Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000833066
Ethics application status
Approved
Date submitted
3/10/2010
Date registered
5/10/2010
Date last updated
8/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of a fully automated online mindfulness program focussing on 18-25 Australian Tertiary Education students
Scientific title
A randomised controlled trial of a fully automated online mindfulness program focussing on 18-25 year TAFE and Further Education Students
Secondary ID [1] 252813 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Efficacy of internet based intervention targeting mental health and wellbeing 258322 0
Condition category
Condition code
Mental Health 258376 258376 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 258507 258507 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project seeks to investigate the efficacy of an internet based fully automated self-help mindfulness program in the promotion of wellbeing and the reduction of symptoms of anxiety and depression amongst 18 to 25 year Australian tertiary education students. The Mindfulness Online program will be located on the Swinburne University's eTherapy Unit website. Participants within the target demographic will be invited to participate via the Swinburne eTherapy webisted and paper-based flyers. The program consists of three sessions designed to make an individual more mindful or aware of moment to moment experiences. The programs duration is 3 weeks. Participants will be randomly allocated into either a control waitlist group or an active experimental group. The experimental group will access the mindfulness program immediately and will be advised to complete one session per week. In addition participants will be encouraged to practise mindfulness each day for five minutes. The participants will be given feedback on their mental health and wellbeing at the beginning of each session and will be asked to provide feedback on their mindfulness practice sessions.
Intervention code [1] 257219 0
Prevention
Intervention code [2] 257335 0
Behaviour
Comparator / control treatment
The study employs a randomised controlled design. Participants will be allocated to either an intervention group who will receive access to the online intervention immediately or to a waitlist control condition.The Waitlist control group will be given access to the intervention after the three month follow up time point for the experimental group.
Control group
Active

Outcomes
Primary outcome [1] 259220 0
Personal Wellbeing Index (PWI-A5)
Timepoint [1] 259220 0
Pre intervention, post intervention, one month and three month follow up
Primary outcome [2] 259221 0
Satisfaction with Life Scale (SWLS)
Timepoint [2] 259221 0
Pre intervention, post intervention, one month and three month follow up
Primary outcome [3] 259222 0
Depression, Anxiety, Stress Scales (DASS-21)
Timepoint [3] 259222 0
Pre intervention, post intervention, one month and three month follow up
Secondary outcome [1] 265627 0
Mindfulness Attention Awareness Scale (MAAS)
Timepoint [1] 265627 0
Pre intervention, post intervention, one month and three month follow up
Secondary outcome [2] 265628 0
The Mental Health Continuum-Short Form (MHC-SF)
Timepoint [2] 265628 0
Pre intervention, post intervention, one month and three month follow up
Secondary outcome [3] 265801 0
Multidimensional Helath Locus of Control Scale (MHLC)
Timepoint [3] 265801 0
Pre intervention only
Secondary outcome [4] 265802 0
General Self Efficacy Scale (GSES)
Timepoint [4] 265802 0
Pre intervention only
Secondary outcome [5] 265803 0
Ten item personality index (TIPI)
Timepoint [5] 265803 0
Pre intervention only
Secondary outcome [6] 265804 0
Credibility Expectancy Questionnaire (CEQ)
Timepoint [6] 265804 0
Pre intervention only

Eligibility
Key inclusion criteria
Participants will be between the ages of 18 and 25 years and will be enrolled within Australian tertiary education courses
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students under 18 years will not be accepted as participants

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment to the either the waitlist controlled group or the experimental group will be carried out through central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once participants give their consent, they will be randomly allocated (based on the date and time of registration, via computer generated random numbers) into one of two groups: a Waitlist Control (WC) group or a Mindfulness Online (MO) group. Once participants finish the pre-intervention surveys they will be informed on the screen about which group they have been allocated to. The WC group will be advised that they will be placed on a waiting list and asked to complete the surveys three more times, and then in 15 weeks they will receive an automated email giving them details of how they can access the MO program. The MO group will be informed of how they can immediately access the MO program. The MO group can then re-enter the MO website at a convenient time and location.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257792 0
Self funded/Unfunded
Name [1] 257792 0
Country [1] 257792 0
Primary sponsor type
University
Name
Swinburne eTherapy Unit and National eTherapy Centre
Address
Swinburne University of Technology
P.O. Box 218
HAWTHORN VIC 3122
Country
Australia
Secondary sponsor category [1] 256995 0
None
Name [1] 256995 0
Address [1] 256995 0
Country [1] 256995 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259684 0
Swinburne University Human Research Ethics Committe (SUHREC)
Ethics committee address [1] 259684 0
Ethics committee country [1] 259684 0
Australia
Date submitted for ethics approval [1] 259684 0
Approval date [1] 259684 0
10/09/2010
Ethics approval number [1] 259684 0
SUHREC 2010/174

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

Contacts
Principal investigator
Name 31652 0
Address 31652 0
Country 31652 0
Phone 31652 0
Fax 31652 0
Email 31652 0
Contact person for public queries
Name 14899 0
Associate Professor Britt Klein
Address 14899 0
Director, eTherapy Unit and the National eTherapy Centre
Faculty of Life and Social Sciences
Swinburne University of Technology
PO Box 218
Hawthorn
VIC 3122
Country 14899 0
Australia
Phone 14899 0
61 3 92148851
Fax 14899 0
61 3 9214 5260
Email 14899 0
[email protected]
Contact person for scientific queries
Name 5827 0
Associate Professor Britt Klein
Address 5827 0
Director, eTherapy Unit and the National eTherapy Centre
Faculty of Life and Social Sciences
Swinburne University
P.O. Box 218
Hawthorn 3122
Australia
Country 5827 0
Australia
Phone 5827 0
61 3 9214 8851
Fax 5827 0
61 3 9214 5260
Email 5827 0
[email protected]

No information has been provided regarding IPD availability


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.