The Effect of Multi-Strategy Approaches on Limiting Digital Exposure

NCT06574932 | Not Yet Recruiting DMC

• 1 other identifier: FAHSS
• Study Type: interventional
• Target: 700
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mental Health Wellness 1

Outcome Measures

Primary Outcomes (1)

• Generalized anxiety

  Generalized anxiety change will be measured by (GAD-7). seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions. GAD-7 total score for the seven items ranges from 0 to 21.Score 0-4: Minimal Anxiety. Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety.

  6-months from baseline

Secondary Outcomes (1)

• Depression

  6-months from baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

The experimental group will be engaged in multi-strategy approaches including screen time and sanity challenges, weekly screen-free days, screen time reduction goals, screen time tracking, structured daily routines, parental involvement, and monitoring, family media plans, alternative engagements, and promotion of offline social interactions.

Behavioral: Multi-Strategic Approach

Control

NO INTERVENTION

The control group will be given no intervention.

Interventions

Multi-Strategic Approach BEHAVIORAL

The experimental group will be engaged in multi-strategy approaches including screen time and sanity challenges, weekly screen-free days, screen time reduction goals, screen time tracking, structured daily routines, parental involvement, and monitoring, family media plans, alternative engagements, and promotion of offline social interactions.

Intervention group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Putra Malaysia: lead
• Green International University: collaborator

Related Publications (5)

• 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.

  PMID: 28093386 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 30815691 BACKGROUND

• 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.

  PMID: 27940701 BACKGROUND

Study Officials

• MUHAMMAD ARSHED, PhD

  University of Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MUHAMMAD Rashaad

CONTACT

03337474991; stunning003@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigators will be blinded
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD studentship

Model Details: Two-arm parallel design randomized control trial

Study Record Dates

• First Submitted: August 25, 2024
• First Posted: August 28, 2024
• Study Start: August 27, 2024
• Primary Completion: April 15, 2025
• Study Completion: May 10, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share