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Enrolling by invitation NCT06837064

Efficacy of Chatbot for Irritable Bowel Syndrome (IBS) Patients

No phase Interventional Irritable Bowel Syndrome Irritable Bowel Syndrome - Constipation Irritable Bowel Syndrome - Diarrhoea Irritable Bowel Syndrome - Mixed

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chatbot supporting system.
Who it may be relevant to
Registry conditions: Irritable Bowel Syndrome, Irritable Bowel Syndrome - Constipation, Irritable Bowel Syndrome - Diarrhoea, Irritable Bowel Syndrome - Mixed. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Change the Health-related quality of life in IBS [Time frame: 8 weeks]
  • Change the Health-related quality of life in IBS [Time frame: 8 weeks]
Secondary outcome measures (3)
  • Change psychological well-being of patients with IBS measured by HADS [Time frame: 8 weeks]
  • Change psychological well-being of patients with IBD measured by VSI [Time frame: 8 weeks]
  • Change psychological well-being of patients with IBS measured by STAI [Time frame: 8 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Russia · 1 center
  • Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of th — Moscow

Identifiers

NCT: NCT06837064 · 2025-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