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

Irritable Bowel Syndrome Clinical Trial

Official title:

Desarrollo de Programas de intervención psicológica Autoadministrable Con Soporte de Nuevas tecnologías Como Tratamiento Para Pacientes Con Trastornos Funcionales Digestivos.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06318572
• Other study ID #: PR(AG)166/2021
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: March 2024
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Behavioral:
• Psychological intervention
Patients will have 3 visits during the 7 weeks study length. On day -7 a first visit will be made verifying that inclusion criteria are met, the informed consent will be obtained and a rectal sensitivity test will be performed. A symptom questionnaire will be delivered to the patient for daily assessment of gastrointestinal symptoms. On day 0, a stool sample will be collected and the symptom questionnaire will be reviewed to confirm inclusion criteria. Patients will begin the program of psychological intervention. A first, session of psychoeducation will be performed, and thereafter sessions of psychotherapy will be performed at home during 6 weeks. At the end of treatment a last visit will be performed, collecting the symptoms scored during the last 7 days. A new stool sample will be collected and a rectal sensitivity study will be performed. Severity of symptom questionnaire will be filled at the beginning, after 3 weeks, at the end of the treatment, at 3 months and at 6 months.
• Placebo
Patients will have 3 visits during the 7 weeks study length. On day -7 a first visit will be made verifying that inclusion criteria are met, the informed consent will be obtained and a rectal sensitivity test will be performed. A symptom questionnaire will be delivered to the patient for daily assessment of gastrointestinal symptoms. On day 0, a stool sample will be collected and the symptom questionnaire will be reviewed to confirm inclusion criteria. Patients will be instructed to take a capsule containing 0.5 g during 6 weeks. At the end of treatment a last visit will be performed, collecting the symptoms scored during the last 7 days, A new stool sample will be collected and a rectal sensitivity study will be performed. Severity of symptom questionnaire will be filled at the beginning, after 3 weeks, at the end of the treatment, at 3 months and at 6 months.

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of abdominal symptoms	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.	6 months
Secondary	IBS related Quality of life	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).	6 weeks
Secondary	Stress	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).	6 weeks
Secondary	Anxiety and depression	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).	6 weeks
Secondary	Somatic co-morbidities	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).	6 weeks
Secondary	Rectal sensitivity	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.	6 weeks
Secondary	Analysis of gut microbiota composition	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.	6 weeks