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Completed

NCT Number: NCT05138952

The Mindful Media Project

Problematic Internet Use (PIU) is an emerging mental health issue. Research consistently shows that university students are disproportionately vulnerable to experiencing PIU, and that this can be linked with both poorer academic performance and mental health outcomes. Despite these adverse consequences, there has been no research to date on treatments for those experiencing PIU.

Preliminary research suggests that one promising candidate is mindfulness meditation. Mindfulness is a popular form of brain training that helps develop an ability to sit with uncomfortable thoughts and emotions, break compulsive behavioural patterns and make more mindful behavioural choices. The current proof-of-concept study aims to investigate the clinical potential of mindfulness meditation in reducing PIU severity for Australian university students who endorse moderate to severe PIU symptoms.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monash University, BrainPark

Melbourne, Victoria, 3800, Australia

About this study

Problematic Use of the Internet (PUI) is an umbrella term encapsulating excessive and uncontrolled engagement with internet-related activities. PIU is increasingly recognised as an emerging mental health issue. It is characterised by a perceived loss of control over internet use despite repeated attempts to regulate it, and excessive internet-specific preoccupations or urges that result in distress and life impairment. Research consistently shows that university students are disproportionately vulnerable to experiencing PIU, and that this can be linked with both poorer academic performance and mental health outcomes.

Despite these adverse consequences, there has been no research to date on treatments for those experiencing PIU. Preliminary research suggests that one promising candidate for addressing PIU is mindfulness meditation. Mindfulness is a popular form of brain training that helps develop an ability to sit with uncomfortable thoughts and emotions, break compulsive behavioural patterns and make more mindful behavioural choices.

The current study is a proof of principal investigation. The primary aim is to evaluate the efficacy of a brief mindfulness meditation intervention for PIU among Australian university students who endorse moderate to severe PIU. The study will investigate a 30 day combination of daily meditation practice using the Headspace Inc supported by weekly online group meditation tuition. In order to support participant engagement in the meditation practices, a range of behaviour change techniques will be applied. A secondary is to evaluation the efficacy of these behaviour change techniques in support engagement.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntary and able to provide informed consent
  • Endorse current moderate to severe PIU on IAT-10
  • Currently attending an Australian university (full-time or part-time, international or domestic student)
  • Ability to adhere to study procedures
  • If taking psychoactive medication, have been stable on same type and dose for at least 4 weeks prior to study commencement

Exclusion criteria

  • History of neurological illness or moderate to severe brain injury
  • Severely impaired visual/auditory ability
  • Diagnosed history of learning difficulty or other condition involving cognitive impairment as a primary feature.
  • Lack of both verbal and written fluency in English
  • Have engaged in > 10 instances of formal mindfulness meditation practice in past 12 months

Treatment and study plan

Mindfulness Meditation

Behavioral

30-day mediation program comprising:

  • Weekly group mediation tuition and support sessions delivered online. Sessions will last 45-60 minutes and focus on mindfulness meditation theory and techniques, and trouble shooting barriers to practice and engagement.
  • 10-minutes of daily mindfulness meditation practice with the Headspace Inc app.

Primary outcomes

  1. Change in Problematic Internet Use (PIU) severity

    Time frame: Change from baseline PIU severity at 1 month (post-intervention).

    10-item abbreviated Internet Addiction Test (IAT-10). Scores range from 10 to 50, with higher scores indicating increasing severity of PIU.

Secondary outcomes

  1. Change in response inhibition

    Time frame: Baseline (0 months), Post-Intervention (1 month), Follow-Up (2-months)

    Stop Signal Task

  2. Change in psychological distress

    Time frame: Change from baseline psychological distress at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).

    The Depression Anxiety Stress Scale (DASS-21) consists of 21 items, 7 items per subscale: depression, anxiety and stress. For each subscale, scores can range from 0 to 42, with higher scores indicating greater severity or worse outcomes.

  3. Change in experiential avoidance

    Time frame: Change from baseline experiential avoidance at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).

    The Brief Experiential Avoidance Questionnaire (BEAQ) is a 15-item short form of the Multidimensional Experiential Avoidance Questionnaire. Scores can range from 15 to 90, with higher scores indicating greater experiential avoidance.

  4. Change in trait mindfulness

    Time frame: Change from baseline trait mindfulness at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).

    The Cognitive Affective Mindfulness Scale Revised (CAMS-R) is a 12-item scale, with scores ranging from 12 to 48. High scores indicate greater mindful qualities.

  5. Change in psychological wellbeing

    Time frame: Change from baseline psychological wellbeing at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).

    The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) is a 14-item measure of psychological wellbeing, with scores ranging from 14 to 70. Higher scores indicate higher levels of mental wellbeing.

  6. Change in resilience

    Time frame: Change from baseline resilience at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).

    The Connor-Davidson Resilience Scale is a 10-item scale measuring resilience. Scores range from 0 to 40, and higher scores indicate higher resilience.

  7. Change in social connectedness

    Time frame: Change from baseline social connectedness at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).

    The Campaign to End Loneliness Tool is a brief 3-item measure of social connectedness. Scores range from 0 to 12, and higher scores reflect greater social connectedness.

  8. Number of participants retained in mindfulness intervention

    Time frame: Post-Intervention (1 month)

    Number of participants who completed the intervention

  9. Engagement in intervention

    Time frame: Post-Intervention (1 month)

    Number of meditation sessions completed

Sponsors and collaborators

Lead sponsor

Monash University

Other

Collaborators

  • Headspace, Inc

Registry information

Official study title

The Mindful Media Project: Can Mindfulness Meditation Reduce for Problematic Internet Use

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 1, 2021
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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