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Enrolling by Invitation

NCT Number: NCT06837064

Efficacy of Chatbot for Irritable Bowel Syndrome (IBS) Patients

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome - Constipation Irritable Bowel Syndrome - Diarrhoea Irritable Bowel Syndrome - Mixed

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Moscow, 127051, Russia

About this study

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:

  • Irritable Bowel Syndrome Quality of Life (IBS-QOL);
  • Quality of Life - Short Form-36 (SF-36);
  • Symptoms of Anxiety and/or Depression - Hospital Anxiety and Depression Scale (HADS);
  • State and Trait Anxiety Levels - State-Trait Anxiety Inventory (STAI);
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • I.M. Sechenov First Moscow State Medical University

Registry information

Official study title

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

Acronym: IrBiS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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