A Persian AI-Based CBT Chatbot and Voice Analysis System for Managing Perceived Stress
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorHamid Reza Marateb
About this trial
This pilot randomized controlled trial aims to evaluate a Persian-language artificial intelligence (AI)-based cognitive behavioral therapy (CBT) chatbot designed to support adults in managing perceived stress.
A total of 120 adults will be randomly assigned to one of three groups: an AI-based CBT chatbot intervention, active mental health educational content, or a waitlist control. The intervention period will last 14 days. The study will evaluate the feasibility, acceptability, safety, and preliminary effectiveness of the AI-based CBT chatbot for perceived stress management. As a separate research component, voice recordings will be collected from participants at baseline and at the end of the study. These recordings will be used solely as research data to train and evaluate an artificial intelligence model for stress detection. The voice-based model will not be used to guide, modify, personalize, or influence the study intervention, chatbot responses, participant allocation, or clinical decision-making during this trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 45 years
Mild or moderate perceived stress based on the Perceived Stress Scale-10 (PSS-10) screening assessment
Ability to use a smartphone
Access to the internet during the study period
Disqualifiers
Severe perceived stress at the initial screening assessment
Active suicidal ideation or risk of self-harm
Acute psychological crisis requiring immediate professional intervention
Active psychosis
Trial design
Design model
Parallel
Treatments tested in this trial
Persian AI-Based CBT Chatbot
BehavioralA Persian-language artificial intelligence-based conversational intervention designed to provide structured support based on cognitive behavioral therapy principles for adults with mild to moderate perceived stress. The chatbot delivers interactive CBT-based exercises, including psychoeducation, identification and restructuring of maladaptive thoughts, coping strategies, behavioral techniques, and stress-management exercises. The intervention is delivered during a 14-day period and incorporates predefined safety guardrails and crisis-management procedures.
Active Mental Health Content
BehavioralStructured, non-adaptive mental health and stress-management educational content provided during the study period. The content is designed to provide general psychoeducation and stress-management support without personalized AI-generated dialogue or adaptive CBT interaction.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: AI-Based CBT ChatbotExperimental treatment 1 intervention
Group B: Active Mental Health ContentActive comparator 1 intervention
Group C: Waitlist ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Perceived Stress Scale-10 (PSS-10) Score
Change in total Perceived Stress Scale-10 (PSS-10) score from baseline to Day 14. The PSS-10 is used to assess perceived stress, with higher scores indicating greater perceived stress. Changes in PSS-10 scores will be compared across the three study groups.
Time frame
Baseline and Day 14Secondary outcomes
1
Change in DASS-21 Stress Subscale Score
Change in the DASS-21 Stress subscale score from baseline to Day 14. The stress subscale will be used as a complementary measure of short-term changes in stress across the three study groups.
Time frame
Baseline and Day 142
Number of Completed Intervention Sessions
Number of scheduled intervention sessions completed by each participant during the 14-day study period.
Time frame
Throughout the 14-day intervention periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hamid Reza Marateb
Lead sponsor
University of Isfahan
Sponsor institution
Isfahan University of Medical Sciences
Collaborator
University of Isfahan
Collaborator
Source ClinicalTrials.gov
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