ANZCTR - Registration

Registration number

ACTRN12617000578303

Ethics application status

Approved

Date submitted

7/04/2017

Date registered

24/04/2017

Date last updated

18/07/2022

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]

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

Anxiety

Depressive symptoms

Condition category

Condition code

Mental Health

Anxiety

Mental Health

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]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

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]

Anxiety symptoms will be measured by using the DASS-21

Timepoint [1]

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]

Depressive symptoms will be measured by using the DASS-21

Timepoint [2]

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]

Stress symptoms will be measured by using the DASS-21

Timepoint [3]

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]

Psychological distress as measured by the K10

Timepoint [1]

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]

Optimism will be measured using the LOT-R

Timepoint [2]

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]

Affective styles will be measured using the ASQ

Timepoint [3]

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]

Time perception will be measured by the TDT

Timepoint [4]

Pre intervention (Week 0), post intervention (Week 5 )

Secondary outcome [5]

Personality traits will be measured by the TIPI

Timepoint [5]

Pre intervention

Secondary outcome [6]

Intervention satisfaction, including engagement, will be measured using the TSQ

Timepoint [6]

Post intervention (Week 5) or 'delayed access' post program intervention (Week 13)

Secondary outcome [7]

Mental health wellbeing will be measured using the MCH-SF

Timepoint [7]

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]

Physical activity levels using single item questions (self developed)

Timepoint [8]

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]

Social Connectedness Rating question using a 5 point scale (self developed)

Timepoint [9]

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]

Alcohol consumption levels (self-developed questions) and followed up with CAGE-AID questions if high alcohol consumption is indicated

Timepoint [10]

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]

Drug use (self-developed questions) and followed up with CAGE-AID questions if high use of drugs is indicated.

Timepoint [11]

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]

Sleep quantity and quality questions (self-developed and 4 ISI items used).

Timepoint [12]

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]

Chronic physical illness diagnosis questions (self developed)

Timepoint [13]

Pre intervention (Week 0)

Secondary outcome [14]

Mental health condition diagnosis questions (self developed)

Timepoint [14]

Pre intervention (Week 0)

Secondary outcome [15]

Current use of prescribed medication(s) question (self-developed)

Timepoint [15]

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]

Use of services for a physical health condition questions (self developed)

Timepoint [16]

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]

Use of mental health services questions (self developed)

Timepoint [17]

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]

Quality of Life Rating question - 6 point scale (self developed)

Timepoint [18]

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]

Mental Health Rating question - 6 point scale (self developed)

Timepoint [19]

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]

Physical Health Rating question - 6 point scale (self developed)

Timepoint [20]

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

Sex

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

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

Stopped early

Date of first participant enrolment

Anticipated

15/05/2017

Actual

5/07/2017

Date of last participant enrolment

Anticipated

31/12/2020

Actual

3/09/2020

Date of last data collection

Anticipated

31/07/2021

Actual

28/01/2022

Sample size

Target

189

Accrual to date

Final

35

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Country [2]

United Kingdom

State/province [2]

Country [3]

United States of America

State/province [3]

Country [4]

Canada

State/province [4]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Federation University

Country [1]

Australia

Primary sponsor type

University

Name

Federation University

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Federation University Higher Research Ethics Committee

Ethics committee address [1]

Federation University Australia. Office 218, Building F, Mt Helen Campus. 
PO Box 663, Ballarat VIC 3353

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/02/2017

Approval date [1]

07/02/2017

Ethics approval number [1]

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)

Public notes

iChooseWell is globally accessible via the web.

Contacts

Principal investigator

Name

Prof Britt Klein

Address

Federation University
University Drive, Mt Helen Campus, 3350, Victoria

Country

Australia

Phone

+61 3 5327 6717

Email

[email protected]

Contact person for public queries

Name

Britt Klein

Address

Federation University
University Drive, Mt Helen Campus, 3350, Victoria

Country

Australia

Phone

+61 3 5327 6717

Email

[email protected]

Contact person for scientific queries

Name

Britt Klein

Address

Federation University
University Drive, Mt Helen Campus, 3350, Victoria

Country

Australia

Phone

+61 3 5327 6717

Email

[email protected]

Trial Review

Documents added manually

Documents added automatically