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Trial registered on ANZCTR


Registration number
ACTRN12622000865718
Ethics application status
Approved
Date submitted
10/06/2022
Date registered
17/06/2022
Date last updated
28/10/2024
Date data sharing statement initially provided
17/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised evaluation trial of the Life Flex digital health program for anxiety and depressive symptoms.
Scientific title
A randomised evaluation trial of the Life Flex digital health transdiagnostic program, offered through the HealthZone platform, on levels of anxiety and depression, hope and emotional regulation in adults.
Secondary ID [1] 307287 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
Ethics approval was obtained an amendment request (approved on the 06/06/2022) based on the originally approved A15-005 application (ACTRN12615000480583) in 2015. This study is a follow-on study of ACTRN12615000480583 using a revised version of the Life Flex program in a new platform, with some additional changes to the previous evaluation assessments (e.g., removal of the 1 month follow-up).

Health condition
Health condition(s) or problem(s) studied:
Anxiety 326567 0
Depression 326568 0
Condition category
Condition code
Mental Health 323816 323816 0 0
Anxiety
Mental Health 323817 323817 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A transdiagnostic, cognitive behavioural and biopsychosocially-based digital health program, offered through the HealthZone platform, for adults with anxiety and depressive symptoms (called Life Flex), will be evaluated using a randomised control design.

To gain access to the study, people are asked to create a ‘HealthZone’ platform (the Life Flex digital health program is one program amongst others that are housed within the HealthZone platform) account. This will involve providing an email address, username and strong password. Once the person has completed this, they will receive a confirmation email which they will need to verify before they can proceed any further. To remain anonymous, we suggest people use an email address that does not contain their first and last name. Once the person has created a HealthZone account, they can then re-enter the platform and sign up specifically for the Life Flex program. Here they will need to consent to participate in the Life Flex study, after reading through this Plain Language Information Statement. People who consent to participate will be given access to the Life Flex digital health program immediately following the pre-intervention assessment but will be randomly allocated to one of two groups: 1) Life Flex digital program A (immediate access to all of the program modules) or; 2) Life Flex program B (weekly, sequential release of the program modules).

Life Flex was specifically designed for this study to provide people with information and strategies to address their anxiety and depressive symptoms and contains six ‘core’ modules, plus an Introduction module delivered over 8 weeks.

The six core Life Flex digital health program modules are:
1. Increasing Biological Flexibility: Looks at the biology of the stress response, understanding what biological flexibility is and what techniques to use to increase biological flexibility (e.g., increasing physical activity, breathing control).
2. Increasing Emotional Flexibility: Looks at what emotions are, increasing emotional awareness, and use of emotional regulation strategies.
3. Increasing Thinking Flexibility: Looks at the role of thoughts in depression and anxiety and how to increase thinking flexibility (e.g., identifying and challenging unhelpful thoughts).
4. Increasing Behavioural Flexibility: Looks at how what we do influences how we think and feel and how to increase behavioural flexibility through reducing avoidance through gradual exposure (for anxiety) and increasing activity through behavioural activation (for depression).
5. Increasing Wellness Flexibility: Looks at wellness and positive emotions and how to increase wellness through various strategies (e.g., acts of kindness, openness to experience, social connectedness).
6. Increasing Life Flex-ability: Recap’s the entire program, reflects over progress and discusses relapse prevention.

Each module will take approximately 25 minutes to complete. In addition, in order to reinforce the module-based information, there are 20-30 minutes of offline activities each week. Offline activities include applying the concepts / techniques discussed in the modules such as self-monitoring depressive and anxiety symptoms, undertaking one of the increasing biological and wellness flexibility intervention strategies, monitoring emotions and thoughts and undertaking the gradual exposure or behavioural activation activity. Participants will also receive automated emails (e.g., to remind them to log on, when to complete ‘during’, post/follow-up intervention questionnaires) and will be asked several questions at the beginning of each week to help gauge their progress. Modules include text, graphics, audio, video, editable forms, gif animations, interactive quizzes and games (e.g., brain training) and downloads. There is also an automated digital conversational agent (ALEX), whose goal is to try and increase motivation levels in those participants who are finding it difficult to complete any Life Flex module. Modules can be accessible via web, mobile or tablet devices.

The Life Flex program is housed within the participant's ‘HealthZone’ dashboard. HealthZone is the parent platform that houses other 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, and My Profile.

