PreventionRESETNCT06910371
Digital Detox Study
A study testing smartphone screen time reduction in people with Prevention and Digital Health, run by Danube University Krems.
Trial summary
The Digital Detox study is designed as a randomized controlled trial (two unblinded parallel groups) to examine the effects of reducing smartphone screentime on mental health. After giving informed consent, participants will be screened for eligibility. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prevention, Digital Health, Smartphone Addiction
- What is being tested?
- smartphone screen time reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2025to 9 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subjects
- greater-equal 18 years
- sufficient German skills
- using a smartphone daily 3 hours or more
- no ongoing psychotherapy, psychological or psychopharmacological treatment
Who cannot join
- Age under 18 years
- insufficient German skills
- Smartphone use less than 3 hours per day
- ongoing psychotherapy, psychological or psychopharmacological treatment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Katja Haider, BA MSc contact
About this study
Official title: Digital Detox Study: A Randomized Controlled Trial
The Digital Detox study is designed as a randomized controlled trial (two unblinded parallel groups) to examine the effects of reducing smartphone screentime on mental health. After giving informed consent, participants will be screened for eligibility. Inclusion criteria are adult subjects (greater-equal 18 years) using their smartphone daily for 3 hours or more, with sufficient German skills and no ongoing psychotherapy, psychological or psychopharmacological treatment. For eligibility screening, participants have to upload a screenshot of their smartphone screen time of the last week, have to state about mental health disorders (self-report) and their sociodemographic variables (age, gender, country of residence, education and professional status, urban/rural nature of place of residence), and have to fill out the following questionnaires: depressive symptoms (PHQ-9), well-being (WHO-5), sleep quality (ISI), stress (PSQ-20), loneliness (three-item loneliness scale), physical activity, and smartphone usage behavior.
If the inclusion criteria are met, participants will be randomized to the intervention or control group. The intervention consists of a three-week screen time reduction to a maximum of 2 hours per day for 3 consecutive weeks. The control group continues to use their smartphones as usual during this time. At the beginning of the study (=baseline T0), all participants will complete the following primary outcome measures (depressive symptoms (PHQ-9), well-being (WHO-5), sleep quality (ISI), stress (PSQ-20)) and secondary outcome measures (loneliness (three-item loneliness scale), craving (CEQ-F), physical activity). Both groups will also complete items on loneliness and physical activity twice during the intervention (after the first and second week of the intervention) to monitor changes in these variables during the intervention. After the three weeks of intervention (post-intervention T1), both groups will again fill out the the same outcome measures as for T0. After the 3-week intervention, there are no further restrictions regarding the participants' smartphone screen time. Follow-up (T2) will be after 3 more weeks and the same outcome measures as for T0 and T1 will be collected.
Read more
The weekly smartphone screen time is assessed via self-reporting and screenshot upload. Information is also provided on the weekly activations of the smartphone and a screenshot is uploaded of the most frequently used apps. All data is collected weekly for the previous week.
The study will be performed entirely via a smartphone app (ESMIra), which is designed especially to run longitudinal studies.
Primary hypotheses:
- H1: Reducing smartphone use to a maximum of 2 hours/day over 3 weeks leads to a difference in the depressive symptoms of the intervention participants before and after participating in the intervention.
- H2: Reducing smartphone use to a maximum of 2 hours/day over 3 weeks leads to a difference in the the sleep quality of the intervention participants before and after participating in the intervention.
- H3: Reducing smartphone use to a maximum of 2 hours/day over 3 weeks leads to a difference in perceived stress of the intervention participants before and after participating in the intervention.
- H4: Reducing smartphone use to a maximum of 2 hours/day over 3 weeks leads to a difference in the well-being of the intervention participants before and after participating in the intervention.
- H5: The reduction in smartphone use to a maximum of 2 hours/day over 3 weeks led to a difference in depressive symptoms between the control and intervention groups at the post-intervention time point.
- H6: The reduction in smartphone use to a maximum of 2 hours/day over 3 weeks led to a difference in sleep quality between the control and intervention groups at the post-intervention time point.
- H7: The reduction in smartphone use to a maximum of 2 hours/day over 3 weeks led to a difference in perceived stress between the control and intervention groups at the post-intervention time point.
- H8: The reduction in smartphone use to a maximum of 2 hours/day over 3 weeks led to a difference in well-being between the control and intervention groups at the post-intervention time point.
Read the detailed description
The study employs a convenience sampling method to recruit participants. Recruitment channels include social media accounts of the university and the department (Instagram: istokay.at, unikrems, and X (formerly Twitter): @PsychiUniKrems), where posts and story updates will provide information about the study. Additionally, emails will be sent to universities, universities of applied sciences, and other educational institutions, and flyers will be distributed. These materials will inform potential participants about the study's purpose and procedures.
Interested individuals can access the study page on ESMira via a link or QR code. There, they provide electronic consent before completing the screening questionnaire, which assesses the study's inclusion and exclusion criteria.
Control group will be offered to also participate in the intervention after study completion.
Data Collection
All data collection and communication with participants will take place exclusively through the ESMira research application. ESMira is compatible with all smartphones and was specifically developed for scientific studies, particularly those with a longitudinal design. The app allows for the administration of questionnaires at pre-specified time points and facilitates fully anonymous communication with participants.
A permanent internet connection is not required for using ESMira. Completed questionnaires are stored locally on the app and automatically uploaded once an internet connection becomes available. Research data is stored in encrypted form on a secure server at the University for Continuing Education Krems. Participant anonymity is ensured through a randomly generated user ID (12 alphanumeric characters, e.g., 4mZm-F8vN-5Vyk) assigned by ESMira.
For more information about ESMira, visit: https://github.com/KL-Psychological-Methodology/.
Data Security and Storage:
In accordance with Article 32 of the DSGVO, data security measures will be implemented to ensure the protection and confidentiality of participant information. The data is stored on a local server and is protected against unauthorized access. Unauthorized reading, copying, modification or deletion is therefore not possible. Furthermore, the data is only collected and stored in pseudonymized form. The personal data is only stored for the duration of the study. After that, it is only stored in a completely anonymized form.
Used questionnaire:
Screening only:
Sociodemographic variables: Age (in years), gender, country of residence, highest completed education, current educational/employment status, urban/rural classification of residence.
Mental health (self-report):
Do you have a mental health condition for which you are currently receiving treatment? (yes/no) Are you currently taking medication for a mental health condition? (yes/no) Smartphone usage: Do you use your smartphone for an average of ≥3 hours per day? (yes/no)
Assessed at screening and all subsequent time points (T0, T1, T2):
Depressive Symptoms (PHQ-9) The Patient Health Questionnaire (PHQ-9) is used to assess depressive symptoms in its validated German version, consisting of 9 items.
Well-being (WHO-5) The validated German version of the World Health Organization Well-Being Index (WHO-5) is used to assess participants' well-being and consists of 5 items.
Sleep Quality (ISI) :
The Insomnia Severity Index (ISI) is used in its validated German version to assess the quality of sleep and consists of 7 items.
Stress (PSQ-20): Stress is assessed using the German version of the short form of the Perceived Stress Questionnaire (PSQ-20), which consists of 20 items.
Loneliness (3-Item Loneliness Questionnaire): Loneliness is assessed using the German version of the Three Items Loneliness Scale, consisting of 3 items.
Physical activity: "On how many of the last 7 days were you physically active for at least 60 minutes?" and "How many minutes did you spend doing sport in the last 7 days?" Craving (CEQ-F) [not in screening]: Craving is measured using the Craving Experience Questionnaire (CEQ-F) in the German version, for behavioral addictions and smartphone use in particular, and consists of 9 items.
Smartphone use (self-report and upload of screenshots of screentime over the last week, activations, and the most frequently used apps).
- Conditions
- Prevention, Digital Health, Smartphone Addiction
- Being tested
- smartphone screen time reduction
- Keywords
- digital detox, screen time reduction, mental health
- Medical subject headings
- Internet Addiction Disorder, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smartphone screen time reductionBehavioural
Smartphone screen time has to be reduced to less-equal 2 hours per day for 3 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone screen time reduction group (IG) | Experimental | Smartphone screen time reduction group (intervention group = IG) will reduce smartphone screen time for 3 weeks to less-equal than 2 hours. After intervention, there are no screen time predefined values until follow-up. Receives: Behavioral: smartphone screen time reduction |
| Control group | No intervention | Control group (CG) will use smartphone unchanged for 6 consecutive weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
The Patient Health Questionnaire (PHQ-9) is used to assess depressive symptoms in its validated German version, consisting of 9 items. Higher scores mean a higher level of depressive symptoms.
Measured: At baseline (t0), after the intervention period (= three weeks after t0) (t1), and at follow-up (t2) in both groups.
Well-being
The validated German version of the World Health Organization Well-Being Index (WHO-5) is used to assess participants' well-being and consists of 5 items. Higher scores mean a higher level of well-being.
Measured: At baseline (t0), after the intervention period (= three weeks after t0) (t1), and at follow-up (t2) in both groups.
Sleep quality
The Insomnia Severity Index (ISI) is used in its validated German version.Higher socres mean a higher level of insomnia symptoms.
Measured: At baseline (t0), after the intervention period (= three weeks after t0) (t1), and at follow-up (t2) in both groups.
Stress
Stress will be evaluated with the German version of the 20-item short form of the Perceived Stress Questionnaire (PSQ-20). Higher scores mean a higher level of stress.
Measured: At baseline (t0), after the intervention period (= three weeks after t0) (t1), and at follow-up (t2) in both groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start31 Mar 2025 (estimated)
- Primary completion19 May 2025 (estimated)
- Study completion9 Jun 2025 (estimated)
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 PreventionStudies 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
- Randomized controlled trial with two unblinded parallel groups)
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
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, Full Professor, Principal investigator, University for Continuing Education Krems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910371
- Sponsor's protocol ID
- EK GZ 15 2024-2027
- Other IDs
- EK GZ 15 2024-2027
- Acronym
- RESET
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
References: Bastien, C. H., Vallières, A., & Morin, C. M. (2001). Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Medicine, 2(4), 297-307. https://doi.org/10.1016/s1389-9457(00)00065-4 Brandtner, A., & Wegmann, E. (2023). The fear in desire: linking desire thinking and fear of missing out in the social media context. BMC Psychology, 11(1), 176. Brähler, E., Mühlan, H., Albani, C., & Schmidt, S. (2007). Teststatistische Prüfung und Normierung der deutschen Versionen des EUROHIS-QOL Lebensqualität-Index und des WHO-5 Wohlbefindens-Index. Diagnostica, 53(2), 83-96. https://doi.org/10.1026/0012-1924.53.2.83 Cornil, A., Long, J., Rothen, S., Perales, J. C., de Timary, P., & Billieux, J. (2019). The gambling craving experience questionnaire: Psychometric properties of a new scale based on the elaborated intrusion theory of desire. Addictive Behaviors, 95, 110-117. Fliege, H., Rose, M., Arck, P., Walter, O. B., Kocalevent, R.-D., Weber, C., & Klapp, B. F. (2005). The Perceived Stress Questionnaire (PSQ) Reconsidered: Validation and reference values from different clinical and healthy adult samples. Psychosomatic Medicine, 67(1). https://doi.org/10.1097/01.psy.0000151491.80178.78 Fliege, H., Rose, M., Arck, P., Levenstein, S., & Klapp, B. F. (2009). PSQ - Perceived Stress Questionnaire. In. Leibniz Institute for Psychology - Open Test Archive. https://doi.org/https://doi.org/10.23668/psycharchives.5138 Fritz, M. The Craving Experience Questionnaire: Validation of a German Version. Gerber, M., Lang, C., Lemola, S., Colledge, F., Kalak, N., Holsboer-Trachsler, E., Pühse, U., & Brand, S. (2016). Validation of the German version of the Insomnia Severity Index in adolescents, young adults and adult workers: results from three crosssectional studies. BMC Psychiatry, 16, 174. https://doi.org/10.1186/s12888-016-0876-8 Klein, E. M., Zenger, M., Tibubos, A. N., Ernst, M., Reiner, I., Schmalbach, B., ... & Beutel, M. E. (2021). Loneliness and its relation to mental health in the general population: Validation and norm values of a brief measure. Journal of affective disorders reports, 4, 100120. Kroenke, K., Spitzer, R. L., & Williams, J. B. (2001). The PHQ-9: validity of a brief depression severity measure. Journal of General Internal Medicine, 16(9), 606-613. https://doi.org/10.1046/j.1525-1497.2001.016009606.x Levenstein, S., Prantera, C., Varvo, V., Scribano, M. L., Berto, E., Luzi, C., & Andreoli, A. (1993). Development of the perceived stress questionnaire: A new tool for psychosomatic research. Journal of Psychosomatic Research, 37(1), 19-32. https://doi.org/https://doi.org/10.1016/0022-3999(93)90120-5 Löwe, B., Spitzer, R. L., Gräfe, K., Kroenke, K., Quenter, A., Zipfel, S., Buchholz, C., Witte, S., & Herzog, W. (2004). Comparative validity of three screening questionnaires for DSM-IV depressive disorders and physicians' diagnoses. Journal of Affective Disorders, 78(2), 131-140. https://doi.org/10.1016/S0165-0327(02)00237-9 Morin, C. M., Belleville, G., Bélanger, L., & Ivers, H. (2011). The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep, 34(5), 601-608. https://doi.org/10.1093/sleep/34.5.601 Reinwarth, A. C., Petersen, J., Beutel, M. E., Hautzinger, M., & Brähler, E. (2024). Social support in older adults: Validation and norm values of a brief form of the Perceived Social Support Questionnaire (F-SozU K-6). Plos one, 19(3), e0299467. Topp, C. W., Østergaard, S. D., Søndergaard, S., & Bech, P. (2015). The WHO-5 Well- Being Index: A Systematic review of the literature. Psychotherapy and Psychosomatics, 84(3), 167-176. https://doi.org/10.1159/000376585
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Detox Study: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06910371
- Acronym / sponsor ID
- RESET / EK GZ 15 2024-2027
- Conditions
- Prevention, Digital Health, Smartphone Addiction
- Keywords
- digital detox, screen time reduction, mental health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Danube University KremsUniversity, hospital or other
- Study start
- 31 Mar 2025 (estimated)
- Primary completion
- 19 May 2025 (estimated)
- Study completion
- 9 Jun 2025 (estimated)
- First posted
- 4 Apr 2025 (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 Digital Detox study is designed as a randomized controlled trial (two unblinded parallel groups) to examine the effects of reducing smartphone screentime on mental health. After giving informed consent, participants will be screened for eligibility. Inclusion criteria are adult subjects (greater-equal 18 years) using their smartphone daily for 3 hours or more, with sufficient German skills and no ongoing psychotherapy, psychological or psychopharmacological treatment. For eligibility screening, participants have to upload a screenshot of their smartphone screen time of the last week, have to state about mental health disorders (self-report) and their sociodemographic variables (age, gender, country of residence, education and professional status, urban/rural nature of place of residence), and have to fill out the following questionnaires: depressive symptoms (PHQ-9), well-being (WHO-5), sleep quality (ISI), stress (PSQ-20), loneliness (three-item loneliness scale), physical activity, and smartphone usage behavior.
If the inclusion criteria are met, participants will be randomized to the intervention or control group. The intervention consists of a three-week screen time reduction to a maximum of 2 hours per day for 3 consecutive weeks. The control group continues to use their smartphones as usual during this time. At the beginning of the study (=baseline T0), all participants will complete the following primary outcome measures (depressive symptoms (PHQ-9), well-being (WHO-5), sleep quality (ISI), stress (PSQ-20)) and secondary outcome measures (loneliness (three-item loneliness scale), craving (CEQ-F), physical activity). Both groups will also complete items on loneliness and physical activity twice during the intervention (after the first and second week of the intervention) to monitor changes in these variables during the intervention. After the three weeks of intervention (post-intervention T1), both groups will again fill out the the same outcome measures as for T0. After the 3-week intervention, there are no further restrictions regarding the participants' smartphone screen time. Follow-up (T2) will be after 3 more weeks and the same outcome measures as for T0 and T1 will be collected.
The weekly smartphone screen time is assessed via self-reporting and screenshot upload. Information is also provided on the weekly activations of the smartphone and a screenshot is uploaded of the most frequently used apps. All data is collected weekly for the previous week.
The study will be performed entirely via a smartphone app (ESMIra), which is designed especially to run longitudinal studies.
Primary hypotheses:
- H1: Reducing smartphone use to a maximum of 2 hours/day over 3 weeks leads to a difference in the depressive symptoms of the intervention participants before and after participating in the intervention.
- H2: Reducing smartphone use to a maximum of 2 hours/day over 3 weeks leads to a difference in the the sleep quality of the intervention participants before and after participating in the intervention.
- H3: Reducing smartphone use to a maximum of 2 hours/day over 3 weeks leads to a difference in perceived stress of the intervention participants before and after participating in the intervention.
- H4: Reducing smartphone use to a maximum of 2 hours/day over 3 weeks leads to a difference in the well-being of the intervention participants before and after participating in the intervention.
- H5: The reduction in smartphone use to a maximum of 2 hours/day over 3 weeks led to a difference in depressive symptoms between the control and intervention groups at the post-intervention time point.
- H6: The reduction in smartphone use to a maximum of 2 hours/day over 3 weeks led to a difference in sleep quality between the control and intervention groups at the post-intervention time point.
- H7: The reduction in smartphone use to a maximum of 2 hours/day over 3 weeks led to a difference in perceived stress between the control and intervention groups at the post-intervention time point.
- H8: The reduction in smartphone use to a maximum of 2 hours/day over 3 weeks led to a difference in well-being between the control and intervention groups at the post-intervention time point.
Detailed description
The study employs a convenience sampling method to recruit participants. Recruitment channels include social media accounts of the university and the department (Instagram: istokay.at, unikrems, and X (formerly Twitter): @PsychiUniKrems), where posts and story updates will provide information about the study. Additionally, emails will be sent to universities, universities of applied sciences, and other educational institutions, and flyers will be distributed. These materials will inform potential participants about the study's purpose and procedures.
Interested individuals can access the study page on ESMira via a link or QR code. There, they provide electronic consent before completing the screening questionnaire, which assesses the study's inclusion and exclusion criteria.
Control group will be offered to also participate in the intervention after study completion.
Data Collection
All data collection and communication with participants will take place exclusively through the ESMira research application. ESMira is compatible with all smartphones and was specifically developed for scientific studies, particularly those with a longitudinal design. The app allows for the administration of questionnaires at pre-specified time points and facilitates fully anonymous communication with participants.
A permanent internet connection is not required for using ESMira. Completed questionnaires are stored locally on the app and automatically uploaded once an internet connection becomes available. Research data is stored in encrypted form on a secure server at the University for Continuing Education Krems. Participant anonymity is ensured through a randomly generated user ID (12 alphanumeric characters, e.g., 4mZm-F8vN-5Vyk) assigned by ESMira.
For more information about ESMira, visit: https://github.com/KL-Psychological-Methodology/.
Data Security and Storage:
In accordance with Article 32 of the DSGVO, data security measures will be implemented to ensure the protection and confidentiality of participant information. The data is stored on a local server and is protected against unauthorized access. Unauthorized reading, copying, modification or deletion is therefore not possible. Furthermore, the data is only collected and stored in pseudonymized form. The personal data is only stored for the duration of the study. After that, it is only stored in a completely anonymized form.
Used questionnaire:
Screening only:
Sociodemographic variables: Age (in years), gender, country of residence, highest completed education, current educational/employment status, urban/rural classification of residence.
Mental health (self-report):
Do you have a mental health condition for which you are currently receiving treatment? (yes/no) Are you currently taking medication for a mental health condition? (yes/no) Smartphone usage: Do you use your smartphone for an average of ≥3 hours per day? (yes/no)
Assessed at screening and all subsequent time points (T0, T1, T2):
Depressive Symptoms (PHQ-9) The Patient Health Questionnaire (PHQ-9) is used to assess depressive symptoms in its validated German version, consisting of 9 items.
