Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000576325
Ethics application status
Approved
Date submitted
7/04/2017
Date registered
24/04/2017
Date last updated
15/07/2022
Date data sharing statement initially provided
21/01/2019
Date results information initially provided
15/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
An open evaluation trial of the ‘LIFE FLeX 4 PTSD’ digital health program for post traumatic stress, anxiety and depressive symptoms.
Scientific title
An open evaluation trial of the ‘LIFE FLeX 4 PTSD’ digital health program, offered through the My Digital Health platform, for reducing post-traumatic stress, anxiety and depressive symptoms in adults with post-traumatic stress disorder symptoms.
Secondary ID [1] 291115 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-traumatic stress 301943 0
Anxiety 301944 0
Depression 301945 0
Condition category
Condition code
Mental Health 301595 301595 0 0
Anxiety
Mental Health 301596 301596 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 297106 0
Treatment: Other
Intervention code [2] 297107 0
Prevention
Intervention code [3] 297108 0
Behaviour
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301004 0
Post-traumatic stress disorders symptoms using the PCL-5
Timepoint [1] 301004 0
Pre intervention (Week 0), post intervention (Week 9) and at the 1 month (Week 13) and 3 month (Week 21) follow-up assessment.
Primary outcome [2] 301005 0
Anxiety symptoms using the GAD-7
Timepoint [2] 301005 0
Pre intervention, during intervention (Week 3, 5, 7), post intervention and at the 1 and 3 month follow-up assessment
Primary outcome [3] 301006 0
Depressive symptoms using the PHQ-9
Timepoint [3] 301006 0
Pre intervention, during intervention (Week 3, 5, 7), post and at the 1 and 3 month follow-up assessments.
Secondary outcome [1] 331404 0
General psychological distress levels using the K10
Timepoint [1] 331404 0
Pre-intervention, post and 1 and 3 month follow-up
Secondary outcome [2] 331405 0
Emotional regulation using the DERS-Brief
Timepoint [2] 331405 0
Pre intervention, post and 1 and 3 month follow-up
Secondary outcome [3] 331406 0
Mental wellness using the MHC-SF
Timepoint [3] 331406 0
Pre-intervention, post and 1 and 3 month follow-up
Secondary outcome [4] 331407 0
Optimism using the LOT-R
Timepoint [4] 331407 0
Pre-intervention, post and 1 and 3 month follow-up
Secondary outcome [5] 331408 0
Quality of life using the EQ-5D
Timepoint [5] 331408 0
Pre-intervention, post and 1 and 3 month follow-up
Secondary outcome [6] 331409 0
Affective style using the ASQ
Timepoint [6] 331409 0
Pre-intervention, post and 1 and 3 month follow-up
Secondary outcome [7] 331411 0
Time perception using the TDT (Time Dilation Test - self developed)
Timepoint [7] 331411 0
Pre-intervention, post and 1 and 3 month follow-up
Secondary outcome [8] 331412 0
Treatment credibility using the TCS
Timepoint [8] 331412 0
Pre intervention
Secondary outcome [9] 331413 0
Personality traits using the TIPI
Timepoint [9] 331413 0
Pre intervention
Secondary outcome [10] 331414 0
Treatment satisfaction, including engagement, will be measured using the TSQ
Timepoint [10] 331414 0
Post intervention
Secondary outcome [11] 331415 0
Physical activity levels using single item questions (self developed)
Timepoint [11] 331415 0
Pre-intervention, post and 1 and 3 month follow-up
Secondary outcome [12] 334044 0
Social Connectedness Rating question using a 5 point scale (self developed)
Timepoint [12] 334044 0
Pre, post and 1 and 3 month follow up
Secondary outcome [13] 334045 0
Alcohol consumption levels (self-developed questions) and followed up with CAGE-AID questions if high alcohol consumption is indicated
Timepoint [13] 334045 0
Pre, post and 1 and 3 month follow up
Secondary outcome [14] 334046 0
Drug use (self-developed questions) and followed up with CAGE-AID questions if high use of drugs is indicated.
Timepoint [14] 334046 0
Pre, post and 1 and 3 month follow up
Secondary outcome [15] 334047 0
Sleep quantity and quality questions (self-developed and 4 ISI items used).
Timepoint [15] 334047 0
Pre, post and 1 and 3 month follow up
Secondary outcome [16] 334048 0
Chronic physical illness diagnosis questions (self developed)
Timepoint [16] 334048 0
Pre intervention
Secondary outcome [17] 334049 0
Mental health condition diagnosis questions (self developed)
Timepoint [17] 334049 0
Pre intervention
Secondary outcome [18] 334050 0
Current use of prescribed medication(s) question (self-developed)
Timepoint [18] 334050 0
Pre, post and 1 and 3 month follow up
Secondary outcome [19] 334051 0
Use of services for a physical health condition questions (self developed)
Timepoint [19] 334051 0
Pre, post and 1 and 3 month follow up
Secondary outcome [20] 334052 0
Use of mental health services questions (self developed)
Timepoint [20] 334052 0
Pre, post and 1 and 3 month follow up
Secondary outcome [21] 334053 0
Quality of Life Rating - 6 point scale (self developed)
Timepoint [21] 334053 0
Pre, post and 1 and 3 month follow up
Secondary outcome [22] 334054 0
Mental Health Rating - 6 point scale (self developed)
Timepoint [22] 334054 0
Pre, post and 1 and 3 month follow up
Secondary outcome [23] 334055 0
Physical Health Rating - 6 point scale (self developed)
Timepoint [23] 334055 0
Pre, post and 1 and 3 month follow up
Secondary outcome [24] 334056 0
Anxiety subtype questions (self developed)
Timepoint [24] 334056 0
Pre, post and 1 and 3 month follow up

