Pure Global
NCT06318572

Development of Self-administrable Psychological Intervention Programs Supported by New Technologies as a Treatment for Patients With Functional Digestive Disorders.

Desarrollo de Programas de intervención psicológica Autoadministrable Con Soporte de Nuevas tecnologías Como Tratamiento Para Pacientes Con Trastornos Funcionales Digestivos.
Hospital Universitari Vall d'Hebron Research Institute·ClinicalTrials.gov·behavioralRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Irritable Bowel Syndrome
Drug/Device/Intervention
Psychological intervention
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
Hospital Universitari Vall d'Hebron Research Institute
Location
Barcelona, Spain
Timeline & enrollment
Phase
N/A
Start date
Mar 09, 2023
End date
Apr 30, 2025
Enrollment
100 participants
Primary outcome

Severity of abdominal symptoms

Summary

Disorders of gut-brain interaction (DGBI) are produced by disturbances in the interplay
 between the gut and the central nervous system. Several psychological factors like anxiety,
 depression and altered coping are over-represented in these disorders. Recent surveys have
 shown that DGBI affect up to 40 % of the general population.
 
 Psychological interventions like cognitive behavioral therapy and hypnosis have been shown to
 be beneficial for managing these disorders. However, access to psychological interventions is
 very limited due to lack of resources to treat these very frequent conditions.
 
 OBJECTIVE: To determine the effects of psychological interventions using specifically
 developed therapeutic programs based on virtual reality, for telematic use at home, on
 symptoms severity, comorbidities, visceral sensitivity and intestinal dysbiosis in patients
 with DGBI.
 
 METHODOLOGY: After development of a program of psycho-education on DGBI using interactive
 immersion by means of virtual reality (VR) a randomized clinical trial will be developed.
 Consecutive patients will be randomized 1:1 to active treatment or placebo. In each patient
 in the active treatment group a session of psychoeducation using specifically developed
 VR-video leaded by a gastroenterologists, will be followed by telematic weekly group sessions
 of psycho-education leaded by a psychologist. During the 6 weeks of the treatment period
 patients will be instructed to perform self-administrable sessions of psychotherapy at home
 (by means VR). Patients in the placebo group willl take a placebo capsule daily.
 
 OUTCOME MEASURES. In all patients, severity of symptoms (primary outcome), QoL, somatic and
 psychological comorbidities (using specific questionnaires), visceral sensitivity (by means
 of a barostat) and microbiota analysis, will be performed before and at the end of the
 treatment period. Symptom severity will be assess also in follow-up phone calls at 3 and 6
 months.

ICD-10 classifications
Irritable bowel syndromeOther and unspecified irritable bowel syndromeIrritable bowel syndrome with mixed bowel habits [IBS-M]Irritable bowel syndrome with predominant constipation [IBS-C]Irritable bowel syndrome with predominant diarrhoea [IBS-D]
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06318572
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06318572 through Pure Global AI's free database. This phase not specified trial is sponsored by Hospital Universitari Vall d'Hebron Research Institute and is currently Recruiting. The study focuses on Irritable Bowel Syndrome. Target enrollment is 100 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.