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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05622604
Other study ID # F22-011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 30, 2022
Est. completion date March 10, 2023

Study information

Verified date April 2023
Source Biola University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to test the effects of using a religious mobile app (i.e., Pray.com) in participants who have high levels of stress. The main question it aims to answer is: •What are the effects of using Pray.com on stress in individuals who report high levels of stress? Participants will complete measures at baseline (i.e., Time 1), four-weeks (i.e., Time 2), and eight weeks (i.e., Time 3). Participants will be randomly assigned one of three conditions: (1) autonomous use (directed to use the app daily), (2) meditative prayer condition (directed to use this feature of the app daily), or (3) wait-list control condition.


Description:

Participants (N = 300) will be adults recruited through social media and faith-based organizations. Participants will first complete a brief screener to determine eligibility for the study. Eligible participants will be invited to participate in the study. Participants will read an informed consent document that will give information about the study and their rights as participants. Participants will be given the opportunity to contact the research team and ask questions. If they agree to participate, participants will be randomly assigned to one of three conditions. Condition 1 is the control condition (i.e., no intervention condition). In Condition 2, participants will be given a free subscription to the Pray.com app and will be directed to use the app five days per week (i.e., autonomous use condition). In Condition 3, participants will be given a free subscription to the Pray.com app and will be directed to listen to a meditation prayer five days per week (i.e., meditative prayer condition). Participants will receive periodic reminders on their phone if they have not used the app. All participants will fill out a series of online questionnaires monthly for a two-month time-period (i.e., Baseline / Time 1, Time 2, and Time 3). Participants will receive a link from the research team when it is time for them to fill out their questionnaire via a secure online data collection portal. After finishing the study, participants will be debriefed and given the opportunity to ask questions about their participation.


Recruitment information / eligibility

Status Completed
Enrollment 314
Est. completion date March 10, 2023
Est. primary completion date March 10, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - over the age of 18 - own a smart phone and be willing to download a mobile app - willing to engage in a Christian practice on a mobile app - score of 14 or greater on the Perceived Stress Scale (indicating at least a moderate level of stress) Exclusion Criteria: - n/a

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
pray.com app (autonomous use)
Participants will be given a free subscription to the Pray.com app and will be directed to use the app five days per week.
pray.com app (meditative prayer condition)
Participants will be given a free subscription to the Pray.com app and will be directed to listen to a meditation prayer five days per week.

Locations

Country Name City State
United States Biola University La Mirada California

Sponsors (1)

Lead Sponsor Collaborator
Biola University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perceived Stress Scale minimum value: 0, maximum value: 40, higher scores indicate higher levels of stress (i.e., worse outcome) 2 months
Secondary Hospital Anxiety and Depression Scale minimum value: 0, maximum value: 42, higher scores indicate higher levels of anxiety/depression (i.e., worse outcome) 2 months
Secondary Mindful Attention Awareness Scale minimum value: 15, maximum value: 90, higher scores indicate higher levels of mindfulness (i.e., better outcome) 2 months
Secondary Copenhagen Burnout Inventory--personal subscale minimum value: 6, maximum value: 30, higher scores indicate higher levels of burnout (i.e., worse outcome) 2 months
Secondary Pittsburgh Sleep Quality Inventory minimum value: 13, maximum value: 52, higher scores indicate higher levels of sleep problems (i.e., worse outcome) 2 months
Secondary Religious Commitment Inventory minimum value: 10, maximum value: 50, higher scores indicate higher levels of religious commitment (i.e., better outcome) 2 months
Secondary Spiritual Well-Being Scale minimum value: 20, maximum value: 120, higher scores indicate higher levels of spiritual well-being (i.e., better outcome) 2 months
Secondary Satisfaction with Life Scale minimum value: 5, maximum value: 35, higher scores indicate higher levels of satisfaction with life (i.e., better outcome) 2 months
Secondary Daily Goal Progress Scale minimum value: 3, maximum value: 15, higher scores indicate higher levels of daily goal progress (i.e., better outcome) 2 months
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