Ignite Creation Date:
2024-05-06 @ 4:25 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04978896
Status:
COMPLETED
Last Update Posted:
2022-04-06
First Post:
2021-07-18
Brief Title:
Effectiveness of a Self-guided Mobile Application in Improving Wellbeing and Stress Coping
Sponsor:
National University of Singapore
Organization:
National University of Singapore
Study Overview
Official Title:
Can a Self-guided Program on a Mobile Application Improve Wellbeing and Stress Coping - A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-04
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:
Excessive and chronic stress is a major public global health concern Young adults are at particular risk to experience heightened stress because of life transitions Short skills-focused self-guided applications SGA on mobile phones are a cost-effective and scalable way to equip users with better stress-coping skills but many SGA stress-coping programmes are not evidence-based existing research is flawed with methodological problems and is also predominantly conducted in Western countries Questions also remain for whom SGAs work moderators and by which pathways mediators
This study is a randomised-controlled trial RCT that evaluates the effectiveness of a recently developed mobile-phone SGA in improving stress coping in young adults
Hypothesis 1 The intervention group will report significantly lower stress symptoms at post-intervention and 1-month follow-up compared to the control group
Hypothesis 2 Coping self-efficacy will mediate the expected relationship between the use of the Stress-SGA and lower stress symptoms ie people with higher coping self-efficacy will benefit more from the Stress-SGA than those with lower coping self-efficacy
Hypothesis 3 Psychological mindedness will moderate the expected relationship between the use of Stress-SGA and lower stress symptoms ie people high in psychological mindedness will benefit more from the Stress-SGA than those with lower psychological mindedness
This study is a randomised-controlled trial RCT that evaluates the effectiveness of a recently developed mobile-phone SGA in improving stress coping in young adults
Hypothesis 1 The intervention group will report significantly lower stress symptoms at post-intervention and 1-month follow-up compared to the control group
Hypothesis 2 Coping self-efficacy will mediate the expected relationship between the use of the Stress-SGA and lower stress symptoms ie people with higher coping self-efficacy will benefit more from the Stress-SGA than those with lower coping self-efficacy
Hypothesis 3 Psychological mindedness will moderate the expected relationship between the use of Stress-SGA and lower stress symptoms ie people high in psychological mindedness will benefit more from the Stress-SGA than those with lower psychological mindedness
Detailed Description:
Procedure
Participants will sign up for the study via a survey link posted on the universitys recruitment sites where they will first read through the Participant Information Sheet which contains information about the study such as study aims methods benefits and risks the confidentiality of data and contact information of the investigators If participants agree to participate they will provide their consent on the online consent form Thereafter they will proceed to complete a series of self-report measures on an online survey platform baseline ratings The online survey consists of the primary outcome measures on stress PSM-9 PHQ-9 GAD7 secondary outcome measures on coping self-efficacy and psychological mindedness CSES PM and demographic information age gender
Next participants will be randomly assigned to either the intervention or active control condition and guided to download the SGA on their personal mobile devices from the Apple App Store or Google Play Store A number code will be provided to them to unlock the app according to their assigned condition The SGA is developed by Intellect Pte Ltd a Singapore based technology firm that collaborates with the supervisor of the study Participants in the intervention condition will take part in the 8-day stress management program while those in the active control condition will take part in the 8-day cooperation learning program Both programs will involve content education and short daily activities averaging about five minutes to fulfil a series of tasks aimed at improving their wellbeing Daily reminders to complete the program will be sent via text messages by the researcher to participants All participants will be instructed to refrain from engaging in any self-guided wellbeing apps other than the given SGA during the duration of the study lasting from the beginning until the end of the 1-month follow-up This minimises potential confounding effects
Upon completion of the 8-day program participants will receive a survey link to complete the same questionnaires and in addition will fill out the App Engagement Scale One month upon completion of the SGA participants will be emailed the survey link to the self-report measures again along with the debrief and an information sheet explaining the main purposes of the study All participants will be given a link to access the complete version of the SGA providing them with access to all the wellbeing programs available for their personal use Participants will be reimbursed with either course credit or a small monetary fee for their time and effort
Participants will sign up for the study via a survey link posted on the universitys recruitment sites where they will first read through the Participant Information Sheet which contains information about the study such as study aims methods benefits and risks the confidentiality of data and contact information of the investigators If participants agree to participate they will provide their consent on the online consent form Thereafter they will proceed to complete a series of self-report measures on an online survey platform baseline ratings The online survey consists of the primary outcome measures on stress PSM-9 PHQ-9 GAD7 secondary outcome measures on coping self-efficacy and psychological mindedness CSES PM and demographic information age gender
Next participants will be randomly assigned to either the intervention or active control condition and guided to download the SGA on their personal mobile devices from the Apple App Store or Google Play Store A number code will be provided to them to unlock the app according to their assigned condition The SGA is developed by Intellect Pte Ltd a Singapore based technology firm that collaborates with the supervisor of the study Participants in the intervention condition will take part in the 8-day stress management program while those in the active control condition will take part in the 8-day cooperation learning program Both programs will involve content education and short daily activities averaging about five minutes to fulfil a series of tasks aimed at improving their wellbeing Daily reminders to complete the program will be sent via text messages by the researcher to participants All participants will be instructed to refrain from engaging in any self-guided wellbeing apps other than the given SGA during the duration of the study lasting from the beginning until the end of the 1-month follow-up This minimises potential confounding effects
Upon completion of the 8-day program participants will receive a survey link to complete the same questionnaires and in addition will fill out the App Engagement Scale One month upon completion of the SGA participants will be emailed the survey link to the self-report measures again along with the debrief and an information sheet explaining the main purposes of the study All participants will be given a link to access the complete version of the SGA providing them with access to all the wellbeing programs available for their personal use Participants will be reimbursed with either course credit or a small monetary fee for their time and effort
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