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A ‘open study’ evaluation trial of the LIFE FLeX eHealth wellbeing program for anxiety and depression.

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000480583
Enrollment
268
Registered
2015-05-14
Start date
2015-09-04
Completion date
2017-07-15
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A cognitive behavioural and biopsychosocially-based program for decreasing symptoms of anxiety and depression (called LIFE FLeX) will be evaluated. The LIFE FLeX eHealth program will be placed within the Federation University eHealth Platform. People who visit the website will be invited to take part in the LIFE FLeX eHealth evaluation study. Those that consent will be given access to the LIFE FLeX program website immediately. 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 ‘Booster’ Module released after post-assessment. 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 week, to monitor their progress. 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). It is expected that people who undertake LIFE FLeX will show reductions in anxiety and / or depressive symptoms at post and follow-up time points as well as increases in positive affect and emotional regulation.

Interventions

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-as

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.

Sponsors

Federation University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 9, 2026