Clinical trial NCT06979778: Testing the Efficacy of the "Syd" App on Improving Quality of Life and Mental Health Among University Students in the Kingdom of Saudi Arabia
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Quality of Life (QOL)
Anxiety
Stress
Affect (Mental Function)
Keywords: syd
QoL
See Yourself Differently
Quality of Life
mHealth
App
RCT
Lead sponsor: iamYiam Limited
Sponsor class: INDUSTRY
Collaborators: name: Alfaisal University
First posted: 2025-05-20
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

1. Does the "syd" app improve the quality of life for university students?
2. Does the "syd" app help lower anxiety and stress in university students
3. 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:

1. Use the "syd" app for 3 months.
2. Complete surveys about their quality of life, anxiety, stress, and feelings.

Detailed 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Known severe psychiatric or cognitive conditions that impede app usage
* Inability to provide informed consent

Primary outcomes:
measure: Change in Quality of Life Domain Scores
timeFrame: From enrolment to the end of treatment at 3 months
Secondary outcomes:
measure: Change in Anxiety Score
timeFrame: From enrolment to the end of treatment at 3 months
measure: Change in Perceived Stress Score
timeFrame: From enrolment to the end of treatment at 3 months
measure: Change in Positive and Negative Affect Scores
timeFrame: From enrolment to the end of treatment at 3 months
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Alfaisal University
Study officials:
affiliation: Alfaisal University
name: Ahmed Abu-Zaid, MD
role: PRINCIPAL_INVESTIGATOR
References: