Digital Detox Study

NCT06910371 | Not Yet Recruiting

• 1 other identifier: EK GZ 15 2024-2027
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Prevention; Digital Health; Smartphone Addiction

Keywords

digital detox; screen time reduction; mental health

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  At baseline (t0), after the intervention period (= three weeks after t0) (t1), and at follow-up (t2) in both groups.

Other Outcomes (4)

• Craving

  At baseline (t0), after the intervention period (= three weeks after t0) (t1), and at follow-up (t2) in both groups.

• Loneliness

  At baseline (t0), after the intervention period (= three weeks after t0) (t1), and at follow-up (t2) in both groups.

• Physical activity

  Weekly from baseline (t0) to post-intervention (t1) (= 3 weeks, 4 times in total), once again at follow-up (t2)

Study Arms (2)

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.

Behavioral: smartphone screen time reduction

Control group

NO INTERVENTION

Control group (CG) will use smartphone unchanged for 6 consecutive weeks.

Interventions

smartphone screen time reduction BEHAVIORAL

Smartphone screen time has to be reduced to less-equal 2 hours per day for 3 consecutive weeks.

Smartphone screen time reduction group (IG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Danube University Krems: lead

Related Publications (1)

• 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

  BACKGROUND

Related Links

• 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.

MeSH Terms

Conditions

Internet Addiction Disorder; Psychological Well-Being

Condition Hierarchy (Ancestors)

Technology Addiction; Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Personal Satisfaction

Study Officials

• Christoph Pieh, Full Professor

  University for Continuing Education Krems

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Pieh, MD, Full Professor

CONTACT

+4327328932530; christoph.pieh@donau-uni.ac.at

Katja Haider, BA MSc

CONTACT

katja.haider@donau-uni.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: Randomized controlled trial with two unblinded parallel groups)

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 4, 2025
• Study Start: March 31, 2025
• Primary Completion: May 19, 2025
• Study Completion: June 9, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share