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| Name | Class |
|---|---|
| Alfaisal University | UNKNOWN |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| syd app | Experimental | 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 |
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| Wait list control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| See Yourself Differently (syd) mobile app | Device | The 'syd' mobile app 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life Domain Scores | 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. | From enrolment to the end of treatment at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anxiety Score | Change in Anxiety scores as measured through the General Anxiety Disorder-7 (GAD-7) questionnaire. The GAD-7 scoring system uses a simple system to assess anxiety levels. Each of the seven questions on the GAD-7 questionnaire is scored from 0 to 3, with 0 representing "not at all" and 3 representing "nearly every day." The total score is calculated by adding up the scores for all seven questions, resulting in a total score ranging from 0 to 21. Score interpretation: 0-4: Minimal to no anxiety; 5-9: Mild anxiety; 10-14: Moderate anxiety; 15 or higher: Severe anxiety. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pedro M Henriques, PhD | Contact | +351928091841 | pedro.henriques@syd.life | |
| Lorena Puica | Contact | lorena@syd.life |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed Abu-Zaid, MD | Alfaisal University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alfaisal University | Riyadh | 11533 | Saudi Arabia |
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| From enrolment to the end of treatment at 3 months |
| Change in Perceived Stress Score | Change in Perceived Stress Score as measured through the Perceived Stress Scale (PSS) questionnaire. The PSS scores are determined by summing individual item responses and interpreting the total score. Higher scores indicate a higher level of perceived stress. The total score can range from 0 to 56, with higher scores reflecting higher levels of stress. | From enrolment to the end of treatment at 3 months |
| Change in Positive and Negative Affect Scores | Change in Positive and Negative Affect Scores as measured through the Positive and Negative Affect Schedule - Expanded Version (PANAS-X) questionnaire. The PANAS-X is composed of 60 items (emotions) on a 5-point scale (1 to 5) where participants can indicating how much they feel each emotion. A total positive and negative affect score is calculated by summing the responses for the respective sets of items. Higher scores on the positive affect scale indicate greater positive affect, while lower scores on the negative affect scale indicate less negative affect. | From enrolment to the end of treatment at 3 months |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
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