A Randomized Controlled Trial to Assess the Efficacy of the "Syd" App on Improving Quality of Life and Mental Health Among University Students in the Kingdom of Saudi Arabia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Change in Quality of Life Domain Scores
研究概览
简要总结
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:
- Does the "syd" app improve the quality of life for university students?
- Does the "syd" app help lower anxiety and stress in university students
- Does the "syd" app help increase positive feelings and decrease negative feelings in university students?
Researchers will compare students who use the "syd" app to see if it works.
Participants will:
- Use the "syd" app for 3 months.
- Complete surveys about their quality of life, anxiety, stress, and feelings.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years.
- •Enrolled as a full-time medical student at the Alfaisal university.
- •Owning a smartphone (iOS or Android) compatible with the "syd" app.
- •Willing to provide informed consent and comply with study procedures
排除标准
- •Known severe psychiatric or cognitive conditions that impede app usage
- •Inability to provide informed consent
研究组 & 干预措施
syd app
The 'syd' application is designed as an AI-powered "Life Quality Mentor" with the primary aim of enhancing users' quality of life. The app focuses on positive habit development, personalised feedback, and continuous support. It offers personalised guidance across various domains, including Physical health, Emotional health, Brain power, Self-awareness, Purpose, Career, Financial health, Social life and Environment. It utilizes an advanced AI platform and offers features like personalised recommendations, supportive interaction with an AI mentor, habit tracking tools, and integration with wearable technology.
The intervention arm will have full access to the 'syd' app and be able to interact with it for the 3 months duration of the trial
干预措施: See Yourself Differently (syd) mobile app (Device)
Wait list control
The wait list control arm will not receive access to the 'syd' app for the 3 months' duration of the trial, but will be given full lifetime access thereafter.
结局指标
主要结局
Change in Quality of Life Domain Scores
时间窗: From enrolment to the end of treatment at 3 months
Quality of Life (QoL) as measured through the WHOQOL-BREF instrument. The WHOQOL-BREF is a 26-item questionnaire which uses a scoring system that assesses quality of life across four domains: physical health, psychological health, social relationships, and environmental health. Each item is scored on a 5-point scale (1-5) and transformed to a 0-100 scale. Domain scores are calculated by summing relevant item scores and transforming them to a 0-100 scale. Higher scores indicate better quality of life in a specific domain.
次要结局
- Change in Anxiety Score(From enrolment to the end of treatment at 3 months)
- Change in Perceived Stress Score(From enrolment to the end of treatment at 3 months)
- Change in Positive and Negative Affect Scores(From enrolment to the end of treatment at 3 months)