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The goal of this clinical trial is to learn if using the "See Yourself Differently" (syd) app can help improve quality of life and mental health for university students in Saudi Arabia. The study also aims to see if the app can help lower anxiety and stress, and increase positive feelings while decreasing negative feelings.
The main questions it aims to answer are:
Researchers will compare students who use the "syd" app to see if it works.
Participants will:
Full description
This clinical trial outlines a prospective, parallel-group, single-blind randomised controlled trial to be conducted at Alfaisal University in the Kingdom of Saudi Arabia. The study will enrol 600 university students and staff members and will run for a 3-month intervention period.
The intervention focuses on the 'syd' mobile application, an AI-powered "Life Quality Mentor" designed to enhance users' quality of life. The app aims to support positive habit development by providing personalised feedback and continuous support. Key features include personalised guidance across various domains such as nutrition, sleep performance, stress management (including guided meditations and journaling), and financial well-being. The 'syd' app utilizes an advanced Artificial Intelligence (AI) platform, offering an AI conversational agent for motivational coaching, habit tracking tools, and integration with wearable technology.
Participants will be randomly allocated to either an experimental group, which will use the 'syd' app, or a control group. Those in the experimental group will be instructed to use the 'syd' app for the 3-month duration of the study.
Data will be collected at multiple time points: at baseline (prior to intervention), monthly during the 3-month intervention period, and at a final follow-up post-intervention. The primary data collection methods will involve validated research instruments (WHOQOL-BREF, PANAS-X, GAD-7, PSS) administered via Typeform surveys. Additionally, in-app data will be collected to monitor app usage, specifically the frequency and duration of engagement. Socio-demographic information will also be gathered.
Survey data will be stored securely within Typeform, and in-app data will be stored within the 'syd' application's database, hosted securely on Amazon Web Services (AWS). All data storage will comply with Alfaisal University's data security policies. To protect participant privacy, data will be anonymised or de-identified where possible, and access will be restricted to authorised research team members. Data will be encrypted during storage and transmission.
For data analysis, linear mixed-effects modelling will be employed, incorporating random intercepts for participants and fixed effects for time, group, and the time x group interaction. The analysis will adhere to intention-to-treat principles. Should missing data occur, multiple imputation will be considered if feasible. Data from Typeform surveys will be exported and cleaned, in-app data will be extracted and processed, and data from these different sources will be merged for comprehensive analysis
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600 participants in 2 patient groups
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Central trial contact
Pedro M Henriques, PhD; Lorena Puica
Data sourced from clinicaltrials.gov
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