Well-being (WHO-5) The validated German version of the World Health Organization Well-Being Index (WHO-5) is used to assess participants' well-being and consists of 5 items.
Sleep Quality (ISI) :
The Insomnia Severity Index (ISI) is used in its validated German version to assess the quality of sleep and consists of 7 items.
Stress (PSQ-20): Stress is assessed using the German version of the short form of the Perceived Stress Questionnaire (PSQ-20), which consists of 20 items.
Loneliness (3-Item Loneliness Questionnaire): Loneliness is assessed using the German version of the Three Items Loneliness Scale, consisting of 3 items.
Physical activity: "On how many of the last 7 days were you physically active for at least 60 minutes?" and "How many minutes did you spend doing sport in the last 7 days?" Craving (CEQ-F) [not in screening]: Craving is measured using the Craving Experience Questionnaire (CEQ-F) in the German version, for behavioral addictions and smartphone use in particular, and consists of 9 items.
Smartphone use (self-report and upload of screenshots of screentime over the last week, activations, and the most frequently used apps).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with two unblinded parallel groups)
| Arm | Type | Receives |
|---|---|---|
| Smartphone screen time reduction group (IG) | Experimental | Behavioral: smartphone screen time reductionSmartphone screen time reduction group (intervention group = IG) will reduce smartphone screen time for 3 weeks to less-equal than 2 hours. After intervention, there are no screen time predefined values until follow-up. |
| Control group | No intervention | –Control group (CG) will use smartphone unchanged for 6 consecutive weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- healthy subjects
- greater-equal 18 years
- sufficient German skills
- using a smartphone daily 3 hours or more
- no ongoing psychotherapy, psychological or psychopharmacological treatment
Key exclusion criteria (4 listed)
- Age under 18 years
- insufficient German skills
- Smartphone use less than 3 hours per day
- ongoing psychotherapy, psychological or psychopharmacological treatment
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 |
|---|---|---|
| smartphone screen time reductionSmartphone screen time has to be reduced to less-equal 2 hours per day for 3 consecutive weeks. | Behavioural | Smartphone screen time reduction group (IG) |
Primary outcome
Depressive symptoms
Time frame: At baseline (t0), after the intervention period (= three weeks after t0) (t1), and at follow-up (t2) in both groups.
The Patient Health Questionnaire (PHQ-9) is used to assess depressive symptoms in its validated German version, consisting of 9 items. Higher scores mean a higher level of depressive symptoms.
Well-being
Time frame: At baseline (t0), after the intervention period (= three weeks after t0) (t1), and at follow-up (t2) in both groups.
The validated German version of the World Health Organization Well-Being Index (WHO-5) is used to assess participants' well-being and consists of 5 items. Higher scores mean a higher level of well-being.
Sleep quality
Time frame: At baseline (t0), after the intervention period (= three weeks after t0) (t1), and at follow-up (t2) in both groups.
The Insomnia Severity Index (ISI) is used in its validated German version.Higher socres mean a higher level of insomnia symptoms.
Stress
Time frame: At baseline (t0), after the intervention period (= three weeks after t0) (t1), and at follow-up (t2) in both groups.
