Efficacy of Chatbot for Irritable Bowel Syndrome (IBS) Patients

NCT06837064 | Enrolling By Invitation

• 1 other identifier: 2025-1
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irritable Bowel Syndrome; Irritable Bowel Syndrome - Constipation; Irritable Bowel Syndrome - Diarrhoea; Irritable Bowel Syndrome - Mixed

Keywords

IBS; Irritable Bowel Syndrome; chatbot; eHealth

Outcome Measures

Primary Outcomes (2)

• Change the Health-related quality of life in IBS

  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

  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 Outcomes (3)

• Change psychological well-being of patients with IBS measured by HADS

  8 weeks

• Change psychological well-being of patients with IBD measured by VSI

  8 weeks

• Change psychological well-being of patients with IBS measured by STAI

  8 weeks

Study Arms (2)

Chatbot group

EXPERIMENTAL

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

Standart care group

NO INTERVENTION

The group will receive standart care.

Interventions

Chatbot supporting system DEVICE

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.

Chatbot group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department: lead
• I.M. Sechenov First Moscow State Medical University: collaborator

Study Sites (1)

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

Moscow, 127051, Russia

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Anton V. Vladzymyrskyy, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director for Research

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 20, 2025
• Study Start: March 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

RU (1)