Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001020875
Ethics application status
Approved
Date submitted
3/09/2012
Date registered
21/09/2012
Date last updated
8/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of web-based loving-kindness meditation and light exercise on wellbeing
Scientific title
Internet-based randomised controlled trial comparing the effect of Loving-kindness meditation (LKM) or light exercise on wellbeing and helping behaviour in UK residents
Secondary ID [1] 281143 0
Nil
Universal Trial Number (UTN)
Trial acronym
WWE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wellbeing 287311 0
Helping behaviour 287312 0
Condition category
Condition code
Public Health 287649 287649 0 0
Epidemiology
Alternative and Complementary Medicine 287650 287650 0 0
Other alternative and complementary medicine
Mental Health 287651 287651 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive web-based Loving-kindness meditation training. The course is free of charge and very easy to follow. It takes the form of an interactive learning website with instructional videos that can be accessed through a standard web browser. The course requires that 5 x 10 minute sessions are completed per week over the 1 month (4 week) intervention period.
Intervention code [1] 285601 0
Prevention
Intervention code [2] 285743 0
Lifestyle
Intervention code [3] 285744 0
Behaviour
Comparator / control treatment
Participants will receive web-based light exercise training. The course is free of charge and very easy to follow. It takes the form of an interactive learning website with instructional videos that can be accessed through a standard web browser. The course requires that 5 x 10 minute sessions are completed per week over the 1 month (4 week) intervention period.
Control group
Active

Outcomes
Primary outcome [1] 287899 0
Wellbeing (Warwick-Edinburgh Mental Wellbeing Scale)
Timepoint [1] 287899 0
1. Baseline
2. Post-intervention
3. Three-month follow-up
Secondary outcome [1] 299018 0
Life satisfaction (Satisfaction with life scale)
Timepoint [1] 299018 0
1. Baseline
2. Post-intervention
3. Three-month follow-up
Secondary outcome [2] 299019 0
Mood (I-panas-sf)
Timepoint [2] 299019 0
1. Baseline
2. Post-intervention
3. Three-month follow-up
Secondary outcome [3] 299020 0
Stress (Perceived stress scale)
Timepoint [3] 299020 0
1. Baseline
2. Post-intervention
3. Three-month follow-up
Secondary outcome [4] 299021 0
Depression, anxiety and irritability (Irritability, depression and anxiety scale)
Timepoint [4] 299021 0
1. Baseline
2. Post-intervention
3. Three-month follow-up
Secondary outcome [5] 299022 0
Empathic concern (Interpersonal reactivity index)
Timepoint [5] 299022 0
1. Baseline
2. Post-intervention
3. Three-month follow-up
Secondary outcome [6] 299023 0
Perspective taking (Interpersonal reactivity index)
Timepoint [6] 299023 0
1. Baseline
2. Post-intervention
3. Three-month follow-up
Secondary outcome [7] 299024 0
Helping behaviour (A sum of 10 GBP will be offered to the first 200 participants after the completion of the training and the post-intervention questionnaires. A choice will be given as to whether to receive the full amount in the form of Amazon vouchers or to donate all or half to a charity of their choice)
Timepoint [7] 299024 0
1. Post-intervention
Secondary outcome [8] 299025 0
Symptoms (Illness symptoms scale)
Timepoint [8] 299025 0
1. Baseline
2. Post-intervention
3. Three-month follow-up

Eligibility
Key inclusion criteria
1. UK resident.
2. Fluent English speaker.
3. Aged 18+.
4. Access to internet at home or at a place where personal activities can be developed without being disturbed.
5. Able to operate a PC unaided.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Having been instructed by GP to avoid regular physical activity.

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)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
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
20/10/2012
Actual
7/02/2013
Date of last participant enrolment
Anticipated
Actual
1/07/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 4525 0
United Kingdom
State/province [1] 4525 0
Throughout the country
Country [2] 5946 0
United States of America
State/province [2] 5946 0
Throughout the country

Funding & Sponsors
Funding source category [1] 285926 0
University
Name [1] 285926 0
Cardiff University
Country [1] 285926 0
United Kingdom
Primary sponsor type
Individual
Name
Julieta Galante
Address
Cochrane Institute of Primary Care and Public Health
Cardiff University
5th Floor, Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
Country
United Kingdom
Secondary sponsor category [1] 284747 0
Individual
Name [1] 284747 0
John Gallacher
Address [1] 284747 0
Cochrane Institute of Primary Care and Public Health
Cardiff University
5th Floor, Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
Country [1] 284747 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287953 0
Cardiff University Medical School Research Ethics Committee
Ethics committee address [1] 287953 0
Cardiff University School of Medicine
UHW Main Building
Heath Park
Cardiff
CF14 4XN
Ethics committee country [1] 287953 0
United Kingdom
Date submitted for ethics approval [1] 287953 0
06/08/2012
Approval date [1] 287953 0
15/08/2012
Ethics approval number [1] 287953 0

Summary
Brief summary
We are interested in comparing two different activities that aim to help people improve their quality of life. We want to use the information collected by this study to clarify the real effectiveness of these activities. In the long run this can help to develop more effective health policies.
Trial website
webwellbeingexperience.co.uk
Trial related presentations / publications
Galante J, Gallacher J, Bekkers M-J, Mitchell C. Internet-based randomised controlled trial of the effect of loving-kindness meditation on wellbeing and helping behaviour. Oral presentation. E-Epi: Expanding the Horizons symposium at EuroEpi 2013, Aarhus, Denmark, 11- 14 August.
Public notes

Contacts
Principal investigator
Name 34655 0
Dr Julieta Galante
Address 34655 0
Cochrane Institute of Primary Care and Public Health Cardiff University 5th Floor, Neuadd Meirionnydd Heath Park Cardiff CF14 4YS
Country 34655 0
United Kingdom
Phone 34655 0
(+44) 0800 0 273 423
Fax 34655 0
Email 34655 0
[email protected]
Contact person for public queries
Name 17902 0
Dr Julieta Galante
Address 17902 0
Cochrane Institute of Primary Care and Public Health
Cardiff University
5th Floor, Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
Country 17902 0
United Kingdom
Phone 17902 0
(+44) 0800 0 273 423
Fax 17902 0
Email 17902 0
[email protected]
Contact person for scientific queries
Name 8830 0
Dr Julieta Galante
Address 8830 0
Cochrane Institute of Primary Care and Public Health
Cardiff University
5th Floor, Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
Country 8830 0
United Kingdom
Phone 8830 0
(+44) (0) 29 20 687 633
Fax 8830 0
Email 8830 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

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