Stress will be evaluated with the German version of the 20-item short form of the Perceived Stress Questionnaire (PSQ-20). Higher scores mean a higher level of stress.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- BackgroundReferences: Bastien, C. H., Vallières, A., & Morin, C. M. (2001). Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Medicine, 2(4), 297-307. https://doi.org/10.1016/s1389-9457(00)00065-4 Brandtner, A., & Wegmann, E. (2023). The fear in desire: linking desire thinking and fear of missing out in the social media context. BMC Psychology, 11(1), 176. Brähler, E., Mühlan, H., Albani, C., & Schmidt, S. (2007). Teststatistische Prüfung und Normierung der deutschen Versionen des EUROHIS-QOL Lebensqualität-Index und des WHO-5 Wohlbefindens-Index. Diagnostica, 53(2), 83-96. https://doi.org/10.1026/0012-1924.53.2.83 Cornil, A., Long, J., Rothen, S., Perales, J. C., de Timary, P., & Billieux, J. (2019). The gambling craving experience questionnaire: Psychometric properties of a new scale based on the elaborated intrusion theory of desire. Addictive Behaviors, 95, 110-117. Fliege, H., Rose, M., Arck, P., Walter, O. B., Kocalevent, R.-D., Weber, C., & Klapp, B. F. (2005). The Perceived Stress Questionnaire (PSQ) Reconsidered: Validation and reference values from different clinical and healthy adult samples. Psychosomatic Medicine, 67(1). https://doi.org/10.1097/01.psy.0000151491.80178.78 Fliege, H., Rose, M., Arck, P., Levenstein, S., & Klapp, B. F. (2009). PSQ - Perceived Stress Questionnaire. In. Leibniz Institute for Psychology - Open Test Archive. https://doi.org/https://doi.org/10.23668/psycharchives.5138 Fritz, M. The Craving Experience Questionnaire: Validation of a German Version. Gerber, M., Lang, C., Lemola, S., Colledge, F., Kalak, N., Holsboer-Trachsler, E., Pühse, U., & Brand, S. (2016). Validation of the German version of the Insomnia Severity Index in adolescents, young adults and adult workers: results from three crosssectional studies. BMC Psychiatry, 16, 174. https://doi.org/10.1186/s12888-016-0876-8 Klein, E. M., Zenger, M., Tibubos, A. N., Ernst, M., Reiner, I., Schmalbach, B., ... & Beutel, M. E. (2021). Loneliness and its relation to mental health in the general population: Validation and norm values of a brief measure. Journal of affective disorders reports, 4, 100120. Kroenke, K., Spitzer, R. L., & Williams, J. B. (2001). The PHQ-9: validity of a brief depression severity measure. Journal of General Internal Medicine, 16(9), 606-613. https://doi.org/10.1046/j.1525-1497.2001.016009606.x Levenstein, S., Prantera, C., Varvo, V., Scribano, M. L., Berto, E., Luzi, C., & Andreoli, A. (1993). Development of the perceived stress questionnaire: A new tool for psychosomatic research. Journal of Psychosomatic Research, 37(1), 19-32. https://doi.org/https://doi.org/10.1016/0022-3999(93)90120-5 Löwe, B., Spitzer, R. L., Gräfe, K., Kroenke, K., Quenter, A., Zipfel, S., Buchholz, C., Witte, S., & Herzog, W. (2004). Comparative validity of three screening questionnaires for DSM-IV depressive disorders and physicians' diagnoses. Journal of Affective Disorders, 78(2), 131-140. https://doi.org/10.1016/S0165-0327(02)00237-9 Morin, C. M., Belleville, G., Bélanger, L., & Ivers, H. (2011). The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep, 34(5), 601-608. https://doi.org/10.1093/sleep/34.5.601 Reinwarth, A. C., Petersen, J., Beutel, M. E., Hautzinger, M., & Brähler, E. (2024). Social support in older adults: Validation and norm values of a brief form of the Perceived Social Support Questionnaire (F-SozU K-6). Plos one, 19(3), e0299467. Topp, C. W., Østergaard, S. D., Søndergaard, S., & Bech, P. (2015). The WHO-5 Well- Being Index: A Systematic review of the literature. Psychotherapy and Psychosomatics, 84(3), 167-176. https://doi.org/10.1159/000376585
- This was the first pilot study on the topic, and its results and experiences now serve as the basis for a follow-up study with a significantly larger study sample. The existing literature largely aligns with the findings of this study.Link provided by the sponsor.
- 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.
Katja Haider, BA MSc contact
Christoph Pieh, Full Professor principal investigator
University for Continuing Education Krems
Questions about this trial
What is this clinical trial studying?
A study testing smartphone screen time reduction in people with Prevention and Digital Health, run by Danube University Krems.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christoph Pieh, MD, Full Professor (+4327328932530, christoph.pieh@donau-uni.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: At baseline (t0), after the intervention period (= three weeks after t0) (t1), and at follow-up (t2) in both groups.). 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 NCT06910371, 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 4 Apr 2025; AzTrials last refreshed its copy on 27 Oct 2026.