Efficacy of Chatbot for Irritable Bowel Syndrome (IBS) Patients

Not Applicable

• Conditions: Irritable Bowel Syndrome; Irritable Bowel Syndrome - Constipation; Irritable Bowel Syndrome - Diarrhoea; Irritable Bowel Syndrome - Mixed

• Registration Number: NCT06837064
• Lead Sponsor: Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department

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.

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 Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-14
• Last Update Submitted: 2025-02-14
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20
• Study Start: 2025-03
• Primary Completion: 2025-05
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change the Health-related quality of life in IBS	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 Outcome Measures

Name	Time	Method
Change psychological well-being of patients with IBS measured by HADS	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.
Change psychological well-being of patients with IBD measured by VSI	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.
Change psychological well-being of patients with IBS measured by STAI	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.

Trial Locations

Locations (1)

Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department; 🇷🇺 Moscow, Russian Federation