Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001484730
Ethics application status
Approved
Date submitted
16/11/2022
Date registered
28/11/2022
Date last updated
28/11/2022
Date data sharing statement initially provided
28/11/2022
Date results provided
28/11/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Problematic Internet Usage: An intervention to help regulate daily personal internet use?
Scientific title
Problematic Internet Usage: Can commitment and progress frameworks help regulate daily personal internet use in adults? A randomised controlled trial
Secondary ID [1] 308431 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Problematic internet use 328230 0
Condition category
Condition code
Mental Health 325281 325281 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The online Intervention is 21 days. Participants in the experimental group were given theory-driven (Dunbar et al., 2017, 2018; Fishbach & Zhang, 2009; Fishbach et al., 2009) feedback depending on the outcome of the comparison of their last two days personal internet hours. If there was a reduction in daily personal internet hours it was considered a success, and commitment feedback was provided. Examples of commitment feedback include “Congratulations. Your commitment to reduce your internet usage is evident.”, “After the success of the previous day, how committed do you feel to your goal to reduce your personal internet usage?” and “Consider when faced with a dilemma whether to use the internet for personal use, you can use the internet for personal use OR do something much more productive”. If the value was the same or worse than previously it was considered a failure, and progress feedback was provided. Examples of progress feedback include “Your results indicate you failed to progress towards your goal to reduce your personal internet usage. This indicates that improvement is required.” and “How much progress towards your goal do you feel you have made after the disappointment of yesterday?”. In order to prevent repetition, four variations of each feedback scenario of commitment and progress conditions were created and randomly selected for each participant on each occasion.
Participants record daily personal internet usage using a study specific measure. Feedback is provided to participants via daily text message (automated). Adherence was not monitored.
Intervention code [1] 324878 0
Behaviour
Comparator / control treatment
Control participants also receive a 21 day intervention. Participants in the active control group were provided with self-monitoring feedback which included showing them their hours for the last two days. Again, four versions were created and randomly presented to each participant. Examples of self-monitoring feedback include: “Yesterday you spent XXX hours on personal internet usage while the day before you spent XXX hours on the internet for personal use.” and “After the results of yesterday, how much motivation towards pursuing your goal do you feel?” The text presented to the experimental and active control groups were approximately equal in length.
Control group
Active

Outcomes
Primary outcome [1] 333142 0
Changes from baseline in self-reported daily personal internet (DPI) hours, self reported via online study specific measure.
Timepoint [1] 333142 0
Baseline, Day 21 (final day of intervention: primary endpoint) and 6 weeks post intervention
Primary outcome [2] 333143 0
Internet Addiction Test (IAT) scores
Timepoint [2] 333143 0
Baseline, Day 21 (final day of intervention: primary endpoint) and 6 weeks post intervention
Secondary outcome [1] 415929 0
Changes in self-reported Depression, Anxiety, Stress Scale-21- Anxiety subscale
Timepoint [1] 415929 0
Baseline, Day 21 (final day of intervention) and 6 weeks post intervention
Secondary outcome [2] 415930 0
social anxiety measures -Short form Social Interaction Anxiety Scale (SIAS-6) and Social Phobia Scale (SPS-6) , These combined measures (overall total) will be assessed as a composite secondary outcome
Timepoint [2] 415930 0
Baseline, Day 21 (final day of intervention) and 6 weeks post intervention
Secondary outcome [3] 416049 0
Changes in self reported Depression, Anxiety and Stress Scales-21 -Depression subscale
Timepoint [3] 416049 0
Baseline, Day 21 (final day of intervention) and 6 weeks post intervention
Secondary outcome [4] 416050 0
Changes in self reported Depression, Anxiety Stress Scale-21 Stress subscale
Timepoint [4] 416050 0
Baseline, Day 21 (final day of intervention) and 6 weeks post intervention

Eligibility
Key inclusion criteria
The target population for these behavior changes are individuals who experience difficulties regulating their time on the internet. Therefore, participants who scored 40 or higher on the IAT were included, as scores of 40-69 on the Internet Addiction Test (IAT) are indicative of individuals who have frequent problems, and scores of 70-100 are indicative of significant issues (Kuss & Lopez-Fernandez, 2016; Laconi et al., 2014).

Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The intervention relies on priming mental representation frameworks via the common understandings and social constructs of the English words commitment and progress. Previous research (Dunbar et al., 2018) showed that this does not occur reliably with participants for whom English is a second language. Therefore, any students for whom English was not their first language were excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central allocation by computer software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All participants who met the inclusion criteria were allocated into an intervention or active control group using a block allocation method (Altman & Bland, 1999; Kang et al., 2008) so that the groups never differed by more than two participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Effect Size from previous research: Cohen’s d = 0.5. Using G*Power 3.1.9.2, leads to 51 participants per condition for a total sample size of N = 102.
A linear mixed effects model was constructed to assess the effect of the intervention on daily personal internet (DPI) hours.
Analysis of covariance (ANCOVA) was used to assess the effect of the intervention on Internet Addiction Test (IAT) scores, controlling for pre-intervention IAT score. The effect was also adjusted for age and gender. Estimates of adjusted mean post-intervention IAT scores for each group were obtained from the model post-hoc.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2019
Date of last participant enrolment
Anticipated
Actual
30/09/2019
Date of last data collection
Anticipated
Actual
15/11/2019
Sample size
Target
102
Accrual to date
Final
94
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 312679 0
University
Name [1] 312679 0
School of Psychology, University of Adelaide
Country [1] 312679 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
University of Adelaide, Adelaide, 5005, South Australia
Country
Australia
Secondary sponsor category [1] 314289 0
None
Name [1] 314289 0
Address [1] 314289 0
Country [1] 314289 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311981 0
University of Adelaide HREC
Ethics committee address [1] 311981 0
Ethics committee country [1] 311981 0
Australia
Date submitted for ethics approval [1] 311981 0
18/01/2018
Approval date [1] 311981 0
02/02/2018
Ethics approval number [1] 311981 0
H-2018-016

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123050 0
Dr Michael Proeve
Address 123050 0
School of Psychology, University of Adelaide, Adelaide, 5005 South Australia
Country 123050 0
Australia
Phone 123050 0
+61 8 8313 3818
Fax 123050 0
Email 123050 0
[email protected]
Contact person for public queries
Name 123051 0
Michael Proeve
Address 123051 0
School of Psychology, University of Adelaide, Adelaide, 5005 South Australia
Country 123051 0
Australia
Phone 123051 0
+61 8 8313 3818
Fax 123051 0
Email 123051 0
[email protected]
Contact person for scientific queries
Name 123052 0
Michael Proeve
Address 123052 0
School of Psychology, University of Adelaide, Adelaide, 5005 South Australia
Country 123052 0
Australia
Phone 123052 0
+61 8 8313 3818
Fax 123052 0
Email 123052 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Restricted due to ethics approval requirements, consent not obtained at time for data sharing.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.