Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
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
Query!
Scientific title
The Mindful Media Project: Can Mindfulness Meditation Reduce for Problematic Internet Use
Query!
Secondary ID [1]
0
0
29159
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Problematic Internet Use
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
BEHAVIORAL
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change in Problematic Internet Use (PIU) severity
Query!
Assessment method [1]
0
0
10-item abbreviated Internet Addiction Test (IAT-10). Scores range from 10 to 50, with higher scores indicating increasing severity of PIU.
Query!
Timepoint [1]
0
0
Change from baseline PIU severity at 1 month (post-intervention).
Query!
Secondary outcome [1]
0
0
Change in response inhibition
Query!
Assessment method [1]
0
0
Stop Signal Task
Query!
Timepoint [1]
0
0
Baseline (0 months), Post-Intervention (1 month), Follow-Up (2-months)
Query!
Secondary outcome [2]
0
0
Change in psychological distress
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Change from baseline psychological distress at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
Query!
Secondary outcome [3]
0
0
Change in experiential avoidance
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Change from baseline experiential avoidance at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
Query!
Secondary outcome [4]
0
0
Change in trait mindfulness
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Change from baseline trait mindfulness at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
Query!
Secondary outcome [5]
0
0
Change in psychological wellbeing
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Change from baseline psychological wellbeing at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
Query!
Secondary outcome [6]
0
0
Change in resilience
Query!
Assessment method [6]
0
0
The Connor-Davidson Resilience Scale is a 10-item scale measuring resilience. Scores range from 0 to 40, and higher scores indicate higher resilience.
Query!
Timepoint [6]
0
0
Change from baseline resilience at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
Query!
Secondary outcome [7]
0
0
Change in social connectedness
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Change from baseline social connectedness at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).
Query!
Secondary outcome [8]
0
0
Number of participants retained in mindfulness intervention
Query!
Assessment method [8]
0
0
Number of participants who completed the intervention
Query!
Timepoint [8]
0
0
Post-Intervention (1 month)
Query!
Secondary outcome [9]
0
0
Engagement in intervention
Query!
Assessment method [9]
0
0
Number of meditation sessions completed
Query!
Timepoint [9]
0
0
Post-Intervention (1 month)
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
60
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
16/08/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
30/12/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
26
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Monash University, BrainPark - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
3800 - Melbourne
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Monash University
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Headspace, Inc
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05138952
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
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