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Trial registered on ANZCTR


Registration number
ACTRN12614000959673
Ethics application status
Approved
Date submitted
29/08/2014
Date registered
9/09/2014
Date last updated
9/09/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Facebook and Mental Wellbeing: A crossover randomised controlled study
Scientific title
In students, does reducing Facebook use for two weeks, compared to normal use, have an effect on self-reported mental wellbeing?
Secondary ID [1] 285262 0
Nil known
Universal Trial Number (UTN)
U1111-1161-0481
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental wellbeing 292908 0
Condition category
Condition code
Mental Health 293197 293197 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Reduced Facebook use for two weeks. Participants were asked to "restrict [their] Facebook use as much as possible for two weeks” and were told “During this time, please avoid using Facebook, including through mobile phones, tablets, and computers.”

Adherence was measured by asking participants whether they had used Facebook Much more/more/same/less/much less than usual.

Study involvement lasted 4 weeks. Two weeks of intervention followed-up by two weeks of control (or vice versa, due to the crossover design). There was no washout period.
Intervention code [1] 290141 0
Behaviour
Comparator / control treatment
Unrestricted Facebook use for two weeks.
Control group
Active

Outcomes
Primary outcome [1] 293067 0
Differences in Warwick and Edinburgh Mental Wellbeing Scale scores between intervention and control period, using paired t-test.
Timepoint [1] 293067 0
Comparing scores at 2 and 4 weeks.
Secondary outcome [1] 310283 0
Stratification of primary outcome by gender and relationship status
Timepoint [1] 310283 0
Comparing scores at 2 and 4 weeks.
Secondary outcome [2] 310284 0
Differences in Warwick and Edinburgh Mental Wellbeing Scale scores using incomplete data using regression analysis and Stata’s clustered sandwich estimator (vce(cluster) function)
Timepoint [2] 310284 0
Comparing scores at 2 and 4 weeks.

Eligibility
Key inclusion criteria
Full-time students at the University of Oxford and regular Facebook users. Regular Facebook users were defined as those that agreed they were "a daily Facebook user".
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were randomised on a rolling basis after completing online informed consent form. Unpredictability of the allocation sequence was ensured by using a computerised random number generation process by the investigator. Furthermore, at randomisation, no data other than the participant’s email address had been collected. Participants were not blinded to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
rand() function in Excel. Simple randomisation using a 1:1 ratio was used: those with a value of less than 0.5 were allocated to Group A, those with a value of 0.5 or more were allocated to Group B.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The statistical significance of the primary outcome (differences in WEMWBS scores between the intervention and control period) was calculated using a paired t-test. Only participants who completed both sets of questionnaires were entered in this analysis.

In a sensitivity analysis, all observations were entered into a regression analysis using Stata’s clustered sandwich estimator (vce(cluster) function) to allow for within-participant correlation in data with repeated observations on individuals, and to minimise missingness.

For secondary outcomes, we stratified analyses by gender (female vs. male) and relationship status (single vs. in a relationship).

All analyses were done in Stata, version 12.1. Observations were entered according to group allocation, following an intention-to-treat approach. Statistical assumptions for paired t-tests were tested using a histogram of the differences in scores and by plotting differences in scores against average scores.

The sample size of 78 was calculated assuming a power of 0.8, an alpha of 0.05, a minimal detectable difference in means of 2 points in WEMWBS score, a 20% dropout rate, and a standard error of measurement (SEM) of 2.78 (mean of the five SEMs reported in Maheswaran et al. 2012, Health and Quality of Life Outcomes)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6326 0
United Kingdom
State/province [1] 6326 0
Oxfordshire

Funding & Sponsors
Funding source category [1] 289882 0
Self funded/Unfunded
Name [1] 289882 0
Address [1] 289882 0
Country [1] 289882 0
Primary sponsor type
Individual
Name
Achim Wolf
Address
University of Oxford, Department of Psychiatry, Warneford Hospital, Oxford, OX3 7JX, United Kingdom
Country
United Kingdom
Secondary sponsor category [1] 288562 0
None
Name [1] 288562 0
Address [1] 288562 0
Country [1] 288562 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291605 0
University of Oxford’s Medical Sciences Interdivisional Research Ethics Committee
Ethics committee address [1] 291605 0
Secretary of IDREC, Research Services, University of Oxford, Wellington Square, Oxford, OX1 2JD
Ethics committee country [1] 291605 0
United Kingdom
Date submitted for ethics approval [1] 291605 0
03/03/2014
Approval date [1] 291605 0
27/03/2014
Ethics approval number [1] 291605 0
MSD-IDREC-C1-2014-035

Summary
Brief summary
We are running a study to examine the relationship between Facebook and Mental Wellbeing. Specifically, we will be looking at the effects of restricting your Facebook use for two weeks.
Trial website
http://oxford-fb.com
Trial related presentations / publications
Kross E, Verduyn P, Demiralp E, Park J, Lee DS, et al. (2013) Facebook use predicts declines in subjective well-being in young adults. PloS one 8: e69841.

Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, et al. (2007) The Warwick-Edinburgh mental well-being scale (WEMWBS): development and UK validation. Health and Quality of life Outcomes 5: 63.

Maheswaran H, Weich S, Powell J, Stewart-Brown S (2012) Evaluating the responsiveness of the Warwick Edinburgh Mental Well-Being Scale (WEMWBS): Group and individual level analysis. Health Qual Life Outcomes 10: 156.
Public notes

Contacts
Principal investigator
Name 51118 0
Mr Achim Wolf
Address 51118 0
University of Oxford, Department of Psychiatry, Warneford Hospital, Oxford, OX3 7JX, United Kingdom
Country 51118 0
United Kingdom
Phone 51118 0
+441865226201
Fax 51118 0
Email 51118 0
achim.wolf@psych.ox.ac.uk
Contact person for public queries
Name 51119 0
Mr Achim Wolf
Address 51119 0
University of Oxford, Department of Psychiatry, Warneford Hospital, Oxford, OX3 7JX, United Kingdom
Country 51119 0
United Kingdom
Phone 51119 0
+441865226201
Fax 51119 0
Email 51119 0
achim.wolf@psych.ox.ac.uk
Contact person for scientific queries
Name 51120 0
Mr Achim Wolf
Address 51120 0
University of Oxford, Department of Psychiatry, Warneford Hospital, Oxford, OX3 7JX, United Kingdom
Country 51120 0
United Kingdom
Phone 51120 0
+441865226201
Fax 51120 0
Email 51120 0
achim.wolf@psych.ox.ac.uk

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary