None listed
Conditions
Brief summary
A cognitive behavioural and biopsychosocially-based program for decreasing symptoms of post-traumatic stress, as well as anxiety and depression (called LIFE FLeX 4 PTSD), will be evaluated. LIFE FLeX 4 PTSD is one of the digital health programs offered through the My Digital Health platform. People visiting the platform, in response to advertisements or through self-interest, will be informed of the availability of the LIFE FLeX 4 PTSD digital health program and invited to participate in the study. People taking part in the study will be provided with immediate access to the program, following completion of the pre-intervention schedule. LIFE FLeX 4 PTSD is designed to provide people with information and strategies to address their post-traumatic stress, anxiety and depressive symptoms and contains six ‘core’ modules, plus an Introduction module, delivered over 8 weeks. There will also be a short ‘Booster’ Module released in Week 11. Each module will take approximately 25 minutes to complete. In addition, in order to reinforce the module-based information, there are 30 minutes of offline activities each week. Participants will also receive automated emails (e.g., to remind them to log on, to complete their daily mood survey, when to complete post/follow-up questionnaires) and will be asked several questions at the beginning of each module to help evaluate the module they previously completed. Participants will complete a pre-intervention assessment (Week 0), during intervention (Week 1-8) assessments, post-intervention assessment (Week 9) and a 1 and 3 month follow-up assessment (Week 13 & Week 21 respectively). Participants will also be asked questions relating to their program engagement levels at post assessment. Program access will continue for another 8 weeks post the 3 month follow-up assessment (Week 29). It is expected that people who undertake LIFE FLeX 4 PTSD program will show reductions in post-traumatic stress, 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.
Interventions
A cognitive behavioural and biopsychosocially-based digital health program for decreasing symptoms of post-traumatic stress, as well as anxiety and depressive symptoms (called LIFE FLeX 4 PTSD), will be evaluated using a quasi-experimental trial design. LIFE FLeX 4 PTSD is designed to provide people with information and strategies to address their post-traumatic stress, anxiety and depressive symptoms and contains six ‘core’ modules, plus an Introduction module, delivered over 8 weeks. There will also be a short 3 page ‘Booster’ module released in Week 11. The six core LIFE FLeX for PTSD digital health 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 (core beliefs, automatic and unhelpful thoughts, intrusive thoughts) and how to increase thinking flexibility (e.g., identifying and challenging unhelpful thoughts). 4. Increasing Behavioural Flexibility: Looks at how our behaviour can influence how we think and feel. The main focus of this module is to assist in the processing of the traumatic event via journal writing based exposure therapy. In addition, avoidance of people, places and situations that reminds the person of the trauma and behavioural activation, if activity levels are low, are also discussed. 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 30 minutes of offline activities each week. Offline activities involve applying the techniques discussed in the modules such as self-monitoring stress and anxiety symptoms, undertaking one of the increasing biological and wellness flexibility intervention strategies, monitoring emotions and thoughts and undertaking the journal writing based exposure therapy exercises. Participants will also receive automated emails (e.g., remind them to log on, to complete their daily mood and lifestyle events survey, when to complete during, post-intervention and follow-up questionnaires). At the beginning of each new module, participants will be asked several questions to help gauge their progress. Modules include text, graphics, audio, video, editable forms, interactive games and downloads. Modules can be accessible via web, mobile or tablet devices. A 'stage release' design has been employed so that program modules are released sequentially, but at the pace that each participant is most comfortable with over the 8 weeks. The LIFE FLeX 4 PTSD 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, participants 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 complete a pre-intervention assessment (Week 0), during intervention (Week 3, 5, 7) assessments, post-intervention assessment (Week 9) and a 1 and 3-month follow-up assessment (Week 13 & Week 21 respectively). While the ‘during’, post-intervention and follow up assessments are scheduled, participants will not be able to access the LIFE FLeX 4 PTSD 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 29 (8 weeks past the 3 month follow-up assessment). Participant engagement with the program will be obtained through by passive analytic data (e.g., what pages / modules they visited / used and when), as well as reviewing the module review questions submitted, completion of daily mood and lifestyle event survey and the scheduled intervention assessments. Passive analytic data will provide information as to intervention adherence over time. Participating healthcare practitioners may be invited to provide feedback about their digital connection experience.
Sponsors
Study design
Eligibility
Inclusion criteria
Participants must be 18 years of age or older. Participants must also endorse having had experienced a traumatic event and report at least a minimal score on the PCL-5 indicating experiencing some recent post-traumatic stress symptoms.
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.