Stress
Conditions
Brief 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.
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.
Interventions
BEHAVIORALpray.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.
BEHAVIORALpray.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.
Sponsors
Biola University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress Scale | 2 months | minimum value: 0, maximum value: 4, higher average item scores indicate higher levels of stress (i.e., worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression Scale | 2 months | minimum value: 0, maximum value: 3, higher average item scores indicate higher levels of anxiety/depression (i.e., worse outcome) |
| Mindful Attention Awareness Scale | 2 months | minimum value: 1, maximum value: 6, higher average item scores indicate higher levels of mindfulness (i.e., better outcome) |
| Copenhagen Burnout Inventory--personal Subscale | 2 months | minimum value: 0, maximum value: 4, higher average item scores indicate higher levels of burnout (i.e., worse outcome) |
| Pittsburgh Sleep Quality Inventory | 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 |
| Religious Commitment Inventory | 2 months | minimum value: 1, maximum value: 5, higher average item scores indicate higher levels of religious commitment (i.e., better outcome) |
| Spiritual Well-Being Scale | 2 months | minimum value: 1, maximum value: 6, higher average item scores indicate higher levels of spiritual well-being (i.e., better outcome) |
| Satisfaction With Life Scale | 2 months | minimum value: 1, maximum value: 7, higher average item scores indicate higher levels of satisfaction with life (i.e., better outcome) |
| Productivity | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| no Intervention Condition no intervention | 80 |
| 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. | 56 |
| 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. | 56 |
| Total | 192 |
Baseline characteristics
| Characteristic | no Intervention Condition | Autonomous Use Condition | Meditative Prayer Condition | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 79 Participants | 55 Participants | 56 Participants | 190 Participants |
| Age, Continuous | 36.46 years STANDARD_DEVIATION 11.17 | 36.54 years STANDARD_DEVIATION 12.13 | 36.45 years STANDARD_DEVIATION 10.48 | 36.48 years STANDARD_DEVIATION 11.19 |
| Copenhagen Burnout Inventory | 3.58 units on a scale STANDARD_DEVIATION 0.67 | 3.50 units on a scale STANDARD_DEVIATION 0.69 | 3.48 units on a scale STANDARD_DEVIATION 0.67 | 3.53 units on a scale STANDARD_DEVIATION 0.68 |
| Hospital Anxiety and Depression Scale Anxiety | 1.65 units on a scale STANDARD_DEVIATION 0.45 | 1.52 units on a scale STANDARD_DEVIATION 0.47 | 1.57 units on a scale STANDARD_DEVIATION 0.49 | 1.59 units on a scale STANDARD_DEVIATION 0.47 |
| Hospital Anxiety and Depression Scale Depression | 1.03 units on a scale STANDARD_DEVIATION 0.53 | .99 units on a scale STANDARD_DEVIATION 0.56 | .95 units on a scale STANDARD_DEVIATION 0.52 | 1.00 units on a scale STANDARD_DEVIATION 0.54 |
| Mindful Attention and Awareness Scale | 3.69 units on a scale STANDARD_DEVIATION 0.77 | 3.63 units on a scale STANDARD_DEVIATION 0.8 | 3.62 units on a scale STANDARD_DEVIATION 0.71 | 3.66 units on a scale STANDARD_DEVIATION 0.76 |
| Perceived Stress Scale -10 | 3.39 units on a scale STANDARD_DEVIATION 0.62 | 3.12 units on a scale STANDARD_DEVIATION 0.52 | 3.19 units on a scale STANDARD_DEVIATION 0.63 | 3.30 units on a scale STANDARD_DEVIATION 0.6 |
| Pittsburgh Sleep Quality Index | 17.96 units on a scale STANDARD_DEVIATION 3.47 | 17.44 units on a scale STANDARD_DEVIATION 3.17 | 17.86 units on a scale STANDARD_DEVIATION 3.04 | 17.82 units on a scale STANDARD_DEVIATION 3.26 |
| Productivity | 3.33 units on a scale STANDARD_DEVIATION 1.05 | 3.53 units on a scale STANDARD_DEVIATION 0.81 | 3.54 units on a scale STANDARD_DEVIATION 0.84 | 3.45 units on a scale STANDARD_DEVIATION 0.93 |
| Race/Ethnicity, Customized Asian or Asian American | 8 Participants | 1 Participants | 2 Participants | 11 Participants |
| Race/Ethnicity, Customized Biracial or multiracial | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 12 Participants | 6 Participants | 21 Participants |
| Race/Ethnicity, Customized Latina/Latino American | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White/Caucasion | 65 Participants | 41 Participants | 44 Participants | 150 Participants |
| Religious Community Inventory | 3.85 units on a scale STANDARD_DEVIATION 0.79 | 3.77 units on a scale STANDARD_DEVIATION 0.85 | 3.78 units on a scale STANDARD_DEVIATION 0.84 | 3.81 units on a scale STANDARD_DEVIATION 0.82 |
| Satisfaction with Life Scale | 4.06 units on a scale STANDARD_DEVIATION 1.39 | 4.18 units on a scale STANDARD_DEVIATION 1.15 | 4.32 units on a scale STANDARD_DEVIATION 1.43 | 4.15 units on a scale STANDARD_DEVIATION 1.35 |
| Sex: Female, Male Female | 53 Participants | 39 Participants | 37 Participants | 129 Participants |
| Sex: Female, Male Male | 27 Participants | 17 Participants | 19 Participants | 63 Participants |
