Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353451
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2024-03-19
Brief Title:
Digital Detox Study A Randomized Controlled Trial
Sponsor:
Danube University Krems
Organization:
Danube University Krems
Study Overview
Official Title:
Smartphone Screen Time Reduction Improves Mental Health A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-03
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 aim of the present RCT is to investigate the effect of smartphone screen time reduction on mental health indicators in healthy 18-29 yo Austrian students
After inclusion and randomization to intervention- and control group normal screen time behavior will be assessed for 10-days After that the mental health parameters will be carried out in both groups as a baseline survey T0 After that intervention group should limit smartphone screen time to less than 2 hours per day for three consecutive weeks Control group should use smartphones as usual After that mental health parameters will be assessed again in both groups post-intervention T1 After T1 there are no further requirements regarding screen time Mental health parameters will be assessed again in both groups at follow-up T2
Main outcome parameters are 1 Well-Being WHO-5 depressive symptoms PHQ-9 stress PSQ-20 and sleep quality ISI
The primary hypothesis stated at Open Science Framework before Enrollment httpsosfioa9k76 is that mental health indicators particularly stress depressive symptoms and sleep quality will improve throughout the intervention compared to the control group as well as to baseline
After inclusion and randomization to intervention- and control group normal screen time behavior will be assessed for 10-days After that the mental health parameters will be carried out in both groups as a baseline survey T0 After that intervention group should limit smartphone screen time to less than 2 hours per day for three consecutive weeks Control group should use smartphones as usual After that mental health parameters will be assessed again in both groups post-intervention T1 After T1 there are no further requirements regarding screen time Mental health parameters will be assessed again in both groups at follow-up T2
Main outcome parameters are 1 Well-Being WHO-5 depressive symptoms PHQ-9 stress PSQ-20 and sleep quality ISI
The primary hypothesis stated at Open Science Framework before Enrollment httpsosfioa9k76 is that mental health indicators particularly stress depressive symptoms and sleep quality will improve throughout the intervention compared to the control group as well as to baseline
Detailed Description:
According to the power-analysis small to medium effect size of d45 power 8 significance level 05 icc 05 a sample of N 100 should be recruited through newsletter notices and social media The inclusion criteria are more than 3 hours of screen time per day no mental disorder no ongoing psychotherapy or use of psychotropic drugs
After signing the informed consent participants have to download an App ESMira which processes the whole study The first step is to fill out sociodemographic data smartphone use and mental health questionnaires After controlling for inclusion- and exclusion criteria ESMira will randomize into intervention- IG and control group CG Participants in the control group CG should continue their smartphone behavior unchanged throughout the entire study period Participants in the intervention group IG should continue their smartphone usage unchanged for the first 10 days Baseline After that the mental health parameters will be carried out in both groups as a baseline survey T0 After that participants of the intervention group should limit their smartphone screen time under two hours per day for three weeks To comply with that participants should use the limiter function of their smartphone or download an additional app A screen shot of the screen time has to be uploaded weekly on Monday for the previous week Monday to Sunday At the end of the intervention t1 the mental health questionnaires will be collected again in both groups After T1 there are no further requirements regarding screen time Mental health parameters will be assessed again in both groups at follow-up T2
During the study period participants will be asked to additionally wear a fitness tracker to measure daily movement as well as objective stress parameters
Data collection and randomization The whole data collection procedure will be carried out through the ESMira App ESMira is a tool for running longitudinal studies ESM AA EMA with completely anonymized communication with participants and data collection
Smartphone screen time Weekly screen time will be documented in both groups using the smartphones built-in screen time measurements
Statistical plan
Repeated measurements ANOVAs rm-ANOVA will be applied to analyze differences Difference between t0 baseline and t1 post-intervention in the intervention group and on the difference between control group and intervention group are the primary hypotheses Effects between- as well as within group will be analyzed for all 3 measurement points as well Furthermore a secondary analysis will be applied to analyze the sub-sample that strictly adhered to the time limits
In case of baseline group-differences variables will be added as covariates in the rm-ANOVA A Greenhouse-Geisser correction will be applied if sphericity assumption is violated In the post hoc tests Bonferroni correction will be applied to adjust for multiple comparisons
Missing values will be dealt with via maximum likelihood estimation Percentage changes in the main outcomes between baseline and post-intervention will be calculated
After signing the informed consent participants have to download an App ESMira which processes the whole study The first step is to fill out sociodemographic data smartphone use and mental health questionnaires After controlling for inclusion- and exclusion criteria ESMira will randomize into intervention- IG and control group CG Participants in the control group CG should continue their smartphone behavior unchanged throughout the entire study period Participants in the intervention group IG should continue their smartphone usage unchanged for the first 10 days Baseline After that the mental health parameters will be carried out in both groups as a baseline survey T0 After that participants of the intervention group should limit their smartphone screen time under two hours per day for three weeks To comply with that participants should use the limiter function of their smartphone or download an additional app A screen shot of the screen time has to be uploaded weekly on Monday for the previous week Monday to Sunday At the end of the intervention t1 the mental health questionnaires will be collected again in both groups After T1 there are no further requirements regarding screen time Mental health parameters will be assessed again in both groups at follow-up T2
During the study period participants will be asked to additionally wear a fitness tracker to measure daily movement as well as objective stress parameters
Data collection and randomization The whole data collection procedure will be carried out through the ESMira App ESMira is a tool for running longitudinal studies ESM AA EMA with completely anonymized communication with participants and data collection
Smartphone screen time Weekly screen time will be documented in both groups using the smartphones built-in screen time measurements
Statistical plan
Repeated measurements ANOVAs rm-ANOVA will be applied to analyze differences Difference between t0 baseline and t1 post-intervention in the intervention group and on the difference between control group and intervention group are the primary hypotheses Effects between- as well as within group will be analyzed for all 3 measurement points as well Furthermore a secondary analysis will be applied to analyze the sub-sample that strictly adhered to the time limits
In case of baseline group-differences variables will be added as covariates in the rm-ANOVA A Greenhouse-Geisser correction will be applied if sphericity assumption is violated In the post hoc tests Bonferroni correction will be applied to adjust for multiple comparisons
Missing values will be dealt with via maximum likelihood estimation Percentage changes in the main outcomes between baseline and post-intervention will be calculated
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