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Completed

NCT Number: NCT07489222

PRAY.COM for Mental Health and Well-Being Among University Students

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PRAY.COM (Online Only)

Westlake Village, California, 91361, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

PRAY.COM Mobile Application

Behavioral

PRAY.COM is a nondenominational, Bible-based faith and prayer mobile application delivering daily prayers, guided meditations, scripture readings, bedtime stories, podcasts, and worship music. Participants were instructed to use the app for at least 10 minutes per day for 8 weeks but were not given specific instructions regarding which features to engage with.

Other names: PRAY.COM

Primary outcomes

  1. Acceptability (satisfaction)

    Time frame: Measured at 4 weeks and 8 weeks

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

  2. Demand

    Time frame: From enrollment to 4 and 8 weeks

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

Secondary outcomes

  1. Perceived appropriateness

    Time frame: 4 weeks and 8 weeks

    Percentage rating PRAY.COM as very or extremely appropriate for students

  2. Intent to continue use

    Time frame: 4 weeks and 8 weeks

    Percentage reporting likely or very likely to continue using PRAY.COM after the study

  3. Depressive symptoms

    Time frame: Baseline, 4 weeks, 8 weeks

    Measured by the Depression Anxiety Stress Scale (DASS-9). Scores range from 0-9 with higher scores indicating greater symptom severity.

  4. Anixety

    Time frame: Baseline, 4 weeks, 8 weeks

    Measured by the Depression Anxiety Stress Scale (DASS-9). Scores range from 0-9 with higher scores indicating greater symptom severity.

  5. Stress

    Time frame: Baseline, 4 weeks, 8 weeks

    Measured by the Depression Anxiety Stress Scale (DASS-9). Scores range from 0-9 with higher scores indicating greater symptom severity.

  6. Loneliness

    Time frame: Baseline, 4 weeks, 8 weeks

    Measured by the UCLA Loneliness Scale (UCLA-3). Total scores range from 3-9, with higher scores indicating greater loneliness.

  7. Sense of Purpose and Meaning

    Time frame: Baseline, 4 weeks, 8 weeks

    Measured by two adapted items from the Claremont Purpose Scale. Scores range from 2-10 with higher scores indicating greater meaning and purppose.

  8. Time Management Confidence

    Time frame: Baseline, 4 weeks, 8 weeks

    Investigator-developed item with a 5-point scale (0=not at all confident to 4=extremely confident)

  9. School-life balance satisfaction

    Time frame: Baseline, 4 weeks, 8 weeks

    Investigator-developed item with a 5-point scale (1=very dissatisfied to 5=very satisfied)

  10. Confidence managing academic challenges

    Time frame: Baseline, 4 weeks, 8 weeks

    Investigator-developed item with a 5-point scale (0=not at all confident to 4=extremely confident)

  11. Feeling overwhelmed

    Time frame: Baseline, 4 weeks, 8 weeks

    Investigator-developed item; 6-point scale (0=never to 5=daily)

  12. Difficulty concentrating

    Time frame: Baseline, 4 weeks, 8 weeks

    Investigator-developed item; 5-point scale (0=not difficult at all to 4=extremely difficult)

  13. Classes missed due to mental health

    Time frame: Baseline, 4 weeks, 8 weeks

    Investigator-developed item; 5-point scale (0=0 to 4=4 or more)

  14. Mental health negatively impacted academics

    Time frame: Baseline, 4 weeks, 8 weeks

    Investigator-developed item; 5-point scale (0=never to 4=always)

  15. Difficulty completing coursework

    Time frame: Baseline, 4 weeks, 8 weeks

    Investigator-developed item; 6-point scale (0=never to 4=daily)

Sponsors and collaborators

Lead sponsor

Fit Minded

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 24, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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