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Trial registered on ANZCTR


Registration number
ACTRN12617001422314
Ethics application status
Approved
Date submitted
5/10/2017
Date registered
9/10/2017
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 evaluation trial of the 'LIFE FLeX - LGBQ' digital health and wellbeing program for lesbian, gay, bisexual or queer adults with anxiety and/or depressive symptoms.
Scientific title
A randomised evaluation trial of the 'LIFE FLeX - LGBQ' digital health and wellbeing transdiagnostic program, offer through the My Digital Health platform, for reducing anxiety and depression and improving emotional regulation in lesbian, gay, bisexual or queer adults.
Secondary ID [1] 293051 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12615000480583

Health condition
Health condition(s) or problem(s) studied:
Anxiety 304967 0
Depressive Symptoms 304968 0
Condition category
Condition code
Mental Health 304297 304297 0 0
Anxiety
Mental Health 304298 304298 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A tailored, transdiagnostic cognitive behavioural and biopsychosocially-based digital health program for lesbian, gay, bisexual or queer (LGBQ) adults, offered through the My Digital Health platform, to decrease symptoms of anxiety and depression (called LIFE FLeX - LGBQ), will be evaluated using a randomised evaluation design. People who consent to participate will be given access to the LIFE FLeX - LGBQ digital health program immediately but will be randomly allocated to one of two groups: 1) LIFE FLeX - LGBQ digital program A (immediate access to all of the program modules) or; 2) LIFE FLeX - LGBQ program B (weekly, sequential release of the program modules).

The LIFE FLeX program is designed to provide adults with information and strategies to address their anxiety and depressive symptoms and contains six ‘core’ modules, plus an Introduction module delivered over 7 weeks. There will also be a short two page ‘Booster’ module three weeks following the post-intervention assessment. The booster module will release at that time and participants will be notified by email that it has been released. This tailored version of the LIFE FLeX program has been updated to better reflect LGBQ adults and their lived experience.

The six core LIFE FLeX – LGBQ 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 (positive affect) Flexibility: Looks at wellness and positive affect 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 module to help gauge their progress. Modules include text, graphics, audio, video, editable forms, interactive games (e.g., brain training) and downloads. Modules can be accessible via web, mobile or tablet devices.

The LIFE FLeX – LGBQ 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. It also includes a ‘Connect to Practitioner’ request button. If clicked, an Australian-based participant can request that we add their healthcare practitioner to their My Digital Health account. If the healthcare practitioner consents to participate, the healthcare practitioner is then digitally connected to the participant’s My Digital Health account.

Participants will be asked to complete a pre-intervention assessment (Week 0), during intervention (Week 3 and Week 5) assessments, post-intervention assessment (Week 8) and a 1- and 3-month follow-up assessment (Week 12 & Week 20 respectively) 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 27.

