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

March 15, 2024 updated by: Hospital Universitari Vall d'Hebron Research Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Behavioral: 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.
Experimental: Psychological 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of abdominal symptoms
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IBS related Quality of life
Time Frame: 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).
6 weeks
Stress
Time Frame: 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).
6 weeks
Anxiety and depression
Time Frame: 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).
6 weeks
Somatic co-morbidities
Time Frame: 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).
6 weeks
Rectal sensitivity
Time Frame: 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.
6 weeks
Analysis of gut microbiota composition
Time Frame: 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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AG)166/2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Irritable Bowel Syndrome

Clinical Trials on Psychological intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe