Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001015538
Ethics application status
Approved
Date submitted
13/09/2015
Date registered
29/09/2015
Date last updated
18/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial and consumer characteristics of iChooseWell eHealth: A comprehensive biopsychosocial online wellbeing program to decrease stress.
Scientific title
A randomised controlled trial and consumer characteristics of a comprehensive biopsychosocial online wellbeing program (iChooseWell) on increasing mental wellbeing and optimism and decreasing depressive, anxiety and stress symptom levels in adults.
Secondary ID [1] 287453 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 296174 0
Anxiety 296257 0
Depressive symptoms 296258 0
Condition category
Condition code
Mental Health 296453 296453 0 0
Anxiety
Mental Health 296454 296454 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised controlled trial will be used to investigate the effectiveness of the iChooseWell program. People taking part in the study will be randomly allocated to either an immediate access to the program, or delayed access (8 week delay).

The iChooseWell eHealth program consists of forty biological, psychological, social, and wellness strategies, all designed to increase mind and body health (e.g., brain & gut nutrition, emotional regulation strategies, problem solving, sleep hygiene, social connectedness, practising gratitude). Participants will be able to choose from the array of biopsychosocial strategies available within iChooseWell. The number of strategies implemented over the course of the trial is self determined by the participant, so they are free to undertake as few or as many as they wish. Background information is also provided on health and wellbeing (e.g., the stress response, brain/neural plasticity) and useful resources are provided (e.g., self monitoring, ‘On the Go’ mobile tools). Each individual wellness strategy is 2-6 webpages in length (taking between 5-20 minutes to read) and its user friendly and interactive components are designed to keep the user engaged. To consolidate learning, participants will be given activities (10 minutes per day on average) to complete offline to practise the principles of the chosen wellness strategies. Participants will also receive automated emails (e.g., to remind them to log on, when to complete post/follow-up questionnaires) and will be asked several questions during the study period to monitor their progress. The iChooseWell program includes text, graphics, audio, video, quizzes, and downloads. iChooseWell can be accessible via web, mobile or tablet devices.

Participants randomised to the iChooseWell eHealth immediate access group will complete a pre-intervention assessment (Week 0), during intervention (Week 3) assessment, post-intervention assessment (Week 5) and a 1 and 3 month follow-up assessment (Week 9 and Week 17). Participants randomised to the delayed access group will complete the same assessment phases and will be given access to the iChooseWell eHealth program following the 1 month follow-up assessment (Week 9). However the delayed access group will be asked to complete the post intervention assessment after they have completed the iChooseWell program (Week 13) and a 1 month follow-up (post program) (Week 17). Access to iChooseWell will be provided for the entire trial period. Adherence will be measured by the number of strategies visited by post assessment (measured via passive analytics) as well as questions regarding engagement levels.
Intervention code [1] 292825 0
Behaviour
Intervention code [2] 292826 0
Lifestyle
Intervention code [3] 292827 0
Prevention
Comparator / control treatment
People allocated to the delayed access group will complete the same questionnaires as the immediate access condition, but will not have access to the iChooseWell program for the first 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 296069 0
Mental health wellbeing will be measured using the MCH-SF
Timepoint [1] 296069 0
Pre intervention (Week 0), post intervention (Week 5) and 1 month follow-up (Week 9).

As well as the 'delayed group - post program assessment' (Week 13) and the 'delayed group - post program access 1 month follow up' or the 3 month follow-up (immediate group) at Week 17.
Primary outcome [2] 296070 0
Negative affect (depression, anxiety and stress) will be measured using the DASS-21
Timepoint [2] 296070 0
Pre intervention (Week 0), during intervention (Week 3), post intervention (Week 5) and 1 month follow-up (Week 9).

As well as the 'delayed group - post program assessment' (Week 13) and the 'delayed group - post program access 1 month follow up' or the 3 month follow-up (immediate group) at Week 17.
Primary outcome [3] 296071 0
Optimism will be measured using the LOT-R
Timepoint [3] 296071 0
Pre intervention (Week 0), during intervention (Week 3), post intervention (Week 5) and 1 month follow-up (Week 9).

As well as the 'delayed group - post program assessment' (Week 13) and the 'delayed group - post program access 1 month follow up' or the 3 month follow-up (immediate group) at Week 17.
Secondary outcome [1] 317429 0
Personality traits will be measured using the TIPI
Timepoint [1] 317429 0
Pre-intervention (Week 0)
Secondary outcome [2] 317430 0
General psychological distress will be measured using the Kessler 6
Timepoint [2] 317430 0
Pre intervention (Week 0), post intervention (Week 5) and 1 month follow-up (Week 9).

As well as the 'delayed group - post program assessment' (Week 13) and the 'delayed group - post program access 1 month follow up' or the 3 month follow-up (immediate group) at Week 17.
Secondary outcome [3] 317431 0
Affective styles will be measured using the ASQ
Timepoint [3] 317431 0
Pre intervention (Week 0), post intervention (Week 5) and 1 month follow-up (Week 9).

As well as the 'delayed group - post program assessment' (Week 13) and the 'delayed group - post program access 1 month follow up' or the 3 month follow-up (immediate group) at Week 17.
Secondary outcome [4] 317432 0
Intervention satisfaction, including engagement, will be measured using the TSQ
Timepoint [4] 317432 0
Post intervention (Week 5 for the immediate group) or delayed group - post program assessment (Week 13 for delayed group)
Secondary outcome [5] 317433 0
Demographic and lifestyle/personal questions using a self developed online measure (e.g., sleep and exercise patterns).
Timepoint [5] 317433 0
Pre intervention (Week 0), post intervention (Week 5) and 1 month follow-up (Week 9)

As well as the 'delayed group - post program assessment' (Week 13) and the 'delayed group - post program access 1 month follow up' or the 3 month follow-up (immediate group) at Week 17.

