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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no intervention condition | No Intervention | no intervention | |
| autonomous use condition | Experimental | Participants will be given a free subscription to the Pray.com app and will be directed to use the app five days per week. |
|
| meditative prayer condition | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pray.com app (autonomous use) | Behavioral | Participants will be given a free subscription to the Pray.com app and will be directed to use the app five days per week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale | minimum value: 0, maximum value: 4, higher average item scores indicate higher levels of stress (i.e., worse outcome) | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Anxiety and Depression Scale | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Hall, PhD | Biola University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biola University | La Mirada | California | 90639 | United States |
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Initial protocol enrollment was 312. However, 120 participants were removed from the study due to suspicions of poor data quality and invalid responses (e.g., same internet protocol addresses across multiple participants, unusual responses), leaving 192 valid participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | no Intervention Condition | no intervention |
| FG001 | 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. 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. |
| FG002 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | no Intervention Condition | no intervention |
| BG001 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Perceived Stress Scale | minimum value: 0, maximum value: 4, higher average item scores indicate higher levels of stress (i.e., worse outcome) | Posted | Mean | Standard Deviation | units on a scale | 2 months |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | no Intervention Condition | no intervention | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Breanne Laird, PhD | Pray.com | 9095574002 | breanne.laird@pray.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 7, 2022 | Nov 8, 2022 | Prot_SAP_ICF_000.pdf |
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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).
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| pray.com app (meditative prayer condition) | Behavioral | 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. |
|
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 | 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 | 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 | 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 | 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 | minimum value: 1, maximum value: 7, higher average item scores indicate higher levels of satisfaction with life (i.e., better outcome) | 2 months |
| Productivity | 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 |
| BG002 | 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. 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Perceived Stress Scale -10 | Mean | Standard Deviation | units on a scale |
|
| Hospital Anxiety and Depression Scale | Mean | Standard Deviation | units on a scale |
|
| Mindful Attention and Awareness Scale | Mean | Standard Deviation | units on a scale |
|
| Copenhagen Burnout Inventory | Mean | Standard Deviation | units on a scale |
|
| Pittsburgh Sleep Quality Index | Mean | Standard Deviation | units on a scale |
|
| Religious Community Inventory | Mean | Standard Deviation | units on a scale |
|
| Spiritual Well-Being Scale | Mean | Standard Deviation | units on a scale |
|
| Satisfaction with Life Scale | Mean | Standard Deviation | units on a scale |
|
| Productivity | Mean | Standard Deviation | units on a scale |
|
| 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. 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. |
|
|
| Secondary | Hospital Anxiety and Depression Scale | minimum value: 0, maximum value: 3, higher average item scores indicate higher levels of anxiety/depression (i.e., worse outcome) | Posted | Mean | Standard Deviation | units on a scale | 2 months |
|
|
|
| Secondary | Mindful Attention Awareness Scale | minimum value: 1, maximum value: 6, higher average item scores indicate higher levels of mindfulness (i.e., better outcome) | Posted | Mean | Standard Deviation | units on a scale | 2 months |
|
|
|
| Secondary | Copenhagen Burnout Inventory--personal Subscale | minimum value: 0, maximum value: 4, higher average item scores indicate higher levels of burnout (i.e., worse outcome) | Posted | Mean | Standard Deviation | units on a scale | 2 months |
|
|
|
| Secondary | Pittsburgh Sleep Quality Inventory | 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 | Posted | Mean | Standard Deviation | score on a scale | 2 months |
|
|
|
| Secondary | Religious Commitment Inventory | minimum value: 1, maximum value: 5, higher average item scores indicate higher levels of religious commitment (i.e., better outcome) | Posted | Mean | Standard Deviation | units on a scale | 2 months |
|
|
|
| Secondary | Spiritual Well-Being Scale | minimum value: 1, maximum value: 6, higher average item scores indicate higher levels of spiritual well-being (i.e., better outcome) | Posted | Mean | Standard Deviation | units on a scale | 2 months |
|
|
|
| Secondary | Satisfaction With Life Scale | minimum value: 1, maximum value: 7, higher average item scores indicate higher levels of satisfaction with life (i.e., better outcome) | Posted | Mean | Standard Deviation | units on a scale | 2 months |
|
|
|
| Secondary | Productivity | 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 | Posted | Mean | Standard Deviation | units on a scale | 2 months |
|
|
|
| 80 |
| 0 |
| 80 |
| 0 |
| 80 |
| EG001 | 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. 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. | 0 | 56 | 0 | 56 | 0 | 56 |
| EG002 | 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. 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. | 0 | 56 | 0 | 56 | 0 | 56 |
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