Ignite Creation Date:
2024-05-06 @ 2:18 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04272138
Status:
COMPLETED
Last Update Posted:
2022-02-28
First Post:
2020-01-13
Brief Title:
A Brief App-based Mobile Health and Well-being Intervention Among Middle-aged Adults
Sponsor:
Arizona State University
Organization:
Arizona State University
Study Overview
Official Title:
Feasibility of Using a Mobile App ie Calm to Decrease Overall Stress in Middle-aged ie 40-64 Years Men and Women Who Report High Stress 15 on PSS
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the preliminary effects of using a mobile app ie Calm to decrease overall stress in middle-aged ie 40-64 years men and women who report high stress greater than 15 on PSS
The study design is a randomized control trial with baseline post-intervention 4 weeks from baseline and follow-up phone interview 5 weeks from baseline assessments Middle-aged adults will be randomized to either a Calm meditation Intervention group or an attention control podcast group Participants will be randomized after the completion of baseline and informed consent
Specific aim 1 Determine the feasibility acceptability demand of using CALM app at least 10 minday to reduce stress greater than 15 on Perceived Stress Scale PSS in middle-aged men and women
Benchmarks for feasibility acceptability Recruitment greater than 40 percent men greater than 75 percent satisfied with intervention 75 percent perceive daily meditation and app components as appropriate and useful demand Retention of men greater than 75 percent greater than 80 percent adherence minutesweek to the meditation intervention
Specific aim 2 Explore the preliminary effect of meditation using Calm on overall perceived stress as compared to the health education group
Specific aim 3 Explore the preliminary effect of meditation using Calm on anxiety and depression
Specific aim 4 Explore gender as a moderator of the effect of meditation using Calm on stress
Specific aim 5 Explore the mediators of mindfulness physical activity eating and coping behaviors on stress anxiety and depression using Calm for meditation
The study design is a randomized control trial with baseline post-intervention 4 weeks from baseline and follow-up phone interview 5 weeks from baseline assessments Middle-aged adults will be randomized to either a Calm meditation Intervention group or an attention control podcast group Participants will be randomized after the completion of baseline and informed consent
Specific aim 1 Determine the feasibility acceptability demand of using CALM app at least 10 minday to reduce stress greater than 15 on Perceived Stress Scale PSS in middle-aged men and women
Benchmarks for feasibility acceptability Recruitment greater than 40 percent men greater than 75 percent satisfied with intervention 75 percent perceive daily meditation and app components as appropriate and useful demand Retention of men greater than 75 percent greater than 80 percent adherence minutesweek to the meditation intervention
Specific aim 2 Explore the preliminary effect of meditation using Calm on overall perceived stress as compared to the health education group
Specific aim 3 Explore the preliminary effect of meditation using Calm on anxiety and depression
Specific aim 4 Explore gender as a moderator of the effect of meditation using Calm on stress
Specific aim 5 Explore the mediators of mindfulness physical activity eating and coping behaviors on stress anxiety and depression using Calm for meditation
Detailed Description:
Recruitment Participants will be recruited during winterspring 2020 Interested participants will be directed to a REDCap link to complete an online eligibility screener The screener will take approximately 10 minutes to complete See Eligibility Survey The survey will be free voluntary and available online Participants will be allowed to skip questions in the survey
Eligibility Once eligibility is determined participants will be sent an informed consent and baseline questionnaire via a REDCap link This measure should take approximately 25 minutes to complete See Informed Consent and Baseline Questionnaires Once Informed Consent is signed and the Baseline Questionnaires are complete participants will be randomized via an online randomizer ie randomizercom to either an attention control podcast group or the Calm meditation group Ineligible participants will be sent an email notifying their status and why
Enrollment The Research Team will email the intervention participants that will include instructions to download Calm See Participant Scripts The control participants will be emailed instructions to download the podcast app See Participant Scripts
Intervention The intervention will run for 4-weeks Intervention participants will complete the 30 day How to Meditate meditation series that provides daily 10-minute meditations and the control group will listen to daily 10-minute health education podcasts Throughout the intervention both groups will be sent reminder emails via REDCap to participate in their assigned practice sessions see Participant Scripts participants will complete online weekly participation logs via REDCap Additionally they will answer one multiple choice EMA ecological momentary assessment question randomly 3x per day between 8am and 8pm via test message assessing how one currently feels see Study Questionnaires
Tracking Participation in the Calm meditations will be tracked meditation name time of day and time spent in meditation by weekly REDCap participation logs and the Calm team
Post-intervention Post-intervention questionnaires and the satisfaction survey will be emailed to intervention and control participants via a link from REDCap See Post-intervention questionnaires The post-intervention survey will take about 25 minutes and the satisfaction survey will take about 10 minutes
Post-intervention interview Post-intervention phone interviews will be conducted the week following the end of the intervention week 5 to no more than 20 participants in each group and take about 15-20 minutes
Eligibility Once eligibility is determined participants will be sent an informed consent and baseline questionnaire via a REDCap link This measure should take approximately 25 minutes to complete See Informed Consent and Baseline Questionnaires Once Informed Consent is signed and the Baseline Questionnaires are complete participants will be randomized via an online randomizer ie randomizercom to either an attention control podcast group or the Calm meditation group Ineligible participants will be sent an email notifying their status and why
Enrollment The Research Team will email the intervention participants that will include instructions to download Calm See Participant Scripts The control participants will be emailed instructions to download the podcast app See Participant Scripts
Intervention The intervention will run for 4-weeks Intervention participants will complete the 30 day How to Meditate meditation series that provides daily 10-minute meditations and the control group will listen to daily 10-minute health education podcasts Throughout the intervention both groups will be sent reminder emails via REDCap to participate in their assigned practice sessions see Participant Scripts participants will complete online weekly participation logs via REDCap Additionally they will answer one multiple choice EMA ecological momentary assessment question randomly 3x per day between 8am and 8pm via test message assessing how one currently feels see Study Questionnaires
Tracking Participation in the Calm meditations will be tracked meditation name time of day and time spent in meditation by weekly REDCap participation logs and the Calm team
Post-intervention Post-intervention questionnaires and the satisfaction survey will be emailed to intervention and control participants via a link from REDCap See Post-intervention questionnaires The post-intervention survey will take about 25 minutes and the satisfaction survey will take about 10 minutes
Post-intervention interview Post-intervention phone interviews will be conducted the week following the end of the intervention week 5 to no more than 20 participants in each group and take about 15-20 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None