Clinical trials

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.