Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318572
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-02-22
Brief Title:
Development of Self-administrable Psychological Intervention Programs Supported by New Technologies as a Treatment for Patients With Functional Digestive Disorders
Sponsor:
Hospital Universitari Vall dHebron Research Institute
Organization:
Hospital Universitari Vall dHebron Research Institute
Study Overview
Official Title:
Desarrollo de Programas de intervención psicológica Autoadministrable Con Soporte de Nuevas tecnologías Como Tratamiento Para Pacientes Con Trastornos Funcionales Digestivos
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 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
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 11 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None