跳至主要内容
临床试验/NCT07489222
NCT07489222已完成不适用

A Faith-Based Mobile Application for Mental Health and Well-Being Among University Students: A Single-Arm Feasibility and Preliminary Effectiveness Trial

Fit Minded1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2025年9月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
450
试验地点
1
主要终点
Acceptability (satisfaction)

研究概览

简要总结

This single-arm feasibility and preliminary effectiveness trial examines PRAY.COM, a faith and prayer mobile application (app), among university students. Enrolled students at Regent University are asked to use the app for at least 10 minutes per day for 8 weeks. Feasibility is assessed by app demand (≥70% weekly use benchmark) and acceptability (≥75% satisfaction benchmark). Preliminary effectiveness is assessed at baseline, 4 weeks, and 8 weeks for mental health (depressive symptoms, anxiety, stress), well-being (loneliness, sense of purpose and meaning), and academic outcomes (time management confidence, school-life balance satisfaction, confidence managing academic challenges, feeling overwhelmed by academic responsibilities, classes missed due to mental health, difficulty concentrating, frequency of mental health negatively impacting academic performance, and difficulty completing coursework). Three analysis groups are examined: completers with confirmed objective app engagement (primary), all 8-week completers (secondary), and all enrolled participants using last observation carried forward imputation (tertiary).

详细描述

This study is a single-arm feasibility and preliminary effectiveness trial conducted with currently enrolled students at Regent University. Participants are recruited via a university-wide email listserv and are asked to use the PRAY.COM app, a faith-based mobile application delivering Daily Prayer, Meditative Prayers, Scripture Readings, Bedtime Bible Stories, Podcasts, Sermons, a Bible in a Year program, and Pray AI (an AI-powered faith companion), for at least 10 minutes per day over 8 weeks. No instructions are given regarding which specific features or content to engage with. Upon completing the baseline survey, participants receive a complimentary premium PRAY.COM subscription for the duration of the study.

Feasibility is assessed across demand and acceptability domains. Demand is operationalized as the percentage of participants reporting at least weekly app use with a benchmark of ≥70%. Acceptability is operationalized as the percentage of participants reporting satisfaction (satisfied or very satisfied) with a benchmark of ≥75%. Additional feasibility indicators include perceived appropriateness for students and intent to continue use. Objective app usage data are obtained directly from PRAY.COM to complement self-reported engagement.

Preliminary effectiveness outcomes are assessed using validated measures at baseline, 4 weeks, and 8 weeks. Mental health outcomes include depressive symptoms, anxiety, and stress (DASS-9; 3 items each, 0-3 scale), and loneliness (UCLA-3; 3 items, 1-3 scale). Well-being outcomes include sense of purpose and meaning (2 items adapted from the Claremont Purpose Scale, 1-5 scale). Academic outcomes include time management confidence, school-life balance satisfaction, confidence managing academic challenges, feeling overwhelmed by academic responsibilities, classes missed due to mental health, difficulty concentrating, frequency of mental health negatively impacting academic performance, and difficulty completing coursework (8 investigator-developed items).

Statistical approach: Pre-post changes are analyzed using Wilcoxon signed-rank tests with normality of change scores assessed via Shapiro-Wilk tests. Effect sizes are calculated as Cohen's d (mean change / SD of change scores). Three analysis groups are examined: 1) the primary per-protocol sample of 8-week completers with confirmed objective app engagement (i.e., having at least one recorded app session exceeding one second); 2) a secondary analysis of all 8-week completers regardless of objective engagement status; and 3) a tertiary full-enrollment analysis using last observation carried forward (LOCF) imputation as a conservative lower-bound estimate, with multiple imputation as a sensitivity check. Additional analyses examine dose-response relationships, subgroup differences (age, sex, race/ethnicity, student type), and baseline severity effects.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Currently enrolled university student with a corresponding institutional email address (@edu)
  • 18 years of age or older
  • US resident
  • Able to read and understand English
  • Willing to complete brief surveys including questions related to faith and faith-based practices
  • Willing to download a faith and prayer mobile application onto a smartphone or tablet

排除标准

  • Not a currently enrolled university student or does not have a corresponding institutional email address
  • Less than 18 years of age
  • Not a US resident
  • Unable to read or understand English
  • Not willing to complete surveys related to faith and faith-based practices
  • Not willing to download a faith and prayer mobile application

结局指标

主要结局

Acceptability (satisfaction)

时间窗: Measured at 4 weeks and 8 weeks

Percentage of participants reporting satisfied or very satisfied; benchmark ≥75%

Demand

时间窗: From enrollment to 4 and 8 weeks

Percentage of participants reporting at least weekly app use; benchmark ≥70%

次要结局

  • Perceived appropriateness(4 weeks and 8 weeks)
  • Intent to continue use(4 weeks and 8 weeks)
  • Time Management Confidence(Baseline, 4 weeks, 8 weeks)
  • School-life balance satisfaction(Baseline, 4 weeks, 8 weeks)
  • Confidence managing academic challenges(Baseline, 4 weeks, 8 weeks)
  • Feeling overwhelmed(Baseline, 4 weeks, 8 weeks)
  • Difficulty concentrating(Baseline, 4 weeks, 8 weeks)
  • Classes missed due to mental health(Baseline, 4 weeks, 8 weeks)
  • Mental health negatively impacted academics(Baseline, 4 weeks, 8 weeks)
  • Difficulty completing coursework(Baseline, 4 weeks, 8 weeks)
  • Depressive symptoms(Baseline, 4 weeks, 8 weeks)
  • Anixety(Baseline, 4 weeks, 8 weeks)
  • Stress(Baseline, 4 weeks, 8 weeks)
  • Loneliness(Baseline, 4 weeks, 8 weeks)
  • Sense of Purpose and Meaning(Baseline, 4 weeks, 8 weeks)

研究者

发起方
Fit Minded
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Jennifer Huberty

Chief Science Officer

Fit Minded

研究点 (1)

Loading locations...

相似试验