- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05138952
The Mindful Media Project
The Mindful Media Project: Can Mindfulness Meditation Reduce for Problematic Internet Use
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Victoria
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Melbourne, Victoria, Australia, 3800
- Monash University, BrainPark
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mindfulness Meditation
30-day program of mindfulness meditation comprising weekly group meditation tuition and support sessions and daily app-based mediation practice.
|
30-day mediation program comprising:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Change from baseline PIU severity at 1 month (post-intervention).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in response inhibition
Time Frame: Baseline (0 months), Post-Intervention (1 month), Follow-Up (2-months)
|
Stop Signal Task
|
Baseline (0 months), Post-Intervention (1 month), Follow-Up (2-months)
|
|
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.
|
Change from baseline psychological distress at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
|
|
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.
|
Change from baseline experiential avoidance at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
|
|
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.
|
Change from baseline trait mindfulness at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
|
|
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.
|
Change from baseline psychological wellbeing at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
|
|
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.
|
Change from baseline resilience at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
|
|
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.
|
Change from baseline social connectedness at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
|
|
Number of participants retained in mindfulness intervention
Time Frame: Post-Intervention (1 month)
|
Number of participants who completed the intervention
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Post-Intervention (1 month)
|
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Engagement in intervention
Time Frame: Post-Intervention (1 month)
|
Number of meditation sessions completed
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Post-Intervention (1 month)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 29159
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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