Development of Self-administrable Psychological Intervention Programs Supported by New Technologies as a Treatment for Patients With Functional Digestive Disorders. - Trial NCT06318572
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.
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Study Focus
Sponsor & Location
Hospital Universitari Vall d'Hebron Research Institute
Timeline & Enrollment
N/A
Mar 09, 2023
Apr 30, 2025
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
Data Source
ClinicalTrials.gov
NCT06318572
Non-Device Trial