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Набор скоро начнётся 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

Без фазы С лечением Quality of Life (QOL) Anxiety Stress Affect (Mental Function)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: See Yourself Differently (syd) mobile app.
Кому может быть актуально
Состояния в реестре: Quality of Life (QOL), Anxiety, Stress, Affect (Mental Function). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Саудовская Аравия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

  • Устройство See Yourself Differently (syd) mobile app
    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 recommen

Первичные конечные точки

  • Change in Quality of Life Domain Scores [Срок оценки: From enrolment to the end of treatment at 3 months]
Вторичные конечные точки (3)
  • Change in Anxiety Score [Срок оценки: From enrolment to the end of treatment at 3 months]
  • Change in Perceived Stress Score [Срок оценки: From enrolment to the end of treatment at 3 months]
  • Change in Positive and Negative Affect Scores [Срок оценки: From enrolment to the end of treatment at 3 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Саудовская Аравия · 1 центр
  • Alfaisal University — Riyadh

Идентификаторы

NCT: NCT06979778 · 20250512

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