Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000699965
Ethics application status
Approved
Date submitted
6/07/2011
Date registered
7/07/2011
Date last updated
7/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the Living Well Feeling Well program for the general public
Scientific title
The effectiveness of the Living Well Feeling Well program for improving wellbeing and life satisfaction in the general public
Secondary ID [1] 252826 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wellbeing 258335 0
Condition category
Condition code
Mental Health 258521 258521 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Living Well Feeling Well program is an online program comprised of 5 modules designed to help people cope with challenging situations and enhance their mental and physical wellbeing. Participants are given 3 weeks to complete the program, which involves about 2 hours of reading material.
Intervention code [1] 257348 0
Prevention
Intervention code [2] 257349 0
Lifestyle
Intervention code [3] 257350 0
Behaviour
Comparator / control treatment
Participants randomly allocated to a waitlist control group are informed that in 3 weeks time they will receive an automated email inviting them to do the Living Well Feeling Well program.
Control group
Active

Outcomes
Primary outcome [1] 259361 0
Wellbeing, as measured by:
* Personal Wellbeing Index (PWI-A) - assesses wellbeing in the following areas: standard of living, health, achieving in life, personal relationships, personal safety, community-connectedness, future security, spirituality/religion
* Psychological Well-Being Scales (PWB) - assesses wellbeing in terms of positive relations with others, self-acceptance, autonomy, personal growth, environmental mastery, purpose in life
Timepoint [1] 259361 0
For intervention group: pre-program (0 weeks), post-program (3 weeks) and follow-up (15 weeks)
For waitlist group: pre-waitlist (0 weeks), post-waitlist (3 weeks), post-LWFW program (6 weeks) and follow-up (18 weeks)
Primary outcome [2] 259362 0
Satisfaction with life, as measured by the Satisfaction With Life Scale (SWLS) and Flourishing Scale (measures perceptions of success in areas such as relationships, self-esteem, purpose and optimism)
Timepoint [2] 259362 0
For intervention group: pre-program (0 weeks), post-program (3 weeks) and follow-up (15 weeks)
For waitlist group: pre-waitlist (0 weeks), post-waitlist (3 weeks), post-LWFW program (6 weeks) and follow-up (18 weeks)
Secondary outcome [1] 265853 0
Psychological distress, as measured by The Kessler 6 (K6)
Timepoint [1] 265853 0
For intervention group: pre-program (0 weeks), post-program (3 weeks) and follow-up (15 weeks)
For waitlist group: pre-waitlist (0 weeks), post-waitlist (3 weeks), post-LWFW program (6 weeks) and follow-up (18 weeks)
Secondary outcome [2] 265854 0
Psychological influences on health behaviour, as measured by three subscales on the Multidimensional Health Questionnaire (MHQ): health expectations-optimism, motivation for healthiness, health illness prevention
Timepoint [2] 265854 0
For intervention group: pre-program (0 weeks), post-program (3 weeks) and follow-up (15 weeks)
For waitlist group: pre-waitlist (0 weeks), post-waitlist (3 weeks), post-LWFW program (6 weeks) and follow-up (18 weeks)
Secondary outcome [3] 265855 0
Ways of coping with stress, as measured by the Brief COPE
Timepoint [3] 265855 0
For intervention group: pre-program (0 weeks), post-program (3 weeks) and follow-up (15 weeks)
For waitlist group: pre-waitlist (0 weeks), post-waitlist (3 weeks), post-LWFW program (6 weeks) and follow-up (18 weeks)
Secondary outcome [4] 265856 0
Program satisfaction, as measured by the Living Well Feeling Well Satisfaction Questionnaire, developed for this study
Timepoint [4] 265856 0
Post-program (3 weeks for intervention group and 6 weeks for waitlist group)

Eligibility
Key inclusion criteria
1) 18 years of age or older
2) Access to the internet
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
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will view http://www.swinburne.edu.au/lss/swinpsyche/etherapy/programs/wellbeing/ in response to advertising and they will find a link to register for the study. They first read an information statement and if they wish to take part they provide online consent. They will then be taken through the set of pre-program questionnaires. Randomisation will be computer generated, after participants have submitted the online consent form. When participants have completed the pre-program questionnaires they will be advised on their computer screen of which group they have been allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation is based on the date and time of registration, via computer generated random numbers.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants in the intervention group receive the intervention after completing the pre-program assessment, which they can do at any time while the trial is open for recruitment. Participants in the waitlist control group receive the intervention group 3-weeks after completing the pre-program assessment. Therefore, participants will complete the program at different times over the course of the study depending on when they register
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 2952 0
New Zealand
State/province [1] 2952 0
Country [2] 2953 0
United States of America
State/province [2] 2953 0

Funding & Sponsors
Funding source category [1] 267388 0
University
Name [1] 267388 0
National eTherapy Centre, Swinburne University
Country [1] 267388 0
Australia
Primary sponsor type
University
Name
Swinburne University
Address
National eTherapy Centre
Swinburne University
Mail H29, PO Box 218
Hawthorn, VIC, 3122
Country
Australia
Secondary sponsor category [1] 257010 0
None
Name [1] 257010 0
Address [1] 257010 0
Country [1] 257010 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259827 0
Swinburne University Human Research Committee
Ethics committee address [1] 259827 0
Swinburne Research
H68, PO Box 218
Hawthorn, VIC, 3122
Ethics committee country [1] 259827 0
Australia
Date submitted for ethics approval [1] 259827 0
10/09/2009
Approval date [1] 259827 0
21/09/2009
Ethics approval number [1] 259827 0
2009/206

Summary
Brief summary
This study is evaluating the effectiveness of the online program, Living Well Feeling Well, for improving mental and physical health. The study is a randomised controlled trial with an intervention group and a waitlist control group. We are aiming to recruit 100 participants and to follow them up at 3 months. The Living Well Feeling Well program contains 5 sections designed to help people cope with challenging situations and enhance their mental and physical health. Participants are given 3 weeks to complete the program, which involves about 2 hours of reading material. Participants in the waitlist group are asked to wait 3 weeks before being offered the program. We predict that at post-intervention participants in the intervention group will report greater wellbeing and satisfaction with life, better coping with stress, and less psychological distress.
Trial website
http://www.swinburne.edu.au/lss/swinpsyche/etherapy/programs/wellbeing/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31741 0
Address 31741 0
Country 31741 0
Phone 31741 0
Fax 31741 0
Email 31741 0
Contact person for public queries
Name 14988 0
A/Prof Britt Klein
Address 14988 0
National eTherapy Centre
Swinburne University
H29, PO Box 218
Hawthorn, VIC, 3122
Country 14988 0
Australia
Phone 14988 0
+61 3 9214 8851
Fax 14988 0
Email 14988 0
[email protected]
Contact person for scientific queries
Name 5916 0
A/Prof Britt Klein
Address 5916 0
National eTherapy Centre
Swinburne University of Technology
H29, PO Box 218
Hawthorn, VIC, 3122
Country 5916 0
Australia
Phone 5916 0
+61 3 9214 8851
Fax 5916 0
Email 5916 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
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Documents added automatically
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