Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-27 @ 10:34 PM
Study NCT ID:
NCT06228495
Status:
COMPLETED
Last Update Posted:
2024-01-29
First Post:
2024-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
mHealth Intervention for Work-Related Stress
Sponsor:
Karolinska Institutet
Organization:
Study Overview
Official Title:
Recovery at Your Fingertips: Pilot Study of an mHealth Intervention for Work-Related Stress Among Nursing Students (DIARY)
Status:
COMPLETED
Status Verified Date:
2024-01
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:
DIARY
Brief Summary:
The objective of the trial is to pilot test the study protocol of a preventive, low-intensive mobile health (mHealth) intervention for work-related stress among nursing students. Work stress is a wide-spread problem affecting individual health as well as incurring substantial societal costs. mHealth solutions are among the most promising options for providing effective, scalable, and standardized interventions to employees.
Detailed Description:
Researchers generally agree that recovery is a key buffer against the negative consequences of stress. Recovery behaviors, such as mindfulness and physical activity, are well-known to have a positive effect on stress-related health problems. For this reason, a behavior change intervention that successfully improves recovery may be effective in combating the long-term effects of stress. In this pilot study, three groups of participants received different versions of an intervention, each version containing a distinct set of recovery strategies.
The motivation of the present study is to pilot test the intervention and a study protocol in preparation for a future randomized controlled trial (RCT). Pilot testing the intervention and study procedures at an early stage is critical to identify potential pitfalls that need to be addressed before conducting a full-scale trial. Through investigating the study and intervention in preparatory phases we can refine the study protocol and intervention design in order to maximize the chances of a successful RCT.
The research questions for this pilot study are:
1. Data collection procedure - What is the recruitment and retention rate of invited participants? Does the randomization algorithm function properly?
2. Engagement - How often do participants use the intervention? Do they find the application easy and engaging to use?
3. Acceptability - Do participants find the intervention overall satisfactory and perceive it as beneficial? Is the digital tool technically stable?
4. Measurement quality - What is the completion rate for questionnaire items? What is the within-person variability in the daily measures?
The motivation of the present study is to pilot test the intervention and a study protocol in preparation for a future randomized controlled trial (RCT). Pilot testing the intervention and study procedures at an early stage is critical to identify potential pitfalls that need to be addressed before conducting a full-scale trial. Through investigating the study and intervention in preparatory phases we can refine the study protocol and intervention design in order to maximize the chances of a successful RCT.
The research questions for this pilot study are:
1. Data collection procedure - What is the recruitment and retention rate of invited participants? Does the randomization algorithm function properly?
2. Engagement - How often do participants use the intervention? Do they find the application easy and engaging to use?
3. Acceptability - Do participants find the intervention overall satisfactory and perceive it as beneficial? Is the digital tool technically stable?
4. Measurement quality - What is the completion rate for questionnaire items? What is the within-person variability in the daily measures?
Study Oversight
Has Oversight DMC:
False
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?: