseline in plasma leptin levels (ng/mL) in CBT + OPT vs. OPT alone, as a marker of energy homeostasis and neuroendocrine regulation.
Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Plasma Serotonin (5-HT)
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Change from baseline in plasma serotonin levels (ng/mL) in CBT + OPT vs. OPT alone, as a marker of enteric nervous system signaling and gut-brain communication.
Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Plasma Brain-Derived Neurotrophic Factor (BDNF)
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Change from baseline in plasma BDNF levels (pg/mL) in CBT + OPT vs. OPT alone, as a marker of neuroplasticity and gut-brain axis modulation.
Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Plasma Cortisol
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Change from baseline in plasma cortisol levels (nmol/L) in CBT + OPT vs. OPT alone, as a marker of hypothalamic-pituitary-adrenal (HPA) axis activation and physiological stress response.
Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Fecal Zonulin
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
Change from baseline in fecal zonulin levels (ng/mL) in CBT + OPT vs. OPT alone, as a marker of intestinal barrier permeability and tight junction regulation.
Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
Fecal Calprotectin
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Change from baseline in fecal calprotectin levels (µg/g) in CBT + OPT vs. OPT alone, as a marker of intestinal mucosal inflammation.
Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Gut Microbiota Alpha Diversity - Observed Species
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
Change from baseline in observed species richness (count). Higher values indicate greater microbial richness.
Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
Gut Microbiota Beta Diversity - UniFrac Distance
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Change from baseline in UniFrac distance (unitless), reflecting phylogenetic dissimilarity between microbial communities. Higher values indicate greater dissimilarity.
Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Gut Microbiota Beta Diversity - Bray-Curtis Dissimilarity
Lasso di tempo: Baseline (T0), 3 months (T1 - end of intervention), 6 months (T2 - intermediate follow-up), 12 months (T3 - final follow-up)
Change from baseline in Bray-Curtis dissimilarity index (unitless). Higher values indicate greater compositional differences.
Baseline (T0), 3 months (T1 - end of intervention), 6 months (T2 - intermediate follow-up), 12 months (T3 - final follow-up)
Relative Abundance of Faecalibacterium prausnitzii
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Change from baseline in relative abundance (%) assessed by 16S rRNA sequencing in CBT + OPT vs. OPT alone.
Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Relative Abundance of Bifidobacterium spp.
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Change from baseline in relative abundance (%) assessed by 16S rRNA sequencing.
Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Predicted Butyrate Production Pathway Abundance
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Change from baseline in predicted abundance (arbitrary units) derived from 16S rRNA data in CBT + OPT vs. OPT alone.
Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Fecal Acetate
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
Change from baseline in fecal acetate concentration (µmol/g) in CBT + OPT vs. OPT alone
Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
Fecal Propionate
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
Change from baseline in fecal propionate concentration (µmol/g).
Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
Fecal Butyrate
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)
Change from baseline in fecal butyrate concentration (µmol/g).
Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Weekly Symptom Diary - Frequency and Intensity of Gastrointestinal Symptoms
Lasso di tempo: Weekly from baseline through 12 months (T3)
Self-reported daily frequency and intensity of gastrointestinal symptoms and medication use, recorded in a structured weekly diary throughout the study period using a numeric rating scale (range: 0-10). Higher scores indicate greater symptom severity.
Weekly from baseline through 12 months (T3)
CBT Adherence Rate
Lasso di tempo: 3 months (T1) and 6 months (T2 - booster session)
Proportion of participants who complete the planned cognitive behavioral therapy (CBT) sessions (10 individual sessions and a booster session at 6 months), expressed as a percentage. Higher values indicate greater adherence to the intervention.
3 months (T1) and 6 months (T2 - booster session)
CBT Drop-out Rate
Lasso di tempo: 3 months (T1) and 6 months (T2 - booster session)
Proportion of participants who discontinue the CBT intervention before completion, expressed as a percentage (%). Higher values indicate lower acceptability of the intervention.
3 months (T1) and 6 months (T2 - booster session)
Medication Use - Consumption of PPIs, Antacids, and Prokinetics
Lasso di tempo: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Change from baseline in the use of pharmacological treatments (proton pump inhibitors, antacids, prokinetics) as a proxy measure of clinical improvement and healthcare resource utilization.
Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)
Automatic Thoughts and Cognitive Triggers (CBT group only)
Lasso di tempo: Throughout the intervention (Months 3-6) and at 6 months (T2)
Exploratory analysis of CBT-specific cognitive variables, including automatic thoughts and behavioral triggers recorded on structured CBT sheets, as potential mediators of symptom improvement in the CBT + OPT group.
Throughout the intervention (Months 3-6) and at 6 months (T2)
Per-Protocol Subgroup Analysis
Lasso di tempo: 12 months (T3)
Pre-specified per-protocol analysis was restricted to participants who completed at least 80% of the CBT sessions and all biological sampling time points to assess treatment efficacy under optimal adherence conditions.
12 months (T3)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 aprile 2026

Completamento primario (Stimato)

1 febbraio 2027

Completamento dello studio (Stimato)

1 dicembre 2028

Date di iscrizione allo studio

Primo inviato

11 febbraio 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 maggio 2026

Primo Inserito (Effettivo)

11 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RC2026-22

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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