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

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

Status: Invitation-only

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

Treatments: Device: Chatbot supporting system

Study type: Interventional

Funder types: Other

Identifiers

NCT06837064

2025-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

Chatbot group

Experimental group

Description:

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.

Treatment:

Device: Chatbot supporting system

Standart care group

No Intervention group

Description:

The group will receive standart care.