Irritable Bowel Syndrome, Irritable Bowel Syndrome - Constipation, Irritable Bowel Syndrome - Diarrhoea, Irritable Bowel Syndrome - Mixed
Conditions
Keywords
IBS, Irritable Bowel Syndrome, chatbot, eHealth
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.
Interventions
DEVICEChatbot 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.
Sponsors
I.M. Sechenov First Moscow State Medical University
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change the Health-related quality of life in IBS | 8 weeks | Change the quality of life in IBS according to Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire. The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. Max score is 100, min score is 0. Higher score means better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Russia
Outcome results
None listed