Digital Detox Study (RESET)

March 27, 2025 updated by: Christoph Pieh, Danube University Krems

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • healthy subjects
  • greater-equal 18 years
  • sufficient German skills
  • using a smartphone daily 3 hours or more
  • no ongoing psychotherapy, psychological or psychopharmacological treatment

Exclusion Criteria:

  • Age under 18 years
  • insufficient German skills
  • Smartphone use less than 3 hours per day
  • ongoing psychotherapy, psychological or psychopharmacological treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Smartphone screen time reduction group (IG)
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.
Behavioral: smartphone screen time reduction
Smartphone screen time has to be reduced to less-equal 2 hours per day for 3 consecutive weeks.
No Intervention: Control group
Control group (CG) will use smartphone unchanged for 6 consecutive weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At baseline (t0), after the intervention period (= three weeks after t0) (t1), and at follow-up (t2) in both groups.
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.
At baseline (t0), after the intervention period (= three weeks after t0) (t1), and at follow-up (t2) in both groups.
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.
At baseline (t0), after the intervention period (= three weeks after t0) (t1), and at follow-up (t2) in both groups.
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.
At baseline (t0), after the intervention period (= three weeks after t0) (t1), and at follow-up (t2) in both groups.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Craving
Time Frame: At baseline (t0), after the intervention period (= three weeks after t0) (t1), and at follow-up (t2) in both groups.
Craving will be assessed with the validated German version of the Craving Experience Questionnaire (CEQ-F). Higher scores mean a higher level of craving.
At baseline (t0), after the intervention period (= three weeks after t0) (t1), and at follow-up (t2) in both groups.
Loneliness
Time Frame: At baseline (t0), after the intervention period (= three weeks after t0) (t1), and at follow-up (t2) in both groups.
Loneliness will be measured with the validated German version of the Three-item-loneliness scale. Higher scores mean a higher level of loneliness.
At baseline (t0), after the intervention period (= three weeks after t0) (t1), and at follow-up (t2) in both groups.
Physical activity
Time Frame: Weekly from baseline (t0) to post-intervention (t1) (= 3 weeks, 4 times in total), once again at follow-up (t2)
Self-stated physical activity (times per week as well as minutes per week) will be assessed (self-statement).
Weekly from baseline (t0) to post-intervention (t1) (= 3 weeks, 4 times in total), once again at follow-up (t2)
Smartphone usage
Time Frame: Weekly from baseline (t0) to follow-up (t2) (= 6 weeks, 7 times in total) in both groups
Smartphone usage will be assessed weekly in both groups via self-report and screenshot upload regarding the screen time, the activations and the most frequently used apps in the previous weeks.
Weekly from baseline (t0) to follow-up (t2) (= 6 weeks, 7 times in total) in both groups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Danube University Krems

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christoph Pieh, Full Professor, University for Continuing Education Krems

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 9, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EK GZ 15 2024-2027 (Other Identifier: University of Continuous Education Krems)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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