Health BehaviorNCT06353451
Digital Detox Study: A Randomized Controlled Trial
A study testing Digital Detox in people with Health Behavior, run by Danube University Krems at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Digital Detox
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteAustria
- Study dates
- 23 Oct 2023to 21 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-29 years old
- male/female
- daily screen time > 3 h/d
- no mental disorder
- no ongoing psychotherapy
- no psychotropic drugs
Who cannot join
- < 18 yo or > 29 yo
- daily screen time < 3 h/d
- mental disorder (self-statement)
- in ongoing psychotherapy
- psychotropic drug use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smartphone Screen Time Reduction Improves Mental Health: A Randomized Clinical Trial
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).
Read more
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.
Read the detailed description
According to the power-analysis (small to medium effect size of d=.45, 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.
- Conditions
- Health Behavior
- Being tested
- Digital Detox
- Keywords
- Smartphone screen time, Digital Detox, Social Media Detox
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital DetoxBehavioural
In the intervention group, smartphone screen time will be reduced to less than 2 hours for 3 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Smartphone screen time should be reduced to less than 2 hours per day for 3 consecutive weeks. Screen time will be controlled by screenshots weekly. Receives: Behavioral: Digital Detox |
| Control group | No intervention | Smartphone usage behavior should continue unchanged. Screen time will be measured by uploaded screenshots weekly. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptoms
Patient Health Questionnaire (PHQ-9):
The PHQ-9 contains nine self-rating items on a four-point scale ranging from 0 ("not at all") to 3 ("nearly every day"), resulting in a total score from 0 to 27. Higher scores indicate more depressive symptoms.
Measured: The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).
Stress
Perceived Stress Questionnaire (PSQ-20):
Each item is rated from almost never (=1) to usually (= 4), with a sum score from 20 to 80. Higher scores indicate more stress.
Measured: The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).
Sleep Quality
Insomnia Severity Index (ISI):
The ISI comprises 7 self-reported items, each rated on a scale from 0 to 4, resulting in sum scores from 0 to 28. Higher scores indicate more insomnia symptoms or less sleep quality.
Measured: The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).
Well-being
World Health Organization well-being questionnaire (WHO-5):
The WHO-5 contains 5 items (0 to 5 points). Scores range from 0 (no well-being) to 25 points (maximal well-being).
Measured: The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).
Secondary outcomes (4)
Problematic smartphone use
Smartphone Addiction Scale Short Version (SAS-SV):
The 10 items range from 1 (=strongly disagree) to 6 (=strongly agree) points with a sum score from 10 to 60. Higher scores indicate problematic smartphone use.
Measured: The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).
Body Appreciation
Body Appreciation Scale-2 (BAS-2):
The scale is comprised of 10 items, which can be rated from "never" (1) to "always" (5). Higher scores indicate a more positive body appreciation.
Measured: The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).
Anxiety Symptoms
Generalized Anxiety Disorder 7 scale (GAD-7):
The GAD-7 contains 7 self-rating items on a four-point scale, from 0 to 3 (maximum score 21). Higher scores indicate more anxiety symptoms.
Measured: The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).
Eating Disorder
SCOFF (Sick, Controll, One stone, Fat, Food) Questionnaire:
Five items can be answered with "yes"=1 or "no"=0. The total score ranges from 0 to 5. A total score of 2 or above indicates disordered eating.
Measured: The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start23 Oct 2023
- Primary completion21 Jan 2024
- Study completion21 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups, non blinded, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danube University Krems
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Pieh, Danube University Krems
- Investigators
- Christoph Pieh, MD, Principal investigator, Danube University Krems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353451
- Sponsor's protocol ID
- EK GZ 67/2021-2024
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dale R, Haider K, Majdandzic J, Hoenigl A, Schwab J, Pieh C. The influence of smartphone reduction on heart rate variability: a secondary analysis from a randomised controlled trial. Health Psychol Behav Med. 2025 Aug 16;13(1):2546376. doi: 10.1080/21642850.2025.2546376. eCollection 2025.
PubMed 40831581
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Screen Time Reduction Improves Mental Health: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06353451
- Acronym / sponsor ID
- EK GZ 67/2021-2024
- Conditions
- Health Behavior
- Keywords
- Smartphone screen time, Digital Detox, Social Media Detox
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Danube University KremsUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 21 Jan 2024 (actual)
- Study completion
- 21 Jan 2024 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
According to the power-analysis (small to medium effect size of d=.45, 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups, non blinded, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Digital DetoxSmartphone screen time should be reduced to less than 2 hours per day for 3 consecutive weeks. Screen time will be controlled by screenshots weekly. |
| Control group | No intervention | –Smartphone usage behavior should continue unchanged. Screen time will be measured by uploaded screenshots weekly. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-29 years old
- male/female
- daily screen time > 3 h/d
- no mental disorder
- no ongoing psychotherapy
Key exclusion criteria (5 listed)
- < 18 yo or > 29 yo
- daily screen time < 3 h/d
- mental disorder (self-statement)
- in ongoing psychotherapy
- psychotropic drug use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital DetoxIn the intervention group, smartphone screen time will be reduced to less than 2 hours for 3 consecutive weeks. | Behavioural | Intervention Group |
Primary outcome
Depressive Symptoms
Time frame: The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).
Patient Health Questionnaire (PHQ-9): The PHQ-9 contains nine self-rating items on a four-point scale ranging from 0 ("not at all") to 3 ("nearly every day"), resulting in a total score from 0 to 27. Higher scores indicate more depressive symptoms.
Stress
Time frame: The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).
Perceived Stress Questionnaire (PSQ-20): Each item is rated from almost never (=1) to usually (= 4), with a sum score from 20 to 80. Higher scores indicate more stress.
Sleep Quality
Time frame: The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).
Insomnia Severity Index (ISI): The ISI comprises 7 self-reported items, each rated on a scale from 0 to 4, resulting in sum scores from 0 to 28. Higher scores indicate more insomnia symptoms or less sleep quality.
Well-being
Time frame: The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).
World Health Organization well-being questionnaire (WHO-5): The WHO-5 contains 5 items (0 to 5 points). Scores range from 0 (no well-being) to 25 points (maximal well-being).
4 secondary outcomes
Problematic smartphone use
Time frame: The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).
Body Appreciation
Time frame: The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).
Anxiety Symptoms
Time frame: The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).
Eating Disorder
Time frame: The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Derived from this study: PubMed 40831581Dale R, Haider K, Majdandzic J, Hoenigl A, Schwab J, Pieh C. The influence of smartphone reduction on heart rate variability: a secondary analysis from a randomised controlled trial. Health Psychol Behav Med. 2025 Aug 16;13(1):2546376. doi: 10.1080/21642850.2025.2546376. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Pieh, MD principal investigator
Danube University Krems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Detox in people with Health Behavior, run by Danube University Krems at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Symptoms (time frame: The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06353451, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.