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
Under 18 years of age, non-English speaking, no internet access

Study design
Purpose of the study
Educational / counselling / training
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 iChooseWell 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 to (sent an automated email). The iChooseWell 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
Pre-, post- and follow-up variables will be subjected to repeated measures MANOVA/ANOVA to determine significant changes over time and between groups; Correlational and multiple regression analyses will be used to determine significant correlates of wellbeing and to determine any potential predictors and discriminators of attrition and adherence; Cluster analysis will look at whether particular ‘subgroups’ (e.g., males vs. females) prefer certain health and wellbeing strategies over others; Open ended data obtained from intervention satisfaction questionnaires may be analysed using protocols of content analysis to identify common themes.

Assuming a small-medium effect (i.e., GPower f test = 0.40), significance set at 5% (p = .05), power at 80%, a total sample size of 107 (this figure also accounts for an expected attrition rate of 40%) will be required to demonstrate statistical significance.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Release of a newer digital health platform and iChooseWell program.
Date of first participant enrolment
Anticipated
1/10/2015
Actual
8/10/2015
Date of last participant enrolment
Anticipated
13/03/2017
Actual
28/01/2017
Date of last data collection
Anticipated
Actual
28/02/2017
Sample size
Target
107
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292022 0
University
Name [1] 292022 0
Federation University
Country [1] 292022 0
Australia
Primary sponsor type
University
Name
Federation University
Address
Centre for Biopsychosocial and eHealth Research & Innovation, University Drive, Mt Helen Campus, Victoria, 3350
Country
Australia
Secondary sponsor category [1] 290692 0
None
Name [1] 290692 0
Address [1] 290692 0
Country [1] 290692 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293508 0
Federation University Higher Research Ethics Committee
Ethics committee address [1] 293508 0
Federation University Australia. Office 218, Building F, Mt Helen Campus. PO Box 663 Ballarat VIC 3353
Ethics committee country [1] 293508 0
Australia
Date submitted for ethics approval [1] 293508 0
Approval date [1] 293508 0
10/09/2015
Ethics approval number [1] 293508 0
A15-141

Summary
Brief summary
A randomised controlled trial will be used to investigate the effectiveness of the iChooseWell program. The iChooseWell program will be 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 iChooseWell program and invited to participate in the study. People who consent to take part in the study will be randomly allocated to either an immediate access to the program condition or a delayed access condition (8 week delay).

The iChooseWell eHealth program consists of forty biological, psychological, social, and wellness strategies, all designed to increase mind and body health (e.g., brain & gut nutrition, emotional regulation strategies, problem solving, sleep hygiene, social connectedness, practising gratitude). Participants will be able to choose from the array of biopsychosocial strategies available within iChooseWell. Background information is also provided on health and wellbeing (e.g., the stress response, brain/neural plasticity) and useful resources are provided (e.g., self monitoring, ‘On the Go’ mobile tools). Each individual wellness strategy is 2-6 web pages in length (taking between 5-20 minutes to read) and its user friendly and interactive components are designed to keep the user engaged. To consolidate learning, participants will be given activities (10 minutes per day on average) to complete offline to practise the principles of the chosen wellness strategies. Participants will also receive automated emails (e.g., to remind them to log on, when to complete post/follow-up questionnaires) and will be asked several questions during the study period to monitor their progress. The iChooseWell program includes text, graphics, audio, video, quizzes, and downloads. iChooseWell can be accessible via web, mobile or tablet devices.

Participants randomised to the iChooseWell eHealth immediate access group will complete a pre-intervention assessment (Week 0), during intervention (Week 3) assessment, post-intervention assessment (Week 5) and a 1 and 3 month follow-up assessment (Week 9 and Week 17). Participants randomised to the delayed access group will complete the same assessment phases and will be given access to the iChooseWell eHealth program following the 1 month follow-up assessment (Week 9). However the delayed access group will be asked to complete the post intervention assessment after they have completed the iChooseWell program (Week 13) and a 1 month follow-up (post program) (Week 17). Access to iChooseWell will be provided for the entire trial period. Adherence will be measured by the number of strategies visited by post assessment (measured via passive analytics) as well as questions regarding engagement levels.

It is expected that people who undertake iChooseWell will show increases in mental health and wellbeing and optimism and reductions in negative affect at post and the 1 month follow-up time points.
Trial website
https://ichoosewell.fedehealth.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60238 0
Prof Britt Klein
Address 60238 0
Federation University University Drive, Mt Helen Campus, 3350, Victoria
Country 60238 0
Australia
Phone 60238 0
+61 353276717
Fax 60238 0
Email 60238 0
[email protected]
Contact person for public queries
Name 60239 0
Prof Britt Klein
Address 60239 0
Federation University University Drive, Mt Helen Campus, 3350, Victoria
Country 60239 0
Australia
Phone 60239 0
+61 353276717
Fax 60239 0
Email 60239 0
[email protected]
Contact person for scientific queries
Name 60240 0
Prof Britt Klein
Address 60240 0
Federation University University Drive, Mt Helen Campus, 3350, Victoria
Country 60240 0
Australia
Phone 60240 0
+61 353276717
Fax 60240 0
Email 60240 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.