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. Participating healthcare practitioners may be invited to provide feedback about their digital connection experience.
Intervention code [1] 299286 0
Treatment: Other
Intervention code [2] 299287 0
Prevention
Intervention code [3] 299288 0
Behaviour
Comparator / control treatment
Participants in both conditions will be asked to complete the same questionnaires and be provided with the exact same content. However, one condition will be able to access all of the program content from their first log in and the other 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] 303561 0
Anxiety symptoms using the GAD-7
Timepoint [1] 303561 0
Pre-intervention, during intervention (Week 3 and 5), post and 1 and 3 month follow-up
Primary outcome [2] 303562 0
Depressive symptoms using the PHQ-9
Timepoint [2] 303562 0
Pre-intervention, during intervention (Week 3 and 5), post and 1 and 3 month follow-up
Primary outcome [3] 303563 0
Emotional regulation by using the DERS-Brief
Timepoint [3] 303563 0
Pre-intervention, post and 1 and 3 month follow-up
Secondary outcome [1] 339375 0
General psychological distress levels using the K10
Timepoint [1] 339375 0
Pre-intervention, post and 1 and 3 month follow-up
Secondary outcome [2] 339376 0
Mental wellness using the MHC-SF
Timepoint [2] 339376 0
Pre-intervention, post and 1 and 3 month follow-up
Secondary outcome [3] 339377 0
Quality of life using the EQ-5D
Timepoint [3] 339377 0
Pre-intervention, post and 1 and 3 month follow-up
Secondary outcome [4] 339378 0
Personality traits using the TIPI
Timepoint [4] 339378 0
Pre intervention
Secondary outcome [5] 339379 0
Treatment satisfaction, including engagement, will be measured using the TSQ
Timepoint [5] 339379 0
Post intervention
Secondary outcome [6] 339380 0
Physical activity levels using single item questions (self developed)
Timepoint [6] 339380 0
Pre-intervention, post and 1 and 3 month follow-up
Secondary outcome [7] 339381 0
Social Connectedness Rating question using a 5 point scale (self developed)
Timepoint [7] 339381 0
Pre, post and 1 and 3 month follow up
Secondary outcome [8] 339382 0
Alcohol consumption levels (self-developed questions) and followed up with CAGE-AID questions if high alcohol consumption is indicated.
Timepoint [8] 339382 0
Pre, post and 1 and 3 month follow up
Secondary outcome [9] 339383 0
Drug use (self-developed questions) and followed up with CAGE-AID questions if high use of drugs is indicated.
Timepoint [9] 339383 0
Pre, post and 1 and 3 month follow up
Secondary outcome [10] 339384 0
Sleep quantity and quality questions (self-developed and 4 ISI items used).
Timepoint [10] 339384 0
Pre, post and 1 and 3 month follow up
Secondary outcome [11] 339385 0
Chronic physical illness diagnosis questions (self developed)
Timepoint [11] 339385 0
Pre intervention
Secondary outcome [12] 339386 0
Mental health condition diagnosis questions (self developed)
Timepoint [12] 339386 0
Pre intervention
Secondary outcome [13] 339387 0
Use of services for a physical health condition questions (self developed)
Timepoint [13] 339387 0
Pre, post and 1 and 3 month follow up
Secondary outcome [14] 339388 0
Use of mental health services questions (self developed)
Timepoint [14] 339388 0
Pre, post and 1 and 3 month follow up
Secondary outcome [15] 339389 0
Quality of Life Rating question - 6 point scale (self developed)
Timepoint [15] 339389 0
Pre, post and 1 and 3 month follow up
Secondary outcome [16] 339390 0
Mental Health Rating question - 6 point scale (self developed)
Timepoint [16] 339390 0
Pre, post and 1 and 3 month follow up
Secondary outcome [17] 339391 0
Physical Health Rating question - 6 point scale (self developed)
Timepoint [17] 339391 0
Pre, post and 1 and 3 month follow up
Secondary outcome [18] 339392 0
Anxiety subtype questions (self developed)
Timepoint [18] 339392 0
Pre, post and 1 and 3 month follow up
Secondary outcome [19] 339464 0
Current use of prescribed medication(s) question (self-developed)
Timepoint [19] 339464 0
Pre, post and 1 and 3 month follow up

Eligibility
Key inclusion criteria
Participants must be 18 years or older and concerned about their anxiety and or depressive symptoms.

LIFE FLeX - LGBQ has been developed for people with depressive and anxiety symptoms and therefore recruitment will focus on people with depression and anxiety. However, those without symptoms are able to register if they wish too. The program is also preventative in nature and therefore non-anxious and/or depressed participants may also benefit from some of the information within the program (e.g., increasing wellness flexibility).
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
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 - LGBQ 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 LIFE FLeX - LGBQ 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-, post- and follow-up variables will be subjected to mixed methods repeated measures to determine significant changes over time.

