- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05622604
The Effect of Religious Practices on Mental and Spiritual Health
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
La Mirada, California, United States, 90639
- Biola University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: no intervention condition
no intervention
|
|
|
Experimental: autonomous use condition
Participants will be given a free subscription to the Pray.com
app and will be directed to use the app five days per week.
|
Participants will be given a free subscription to the Pray.com
app and will be directed to use the app five days per week.
|
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress Scale
Time Frame: 2 months
|
minimum value: 0, maximum value: 4, higher average item scores indicate higher levels of stress (i.e., worse outcome)
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital Anxiety and Depression Scale
Time Frame: 2 months
|
minimum value: 0, maximum value: 3, higher average item scores indicate higher levels of anxiety/depression (i.e., worse outcome)
|
2 months
|
|
Mindful Attention Awareness Scale
Time Frame: 2 months
|
minimum value: 1, maximum value: 6, higher average item scores indicate higher levels of mindfulness (i.e., better outcome)
|
2 months
|
|
Copenhagen Burnout Inventory--personal Subscale
Time Frame: 2 months
|
minimum value: 0, maximum value: 4, higher average item scores indicate higher levels of burnout (i.e., worse outcome)
|
2 months
|
|
Pittsburgh Sleep Quality Inventory
Time Frame: 2 months
|
Each component score of the scale ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance.
The seven component scores are then summed to obtain a total score, which ranges from 0 to 21.
Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties
|
2 months
|
|
Religious Commitment Inventory
Time Frame: 2 months
|
minimum value: 1, maximum value: 5, higher average item scores indicate higher levels of religious commitment (i.e., better outcome)
|
2 months
|
|
Spiritual Well-Being Scale
Time Frame: 2 months
|
minimum value: 1, maximum value: 6, higher average item scores indicate higher levels of spiritual well-being (i.e., better outcome)
|
2 months
|
|
Satisfaction With Life Scale
Time Frame: 2 months
|
minimum value: 1, maximum value: 7, higher average item scores indicate higher levels of satisfaction with life (i.e., better outcome)
|
2 months
|
|
Productivity
Time Frame: 2 months
|
Participants' level of productivity was measured by three items (Vogel et al., 2022): Participants were asked to rate their responses on a scale from 1 = strongly disagree to 5 = strongly agree.
Participants' mean responses were calculated, with higher scores indicating higher perceived efficiency and productivity
|
2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Todd Hall, PhD, Biola University
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- F22-011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Stress
-
Massachusetts General HospitalCompletedStress | Emotional Stress | Psychological Stress | Social Stress | Life StressUnited States
-
Center for Advanced Facial Plastic SurgeryCompletedStress | Stress, Physiological | Stress Response | Stress (Psychology) | Healthy Adult Female Participants | Stress, Psychologic | Stress Perception | Stress Levels | Stress, Psychological CumulativeUnited States
-
Amsterdam UMC, location VUmcRigshospitalet, Denmark; Universitätsklinikum Hamburg-EppendorfNot yet recruitingStress | Stress and Burnout | Stress BiomarkersGermany, Denmark
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California Initiative...CompletedStress | Stress, Psychological | Stress, Emotional | Stress, Physiological | Stress ReactionUnited States
-
Amasya UniversityCompletedThe Effect of Online Stress Management Program on Nurses' Individual Workload Perception, and StressStress | Nursing | Stress ManagementTurkey (Türkiye)
-
Canterbury Christ Church UniversitySussex Partnership NHS Foundation TrustEnrolling by invitationOccupational Stress or Workplace StressUnited Kingdom
-
University of PadovaCompletedStress | Stress Disorder | Work Related StressItaly
-
University of Thi-QarCompletedPsychological Stress | Academic StressIraq
-
University of North Carolina, Chapel HillWashington University School of Medicine; United States Department of Defense; University of Florida and other collaboratorsRecruitingPost-traumatic Stress Disorder | Acute Stress Disorder | Acute Stress ReactionUnited States
-
Dana-Farber Cancer InstituteCompletedStress | Post Traumatic Stress Disorder | Work Related StressUnited States
Clinical Trials on pray.com app (autonomous use)
-
Dow University of Health SciencesNational Institutes of Health (NIH)Active, not recruiting
-
Heinrich-Heine University, DuesseldorfCompletedRheumatoid ArthritisGermany
-
University of ValenciaCompletedObsessive-Compulsive DisorderSpain
-
VA Office of Research and DevelopmentCompleted
-
Goethe UniversityTechnische Universität Dresden; Mindable Health GmbHRecruitingSocial AnxietyGermany
-
Stanford UniversityChildren's Hospital of Philadelphia; University of Pittsburgh Medical CenterCompleted
-
Chelsea and Westminster NHS Foundation TrustSuspendedSmoking | Smoking Cessation | Smoking Reduction | Smoking HabitUnited Kingdom
-
University of Michigan Rogel Cancer CenterRogel Cancer Center Cancer Control and Population Sciences O-SURE initiativeCompletedOvarian CancerUnited States
-
Stanford UniversityNational Institutes of Health (NIH); Medable Inc.CompletedCancerUnited States
-
Casa di Cura Dott. PederzoliRecruitingPain Management | Pancreatectomy | Caregiver | Post Surgery Patients | Nutritional Evaluation | Ductal Adenocarcinoma of PancreasItaly