Clinical trial NCT05138952: The Mindful Media Project
Official title: The Mindful Media Project: Can Mindfulness Meditation Reduce for Problematic Internet Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Problematic Internet Use
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: Headspace, Inc
First posted: 2021-12-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Problematic Internet Use (PIU) severity
timeFrame: Change from baseline PIU severity at 1 month (post-intervention).
Secondary outcomes:
measure: Change in response inhibition
timeFrame: Baseline (0 months), Post-Intervention (1 month), Follow-Up (2-months)
measure: Change in psychological distress
timeFrame: Change from baseline psychological distress at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
measure: Change in experiential avoidance
timeFrame: Change from baseline experiential avoidance at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
measure: Change in trait mindfulness
timeFrame: Change from baseline trait mindfulness at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
measure: Change in psychological wellbeing
timeFrame: Change from baseline psychological wellbeing at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
measure: Change in resilience
timeFrame: Change from baseline resilience at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
measure: Change in social connectedness
timeFrame: Change from baseline social connectedness at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
measure: Number of participants retained in mindfulness intervention
timeFrame: Post-Intervention (1 month)
measure: Engagement in intervention
timeFrame: Post-Intervention (1 month)
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Monash University, BrainPark
state: Victoria
Study officials:
References: