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Mental Health Wellness 1NCT06574932

The Effect of Multi-Strategy Approaches on Limiting Digital Exposure

A study testing Multi-Strategic Approach in people with Mental Health Wellness 1, run by Universiti Putra Malaysia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 25 years
Conditions the study is for
Mental Health Wellness 1
What is being tested?
Multi-Strategic Approach
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
No sites listed yet
Study dates
27 Aug 2024to 10 May 2025
Phase
Interventional
Are there results?
None posted in the registry

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 to 25 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

MUHAMMAD Rashaad contact

03337474991

stunning003@gmail.com

About this study

Official title: Screen Time and Sanity: The Impact of Multi-Strategy Approaches on Limiting Digital Exposure to Enhance Adolescent Mental Health

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.

Read the 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.

Being tested
Multi-Strategic Approach

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-Strategic ApproachBehavioural

    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.

Study groups in NCT06574932
Study groupRoleWhat they receive
Intervention groupExperimentalThe 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.
Receives: Behavioral: Multi-Strategic Approach
ControlNo interventionThe control group will be given no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6-months from baseline

Secondary outcomes (1)

  1. Depression

    Depression change will be measured by PHQ-9. PHQ-9 scores can be used to plan and monitor treatment. To score the instrument, tally the numbers of all the checked responses under each heading (not at all=0, several days=1, more than half the days=2, and nearly every day=3). Add the numbers together to total the score on the bottom of the questionnaire. PHQ-9 comprises five categories, where a cut-off point of 0-4 indicates no depressive symptoms, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, 15-19 moderately-severe depressive symptoms, and 20-27 severe depressive symptoms

    Measured: 6-months from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2024
  2. Study start27 Aug 2024 (estimated)
  3. Primary completion15 Apr 2025 (estimated)
  4. Study completion10 May 2025 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-arm parallel design randomized control trial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06574932
Sponsor's protocol ID
FAHSS
Status last verified
Aug 2024
First submitted
25 Aug 2024
Last updated
28 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The study protocol, statistical plan, and results will be disseminated through publications in peer-reviewed Journals.

Publications

  • 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.

    PubMed 28093386

  • 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

  • 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

  • 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.

    PubMed 30815691

  • 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.

    PubMed 27940701

Questions about this trial

What is this clinical trial studying?

A study testing Multi-Strategic Approach in people with Mental Health Wellness 1, run by Universiti Putra Malaysia.

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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Aug 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact MUHAMMAD Rashaad (03337474991, stunning003@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Generalized anxiety (time frame: 6-months from baseline). 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 NCT06574932, which also lists 5 linked publications.

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 28 Aug 2024.

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