NCT06837064

Efficacy of Chatbot for Irritable Bowel Syndrome (IBS) Patients

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irritable Bowel Syndrome
• Irritable Bowel Syndrome - Constipation
• Irritable Bowel Syndrome - Diarrhoea
• Irritable Bowel Syndrome - Mixed

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-05-01
• Completion: 2025-08-01
• First posted: 2025-02-20
• Last updated: 2025-02-20

Locations

1 site across 1 country: Russia