Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001282673
Ethics application status
Approved
Date submitted
7/11/2014
Date registered
8/12/2014
Date last updated
24/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving Wellness: A randomised controlled trial comparing the Mindfulness eHealth and Physical Activity eHealth programs.
Scientific title
A randomised controlled trial comparing the Mindfulness eHealth and Physical Activity eHealth programs on wellness outcomes in adults.
Secondary ID [1] 285607 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Well being in adults 293454 0
Condition category
Condition code
Mental Health 293735 293735 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomized controlled trial will be employed to investigate the effectiveness of the Mindfulness eHealth program and the Physical Activity eHealth program in comparison to a delayed access (8 weeks) wait control group as a means to increase wellbeing. People visiting the Wellbeing study website, in response to advertisements or through self interest, will be informed of the availability of the study and invited to register their interest. Following completion of the pre-intervention assessments, people taking part in the study will be randomly allocated to one of the three groups above.

The Mindfulness eHealth program consists of three weekly online modules designed to help an individual become more mindful or more aware of moment-to-moment experiences (e.g., thoughts, feelings, images, sensations). The Physical Activity eHealth program consists of three weekly online modules designed to increase physical activity, through increased awareness regarding the benefits, understanding the barriers to physical activity. The online modules from both programs will take approximately 15 minutes to complete each week, as well as some offline activities (e.g., engaging in a brief physical activity, practicing mindfulness). All participants are asked to answer questions about how they are feeling and what they have been doing via the secure website and a mobile app survey form. All participants will also wear the BASIS wrist watch continuously, which is just like a normal watch but it also automatically tracks the number of steps taken and their sleep (e.g., total time asleep, number of interruptions, quality of sleep) over the first 7 weeks of the study. Participants will also receive emails (e.g., when to complete post questionnaires) to help keep them on track.

Participants allocated to the immediate start intervention groups (Mindfulness or Physical Activity eHealth) will complete online questionnaires via a secure website at pre-intervention (Week 0), during-intervention, post-intervention (Week 4), 4 weeks post intervention (Week 8) and at a three month follow-up (Week 16).

The delayed start wait group will be provided access to their choice of either the Physical Activity eHealth or Mindfulness eHealth program following the Week 8 assessment phase. Therefore participants allocated to the delayed start wait group will complete pre-intervention (Week 0), during-wait intervention, post-wait intervention (Week 4), 4 weeks post-wait intervention (Week 8) and a post intervention assessment once they have completed a ehealth program (Week 12).

All participants will also be asked to meet with the researchers on two occasions (Week 0 and Week 8) to undertake three brief computerised cognitive tests (15 minutes), have their resting heart rate variability measured (10 minutes) and to provide a salivary cortisol and blood sample.
Intervention code [1] 290561 0
Other interventions
Intervention code [2] 290741 0
Behaviour
Intervention code [3] 290742 0
Lifestyle
Comparator / control treatment
Mindfulness eHealth Intervention vs Physical Activity eHealth Intervention vs Wait list control.

The wait list control condition will receive access to the intervention of their choice (mindfulness or physical activity) after the completion of the 1 month follow-up assessments.
Control group
Active

Outcomes
Primary outcome [1] 293535 0
Depression symptoms using the depression scale of the DASS-21 questionnaire
Timepoint [1] 293535 0
Main analysis - Pre-intervention, during intervention (Week 2 and 3), post intervention and at the 1 month follow up.
Primary outcome [2] 293740 0
Anxiety symptoms using the anxiety scale of the DASS-21 questionnaire
Timepoint [2] 293740 0
Main analysis - Pre-intervention, during intervention (Week 2, Week 3), post intervention and 1 month follow-up
Primary outcome [3] 293741 0
Stress symptoms using the stress scale of the DASS-21 questionnaire
Timepoint [3] 293741 0
Main analysis - Pre-intervention, during intervention (Week 2, Week 3), post intervention and 1 month follow-up
Secondary outcome [1] 311285 0
Emotional Regulation using self report measures (Difficulties in Emotional Regulation Scale; Attention and Action Questionnaire; Affective Style Questionnaire)
Timepoint [1] 311285 0
Main analysis - Pre-intervention, post intervention and 1 month follow-up
Secondary outcome [2] 311707 0
Psychological Distress using the Kessler-6
Timepoint [2] 311707 0
Main analysis - Pre-intervention, post intervention and 1 month follow-up
Secondary outcome [3] 311708 0
Perceived Stress using the Perceived Stress Scale and as a biomarker of stress, cortisol sampling (drool method) will be used
Timepoint [3] 311708 0
Perceived Stress - Pre-intervention, post intervention and 1 month follow-up (main analysis)
and cortisol at pre-intervention and the 1 month follow-up
Secondary outcome [4] 311709 0
Wellbeing using self report measures (Mental Health Continuum-Short Form; Revised – Life Orientation Test; Mindfulness Attention Awareness Scale; International Physical Activity Questionnaire – Short Form; Pittsburgh Sleep Quality Index)
Timepoint [4] 311709 0
Main analysis - Pre-intervention, post intervention and 1 month follow-up
Secondary outcome [5] 311710 0
Physiological functioning using resting heart rate variability. HRV will be measured using the Polar RS800CX HRV device.
Timepoint [5] 311710 0
Pre-intervention and the 1 month follow-up
Secondary outcome [6] 311711 0
Personality traits using the Ten Item Personality Index.
Timepoint [6] 311711 0
Pre-intervention
Secondary outcome [7] 311712 0
Cognitive changes using the computerised Stroop Test, Go/No Go and Trail Making Tests
Timepoint [7] 311712 0
Pre-intervention and at the 1 month follow-up
Secondary outcome [8] 311713 0
Biometric data from the BASIS wrist watch (e.g., sleep quality, physical activity (number of steps)).
Timepoint [8] 311713 0
Continuously from intervention start until the 1 month follow-up
Secondary outcome [9] 311714 0
Real time mood changes via the Affective mobile app survey. Participants will receive random alerts during the day, asking them to complete a brief mobile app survey addressing how they are feeling/what they are doing.
Timepoint [9] 311714 0
Alerts are sent from intervention start to the 1 month follow-up
Secondary outcome [10] 311715 0
Intervention Credibility as measured by the Treatment Credibility Scale
Timepoint [10] 311715 0
Pre-intervention
Secondary outcome [11] 311716 0
Intervention Satisfaction as measured by the Intervention Satisfaction Questionnaire
Timepoint [11] 311716 0
Post intervention
Secondary outcome [12] 313587 0
Blood bio-markers of health: Health changes caused by the intervention will be measured in context with the latest genome-wide microarrays and validated (by quantitative PCR or sequencing) to identify blood biomarkers.
Timepoint [12] 313587 0
Pre-intervention and the 1 month follow-up

Eligibility
Key inclusion criteria
18 years of age or older, have access to the internet, an internet-connected mobile phone, and be able to attend two assessment sessions onsite.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Given the nature of the assessments, self-monitoring and the inclusion of the physical activity intervention, those meeting the following criteria would not be able to participate: pregnant, having a documented life threatening illness (e.g., cancer) or traumatic brain injury, cardiovascular disease, debilitating physical mobility issues or a current untreated severe (psychotic) mental illness.

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 asked to consent and register their interest online via the Wellness site. Participants will then be contacted and an appointment made to meet with one of the researchers face to face. Following the completion of all of the pre-assessment measures, the participant will be informed about what condition they have been randomly allocated to (and details provided regarding intervention URL address for those receiving immediate access to one of the two eHealth programs). Participants will be randomly allocated using a block design method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation via block design method (1,2,3)
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/multilevel modeling.

Previous research has reported medium effects for the primary measures of interest (depression, anxiety and stress symptoms). Therefore, assuming a small-medium effect (i.e. GPower f(v) test = 0.35), significance set at 5% (p = .05), power at 80%, a sample of 52 will be required to demonstrate statistical significance. However allowing for a 40% attrition rate, we will be required to recruit a total of N = 87 participants or n = 29 in each group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/12/2014
Actual
17/01/2015
Date of last participant enrolment
Anticipated
29/02/2016
Actual
22/09/2015
Date of last data collection
Anticipated
Actual
14/02/2016
Sample size
Target
90
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 290200 0
University
Name [1] 290200 0
Federation University
Country [1] 290200 0
Australia
Primary sponsor type
University
Name
Federation Universtiy
Address
University Drive, Mt Helen Campus, 3350 Victoria
Country
Australia
Secondary sponsor category [1] 288912 0
None
Name [1] 288912 0
Address [1] 288912 0
Country [1] 288912 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291911 0
Federation University Human Research Ethics Committee
Ethics committee address [1] 291911 0
University Drive, Mt Helen Campus, 3350 Victoria.
Ethics committee country [1] 291911 0
Australia
Date submitted for ethics approval [1] 291911 0
Approval date [1] 291911 0
04/08/2014
Ethics approval number [1] 291911 0
A14-095

Summary
Brief summary
A randomised controlled trial will be employed to investigate the effectiveness of the Mindfulness eHealth program and the Physical Activity eHealth program in comparison to a delayed access (8 weeks) wait control group as a means to increase wellbeing. People visiting the Wellbeing study website, in response to advertisements or through self interest, will be informed of the availability of the study and invited to participate. Following completion of the pre-intervention assessments, people taking part in the study will be randomly allocated to one of the three groups above.

Participants allocated to the immediate start intervention groups (Mindfulness or Physical Activity eHealth) will complete online questionnaires at pre-intervention (Week 0), during-intervention, post-intervention (Week 4), 4 weeks post intervention (Week 8) and at a three month follow-up (Week 16).

The delayed start wait group will be provided access to their choice of either the Physical Activity eHealth or Mindfulness eHealth program following the Week 8 assessment phase. Therefore participants allocated to the delayed start wait group will complete pre-intervention (Week 0), during-wait intervention, post-wait intervention (Week 4), 4 weeks post-wait intervention (Week 8) and a post intervention assessment once they have completed a ehealth program (Week 12).

All participants will also be asked to meet with the researchers on two occasions (Week 0 and Week 8) to undertake three brief computerised cognitive tests (15 minutes), have their resting heart rate variability measured (10 minutes) and to provide a salivary cortisol and blood sample.
Trial website
https://www.wellness.fedehealth.org.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52566 0
Prof Britt Klein
Address 52566 0
Federation University,
University Drive, Mt Helen Campus, 3350 Victoria
Country 52566 0
Australia
Phone 52566 0
61 03 5327 6717
Fax 52566 0
Email 52566 0
[email protected]
Contact person for public queries
Name 52567 0
Prof Britt Klein
Address 52567 0
Federation University,
University Drive, Mt Helen Campus, 3350 Victoria
Country 52567 0
Australia
Phone 52567 0
61 03 5327 6717
Fax 52567 0
Email 52567 0
[email protected]
Contact person for scientific queries
Name 52568 0
Prof Britt Klein
Address 52568 0
Federation University,
University Drive, Mt Helen Campus, 3350 Victoria
Country 52568 0
Australia
Phone 52568 0
61 03 5327 6717
Fax 52568 0
Email 52568 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
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