Clinical trial NCT06837064: Efficacy of Chatbot for Irritable Bowel Syndrome (IBS) Patients
Official title: Evaluation of the Efficacy of Chatbot-based Automated Support System for Patients with Irritable Bowel Syndrome (IBS)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Irritable Bowel Syndrome
Irritable Bowel Syndrome - Constipation
Irritable Bowel Syndrome - Diarrhoea
Irritable Bowel Syndrome - Mixed
Keywords: IBS
Irritable Bowel Syndrome
chatbot
eHealth
Lead sponsor: Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
Sponsor class: OTHER
Collaborators: name: I.M. Sechenov First Moscow State Medical University
First posted: 2025-02-20
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change the Health-related quality of life in IBS
timeFrame: 8 weeks
measure: Change the Health-related quality of life in IBS
timeFrame: 8 weeks
Secondary outcomes:
measure: Change psychological well-being of patients with IBS measured by HADS
timeFrame: 8 weeks
measure: Change psychological well-being of patients with IBD measured by VSI
timeFrame: 8 weeks
measure: Change psychological well-being of patients with IBS measured by STAI
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
Study officials:
affiliation: Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
name: Anton V. Vladzymyrskyy, PhD
role: STUDY_DIRECTOR
References: