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Trial registered on ANZCTR


Registration number
ACTRN12610000904077
Ethics application status
Approved
Date submitted
17/10/2010
Date registered
25/10/2010
Date last updated
29/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of a fully automated online mindfulness-based intervention used by people with problematic alcohol use
Scientific title
A randomised controlled trial of a fully automated online mindfulness-based intervention used by people with problematic alcohol use
Secondary ID [1] 252857 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 in a sample of people who drink alcohol to harmful levels 258380 0
Condition category
Condition code
Mental Health 258551 258551 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 258552 258552 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 people who drink alcohol to harmful levels.

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 by email 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 complete the AUDIT (Alcohol Use Disorders Identification Test) to determine eligibility for the study (a score of 8 or higher) and eligible 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. Each session is expected to take 20 minutes and is conducted in participants' own time, within the 3 week period. In addition, participants will be encouraged to practise mindfulness each day for five minutes.

Both the active experimental group and the waitlist control group will be required to log in and complete a series of questionnaires at pre intervention (25 minutes), post intervention, 1 month follow up and 3 month follow up (20 minutes each). The waitlist control group are not required to undertake further activities during the 3 week intervention phase.
Intervention code [1] 257374 0
Prevention
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 (15 weeks after completion of pre-intervention quetionnaires).
Control group
Active

Outcomes
Primary outcome [1] 259390 0
Alcohol Use Disorders Identification Test (AUDIT)
Timepoint [1] 259390 0
Pre intervention, post intervention, one month and three month follow up
Primary outcome [2] 259391 0
Depression, Anxiety, Stress Scales (DASS-21)
Timepoint [2] 259391 0
Pre intervention, post intervention, one month and three month follow up
Primary outcome [3] 259392 0
Personal Wellbeing Index (PWI-A5)
Timepoint [3] 259392 0
Pre intervention, post intervention, one month and three month follow up
Secondary outcome [1] 265921 0
Satisfaction with Life Scale (SWLS)
Timepoint [1] 265921 0
Pre intervention, post intervention, one month and three month follow up
Secondary outcome [2] 265922 0
The Severity of Dependence Scale (SDS)
Timepoint [2] 265922 0
Pre intervention, post intervention, one month and three month follow up
Secondary outcome [3] 265923 0
Mindfulness Attention Awareness Scale (MAAS)
Timepoint [3] 265923 0
Pre intervention, post intervention, one month and three month follow up
Secondary outcome [4] 265924 0
The Mental Health Continuum-Short Form (MHC-SF)
Timepoint [4] 265924 0
Pre intervention, post intervention, one month and three month follow up
Secondary outcome [5] 265925 0
Multidimensional Helath Locus of Control Scale (MHLC)
Timepoint [5] 265925 0
Pre intervention only
Secondary outcome [6] 265926 0
Credibility Expectancy Questionnaire (CEQ)
Timepoint [6] 265926 0
Pre intervention only

Eligibility
Key inclusion criteria
Participants will be aged 18 years or over and will obtain a score of 8 or higher on the Alcohol Use Disorders Identification Test (AUDIT).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People under the age of 18 years and those scoring 7 or lower on the Alcohol Use Disorders Identification Test (AUDIT) will be excluded.

This is a open-access health promotion wellbeing program, not designed to 'treat' any condition. Nor are we targeting people or assessing for alcohol abuse/dependence disorders. Therefore we cannot confirm that participants will be healthy.

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 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 and obtain a score of 8 or more on the AUDIT, 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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257825 0
Self funded/Unfunded
Name [1] 257825 0
Address [1] 257825 0
Country [1] 257825 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] 257026 0
None
Name [1] 257026 0
Address [1] 257026 0
Country [1] 257026 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259855 0
Swinburne University Human Research Ethics Committe (SUHREC)
Ethics committee address [1] 259855 0
Research Ethics Officer
Office of Research and Graduate Studies (H68)
Swinburne University of Technology
P.O. Box 218
HAWTHORN VIC 3122
Ethics committee country [1] 259855 0
Australia
Date submitted for ethics approval [1] 259855 0
Approval date [1] 259855 0
04/10/2010
Ethics approval number [1] 259855 0
SUHREC 2010/170

Summary
Brief summary
Swinburne's eTherapy Unit will run a research trial to investigate the efficacy of a fully automated self-help online mindfulness intervention, Mindfulness Online, in the promotion of wellbeing amongst people who drink alcohol to harmful levels. Swinburne University of Technology's eTherapy Unit and National eTherapy Centre (NeTC) have developed numerous internet-based prevention and treatment programs that are available to the general public for the treatment of clinical conditions and the promotion of well being. To continue the development of effective online programs, information relating to the appropriateness and efficacy of specific programs for specific user groups is required. The current project seeks to examine the efficacy of the Mindfulness Online program (developed by Dr Jo Mitchell) in its application to adults aged 18 years and over, who scored 8 or higher on the AUDIT. The results of this research will inform future development and recommendation of internet based interventions for specific user groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31760 0
Address 31760 0
Country 31760 0
Phone 31760 0
Fax 31760 0
Email 31760 0
Contact person for public queries
Name 15007 0
Associate Professor Britt Klein
Address 15007 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 15007 0
Australia
Phone 15007 0
61 3 9214 8851
Fax 15007 0
61 3 9214 5260
Email 15007 0
bklein@swin.edu.au
Contact person for scientific queries
Name 5935 0
Associate Professor Britt Klein
Address 5935 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 5935 0
Australia
Phone 5935 0
61 3 9214 8851
Fax 5935 0
61 3 9214 5260
Email 5935 0
bklein@swin.edu.au

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