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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

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05138952