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

Not Applicable

Recruiting

• Conditions: Irritable Bowel Syndrome
• Interventions: Behavioral: Placebo; Behavioral: Psychological intervention

• Registration Number: NCT06318572
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-09
• Study First Submitted: 2024-02-22
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Study First Posted: 2024-03-19
• Last Update Posted: 2024-03-19
• Primary Completion: 2024-12-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• BMI (Body Mass Index) between 18.5-24.99, with variations of up to 15%.
• Ability to understand instructions and follow protocol.
• Access to internet network from usual residence.

Exclusion Criteria

• Previous history of abdominal surgery with the exception of appendectomy and herniorrhaphy.
• Abuse of alcohol, tobacco or narcotics.
• Medical evidence of organic gastrointestinal pathology, hepatopathy, endocrinopathy, heart disease or contagious disease, as well as major psychiatric disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Psychological intervention	Psychological intervention	-

Primary Outcome Measures

Name	Time	Method
Severity of abdominal symptoms	6 months	Changes from basal scores in the severity of abdominal symptoms will be calculated using the irritable bowel syndrome-symptom severity score (IBS-SSS), where score 0 is the lack of symptoms, and score 500 is maximal severity of symptoms.

Secondary Outcome Measures

Name	Time	Method
Somatic co-morbidities	6 weeks	Changes from basal scores in the somatic co-morbidities will be calculated using the personal health questionnaire (PHQ-15). Score range 0 (no somatization-30 highest somatization).
IBS related Quality of life	6 weeks	Changes from basal scores in the IBS related quality of life will be calculated using the irritable Bowel Syndrome Quality of Life Questionnaires (IBS-QoL). Rated from 0-100 % (worst-best quality of life).
Stress	6 weeks	Changes from basal scores in the patients perceived stress will be calculated using the perceived stress scale (PSS). Score range 0 (no stress-40 highest perceived stress).
Anxiety and depression	6 weeks	Changes from basal scores in the anxiety and depression rated by patients will be calculated using the hospital anxiety and depression scale (HAD). Score range 0 (no anxiety/depression-21 highest anxiety and depression in the respective scales).
Rectal sensitivity	6 weeks	Changes from basal scores in the sensitivity induced by progressive rectal distension applied by means of a barostat, will be calculated using a 0 (no perception)-6 (painful sensation) score scale.
Analysis of gut microbiota composition	6 weeks	Changes from basal scores in the alfa and beta diversity and relative abundance of gut microbes will be calculated using 16S rRNA bacterial metagenomic sequencing.

Trial Locations

Locations (1)

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain