Clinical trial NCT06574932: The Effect of Multi-Strategy Approaches on Limiting Digital Exposure
Official title: Screen Time and Sanity: The Impact of Multi-Strategy Approaches on Limiting Digital Exposure to Enhance Adolescent Mental Health
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mental Health Wellness 1
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: Green International University
First posted: 2024-08-28
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm parallel design randomized control trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In the digital age, university students are increasingly immersed in a technology-driven environment where smartphones, social media, and various digital platforms play a central role in their daily lives. While these technologies offer significant benefits, such as enhanced connectivity, access to information, and educational resources, they also pose potential risks to mental health. Excessive screen time, constant connectivity, and the pressure to maintain an online presence can lead to negative outcomes, including anxiety, depression, sleep disturbances, and reduced academic performance.

Detailed description: Recent research highlights the growing concern over the impact of digital overuse on students' mental well-being. The constant barrage of notifications, the pressure to stay connected, and the addictive nature of social media can create a state of perpetual stress and distraction. This, in turn, can hinder students' ability to focus, engage in meaningful social interactions, and maintain a healthy balance between their academic and personal lives.

A multi-assignment program offers a promising intervention to counteract these negative effects. By encouraging students to disconnect from digital devices and reduce their online engagement temporarily, a digital detox can provide the opportunity to reset their relationship with technology. This period of disconnection allows students to regain control over their time, reduce stress, and foster healthier habits that support their mental well-being.

Eligibility criteria: Inclusion Criteria:

* Participants must be enrolled as students at any of the three universities of Lahore.
* Participants should be 18 to 25 years old, as this demographic is typically more engaged in smartphone usage and may experience varying mental health effects.
* Participants must own and regularly use a smartphone. Regular use is a smartphone for at least two hours per day.
* Participants must be willing to provide written informed consent, acknowledging their understanding of the study and agreeing to participate voluntarily.
* Participants must be able to read and understand the language in which the questionnaires and assessments are administered (likely English or Urdu, depending on the study design).
* Only full-time students will be included to ensure that their daily routines and stress levels are more comparable across the study group.

Exclusion Criteria:

* Individuals who have been diagnosed with severe psychiatric disorders (such as schizophrenia, bipolar disorder, or other major psychiatric conditions) will be excluded. These conditions could introduce confounding variables that may affect the study's results.
* Individuals who are currently undergoing treatment for severe mental health conditions or are taking medication that could significantly impact mental health and smartphone usage will be excluded to avoid confounding effects.
* Individuals who have recently experienced major life events (such as the death of a close family member, major accidents, or other significant trauma) within the last six months may be excluded, as these events could influence mental health independently of smartphone use.

Primary outcomes:
measure: Generalized anxiety
timeFrame: 6-months from baseline
Secondary outcomes:
measure: Depression
timeFrame: 6-months from baseline
Other outcomes:
Locations:
Study officials:
affiliation: University of Lahore
name: MUHAMMAD ARSHED, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shakya HB, Christakis NA. Association of Facebook Use With Compromised Well-Being: A Longitudinal Study. Am J Epidemiol. 2017 Feb 1;185(3):203-211. doi: 10.1093/aje/kww189.
citation: Basen I. You can't stop checking your phone because Silicon Valley designed it that way. CBC Radio 2018 Sept 14. Available: www.cbc.ca/radio/thesundayedition/the-sunday-edition-september-16-2018-1.4822353/you-can-t-stop-checking-your-phone-because-silicon-valley-designed-it-that-way-1.4822360
citation: NHS Digital. Mental Health of Children and Young People in England, 2017: Summary of key findings. NHS Digital; 2018 [cited 2019 Sep 21]. Available from: https://files.digital.nhs.uk/A6/EA7D58/MHCYP%202017%20Summary.pdf
citation: Patalay P, Gage SH. Changes in millennial adolescent mental health and health-related behaviours over 10 years: a population cohort comparison study. Int J Epidemiol. 2019 Oct 1;48(5):1650-1664. doi: 10.1093/ije/dyz006.
citation: Mojtabai R, Olfson M, Han B. National Trends in the Prevalence and Treatment of Depression in Adolescents and Young Adults. Pediatrics. 2016 Dec;138(6):e20161878. doi: 10.1542/peds.2016-1878. Epub 2016 Nov 14.