Participants will be asked to complete a pre-intervention assessment (Week 0), during intervention (Week 3, 5 & 7) assessments, post-intervention assessment (Week 9) and at a 3-month follow-up assessment (Week 21) and they will be able to access the Life Flex program 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 26.

Participant engagement with the program will be obtained through by passive analytic data (e.g., what pages / strategies they visited / used and when), be asked to complete a weekly brief check-in survey asking them about module reading and offline activity progress, as well as reviewing the completion of daily mood and lifestyle event survey data and the scheduled intervention assessments. Participants may be invited to provide additional feedback about their digital connection experience after post-intervention assessment via telephone, video-chat or a messaging session (real-time).
Intervention code [1] 323730 0
Treatment: Other
Intervention code [2] 323784 0
Behaviour
Comparator / control treatment
Participants in the 'scheduled' condition will be provided with a 'scheduled release' of the program modules. That is, each week one new module will be made available to them.
Control group
Active

Outcomes
Primary outcome [1] 331606 0
Anxiety symptoms using the Generalised Anxiety Disorder-7 (GAD-7) survey
Timepoint [1] 331606 0
Pre-intervention (Week 0), during intervention (Week 3, 5, 7), post (week 9, primary endpoint) and 3 month follow-up (Week 21).
Primary outcome [2] 331607 0
Depressive symptoms using the Patient Health Questionnaire-8 (PHQ-8)
Timepoint [2] 331607 0
Pre-intervention (Week 0), during intervention (Week 3, 5, 7), post (week 9, primary endpoint) and 3 month follow-up (Week 21).
Secondary outcome [1] 410485 0
Emotional dysregulation by using the Difficulties in Emotional Regulation Scale - Brief.
Timepoint [1] 410485 0
Pre-intervention (Week 0), post (Week 9) and 3 month follow-up (Week 21).
Secondary outcome [2] 410486 0
Hope using the Adult Hope Scale
Timepoint [2] 410486 0
Pre-intervention (Week 0), post (Week 9) and 3 month follow-up (Week 21).
Secondary outcome [3] 410487 0
Quality of life using the EuroQual-5 (EQ-5D)
Timepoint [3] 410487 0
Pre-intervention (Week 0), post (Week 9) and 3 month follow-up (Week 21).
Secondary outcome [4] 410488 0
Mental wellness using the Mental Health Continuum - Short Form
Timepoint [4] 410488 0
Pre-intervention (Week 0), post (Week 9) and 3 month follow-up (Week 21).
Secondary outcome [5] 410489 0
Insomnia symptoms using the Insomnia Severity Index
Timepoint [5] 410489 0
Pre-intervention (Week 0), post (Week 9) and 3 month follow-up (Week 21).
Secondary outcome [6] 410492 0
Treatment satisfaction, including engagement, will be measured using the Treatment Satisfaction Questionnaire.
Timepoint [6] 410492 0
Post intervention (Week 9)
Secondary outcome [7] 410493 0
Drug use (self-developed questions) and followed up with the CAGE Adapted to Include Drugs (CAGE-AID) Questionnaire, if high use of drugs is indicated.
Timepoint [7] 410493 0
Pre-intervention (Week 0), post (Week 9) and 3 month follow-up (Week 21).
Secondary outcome [8] 410494 0
Alcohol consumption levels (self-developed questions) and followed up the CAGE-AID Questionnaire, if high alcohol consumption is indicated.
Timepoint [8] 410494 0
Pre-intervention (Week 0), post (Week 9) and 3 month follow-up (Week 21).
Secondary outcome [9] 410495 0
Social Connectedness Rating question using a 5 point scale (self developed)
Timepoint [9] 410495 0
Pre-intervention (Week 0), post (Week 9) and 3 month follow-up (Week 21).
Secondary outcome [10] 410498 0
Current use of prescribed medication(s) question (self-developed)
Timepoint [10] 410498 0
Pre-intervention (Week 0), post (Week 9) and 3 month follow-up (Week 21).
Secondary outcome [11] 410499 0
Use of services for a physical health condition questions (self developed)
Timepoint [11] 410499 0
Pre-intervention (Week 0), post (Week 9) and 3 month follow-up (Week 21).
Secondary outcome [12] 410500 0
Use of mental health services questions (self developed)
Timepoint [12] 410500 0
Pre-intervention (Week 0), post (Week 9) and 3 month follow-up (Week 21).
Secondary outcome [13] 410501 0
Quality of Life Rating question - 6 point scale (self developed)
Timepoint [13] 410501 0
Pre-intervention (Week 0), post (Week 9) and 3 month follow-up (Week 21).
Secondary outcome [14] 410502 0
Mental Health Rating question - 6 point scale (self developed)
Timepoint [14] 410502 0
Pre-intervention (Week 0), post (Week 9) and 3 month follow-up (Week 21).
Secondary outcome [15] 410503 0
Physical Health Rating question - 6 point scale (self developed)
Timepoint [15] 410503 0
Pre-intervention (Week 0), post (Week 9) and 3 month follow-up (Week 21).
Secondary outcome [16] 410504 0
Anxiety disorder subtype questions (self developed)
Timepoint [16] 410504 0
Pre-intervention (Week 0), post (Week 9) and 3 month follow-up (Week 21).
Secondary outcome [17] 413672 0
Digital Working Alliance Inventory
Timepoint [17] 413672 0
Post-Assessment (Week 9)
Secondary outcome [18] 413673 0
User Engagement Scale - Short Form
Timepoint [18] 413673 0
Post Assessment (Week 9)
Secondary outcome [19] 413674 0
System Usability Scale
Timepoint [19] 413674 0
During Assessment (Week 2)

Eligibility
Key inclusion criteria
Participants must be 18 years or older, reside in Australia and concerned about their anxiety and or depressive symptoms.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No internet access, does not create a HealthZone account (requires the provision of a valid email address), does not provide consent to study conditions.

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 Life Flex child website (or via the parent website - HealthZone) following ‘HealthZone’ account creation. Once an account is created, they will be required to provide their informed consent after reading through the Life Flex 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 HealthZone 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-, post- and follow-up variables will be subjected to mixed methods repeated measures and/or latent class modelling to determine significant changes over time, for whom.

Overall medium to large effect sizes are obtained when providing people with fully automated self-help transdiagnostic programs. Therefore, assuming a conservative medium-large 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 on the primary analysis. However, allowing for a 50% attrition rate, we will be required to recruit 150 participants.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/08/2022
Actual
1/08/2022
Date of last participant enrolment
Anticipated
15/07/2023
Actual
6/09/2023
Date of last data collection
Anticipated
9/02/2024
Actual
28/11/2023
Sample size
Target
150
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311582 0
University
Name [1] 311582 0
Federation University
Country [1] 311582 0
Australia
Primary sponsor type
University
Name
Federation University
Address
University Drive, Mt Helen Campus, Victoria, 3350
Country
Australia
Secondary sponsor category [1] 313021 0
None
Name [1] 313021 0
Address [1] 313021 0
Country [1] 313021 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311031 0
Federation University Higher Research Ethics Committee
Ethics committee address [1] 311031 0
Ethics committee country [1] 311031 0
Australia
Date submitted for ethics approval [1] 311031 0
02/06/2022
Approval date [1] 311031 0
06/06/2022
Ethics approval number [1] 311031 0
A15-005

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119754 0
Prof Britt Klein
Address 119754 0
Federation University Australia (Churchill Campus)
Northways Road, Churchill VIC 3842
Country 119754 0
Australia
Phone 119754 0
+61 353276717
Fax 119754 0
Email 119754 0
b.klein@federation.edu.au
Contact person for public queries
Name 119755 0
Britt Klein
Address 119755 0
Federation University Australia (Churchill Campus)
Northways Road, Churchill VIC 3842
Country 119755 0
Australia
Phone 119755 0
+61 353276717
Fax 119755 0
Email 119755 0
b.klein@federation.edu.au
Contact person for scientific queries
Name 119756 0
Britt Klein
Address 119756 0
Federation University Australia (Churchill Campus)
Northways Road, Churchill VIC 3842
Country 119756 0
Australia
Phone 119756 0
+61 353276717
Fax 119756 0
Email 119756 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?
Any relevant participant data collected during the trial, after non-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 non-identified data and approval granted. The Principal Investigator can be contacted via email (b.klein@federation.edu.au).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16313Informed consent form https://lifeflex.healthzone.org.au/plis/ 



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.