NCT05138952

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

August 16, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

1 month

First QC Date

August 10, 2021

Last Update Submit

April 4, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from baseline PIU severity at 1 month (post-intervention).

Secondary Outcomes (9)

  • Change in response inhibition

    Baseline (0 months), Post-Intervention (1 month), Follow-Up (2-months)

  • Change in psychological distress

    Change from baseline psychological distress at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).

  • Change in experiential avoidance

    Change from baseline experiential avoidance at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).

  • Change in trait mindfulness

    Change from baseline trait mindfulness at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).

  • Change in psychological wellbeing

    Change from baseline psychological wellbeing at 1 month (post-intervention) and 2 months (one-month follow-up post intervention).

  • +4 more secondary outcomes

Study Arms (1)

Mindfulness Meditation

EXPERIMENTAL

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

Behavioral: Mindfulness Meditation

Interventions

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.

Mindfulness Meditation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monash University, BrainPark

Melbourne, Victoria, 3800, Australia

Location

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Fellow

Study Record Dates

First Submitted

August 10, 2021

First Posted

December 1, 2021

Study Start

August 16, 2021

Primary Completion

September 16, 2021

Study Completion

December 30, 2021

Last Updated

April 6, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations