An interventional study of Chatbot supporting system in Irritable Bowel Syndrome, Irritable Bowel Syndrome - Constipation and Irritable Bowel Syndrome - Diarrhoea, sponsored by Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department. Enrolling by invitation at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-20.
Sponsored by Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department · Not applicable, Interventional, and Supportive care
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:
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.
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
This study's planned enrollment of 54 is below the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department is the lead sponsor of 11 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The group will receive access to the automated chatbot supporting system. Each patient will receive a unique access code (token) to register for the chatbot. Only patients with tokens present in the authorized database will be able to register, thus ensuring that the chatbot is exclusively used by study participants.
Device: Chatbot supporting system
The group will receive standart care.
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.
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
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Mar 2025; primary completion for May 2025, 2 months later.
Of 305 non-industry interventional studies with no phase under Irritable Bowel Syndrome, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 40. This study's planned 2 months is below that.
Counting every sponsor, half of 357 studies reached it within 19 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department