Eligibility
Key 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.
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 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
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 4 PTSD 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 4 PTSD Plain Language Information Statement. Following informed consent, participants will then be presented with the pre- intervention assessment questionnaires. Once completed, the participant is provided access to the LIFE FLeX 4 PTSD program immediately.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Pre-, post- and follow-up variables will be subjected to mixed methods repeated measures to determine significant changes over time.

Previous research has reported medium to large effects can be expected for the primary measures of interest (PTSD symptoms). Therefore, assuming a conservative small-medium effect (i.e. GPower f(v) test = 0.30), significance set at 5% (p = .05), power at 80%, a sample of 35 will be required to demonstrate statistical significance on the primary analysis. However, allowing for a 50% attrition rate, we will be required to recruit N = 70 participants.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
We have closed this trial as we are retiring the My Digital Health platform and shifting to a new upgraded platform.
Date of first participant enrolment
Anticipated
15/05/2017
Actual
23/07/2017
Date of last participant enrolment
Anticipated
31/12/2020
Actual
7/08/2021
Date of last data collection
Anticipated
31/07/2021
Actual
15/01/2022
Sample size
Target
70
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 8816 0
New Zealand
State/province [1] 8816 0
Country [2] 8817 0
United Kingdom
State/province [2] 8817 0
Country [3] 8818 0
United States of America
State/province [3] 8818 0
Country [4] 8819 0
Canada
State/province [4] 8819 0

Funding & Sponsors
Funding source category [1] 295554 0
University
Name [1] 295554 0
Federation University
Country [1] 295554 0
Australia
Primary sponsor type
University
Name
Federation University
Address
University Drive, Mt Helen Campus, Victoria, 3350, Australia
Country
Australia
Secondary sponsor category [1] 294375 0
None
Name [1] 294375 0
Address [1] 294375 0
Country [1] 294375 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296875 0
Federation University Higher Research Ethics Committee
Ethics committee address [1] 296875 0
Federation University Australia. Office 218, Building F, Mt Helen Campus. PO Box 663 Ballarat VIC 3353
Ethics committee country [1] 296875 0
Australia
Date submitted for ethics approval [1] 296875 0
27/06/2016
Approval date [1] 296875 0
04/08/2016
Ethics approval number [1] 296875 0
A16 - 199

Summary
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.
Trial website
https://lifeflexptsd.mydigitalhealth.org.au (direct, child website)
https://www.mydigitalhealth.org.au (parent site)
Trial related presentations / publications
Public notes
LIFE FLeX 4 PTSD is globally accessible via the web.

Contacts
Principal investigator
Name 72298 0
Prof Britt Klein
Address 72298 0
Federation University
University Drive, Mt Helen Campus, 3350, Victoria
Country 72298 0
Australia
Phone 72298 0
+61 3 5327 6717
Fax 72298 0
Email 72298 0
b.klein@federation.edu.au
Contact person for public queries
Name 72299 0
Prof Britt Klein
Address 72299 0
Federation University
University Drive, Mt Helen Campus, 3350, Victoria
Country 72299 0
Australia
Phone 72299 0
+61 3 5327 6717
Fax 72299 0
Email 72299 0
b.klein@federation.edu.au
Contact person for scientific queries
Name 72300 0
Prof Britt Klein
Address 72300 0
Federation University
University Drive, Mt Helen Campus, 3350, Victoria
Country 72300 0
Australia
Phone 72300 0
+61 3 5327 6717
Fax 72300 0
Email 72300 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.
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 de-identified data and approval granted.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1090Informed consent form    https://lifeflexptsd.mydigitalhealth.org.au/plain-... [More Details]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.