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Trial registered on ANZCTR


Registration number
ACTRN12617000578303
Ethics application status
Approved
Date submitted
7/04/2017
Date registered
24/04/2017
Date last updated
21/01/2019
Date data sharing statement initially provided
21/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of iChooseWell digital health: A comprehensive biopsychosocial strategies-based wellbeing program.
Scientific title
A randomised controlled trial and consumer characteristics of a comprehensive biopsychosocial strategies-based wellbeing digital health program (iChooseWell), offered through the My Digital Health platform, on decreasing stress, anxiety and depressive symptom levels in adults.
Secondary ID [1] 291134 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
Ethics approval was obtained via two amendment requests (one approved on the 27/07/2016 and a subsequent one approved on the 07/02/2017) based on the originally approved A15-141 application (ACTRN12615001015538).

Health condition
Health condition(s) or problem(s) studied:
Stress 301964 0
Anxiety 301965 0
Depressive symptoms 301966 0
Condition category
Condition code
Mental Health 301616 301616 0 0
Anxiety
Mental Health 301617 301617 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised controlled trial will be employed to investigate the effectiveness of the iChooseWell digital health program offered through the My Digital Health platform. People taking part in the study will be randomly allocated to either an immediate access to the program, or delayed access (by 8 weeks).

The iChooseWell digital health is a self-help program consisting of forty-one biological, psychological, social, and wellness strategies, all designed to increase mind and body health (e.g., brain & gut nutrition, emotional regulation strategies, sleep hygiene, social connectedness, practising gratitude). Participants will be able to choose from all of the biopsychosocial strategies available within the iChooseWell program. Although the number of strategies implemented over the course of the trial is self-determined by the participant, the program does recommend implementing one new strategy per week and undertaking the biopsychosocial self-monitoring of daily mood and lifestyle events (e.g., sleep, social contact, use of alcohol, etc).

Background information is also provided on health and wellbeing (e.g., the stress response, brain/neural plasticity) and useful tools and resources are provided to assist in implementing a particular strategy. Each individual wellness strategy is 2-6 pages (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., remind them to log on, when to complete during, post-intervention and follow-up questionnaires). The iChooseWell program includes text, graphics, audio, video, quizzes, interactive games and downloads. iChooseWell can be accessible via web, mobile or tablet devices.

The iChooseWell program is housed within the participant's ‘My Digital Health’ dashboard. My Digital Health is the parent platform that houses a variety of digital health programs. Via the participant’s dashboard, they are able to access several resources. This includes: My Dashboard, My Inbox, My Daily Monitoring, My Progress Graphs, My Timeline, My Profile and My Tutorial.

Participants randomised to the iChooseWell digital health 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 digital health 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. However, while the during, post-intervention and follow up assessments are scheduled, participants will not be able to access the program until they have completed the scheduled assessments (or after the expiry time to complete the scheduled assessment has lapsed). Participants will retain access to the program until Week 21.

Participant engagement with the program will be obtained through by passive analytic data (e.g., what pages / strategies they visited / used and when), as well as reviewing the completion of daily mood and lifestyle event survey data and the scheduled intervention assessments.
Intervention code [1] 297114 0
Prevention
Intervention code [2] 297794 0
Lifestyle
Intervention code [3] 297795 0
Behaviour
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. In addition, participants in the delayed access group will not have access to the daily self-monitoring survey and graph during their 8 week ‘wait’ period.
Control group
Active

Outcomes
Primary outcome [1] 301015 0
Anxiety symptoms will be measured by using the DASS-21
Timepoint [1] 301015 0
Pre intervention (Week 0), during intervention (Week 3), post intervention (Week 5) and 1 month (Week 9) and 3 month follow-up (Week 17) for the immediate access condition.

Pre intervention (Week 0), during intervention (Week 3), post intervention (Week 5), 1 month follow-up (Week 9), 'delayed start' post-program intervention (Week 13) and 'delayed access' 1 month follow-up (Week 17). for the delayed access condition.
Primary outcome [2] 301024 0
Depressive symptoms will be measured by using the DASS-21
Timepoint [2] 301024 0
Pre intervention (Week 0), during intervention (Week 3), post intervention (Week 5) and 1 month (Week 9) and 3 month follow-up (Week 17) for the immediate access condition.

Pre intervention (Week 0), during intervention (Week 3), post intervention (Week 5), 1 month follow-up (Week 9), 'delayed start' post-program intervention (Week 13) and 'delayed access' 1 month follow-up (Week 17). for the delayed access condition.
Primary outcome [3] 301782 0
Stress symptoms will be measured by using the DASS-21
Timepoint [3] 301782 0
Pre intervention (Week 0), during intervention (Week 3), post intervention (Week 5) and 1 month (Week 9) and 3 month follow-up (Week 17) for the immediate access condition.

Pre intervention (Week 0), during intervention (Week 3), post intervention (Week 5), 1 month follow-up (Week 9), 'delayed start' post-program intervention (Week 13) and 'delayed access' 1 month follow-up (Week 17). for the delayed access condition.
Secondary outcome [1] 331461 0
Psychological distress as measured by the K10
Timepoint [1] 331461 0
Pre intervention (Week 0), post intervention (Week 5 ) and 1 month follow-up (Week 9). 'delayed access' post program intervention (Week 13), 3 month follow up or 'delayed access' 1 month follow up (Week 17).
Secondary outcome [2] 331489 0
Optimism will be measured using the LOT-R
Timepoint [2] 331489 0
Pre intervention (Week 0), during intervention (Week 3), post intervention (Week 5 ) and 1 month follow-up (Week 9). 'delayed access' post program intervention (Week 13), 3 month follow up or 'delayed access' 1 month follow up (Week 17).
Secondary outcome [3] 331490 0
Affective styles will be measured using the ASQ
Timepoint [3] 331490 0
Pre intervention (Week 0), post intervention (Week 5 ) and 1 month follow-up (Week 9). 'delayed access' post program intervention (Week 13), 3 month follow up or 'delayed access' 1 month follow up (Week 17).
Secondary outcome [4] 331491 0
Time perception will be measured by the TDT
Timepoint [4] 331491 0
Pre intervention (Week 0), post intervention (Week 5 )
Secondary outcome [5] 331492 0
Personality traits will be measured by the TIPI
Timepoint [5] 331492 0
Pre intervention
Secondary outcome [6] 331493 0
Intervention satisfaction, including engagement, will be measured using the TSQ
Timepoint [6] 331493 0
Post intervention (Week 5) or 'delayed access' post program intervention (Week 13)
Secondary outcome [7] 331496 0
Mental health wellbeing will be measured using the MCH-SF
Timepoint [7] 331496 0
Pre intervention (Week 0), post intervention (Week 5 ) and 1 month follow-up (Week 9). 'delayed access' post program intervention (Week 13), 3 month follow up or 'delayed access' 1 month follow up (Week 17).
Secondary outcome [8] 333856 0
Physical activity levels using single item questions (self developed)
Timepoint [8] 333856 0
Pre intervention (Week 0), post intervention (Week 5 ) and 1 month follow-up (Week 9). 'delayed access' post program intervention (Week 13), 3 month follow up or 'delayed access' 1 month follow up (Week 17).
Secondary outcome [9] 334082 0
Social Connectedness Rating question using a 5 point scale (self developed)
Timepoint [9] 334082 0
Pre intervention (Week 0), post intervention (Week 5 ) and 1 month follow-up (Week 9). 'delayed access' post program intervention (Week 13), 3 month follow up or 'delayed access' 1 month follow up (Week 17).
Secondary outcome [10] 334083 0
