protocolSection identificationModule nctId: NCT06353451, orgStudyIdInfo id: EK GZ 67/2021-2024, briefTitle: Digital Detox Study: A Randomized Controlled Trial, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-23, primaryCompletionDateStruct date: 2024-01-21, completionDateStruct date: 2024-01-21, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Danube University Krems, class: OTHER, descriptionModule briefSummary: 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: https://osf.io/a9k76) 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., conditionsModule conditions: Health Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two groups, non blinded, randomized controlled trial, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 111, type: ACTUAL, armsInterventionsModule interventions name: Digital Detox, outcomesModule primaryOutcomes measure: Depressive Symptoms, primaryOutcomes measure: Stress, primaryOutcomes measure: Sleep Quality, primaryOutcomes measure: Well-being, secondaryOutcomes measure: Problematic smartphone use, secondaryOutcomes measure: Body Appreciation, secondaryOutcomes measure: Anxiety Symptoms, secondaryOutcomes measure: Eating Disorder, otherOutcomes measure: Physical Activity, otherOutcomes measure: Heart rate variability (HRV), otherOutcomes measure: Resting Heart Rate (RHR), otherOutcomes measure: Screen time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 29 Years, stdAges: ADULT, contactsLocationsModule locations facility: Danube University Krems, city: Krems, state: Lower Austria, zip: 3500, country: Austria, geoPoint lat: 48.40921, lon: 15.61415, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-11-08, uploadDate: 2024-03-26T06:01, filename: Prot_SAP_000.pdf, size: 251127, hasResults: False