Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001318673
Ethics application status
Approved
Date submitted
4/12/2014
Date registered
16/12/2014
Date last updated
9/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial and consumer characteristics of the Mindful eHealth wellbeing program.
Scientific title
The efficacy of the Mindful eHealth program to increase wellbeing in adults: A randomised controlled trial.
Secondary ID [1] 285783 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Wellbeing 293669 0
Anxiety 293730 0
Depression 293771 0
Condition category
Condition code
Mental Health 293968 293968 0 0
Depression
Mental Health 293970 293970 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised controlled trial will be used to investigate the effectiveness of the Mindful eHealth program. The Mindful eHealth program is placed within the Federation eHealth Platform. People visiting the website, in response to advertisements or through self interest, will be informed of the availability of the Mindful eHealth program and invited to participate in the study. People taking part in the study will be randomly allocated to either an immediate access to the online program, or delayed assess (15 week delay).

The Mindful eHealth program 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) and simply accepting what is there and not wanting it to change it in any way. Participants will spend a week on each session before moving onto the next session, so as to practise and to reinforce the session material learnt. Each session will last 15 minutes and its user friendly and interactive components are designed to keep the user engaged. To consolidate learning, participants will be given activities (five minutes per day) to complete offline to practise the principles of mindfulness and asked to provide simple feedback on this practise at the next session.

Participants will also be sent automated emails (e.g., reminding them to log on (when they haven't for a period of time), when to complete questionnaires (with automated reminders when they are not completed in a timely manner), when new modules are released).

Participants will complete online questionnaires at pre-program, during-program, post-program, and at one and three month follow-up stages of the study and will have access to the eHealth program for the duration of the study.

Intervention code [1] 290744 0
Treatment: Other
Intervention code [2] 290745 0
Behaviour
Comparator / control treatment
People allocated to the delayed access will complete the same questionnaires as the immediate start condition, but will not have access to the Mindful eHealth program for 15 weeks.
Control group
Active

Outcomes
Primary outcome [1] 293744 0
Depressive symptoms via the Depression Scale using the DASS-21.
Timepoint [1] 293744 0
Pre-intervention, during intervention (Week 2, Week 3), post intervention, 1 month and 3 month follow-up.
Secondary outcome [1] 311727 0
Anxiety symptoms via the Anxiety Scale using the DASS-21.
Timepoint [1] 311727 0
Pre-intervention, during intervention (Week 2, Week 3), post intervention, 1 month and 3 month follow-up.
Secondary outcome [2] 311728 0
Perceived Stress - using the Perceived Stress Scale.
Timepoint [2] 311728 0
Pre-intervention, post intervention, 1 month and 3 month follow-up.
Secondary outcome [3] 311729 0
Wellbeing using the Mental Health Continuum Short Form; Flourishing Scale; Personal Wellbeing Index; Mindfulness Attention Awareness Scale.
Timepoint [3] 311729 0
Pre-intervention, post intervention, 1 and 3 month follow-up.
Secondary outcome [4] 311730 0
Psychological Distress using the Kessler-6.
Timepoint [4] 311730 0
Pre-intervention, post intervention, 1 and 3 month follow-up.
Secondary outcome [5] 311731 0
Intervention Credibility using the Treatment Credibility Scale.
Timepoint [5] 311731 0
Pre-Intervention.
Secondary outcome [6] 311732 0
Intervention Satisfaction using the Intervention Satisfaction Questionnaire.
Timepoint [6] 311732 0
Post intervention.

Eligibility
Key inclusion criteria
Participants must be 18 years or older, have access to the internet, provide consent and be able to register online using an email address.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There is no key exclusion criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be invited to register for the study on the Mindful eHealth website where they will be taken to the Plain Language Information Statement and must provide informed consent to proceed. Following account creation, participants are asked to complete the pre-intervention online questionnaires. Once completed the participant is informed as to which condition they have been randomly allocated too (on screen and sent an automated email). The Mindful eHealth program software randomly allocates (and informs) participants using a block design method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block design method.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Repeated measures ANOVA/mixed modelling.

Previous research has reported medium effects can be expected. Therefore, assuming a small-medium effect (i.e. GPower f(v) test = 0.40), significance set at 5% (p = .05), power at 80%, a sample of 73 will be required to demonstrate statistical significance. However allowing for a 30% attrition rate, we will be required to recruit 104 participants.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Given delays with getting the first digital platform ready to go 'live', we decided to use this digital program within a larger RCT study instead. Therefore, we did not offer/start this particular quasi-experimental trial study.
Date of first participant enrolment
Anticipated
22/12/2014
Actual
Date of last participant enrolment
Anticipated
30/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
104
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 290347 0
University
Name [1] 290347 0
Federation University
Country [1] 290347 0
Australia
Primary sponsor type
University
Name
Federation Unversity
Address
University Drive, Mt Helen Campus, Victoria, 3350
Country
Australia
Secondary sponsor category [1] 289069 0
None
Name [1] 289069 0
Address [1] 289069 0
Country [1] 289069 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292050 0
Federation University Higher Research Ethics Committee
Ethics committee address [1] 292050 0
Federation University Australia. Office 218, Building F, Mt Helen Campus. PO Box 663 Ballarat VIC 3353
Ethics committee country [1] 292050 0
Australia
Date submitted for ethics approval [1] 292050 0
Approval date [1] 292050 0
25/06/2014
Ethics approval number [1] 292050 0
A14-085

Summary
Brief summary
A randomised controlled trial will be used to investigate the effectiveness of the Mindful eHealth program. The Mindful eHealth program is placed within the Federation eHealth Platform. People visiting the website, in response to advertisements or through self interest, will be informed of the availability of the Mindful eHealth program and invited to participate in the study. People taking part in the study will be randomly allocated to either an immediate access to the online program, or delayed assess (15 week delay).

The Mindful eHealth program 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) and simply accepting what is there and not wanting it to change it in any way. Participants will spend a week on each session before moving onto the next session, so as to practise and to reinforce the session material learnt.

Participants will complete online questionnaires at pre-program, during-program, post-program, and at one and three month follow-up stages of the study.
Trial website
www.mindful.fedehealth.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53250 0
Prof Britt Klein
Address 53250 0
Federation University,
University Drive, Mt Helen Campus, 3350, Victoria
Country 53250 0
Australia
Phone 53250 0
+61 3 53276717
Fax 53250 0
Email 53250 0
[email protected]
Contact person for public queries
Name 53251 0
Ms Sue Lauder
Address 53251 0
Federation University,
University Drive, Mt Helen Campus, 3350, Victoria
Country 53251 0
Australia
Phone 53251 0
+61 3 53279845
Fax 53251 0
Email 53251 0
[email protected]
Contact person for scientific queries
Name 53252 0
Prof Britt Klein
Address 53252 0
Federation University,
University Drive, Mt Helen Campus, 3350, Victoria
Country 53252 0
Australia
Phone 53252 0
+61 3 53276717
Fax 53252 0
Email 53252 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.