Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000463077
Ethics application status
Approved
Date submitted
3/06/2010
Date registered
8/06/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Identifying user and usage characteristics of Mindfulness Online from the general public
Scientific title
Identifying user and usage characteristics of Mindfulness Online from the general public
Secondary ID [1] 251902 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attrition in internet-based intervention targeting well being 257492 0
Condition category
Condition code
Mental Health 257644 257644 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 257645 257645 0 0
Health promotion/education
Public Health 257646 257646 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project seeks to investigate how an online intervention is being used. Specifically, the project seeks to determine which user characteristics affect attrition. If differences in characteristics can be identified, this knowledge may assist in creating a more tailored individualised treatment programs.

The Mindfulness Online program will be placed on Swinburne University’s eTherapy Unit website. People visiting the website will be invited to participate in the project. Mindfulness Online consists of three sessions designed to make an individual more mindful or being aware of moment-to-moment experiences (e.g., thoughts, feelings, images, sensations); simply accepting what is there and not wanting it to change it in any way. Participants are recommended to spend a week on each session before moving onto the next session so as to practise and to reinforce material learnt. Each session will last approximately 20 minutes. Participants will be given activities (five minutes per day) to complete offline to practise the principles of mindfulness and asked to provide feedback on this practise at the next session.
Intervention code [1] 256586 0
Prevention
Intervention code [2] 256626 0
Behaviour
Intervention code [3] 256627 0
Lifestyle
Comparator / control treatment
No control treatment is being investigated. This study is investigating user characteristics and their effects on attrition from the program.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258550 0
Personal Wellbeing Index (PWI-A)
Timepoint [1] 258550 0
Participants will complete online assessment pre-program (0 weeks), post-program (3 weeks) and at one month follow-up (4 weeks post program).
Primary outcome [2] 258551 0
Satisfaction with Life Scale (SWLS)
Timepoint [2] 258551 0
Participants will complete online assessment pre-program (0 weeks), post-program (3 weeks) and at one month follow-up (4 weeks post program).
Primary outcome [3] 258552 0
Depression, Anxiety, Stress Scales (DASS-21)
Timepoint [3] 258552 0
Participants will complete online assessment pre-program (0 weeks), post-program (3 weeks) and at one month follow-up (4 weeks post program).
Secondary outcome [1] 264395 0
Mindfulness Attention Awareness Scale (MAAS)
Timepoint [1] 264395 0
Participants will complete online assessment pre-program (0 weeks), post-program (3 weeks) and at one month follow-up (4 weeks post program).
Secondary outcome [2] 264396 0
Mental Health Continuum-Short Form (MHC-SF)
Timepoint [2] 264396 0
Participants will complete online assessment pre-program (0 weeks), post-program (3 weeks) and at one month follow-up (4 weeks post program).
Secondary outcome [3] 264397 0
Multidimensional Health Locus of Control Scale (MHLC) Form C
Timepoint [3] 264397 0
Participants will only complete this online assessment pre-program (0 week).
Secondary outcome [4] 264470 0
General Self-Efficacy Scale (GSES)
Timepoint [4] 264470 0
Participants will only complete this online assessment pre-program (0 week).
Secondary outcome [5] 264471 0
Ten Item Personality Index (TIPI)
Timepoint [5] 264471 0
Participants will only complete this online assessment pre-program (0 week).
Secondary outcome [6] 264472 0
Credibility/expectancy questionnaire (CEQ)
Timepoint [6] 264472 0
Participants will only complete this online assessment pre-program (0 week).

Eligibility
Key inclusion criteria
Have access to the internet.
Be an Australian resident.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
55
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257080 0
Self funded/Unfunded
Name [1] 257080 0
Country [1] 257080 0
Australia
Primary sponsor type
University
Name
eTherapy Unit and National eTherapy Centre
Address
Swinburne University of Technology
Mail H29
PO Box 218
Hawthorn
VICTORIA 3122
Country
Australia
Secondary sponsor category [1] 256339 0
None
Name [1] 256339 0
Address [1] 256339 0
Country [1] 256339 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259104 0
Swinburne Universtiy of Technology Human Research Ethics Committee (SUHREC)
Ethics committee address [1] 259104 0
Ethics committee country [1] 259104 0
Australia
Date submitted for ethics approval [1] 259104 0
Approval date [1] 259104 0
18/05/2010
Ethics approval number [1] 259104 0
SUHREC 2010/071

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

Contacts
Principal investigator
Name 31242 0
Address 31242 0
Country 31242 0
Phone 31242 0
Fax 31242 0
Email 31242 0
Contact person for public queries
Name 14489 0
Associate Professor Britt Klein
Address 14489 0
eTherapy Unit and National eTherapy Centre
Faculty of Life and Social Sciences
Swinburne University of Technology
PO Box 218
Hawthorn
VIC 3122
Country 14489 0
Australia
Phone 14489 0
+61 3 9214 8851
Fax 14489 0
+61 3 9214 5260
Email 14489 0
[email protected]
Contact person for scientific queries
Name 5417 0
Associate Professor Britt Klein
Address 5417 0
eTherapy Unit and National eTherapy Centre
Faculty of Life and Social Sciences
Swinburne University of Technology
PO Box 218
Hawthorn
VIC 3122
Country 5417 0
Australia
Phone 5417 0
+61 3 9214 8851
Fax 5417 0
+61 3 9214 5260
Email 5417 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.