Mental HealthNCT07489222
PRAY.COM for Mental Health and Well-Being Among University Students
A study testing PRAY.COM Mobile Application in people with Mental Health and Well-Being, run by Fit Minded at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Well-Being
- What is being tested?
- PRAY.COM Mobile Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
PRAY.COM (Online Only)
Westlake Village, California, 91361
About this study
Official title: A Faith-Based Mobile Application for Mental Health and Well-Being Among University Students: A Single-Arm Feasibility and Preliminary Effectiveness Trial
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).
Read the 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.
- Conditions
- Mental Health, Well-Being
- Being tested
- PRAY.COM Mobile Application
- Keywords
- Faith-based intervention, Mobile health, mHealth, University students, college mental health, mobile application, Feasibility, mental health, well-being, digital mental health intervention
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRAY.COM Mobile ApplicationBehavioural
Also called PRAY.COM
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.
| Study group | Role | What they receive |
|---|---|---|
| PRAY.COM App | Experimental | 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. Receives: Behavioral: PRAY.COM Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability (satisfaction)
Percentage of participants reporting satisfied or very satisfied; benchmark ≥75%
Measured: Measured at 4 weeks and 8 weeks
Demand
Percentage of participants reporting at least weekly app use; benchmark ≥70%
Measured: From enrollment to 4 and 8 weeks
Secondary outcomes (15)
Perceived appropriateness
Percentage rating PRAY.COM as very or extremely appropriate for students
Measured: 4 weeks and 8 weeks
Intent to continue use
Percentage reporting likely or very likely to continue using PRAY.COM after the study
Measured: 4 weeks and 8 weeks
Depressive symptoms
Measured by the Depression Anxiety Stress Scale (DASS-9). Scores range from 0-9 with higher scores indicating greater symptom severity.
Measured: Baseline, 4 weeks, 8 weeks
Anixety
Measured by the Depression Anxiety Stress Scale (DASS-9). Scores range from 0-9 with higher scores indicating greater symptom severity.
Measured: Baseline, 4 weeks, 8 weeks
Stress
Measured by the Depression Anxiety Stress Scale (DASS-9). Scores range from 0-9 with higher scores indicating greater symptom severity.
Measured: Baseline, 4 weeks, 8 weeks
Loneliness
Measured by the UCLA Loneliness Scale (UCLA-3). Total scores range from 3-9, with higher scores indicating greater loneliness.
Measured: Baseline, 4 weeks, 8 weeks
Sense of Purpose and Meaning
Measured by two adapted items from the Claremont Purpose Scale. Scores range from 2-10 with higher scores indicating greater meaning and purppose.
Measured: Baseline, 4 weeks, 8 weeks
Time Management Confidence
Investigator-developed item with a 5-point scale (0=not at all confident to 4=extremely confident)
Measured: Baseline, 4 weeks, 8 weeks
School-life balance satisfaction
Investigator-developed item with a 5-point scale (1=very dissatisfied to 5=very satisfied)
Measured: Baseline, 4 weeks, 8 weeks
Confidence managing academic challenges
Investigator-developed item with a 5-point scale (0=not at all confident to 4=extremely confident)
Measured: Baseline, 4 weeks, 8 weeks
Feeling overwhelmed
Investigator-developed item; 6-point scale (0=never to 5=daily)
Measured: Baseline, 4 weeks, 8 weeks
Difficulty concentrating
Investigator-developed item; 5-point scale (0=not difficult at all to 4=extremely difficult)
Measured: Baseline, 4 weeks, 8 weeks
Classes missed due to mental health
Investigator-developed item; 5-point scale (0=0 to 4=4 or more)
Measured: Baseline, 4 weeks, 8 weeks
Mental health negatively impacted academics
Investigator-developed item; 5-point scale (0=never to 4=always)
Measured: Baseline, 4 weeks, 8 weeks
Difficulty completing coursework
Investigator-developed item; 6-point scale (0=never to 4=daily)
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start3 Sep 2025
- Primary completion21 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fit Minded
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Jennifer Huberty, Fit Minded
- Investigators
- Jennifer Huberty, PhD, Principal investigator, Fit Minded
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489222
- Sponsor's protocol ID
- 25-206-1708-01
- Other IDs
- 25-206-1708
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared. De-identified data may be made available upon reasonable request to the corresponding author.
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.
PubMed 38306173Laird 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.
PubMed 38358455
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Faith-Based Mobile Application for Mental Health and Well-Being Among University Students: A Single-Arm Feasibility and Preliminary Effectiveness Trial
- ClinicalTrials.gov ID
- NCT07489222
- Acronym / sponsor ID
- 25-206-1708-01
- Conditions
- Mental Health, Well-Being
- Keywords
- Faith-based intervention, Mobile health, mHealth, University students, college mental health, mobile application, Feasibility, mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Fit MindedIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRAY.COM App | Experimental | Behavioral: PRAY.COM Mobile ApplicationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRAY.COM Mobile ApplicationAlso: PRAY.COMPRAY.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. | Behavioural | PRAY.COM App |
Primary outcome
Acceptability (satisfaction)
Time frame: Measured at 4 weeks and 8 weeks
Percentage of participants reporting satisfied or very satisfied; benchmark ≥75%
Demand
Time frame: From enrollment to 4 and 8 weeks
Percentage of participants reporting at least weekly app use; benchmark ≥70%
15 secondary outcomes
Perceived appropriateness
Time frame: 4 weeks and 8 weeks
Intent to continue use
Time frame: 4 weeks and 8 weeks
Depressive symptoms
Time frame: Baseline, 4 weeks, 8 weeks
Anixety
Time frame: Baseline, 4 weeks, 8 weeks
Stress
Time frame: Baseline, 4 weeks, 8 weeks
Loneliness
Time frame: Baseline, 4 weeks, 8 weeks
Sense of Purpose and Meaning
Time frame: Baseline, 4 weeks, 8 weeks
Time Management Confidence
Time frame: Baseline, 4 weeks, 8 weeks
School-life balance satisfaction
Time frame: Baseline, 4 weeks, 8 weeks
Confidence managing academic challenges
Time frame: Baseline, 4 weeks, 8 weeks
Feeling overwhelmed
Time frame: Baseline, 4 weeks, 8 weeks
Difficulty concentrating
Time frame: Baseline, 4 weeks, 8 weeks
Classes missed due to mental health
Time frame: Baseline, 4 weeks, 8 weeks
Mental health negatively impacted academics
Time frame: Baseline, 4 weeks, 8 weeks
Difficulty completing coursework
Time frame: Baseline, 4 weeks, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- BackgroundLaird 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.
- Background: PubMed 38306173Laird 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.
- Background: PubMed 38358455Laird 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.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared. De-identified data may be made available upon reasonable request to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Huberty, PhD principal investigator
Fit Minded
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRAY.COM Mobile Application in people with Mental Health and Well-Being, run by Fit Minded at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (satisfaction) (time frame: Measured at 4 weeks and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07489222, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.