Alcohol consumption levels (self-developed questions) and followed up with CAGE-AID questions if high alcohol consumption is indicated
Timepoint [10] 334083 0
Pre intervention (Week 0), post intervention (Week 5 ) and 1 month follow-up (Week 9). 'delayed access' post program intervention (Week 13), 3 month follow up or 'delayed access' 1 month follow up (Week 17).
Secondary outcome [11] 334084 0
Drug use (self-developed questions) and followed up with CAGE-AID questions if high use of drugs is indicated.
Timepoint [11] 334084 0
Pre intervention (Week 0), post intervention (Week 5 ) and 1 month follow-up (Week 9). 'delayed access' post program intervention (Week 13), 3 month follow up or 'delayed access' 1 month follow up (Week 17).
Secondary outcome [12] 334085 0
Sleep quantity and quality questions (self-developed and 4 ISI items used).
Timepoint [12] 334085 0
Pre intervention (Week 0), post intervention (Week 5 ) and 1 month follow-up (Week 9). 'delayed access' post program intervention (Week 13), 3 month follow up or 'delayed access' 1 month follow up (Week 17).
Secondary outcome [13] 334086 0
Chronic physical illness diagnosis questions (self developed)
Timepoint [13] 334086 0
Pre intervention (Week 0)
Secondary outcome [14] 334087 0
Mental health condition diagnosis questions (self developed)
Timepoint [14] 334087 0
Pre intervention (Week 0)
Secondary outcome [15] 334088 0
Current use of prescribed medication(s) question (self-developed)
Timepoint [15] 334088 0
Pre intervention (Week 0), post intervention (Week 5 ) and 1 month follow-up (Week 9). 'delayed access' post program intervention (Week 13), 3 month follow up or 'delayed access' 1 month follow up (Week 17).
Secondary outcome [16] 334089 0
Use of services for a physical health condition questions (self developed)
Timepoint [16] 334089 0
Pre intervention (Week 0), post intervention (Week 5 ) and 1 month follow-up (Week 9). 'delayed access' post program intervention (Week 13), 3 month follow up or 'delayed access' 1 month follow up (Week 17).
Secondary outcome [17] 334090 0
Use of mental health services questions (self developed)
Timepoint [17] 334090 0
Pre intervention (Week 0), post intervention (Week 5 ) and 1 month follow-up (Week 9). 'delayed access' post program intervention (Week 13), 3 month follow up or 'delayed access' 1 month follow up (Week 17).
Secondary outcome [18] 334091 0
Quality of Life Rating question - 6 point scale (self developed)
Timepoint [18] 334091 0
Pre intervention (Week 0), post intervention (Week 5 ) and 1 month follow-up (Week 9). 'delayed access' post program intervention (Week 13), 3 month follow up or 'delayed access' 1 month follow up (Week 17).
Secondary outcome [19] 334092 0
Mental Health Rating question - 6 point scale (self developed)
Timepoint [19] 334092 0
Pre intervention (Week 0), post intervention (Week 5 ) and 1 month follow-up (Week 9). 'delayed access' post program intervention (Week 13), 3 month follow up or 'delayed access' 1 month follow up (Week 17).
Secondary outcome [20] 334093 0
Physical Health Rating question - 6 point scale (self developed)
Timepoint [20] 334093 0
Pre intervention (Week 0), post intervention (Week 5 ) and 1 month follow-up (Week 9). 'delayed access' post program intervention (Week 13), 3 month follow up or 'delayed access' 1 month follow up (Week 17).