Overall medium to large effect sizes are obtained when providing people with fully automated self-help transdiagnostic programs. However it is currently unknown what difference one might expect when varying how the modules are delivered. Therefore, assuming a conservative small effect (i.e. GPower f(v) test = 0.20), significance set at 5% (p = .05), power at 80%, a sample of 277 will be required to demonstrate statistical significance on the primary analysis. However, allowing for a 50% attrition rate, we will be required to recruit 416 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] 9257 0
New Zealand
State/province [1] 9257 0
Country [2] 9258 0
Canada
State/province [2] 9258 0
Country [3] 9259 0
United Kingdom
State/province [3] 9259 0
Country [4] 9260 0
United States of America
State/province [4] 9260 0

Funding & Sponsors
Funding source category [1] 297676 0
University
Name [1] 297676 0
Federation University
Address [1] 297676 0
University Drive, Mt Helen Campus, Victoria, 3350
Country [1] 297676 0
Australia
Primary sponsor type
University
Name
Federation University
Address
University Drive, Mt Helen Campus, Victoria, 3350
Country
Australia
Secondary sponsor category [1] 296695 0
None
Name [1] 296695 0
Address [1] 296695 0
Country [1] 296695 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298748 0
Federation University Higher Research Ethics Committee
Ethics committee address [1] 298748 0
Federation University Australia. Office 218, Building F, Mt Helen Campus. PO Box 663, Ballarat VIC 3353
Ethics committee country [1] 298748 0
Australia
Date submitted for ethics approval [1] 298748 0
26/09/2017
Approval date [1] 298748 0
27/09/2017
Ethics approval number [1] 298748 0
A15-005

Summary
Brief summary
A tailored, transdiagnostic cognitive behavioural and biopsychosocially-based digital health program for lesbian, gay, bisexual or queer adults to decrease symptoms of anxiety and depression (called LIFE FLeX - LGBQ) will be evaluated. LIFE FLeX - LGBQ digital health is one of the digital health programs offered through the My Digital Health platform. People who consent will be given access to the LIFE FLeX - LGBQ program immediately but are randomly allocated to one of two groups: 1) LIFE FLeX - LGBQ digital health program A (immediate access to all of the program modules) and; 2) LIFE FLeX - LGBQ program B (weekly, sequential release of the program modules).

The LIFE FLeX program is designed 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 7 weeks. There will also be a short ‘Booster’ Module released in Week 10. This tailored version of the LIFE FLeX program has been updated to better reflect LGBQ adults and their lived experience.

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. 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 to self-monitor their mood and daily lifestyle events (e.g., sleep) and asked several questions at the beginning of each module, to monitor their progress.

Participants will complete a pre-intervention assessment (Week 0), during intervention (Week 1-7) assessments, post-intervention assessment (Week 8) and a 1 and 3-month follow-up assessment (Week 12 & Week 20 respectively).

It is expected that people who undertake LIFE FLeX - LGBQ will show reductions in anxiety and / or depressive symptoms at post-intervention assessment and follow-up assessment time points, as well as increases in positive affect and emotional regulation.
Trial website
https://lifeflexlgbq2.mydigitalhealth.org.au (direct, child website)
https://www.mydigitalhealth.org.au (parent site)
Trial related presentations / publications
Public notes
LIFE FLeX - LGBQ is globally accessible via the web.

Contacts
Principal investigator
Name 78102 0
Prof Britt Klein
Address 78102 0
Federation University. University Drive, Mt Helen Campus, 3350, Victoria
Country 78102 0
Australia
Phone 78102 0
+61 3 5327 6717
Fax 78102 0
Email 78102 0
b.klein@federation.edu.au
Contact person for public queries
Name 78103 0
Prof Britt Klein
Address 78103 0
Federation University. University Drive, Mt Helen Campus, 3350, Victoria
Country 78103 0
Australia
Phone 78103 0
+61 3 5327 6717
Fax 78103 0
Email 78103 0
b.klein@federation.edu.au
Contact person for scientific queries
Name 78104 0
Prof Britt Klein
Address 78104 0
Federation University. University Drive, Mt Helen Campus, 3350, Victoria
Country 78104 0
Australia
Phone 78104 0
+61 3 5327 6717
Fax 78104 0
Email 78104 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.
By what mechanism will data be made available?
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
Attachments/websites
Type [1] 1093 0
Informed consent form
URL/details/comments [1] 1093 0
https://lifeflexlgbq2.mydigitalhealth.org.au/plain-language-information-statement/ (participant version)
https://lifeflexlgbq2.mydigitalhealth.org.au/plis_hcp/ (healthcare practitioner version)
Attachment [1] 1093 0
Summary results
Not applicable