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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
54
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.
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
Moscow, Russia
Change the Health-related quality of life in IBS
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
Time frame: 8 weeks
Change the Health-related quality of life in IBS
Change the quality of life in IBS according to Short Form-36 (SF-36) questionnaire. The questionnaire consists of 8 sections: * Vitality; * Physical functioning; * Bodily pain; * General health perceptions; * Physical role functioning; * Emotional role functioning; * Social role functioning; * Mental health; For each section scores range from 0 to 100. Lower scores mean more disability, higher scores mean less disability.
Time frame: 8 weeks
Change psychological well-being of patients with IBS measured by HADS
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.
Time frame: 8 weeks
Change psychological well-being of patients with IBD measured by VSI
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.
Time frame: 8 weeks
Change psychological well-being of patients with IBS measured by STAI
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.
Time frame: 8 weeks
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