Eligibility
Key inclusion criteria
Participants must be 18 years of age or older.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No internet access, does not create a My Digital Health account (requires the provision of a valid email address), does not provide consent to study conditions.

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 be invited to register for the study on the iChooseWell child website (or via the parent website - My Digital Health) following ‘My Digital Health’ account creation. Once an account is created, they will be required to provide their informed consent after reading through the iChooseWell evaluation study Plain Language Information Statement. Following informed consent, participants will then be presented with the pre-intervention assessment questionnaires. Once completed the participant will then be informed as to which condition they have been randomly allocated to (on screen and also sent an automated email). The My Digital Health platform software randomly allocates participants.
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-intervention, during, post- and 1 month follow-up variables will be subjected to mixed methods repeated measures to determine significant changes over time and condition.

Previous research has reported small-medium effects can be expected. Therefore, assuming a small-medium effect (i.e., GPower f(v) test = 0.30), significance set at 5% (p = .05), power at 80%, a total sample size of 126 will be required to demonstrate statistical significance on the primary analysis. However, allowing for a 50% attrition rate, we will be required to recruit N = 189 participants.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 8812 0
New Zealand
State/province [1] 8812 0
Country [2] 8813 0
United Kingdom
State/province [2] 8813 0
Country [3] 8814 0
United States of America
State/province [3] 8814 0
Country [4] 8815 0
Canada
State/province [4] 8815 0

Funding & Sponsors
Funding source category [1] 295572 0
University
Name [1] 295572 0
Federation University
Address [1] 295572 0
University Drive, Mt Helen Campus, Victoria, 3350
Country [1] 295572 0
Australia
Primary sponsor type
University
Name
Federation University
Address
University Drive, Mt Helen Campus, Victoria, 3350
Country
Australia
Secondary sponsor category [1] 294398 0
None
Name [1] 294398 0
Address [1] 294398 0
Country [1] 294398 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296892 0
Federation University Higher Research Ethics Committee
Ethics committee address [1] 296892 0
Federation University Australia. Office 218, Building F, Mt Helen Campus.
PO Box 663, Ballarat VIC 3353
Ethics committee country [1] 296892 0
Australia
Date submitted for ethics approval [1] 296892 0
03/02/2017
Approval date [1] 296892 0
07/02/2017
Ethics approval number [1] 296892 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 offered through the My Digital Health 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 41 biological, psychological, social, and wellness strategies, all designed to increase mind and body health (e.g., 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 between 2-6 pages (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., remind them to log on, when to complete post/follow-up questionnaires). The iChooseWell program includes text, graphics, audio, video, interactive games, quizzes, and downloads. iChooseWell can be accessible via web, mobile or tablet devices.

Participants randomised to the iChooseWell 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 digital health 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. Engagement will be measured by the number of strategies visited by post assessment (measured via passive analytics).

It is expected that people who undertake iChooseWell immediately will show greater reductions in negative affect and increases in mental health and wellbeing and optimism and at post-intervention and the 1 month follow-up time point, as compared to the delayed access group.
Trial website
https://icw.mydigitalhealth.org.au/ (direct child site)
https://www.mydigitalhealth.org.au (parent site)
Trial related presentations / publications
Public notes
iChooseWell is globally accessible via the web.

Contacts
Principal investigator
Name 72354 0
Prof Britt Klein
Address 72354 0
Federation University
University Drive, Mt Helen Campus, 3350, Victoria
Country 72354 0
Australia
Phone 72354 0
+61 3 5327 6717
Fax 72354 0
Email 72354 0
b.klein@federation.edu.au
Contact person for public queries
Name 72355 0
Prof Britt Klein
Address 72355 0
Federation University
University Drive, Mt Helen Campus, 3350, Victoria
Country 72355 0
Australia
Phone 72355 0
+61 3 5327 6717
Fax 72355 0
Email 72355 0
b.klein@federation.edu.au
Contact person for scientific queries
Name 72356 0
Prof Britt Klein
Address 72356 0
Federation University
University Drive, Mt Helen Campus, 3350, Victoria
Country 72356 0
Australia
Phone 72356 0
+61 3 5327 6717
Fax 72356 0
Email 72356 0
b.klein@federation.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Relevant individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
No start or end date as yet determined.
Available to whom?
Case-by-case basis at the discretion of Principal Investigator.
Available for what types of analyses?
Case-by-case basis at the discretion of Principal Investigator.
How or where can data be obtained?
Access subject to approval by Principal Investigator, followed by submission to the Ethical Review Committee to access the de-identified data and approval granted.
What supporting documents are/will be available?
Informed consent form
How or where can supporting documents be obtained?
Type [1] 1110 0
Informed consent form
Citation [1] 1110 0
Link [1] 1110 0
Email [1] 1110 0
Other [1] 1110 0
https://icw.mydigitalhealth.org.au/plain-language-information-statement/
Attachment [1] 1110 0
Summary results
No Results