- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07827703
Effects of Digital Detox on Mental Health in Young Adults: A Randomized Controlled Trial
The goal of this clinical trial is to learn whether a short, self-guided program for cutting down smartphone screen time can reduce symptoms of depression in young adults. It includes students in Oslo, Norway, who have applied for help at the student mental health service (SiO Mental Health).
The main questions it aims to answer are:
- Does a 2-week screen time reduction program reduce symptoms of depression?
- Does it reduce symptoms of anxiety?
- Can a simple, widely available phone app reduce screen time, and does the reduction last?
Researchers will compare students who start the program right away with students who continue their usual care for 2 weeks and receive the same program afterwards. Participants are placed in one of the two groups by chance, like flipping a coin.
Participants will:
- Answer questionnaires about depression and anxiety symptoms at the start and again after 2 weeks
- Upload screenshots of the Screen Time summary on their iPhone at the start, after 2 weeks, and after 12 weeks
- Install an app that blocks the apps they find most distracting and keep it active for 2 weeks, if they are placed in the program group
- Take part entirely online, with no clinic visits and no contact with the study team
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Thomas Mildestvedt, Professor
- Phone Number: +47 55586163
- Email: thomas.mildestvedt@uib.no
Study Locations
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-
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Oslo, Norway
- Studentsamskipnaden i Oslo
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Contact:
- Thomas Mildestvedt, Professor
- Phone Number: +47 55586163
- Email: thomas.mildestvedt@uib.no
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Has applied for care at SiO Mental Health, the student mental health service in Oslo, and has received the service's response to the application
- Owns an iPhone (the screen time restriction tool requires iOS)
- Able to understand written Norwegian
- Provides informed consent
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Care as usual
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Experimental: Screen time reduction
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Two-week self-guided use of an iOS screen time restriction app.
Participants block their most distracting apps, with notifications disabled.
Unlocking requires a 30-second delay, allows 10 minutes of access, then a 5-minute cooldown.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptoms of depression (PHQ-9)
Time Frame: From enrollment to the end of intervention at 2 weeks
|
Patient Health Questionnaire-9, range 0 to 27, higher scores indicate more depressive symptoms.
|
From enrollment to the end of intervention at 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptoms of anxiety (GAD-7)
Time Frame: From enrollment to the end of intervention at 2 weeks
|
Generalized Anxiety Disorder-7, range 0 to 21, higher scores indicate more anxiety symptoms.
|
From enrollment to the end of intervention at 2 weeks
|
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Total smartphone screen time
Time Frame: 2 weeks and 12 weeks after randomization
|
2 weeks and 12 weeks after randomization
|
|
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Smartphone screen time by app category
Time Frame: 2 weeks and 12 weeks after randomization
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2 weeks and 12 weeks after randomization
|
|
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Number of daily smartphone pickups
Time Frame: 2 weeks and 12 weeks after randomization
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2 weeks and 12 weeks after randomization
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported changes in sleep, physical activity, social interaction and concentration
Time Frame: 2 weeks
|
Single-item Likert-scale questions on perceived change in each domain during the 2-week period.
|
2 weeks
|
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Self-reported changes in phone use behaviors
Time Frame: 2 weeks
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Single-item Likert-scale questions on perceived change in phone use habits during the 2-week period.
|
2 weeks
|
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Adherence to the screen time restriction tool
Time Frame: 2 weeks
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Self-reported proportion of the 2-week period with the tool kept active, reported by the intervention group.
|
2 weeks
|
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Perceived usefulness and burden of the tool
Time Frame: 2 weeks and 12 weeks
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Self-reported usefulness, burden and intention to continue use, reported by the intervention group at 2 weeks and by both groups at 12 weeks.
|
2 weeks and 12 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas Mildestvedt, Professor, University of Bergen
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000700
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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