Problematic Internet UseNCT05138952
The Mindful Media Project
A study testing Mindfulness Meditation in people with Problematic Internet Use, run by Monash University at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Problematic Internet Use
- What is being tested?
- Mindfulness Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteAustralia
- Study dates
- 16 Aug 2021to 30 Dec 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Problematic Internet Use
- Being tested
- Mindfulness Meditation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness MeditationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Meditation | Experimental | 30-day program of mindfulness meditation comprising weekly group meditation tuition and support sessions and daily app-based mediation practice. Receives: Behavioral: Mindfulness Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Problematic Internet Use (PIU) severity
10-item abbreviated Internet Addiction Test (IAT-10). Scores range from 10 to 50, with higher scores indicating increasing severity of PIU.
Measured: Change from baseline PIU severity at 1 month (post-intervention).
Secondary outcomes (9)
Change in response inhibition
Stop Signal Task
Measured: Baseline (0 months), Post-Intervention (1 month), Follow-Up (2-months)
Change in psychological distress
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.
Measured: Change from baseline psychological distress at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
Change in experiential avoidance
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.
Measured: Change from baseline experiential avoidance at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
Change in trait mindfulness
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.
Measured: Change from baseline trait mindfulness at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
Change in psychological wellbeing
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.
Measured: Change from baseline psychological wellbeing at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
Change in resilience
The Connor-Davidson Resilience Scale is a 10-item scale measuring resilience. Scores range from 0 to 40, and higher scores indicate higher resilience.
Measured: Change from baseline resilience at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
Change in social connectedness
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.
Measured: 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
Number of participants who completed the intervention
Measured: Post-Intervention (1 month)
Engagement in intervention
Number of meditation sessions completed
Measured: Post-Intervention (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start16 Aug 2021
- Primary completion16 Sep 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problematic Internet UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- Headspace, Inc
- Responsible party
- Principal investigator, Rebecca Segrave, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138952
- Sponsor's protocol ID
- 29159
- Status last verified
- Apr 2022
- First submitted
- 10 Aug 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mindful Media Project: Can Mindfulness Meditation Reduce for Problematic Internet Use
- ClinicalTrials.gov ID
- NCT05138952
- Acronym / sponsor ID
- 29159
- Conditions
- Problematic Internet Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- Headspace, Inc
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Meditation | Experimental | Behavioral: Mindfulness Meditation30-day program of mindfulness meditation comprising weekly group meditation tuition and support sessions and daily app-based mediation practice. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Meditation30-day mediation program comprising: 1. 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. 2. 10-minutes of daily mindfulness meditation practice with the Headspace Inc app. | Behavioural | Mindfulness Meditation |
Primary outcome
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.
9 secondary outcomes
Change in response inhibition
Time frame: 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).
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).
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).
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).
Change in resilience
Time frame: 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).
Number of participants retained in mindfulness intervention
Time frame: Post-Intervention (1 month)
Engagement in intervention
Time frame: Post-Intervention (1 month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
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The Effect of a Digital Literacy Program on Problematic Internet Use, Emotion Regulation, and Loneliness in Adolescents: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation in people with Problematic Internet Use, run by Monash University at 1 site in Australia.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Problematic Internet Use (PIU) severity (time frame: Change from baseline PIU severity at 1 month (post-intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2022.