- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Thomas Mildestvedt, Professor
- Telefonnummer: +47 55586163
- E-post: thomas.mildestvedt@uib.no
Studiesteder
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Oslo, Norge
- Studentsamskipnaden i Oslo
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Ta kontakt med:
- Thomas Mildestvedt, Professor
- Telefonnummer: +47 55586163
- E-post: thomas.mildestvedt@uib.no
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: Ta vare som vanlig
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Eksperimentell: 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Symptoms of depression (PHQ-9)
Tidsramme: From enrollment to the end of intervention at 2 weeks
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Patient Health Questionnaire-9, range 0 to 27, higher scores indicate more depressive symptoms.
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From enrollment to the end of intervention at 2 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Symptoms of anxiety (GAD-7)
Tidsramme: From enrollment to the end of intervention at 2 weeks
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Generalized Anxiety Disorder-7, range 0 to 21, higher scores indicate more anxiety symptoms.
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From enrollment to the end of intervention at 2 weeks
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Total smartphone screen time
Tidsramme: 2 weeks and 12 weeks after randomization
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2 weeks and 12 weeks after randomization
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Smartphone screen time by app category
Tidsramme: 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
Tidsramme: 2 weeks and 12 weeks after randomization
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2 weeks and 12 weeks after randomization
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Self-reported changes in sleep, physical activity, social interaction and concentration
Tidsramme: 2 weeks
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Single-item Likert-scale questions on perceived change in each domain during the 2-week period.
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2 weeks
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Self-reported changes in phone use behaviors
Tidsramme: 2 weeks
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Single-item Likert-scale questions on perceived change in phone use habits during the 2-week period.
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2 weeks
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Adherence to the screen time restriction tool
Tidsramme: 2 weeks
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Self-reported proportion of the 2-week period with the tool kept active, reported by the intervention group.
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2 weeks
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Perceived usefulness and burden of the tool
Tidsramme: 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.
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2 weeks and 12 weeks
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Thomas Mildestvedt, Professor, University of Bergen
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1000700
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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