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

5. maj 2026 opdateret af: 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

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Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.
Eksperimentel: 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.
Medicin: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Reduction in gastrointestinal symptom severity as assessed by the Leeds Dyspepsia Questionnaire - Short Form (LDQ-SF)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Anxiety and Depression - Hospital Anxiety and Depression Scale (HADS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Weekly Symptom Diary - Frequency and Intensity of Gastrointestinal Symptoms
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

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Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. april 2026

Primær færdiggørelse (Anslået)

1. februar 2027

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

11. februar 2026

Først indsendt, der opfyldte QC-kriterier

5. maj 2026

Først opslået (Faktiske)

11. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RC2026-22

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