Efficacy of Chatbot for Irritable Bowel Syndrome (IBS) Patients (IrBiS)

February 14, 2025 updated by: Anton V. Vladzymyrskyy, Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department

Evaluation of the Efficacy of Chatbot-based Automated Support System for Patients with Irritable Bowel Syndrome (IBS)

The goal of this clinical trial is to evaluate the efficacy of an automated chatbot system in improving quality of life, reducing depression and anxiety, and decreasing visceral sensitivity in patients with Irritable Bowel Syndrome. The main research question is:

Is an automated chatbot as effective for patients with IBS as standard care? Participants will be asked to complete online surveys to assess quality of life, symptoms of depression and anxiety, and visceral sensitivity before and after the intervention.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The study consists of three stages:

Stage 1: Patients with Irritable Bowel Syndrome (IBS) who meet the eligibility criteria will be invited to participate in the study. After providing written informed consent, all participants will be asked to complete a set of questionnaires to assess various parameters:

  1. Irritable Bowel Syndrome Quality of Life (IBS-QOL);
  2. Quality of Life - Short Form-36 (SF-36);
  3. Symptoms of Anxiety and/or Depression - Hospital Anxiety and Depression Scale (HADS);
  4. State and Trait Anxiety Levels - State-Trait Anxiety Inventory (STAI);
  5. Visceral Sensitivity - Visceral Sensitivity Index (VSI);

Stage 2: Participants will be randomized into one of two groups: a chatbot group (intervention) and a standard care group (control). Prior to enrollment, both groups will receive a consultation with a gastroenterologist providing information on lifestyle, diet, and treatment. The intervention group will receive the access to a chatbot.

At the fourth and eighth week of follow-up participants in both groups will be asked to re-complete the set of questionnaires (IBS-QOL, SF-36, HADS, STAI, VSI). No routine gastroenterologist consultations will be scheduled during the follow-up period.

Stage 3: Results from the questionnaires will be analyzed and used to formulate conclusions.

Study Type

Interventional

Enrollment (Estimated)

54

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

  • Russian Federation
      • Moscow, Russian Federation, 127051
        • Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department

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:

  • Adults ≥18 years;
  • Diagnosed with IBS;
  • Signed informed consent.

Exclusion Criteria:

  • Age under 18 years;
  • Pregnant individuals;
  • Patients with cognitive or sensory impairments that hinder understanding of questions in surveys, scales, or instruments used in the study;
  • Patients unable to use a chatbot;
  • Patients currently participating in any other clinical trial or experimental study;
  • Patients with psychotic symptoms;
  • Patients with other conditions that may influence the endpoints of the current study.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chatbot group
The group will receive access to the automated chatbot supporting system. Each patient will receive a unique access code (token) to register for the chatbot. Only patients with tokens present in the authorized database will be able to register, thus ensuring that the chatbot is exclusively used by study participants.
Device: Chatbot supporting system

The intervention tool is the automated chatbot supporting system, which contains:

A) educational information (therapeutic education and psychoeducation); B) symptom monitoring (stool quality and frequency, assessment of mood, sleep quality, physical activity, and dietary adherence on a scale of 0 to 10); C) behavioral distraction techniques, and body tension reduction techniques.
No Intervention: Standart care group
The group will receive standart care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change the Health-related quality of life in IBS
Time Frame: 8 weeks

Change the quality of life in IBS according to Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire. The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. Max score is 100, min score is 0.

Higher score means better outcome
8 weeks
Change the Health-related quality of life in IBS
Time Frame: 8 weeks

Change the quality of life in IBS according to Short Form-36 (SF-36) questionnaire. The questionnaire consists of 8 sections:

  • Vitality;
  • Physical functioning;
  • Bodily pain;
  • General health perceptions;
  • Physical role functioning;
  • Emotional role functioning;
  • Social role functioning;
  • Mental health; For each section scores range from 0 to 100. Lower scores mean more disability, higher scores mean less disability.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change psychological well-being of patients with IBS measured by HADS
Time Frame: 8 weeks
Change psychological well-being of patients with IBS according to Hospital Anxiety and Depression Scale (HADS). Each item is scored on a response-scale with four alternatives ranging between 0 and 3. Score 8-10 for doubtful cases and ≥11 for definite cases of depression and anxiety.
8 weeks
Change psychological well-being of patients with IBD measured by VSI
Time Frame: 8 weeks
Change psychological well-being of patients with IBD according to Visceral Sensitivity Index (VSI). Min value is 0, max value is 75. 0-10 - no GI-specific anxiety; 11-30 - moderate GI-specific anxiety; 31 - 75 - severe GI-specific anxiety; Lower score means better outcome.
8 weeks
Change psychological well-being of patients with IBS measured by STAI
Time Frame: 8 weeks
Change psychological well-being of patients with IBS measured by State-Trait Anxiety Inventory (STAI) questionnaire. The STAI has 20 items to assess trait anxiety and 20 to assess state anxiety. The score range for each subscale is 20-80, the higher score indicating anxiety.
8 weeks

Collaborators and Investigators

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

Sponsor

Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department

Collaborators

I.M. Sechenov First Moscow State Medical University

Investigators

  • Study Director: Anton V. Vladzymyrskyy, PhD, Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department

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 (Estimated)

March 1, 2025

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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