| Spiritual Well-Being Scale | 4.51 units on a scale STANDARD_DEVIATION 0.84 | 4.56 units on a scale STANDARD_DEVIATION 0.68 | 4.54 units on a scale STANDARD_DEVIATION 0.76 | 4.53 units on a scale STANDARD_DEVIATION 0.78 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 56 | 0 / 56 |
| other Total, other adverse events | 0 / 80 | 0 / 56 | 0 / 56 |
| serious Total, serious adverse events | 0 / 80 | 0 / 56 | 0 / 56 |
Outcome results
Primary
Perceived Stress Scale
minimum value: 0, maximum value: 4, higher average item scores indicate higher levels of stress (i.e., worse outcome)
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| no Intervention Condition | Perceived Stress Scale | 2.79 units on a scale | Standard Deviation 0.65 |
| Autonomous Use Condition | Perceived Stress Scale | 2.71 units on a scale | Standard Deviation 0.57 |
| Meditative Prayer Condition | Perceived Stress Scale | 2.65 units on a scale | Standard Deviation 0.65 |
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)
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| no Intervention Condition | Copenhagen Burnout Inventory--personal Subscale | 2.93 units on a scale | Standard Deviation 0.91 |
| Autonomous Use Condition | Copenhagen Burnout Inventory--personal Subscale | 2.80 units on a scale | Standard Deviation 0.72 |
| Meditative Prayer Condition | Copenhagen Burnout Inventory--personal Subscale | 2.76 units on a scale | Standard Deviation 0.79 |
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)
Time frame: 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| no Intervention Condition | Hospital Anxiety and Depression Scale | Anxiety | 1.17 units on a scale | Standard Deviation 0.49 |
| no Intervention Condition | Hospital Anxiety and Depression Scale | Depression | .66 units on a scale | Standard Deviation 0.5 |
| Autonomous Use Condition | Hospital Anxiety and Depression Scale | Anxiety | 1.00 units on a scale | Standard Deviation 0.46 |
| Autonomous Use Condition | Hospital Anxiety and Depression Scale | Depression | .63 units on a scale | Standard Deviation 0.56 |
| Meditative Prayer Condition | Hospital Anxiety and Depression Scale | Anxiety | .95 units on a scale | Standard Deviation 0.46 |
| Meditative Prayer Condition | Hospital Anxiety and Depression Scale | Depression | .59 units on a scale | Standard Deviation 0.46 |
Secondary
Mindful Attention Awareness Scale
minimum value: 1, maximum value: 6, higher average item scores indicate higher levels of mindfulness (i.e., better outcome)
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| no Intervention Condition | Mindful Attention Awareness Scale | 3.14 units on a scale | Standard Deviation 0.96 |
| Autonomous Use Condition | Mindful Attention Awareness Scale | 2.87 units on a scale | Standard Deviation 0.75 |
| Meditative Prayer Condition | Mindful Attention Awareness Scale | 2.89 units on a scale | Standard Deviation 0.96 |
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
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| no Intervention Condition | Pittsburgh Sleep Quality Inventory | 13.43 score on a scale | Standard Deviation 3.13 |
| Autonomous Use Condition | Pittsburgh Sleep Quality Inventory | 13.21 score on a scale | Standard Deviation 2.88 |
| Meditative Prayer Condition | Pittsburgh Sleep Quality Inventory | 13.55 score on a scale | Standard Deviation 2.91 |
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
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| no Intervention Condition | Productivity | 3.86 units on a scale | Standard Deviation 0.82 |
| Autonomous Use Condition | Productivity | 3.86 units on a scale | Standard Deviation 0.89 |
| Meditative Prayer Condition | Productivity | 4.00 units on a scale | Standard Deviation 0.86 |
Secondary
Religious Commitment Inventory
minimum value: 1, maximum value: 5, higher average item scores indicate higher levels of religious commitment (i.e., better outcome)
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| no Intervention Condition | Religious Commitment Inventory | 4.06 units on a scale | Standard Deviation 0.74 |
| Autonomous Use Condition | Religious Commitment Inventory | 3.85 units on a scale | Standard Deviation 0.93 |
| Meditative Prayer Condition | Religious Commitment Inventory | 4.07 units on a scale | Standard Deviation 0.76 |
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)
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| no Intervention Condition | Satisfaction With Life Scale | 4.92 units on a scale | Standard Deviation 1.35 |
| Autonomous Use Condition | Satisfaction With Life Scale | 4.86 units on a scale | Standard Deviation 1.32 |
| Meditative Prayer Condition | Satisfaction With Life Scale | 4.91 units on a scale | Standard Deviation 1.31 |
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)
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| no Intervention Condition | Spiritual Well-Being Scale | 4.89 units on a scale | Standard Deviation 0.79 |
| Autonomous Use Condition | Spiritual Well-Being Scale | 4.79 units on a scale | Standard Deviation 1.02 |
| Meditative Prayer Condition | Spiritual Well-Being Scale | 4.85 units on a scale | Standard Deviation 0.77 |