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Trial registered on ANZCTR


Registration number
ACTRN12615000480583
Ethics application status
Approved
Date submitted
30/04/2015
Date registered
14/05/2015
Date last updated
18/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A ‘open study’ evaluation trial of the LIFE FLeX eHealth wellbeing program for anxiety and depression.
Scientific title
A open study evaluation trial of the LIFE FLeX eHealth wellbeing program for reducing anxiety and depression and increasing emotional regulation and positive affect in adults with depression and anxiety.
Secondary ID [1] 286210 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 294922 0
Depression 294923 0
Condition category
Condition code
Mental Health 295173 295173 0 0
Anxiety
Mental Health 295174 295174 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An cognitive behavioural and biopsychosocially-based e-mental health program for decreasing symptoms of anxiety and depression (called LIFE FLeX) will be evaluated using a quasi experimental trial design.


LIFE FLeX 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 two page ‘Booster’ Module three weeks following the post-assessment. Participants will be notified by email as to when they should access it.


The six core LIFE FLeX eHealth modules are:

1. Increasing Biological Flexibility
2. Increasing Emotional Flexibility
3. Increasing Thinking Flexibility
4. Increasing Behavioural Flexibility
5. Increasing Wellness (positive affect) Flexibility
6. Increasing Life FleX-ability


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 several questions at the beginning of each module to monitor their progress. A 'stage release' design has been employed so that modules are released sequentially, but at the pace that each participant is most comfortable with over the 7 weeks. Modules include text, graphics, audio, video, editable forms and downloads. Modules can be accessible via web, mobile or tablet devices.

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) and they will be able to access the program for the entire trial period. Participant engagement with the program will be monitored by them 'releasing' of each new module, asking module review questions at the beginning of each new module and at the post assessment stage, and the completion of the daily electronic mood monitoring form.
Intervention code [1] 291806 0
Treatment: Other
Intervention code [2] 291807 0
Prevention
Intervention code [3] 291808 0
Behaviour
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294931 0
Anxiety symptoms using the GAD-7 and specific anxiety disorder type questions (self developed)
Timepoint [1] 294931 0
Pre-intervention, during intervention (Week 2 and 5), post and 1 and 3 month follow-up
Primary outcome [2] 294932 0
Depressive symptoms using the PHQ-9
Timepoint [2] 294932 0
Pre-intervention, during intervention (Week 2 and 5), post and 1 and 3 month follow-up
Secondary outcome [1] 314377 0
General psychological distress levels using the Kessler 6
Timepoint [1] 314377 0
Pre-intervention, post and 1 and 3 month follow-up
Secondary outcome [2] 314378 0
Emotional dysregulation by using the DERS
Timepoint [2] 314378 0
Pre-intervention, post and 1 and 3 month follow-up
Secondary outcome [3] 314380 0
Mental wellness using the MHC-SF
Timepoint [3] 314380 0
Pre-intervention, post and 1 and 3 month follow-up
Secondary outcome [4] 314381 0
Optimism using the LOT-R
Timepoint [4] 314381 0
Pre-intervention, post and 1 and 3 month follow-up
Secondary outcome [5] 314382 0
Quality of life using the EQ-5D
Timepoint [5] 314382 0
Pre-intervention, post and 1 and 3 month follow-up
Secondary outcome [6] 314383 0
Treatment credibility using the TCS
Timepoint [6] 314383 0
Pre-intervention
Secondary outcome [7] 314384 0
Treatment satisfaction, including engagement, will be measured using the TSQ
Timepoint [7] 314384 0
Post intervention
Secondary outcome [8] 314385 0
Demographic and lifestyle/personal questions using a self developed measure (e.g., age, gender, sleep, drug and alcohol use, exercise patterns)
Timepoint [8] 314385 0
Pre-intervention, post and 1 and 3 month follow-up

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?
No
Key exclusion criteria
There are no key exclusion criteria.

LIFE FLeX has been written 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 (given this is a fully automated self help program). In addition, the program is also preventative in nature - thus 'healthy' participants may also benefit from some of the information within the program (e.g., increasing wellness flexibility).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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 eHealth 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 provided access to the LIFE FLeX program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
1. Pre-, post- and follow-up variables will be subjected to repeated measures MANOVA and ANOVA to determine significant changes over time.
2. Correlational and multiple regression analyses will be used to determine any potential predictors and discriminators of attrition and adherence.
3. 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 = 0.25), significance set at 5% (p = .05) and power at 80%, a total sample size of 80 (this figure also accounts for an expected attrition rate of 50%) will be required to demonstrate statistical significance on the primary outcome measure.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/07/2015
Actual
4/09/2015
Date of last participant enrolment
Anticipated
13/03/2017
Actual
15/07/2017
Date of last data collection
Anticipated
Actual
6/08/2017
Sample size
Target
80
Accrual to date
Final
268
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291180 0
University
Name [1] 291180 0
Federation University
Country [1] 291180 0
Australia
Primary sponsor type
University
Name
Federation University
Address
University Drive, Mt Helen Campus, Victoria, 3350
Country
Australia
Secondary sponsor category [1] 289860 0
None
Name [1] 289860 0
Address [1] 289860 0
Country [1] 289860 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292752 0
Federation University Higher Research Ethics Committee
Ethics committee address [1] 292752 0
Ethics committee country [1] 292752 0
Australia
Date submitted for ethics approval [1] 292752 0
Approval date [1] 292752 0
12/02/2015
Ethics approval number [1] 292752 0
A15-005

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

Contacts
Principal investigator
Name 55086 0
Prof Britt Klein
Address 55086 0
Federation University University Drive, Mt Helen Campus, 3350, Victoria
Country 55086 0
Australia
Phone 55086 0
+61 3 53276717
Fax 55086 0
Email 55086 0
b.klein@federation.edu.au
Contact person for public queries
Name 55087 0
Britt Klein
Address 55087 0
Federation University University Drive, Mt Helen Campus, 3350, Victoria
Country 55087 0
Australia
Phone 55087 0
+61 3 5327 6717
Fax 55087 0
Email 55087 0
b.klein@federation.edu.au
Contact person for scientific queries
Name 55088 0
Britt Klein
Address 55088 0
Federation University University Drive, Mt Helen Campus, 3350, Victoria
Country 55088 0
Australia
Phone 55088 0
+61 3 53276717
Fax 55088 0
Email 55088 0
b.klein@federation.edu.au

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.