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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05138952




Registration number
NCT05138952
Ethics application status
Date submitted
10/08/2021
Date registered
1/12/2021
Date last updated
6/04/2022

Titles & IDs
Public title
The Mindful Media Project
Scientific title
The Mindful Media Project: Can Mindfulness Meditation Reduce for Problematic Internet Use
Secondary ID [1] 0 0
29159
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Problematic Internet Use 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Mindfulness Meditation

Experimental: Mindfulness Meditation - 30-day program of mindfulness meditation comprising weekly group meditation tuition and support sessions and daily app-based mediation practice.


BEHAVIORAL: Mindfulness Meditation
30-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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Problematic Internet Use (PIU) severity
Timepoint [1] 0 0
Change from baseline PIU severity at 1 month (post-intervention).
Secondary outcome [1] 0 0
Change in response inhibition
Timepoint [1] 0 0
Baseline (0 months), Post-Intervention (1 month), Follow-Up (2-months)
Secondary outcome [2] 0 0
Change in psychological distress
Timepoint [2] 0 0
Change from baseline psychological distress at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
Secondary outcome [3] 0 0
Change in experiential avoidance
Timepoint [3] 0 0
Change from baseline experiential avoidance at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
Secondary outcome [4] 0 0
Change in trait mindfulness
Timepoint [4] 0 0
Change from baseline trait mindfulness at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
Secondary outcome [5] 0 0
Change in psychological wellbeing
Timepoint [5] 0 0
Change from baseline psychological wellbeing at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
Secondary outcome [6] 0 0
Change in resilience
Timepoint [6] 0 0
Change from baseline resilience at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
Secondary outcome [7] 0 0
Change in social connectedness
Timepoint [7] 0 0
Change from baseline social connectedness at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
Secondary outcome [8] 0 0
Number of participants retained in mindfulness intervention
Timepoint [8] 0 0
Post-Intervention (1 month)
Secondary outcome [9] 0 0
Engagement in intervention
Timepoint [9] 0 0
Post-Intervention (1 month)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/12/2021
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash University, BrainPark - Melbourne
Recruitment postcode(s) [1] 0 0
3800 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Headspace, Inc
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05138952
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05138952