- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07489222
PRAY.COM for Mental Health and Well-Being Among University Students
A Faith-Based Mobile Application for Mental Health and Well-Being Among University Students: A Single-Arm Feasibility and Preliminary Effectiveness Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Westlake Village, California, United States, 91361
- PRAY.COM (Online Only)
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PRAY.COM App
Participants were asked to used the PRAY.COM mobile app for at least 10 minutes per day for 8 weeks, with assessments at baseline, 4 weeks, and 8 weeks.
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability (satisfaction)
Time Frame: Measured at 4 weeks and 8 weeks
|
Percentage of participants reporting satisfied or very satisfied; benchmark ≥75%
|
Measured at 4 weeks and 8 weeks
|
|
Demand
Time Frame: From enrollment to 4 and 8 weeks
|
Percentage of participants reporting at least weekly app use; benchmark ≥70%
|
From enrollment to 4 and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived appropriateness
Time Frame: 4 weeks and 8 weeks
|
Percentage rating PRAY.COM as very or extremely appropriate for students
|
4 weeks and 8 weeks
|
|
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
|
4 weeks and 8 weeks
|
|
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.
|
Baseline, 4 weeks, 8 weeks
|
|
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.
|
Baseline, 4 weeks, 8 weeks
|
|
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.
|
Baseline, 4 weeks, 8 weeks
|
|
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.
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Baseline, 4 weeks, 8 weeks
|
|
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.
|
Baseline, 4 weeks, 8 weeks
|
|
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)
|
Baseline, 4 weeks, 8 weeks
|
|
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)
|
Baseline, 4 weeks, 8 weeks
|
|
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)
|
Baseline, 4 weeks, 8 weeks
|
|
Feeling overwhelmed
Time Frame: Baseline, 4 weeks, 8 weeks
|
Investigator-developed item; 6-point scale (0=never to 5=daily)
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Baseline, 4 weeks, 8 weeks
|
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Difficulty concentrating
Time Frame: Baseline, 4 weeks, 8 weeks
|
Investigator-developed item; 5-point scale (0=not difficult at all to 4=extremely difficult)
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Baseline, 4 weeks, 8 weeks
|
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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)
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Baseline, 4 weeks, 8 weeks
|
|
Mental health negatively impacted academics
Time Frame: Baseline, 4 weeks, 8 weeks
|
Investigator-developed item; 5-point scale (0=never to 4=always)
|
Baseline, 4 weeks, 8 weeks
|
|
Difficulty completing coursework
Time Frame: Baseline, 4 weeks, 8 weeks
|
Investigator-developed item; 6-point scale (0=never to 4=daily)
|
Baseline, 4 weeks, 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer Huberty, PhD, Fit Minded
Publications and helpful links
General Publications
- Laird B, Hook JN, Van Tongeren DR, Zuniga S, Hall T, Huberty J. The impact of using a faith and prayer mobile application, Pray. com, on mental health and well-being. Spirituality in Clinical Practice. 2025 Dec;12(4):502.
- Laird B, Zuniga S, Hook JN, Van Tongeren DR, Joeman L, Huberty J. Mental Health and Well-Being in Racial or Ethnic Minority Individuals After Using a Faith and Prayer Mobile App (Pray.com): Feasibility and Preliminary Efficacy Trial. JMIR Form Res. 2024 Feb 2;8:e52560. doi: 10.2196/52560.
- Laird B, Van Tongeren DR, Hook JN, Do B, Hall T, Huberty J. Exploring User Perceptions of a Mobile App for Religious Practices. J Relig Health. 2024 Jun;63(3):2068-2090. doi: 10.1007/s10943-024-02004-9. Epub 2024 Feb 15.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-206-1708-01
- 25-206-1708 (Other Identifier: BRANY IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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