Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000103369
Ethics application status
Approved
Date submitted
10/01/2017
Date registered
18/01/2017
Date last updated
18/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of an online stress-reduction program in a workplace environment
Scientific title
Effectiveness of an online stress-reduction program in a workplace environment
Secondary ID [1] 290847 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 301523 0
Wellbeing 301525 0
Resilience 301526 0
Circadian heart pattern 301583 0
Condition category
Condition code
Mental Health 301244 301244 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Medibio ‘Unwind’ Stress Reduction program

The Medibio ‘Unwind’ Stress Reduction program is an internet based program delivered via web browser and has been optimised for smartphone viewing using a ‘mobile first’ development process. This program will be accessible for participants once they have read the participant information statement, provided consent, and logged in to the program using their nominated email address and their study generated user identification number. Participants are asked to complete a program consisting of seven 20-30 minute modules in a 6 weeks period. This program provides strategies to users to manage stress and develop resilience to better cope with stressful circumstances. It achieves these broad aims by directly helping users to recognise and understand their own triggers for stress, and develop adaptive ways managing their stress levels. It provides evidence-supported tools for users to manage symptoms of arousal such as breathing techniques, progressive muscle relaxation and mindfulness. The program provides information on the important elements of attaining and keeping good health such as an appropriate exercise regime, getting enough sleep, cutting down on alcohol, smoking and caffeine, maintaining a balanced diet and taking time out to restore their energy levels. The interactive program includes animation, audio and video content developed internally and sourced from the internet. For example, the program provides links to external video content on the benefits of ‘random acts of kindness’ as well as ‘guided visualisation’ exercises for stress-reduction. The program also aims to have users reflect on challenging experiences to in order to build resilience, and provides the user with a range of positive coping options to reduce reliance on maladaptive coping. Throughout the modules, learning and understanding is reinforced through guided questionnaires and quizzes, homework tasks and pre-loaded feedback. The unique usefulness of the Medibio ‘Unwind’ Stress Reduction program culminates in the development of a personalised ‘Wellbeing Plan’ in module 7. This Wellbeing Plan is based upon users understanding of, and preference for the various tools exposed to the user to assist in stress reduction.
Intervention code [1] 296786 0
Lifestyle
Intervention code [2] 296787 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300704 0
Change in stress level as assessed by the Perceived Stress Scale (Cohen, 1983)
Timepoint [1] 300704 0
At baseline and after 7 weeks (after using the Medibio ‘Unwind’ Stress Reduction program)
Primary outcome [2] 300705 0
Change in mental health symptoms as assessed by change in DASS-21
Timepoint [2] 300705 0
At baseline and after 7 weeks (after using the Medibio ‘Unwind’ Stress Reduction program)
Primary outcome [3] 300706 0
Change in resilience as assessed by the Brief Resilience Scale *smith et al., 2008)
Timepoint [3] 300706 0
At baseline and after 7 weeks (after using the Medibio ‘Unwind’ Stress Reduction program)
Secondary outcome [1] 330659 0
Change in circadian heart pattern derived from the participant ECG data file recorded on the ‘Zephyr BioHarness 3 BTLE’ monitor.
The participant wears this device for up to 24 hours (wearing for a minimum of the sleep period, and for one hour either side of the sleep period), at baseline and after 7 weeks,
Timepoint [1] 330659 0
At baseline and after 7 weeks (after using the Medibio ‘Unwind’ Stress Reduction program)
Secondary outcome [2] 330660 0
Change in work stressors as assessed by the Workplace Bullying Question
Timepoint [2] 330660 0
At baseline and after 7 weeks (after using the Medibio ‘Unwind’ Stress Reduction program)
Secondary outcome [3] 330661 0
User acceptability, feedback responses and suitability of the Medibio ‘Unwind’ Stress Reduction program as assessed by questions embedded in each module of the stress reduction program. Rate how you felt about this module: waste of time, Not that useful, Boring, Average, Somewhat useful, Enjoyable, Excellent.
Timepoint [3] 330661 0
After completing each specific module
Secondary outcome [4] 330665 0
User acceptability, feedback response and comfort ratings of the Zephyr BioHarness 3 BTLE as assessed through questions embedded in the App.
The participant wears this device for up to 24 hours (wearing for a minimum of the sleep period, and for one hour either side of the sleep period), at baseline and after 7 weeks,
Timepoint [4] 330665 0
At baseline, after wearing the Zephyr BioHarness 3 BTLE for up to 24 hours, and after 7 weeks after wearing the Zephyr BioHarness 3 BTLE for up to 24 hours.
Secondary outcome [5] 330666 0
Any unwanted or perceived side effects of the stress reduction program will be elicited through an open ended question
Timepoint [5] 330666 0
After 7 weeks (after using the Medibio ‘Unwind’ Stress Reduction program)
Secondary outcome [6] 330841 0
Change in well begin as assessed by the WHO-5 Well-being Index
Timepoint [6] 330841 0
At baseline and after 7 weeks (after using the Medibio ‘Unwind’ Stress Reduction program)
Secondary outcome [7] 330842 0
Change in sleep quality as assessed by the Bergen Insomnia Scale
Timepoint [7] 330842 0
At baseline and after 7 weeks (after using the Medibio ‘Unwind’ Stress Reduction program)

Eligibility
Key inclusion criteria
All Fortescue employees and Fortescue contractors will be invited to participate in the present study. We plan no other inclusion criteria to enable the evaluation of potential groups who may benefit more
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There are no a priori exclusion criteria

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)
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
The primary analysis is a pre-post comparison of self-report and CHR assessments before and after the Medibio ‘Unwind’ Stress Reduction Tool.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/02/2017
Actual
Date of last participant enrolment
Anticipated
22/04/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 15050 0
6004 - East Perth
Recruitment postcode(s) [2] 15051 0
6751 - Mulga Downs
Recruitment postcode(s) [3] 15052 0
6722 - South Hedland

Funding & Sponsors
Funding source category [1] 295313 0
Commercial sector/Industry
Name [1] 295313 0
Medibio
Country [1] 295313 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney,
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 294137 0
None
Name [1] 294137 0
Address [1] 294137 0
Country [1] 294137 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296647 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 296647 0
Ethics committee country [1] 296647 0
Australia
Date submitted for ethics approval [1] 296647 0
30/09/2016
Approval date [1] 296647 0
18/10/2016
Ethics approval number [1] 296647 0
2016/741

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

Contacts
Principal investigator
Name 71482 0
Prof Nicholas Glozier
Address 71482 0
Brain and Mind Centre & Discipline of Psychiatry, university of Sydney
Level 5 Professor Marie Bashir Centre, Missenden Road, Camperdown. NSW 2050
Country 71482 0
Australia
Phone 71482 0
+61 2 9515 1596
Fax 71482 0
Email 71482 0
[email protected]
Contact person for public queries
Name 71483 0
Elizabeth Stratton
Address 71483 0
Brain and Mind Centre & Discipline of Psychiatry, university of Sydney
Level 5 Professor Marie Bashir Centre, Missenden Road, Camperdown. NSW 2050
Country 71483 0
Australia
Phone 71483 0
+61 2 9515 1439
Fax 71483 0
Email 71483 0
[email protected]
Contact person for scientific queries
Name 71484 0
Elizabeth Stratton
Address 71484 0
Brain and Mind Centre & Discipline of Psychiatry, university of Sydney
Level 5 Professor Marie Bashir Centre, Missenden Road, Camperdown. NSW 2050
Country 71484 0
Australia
Phone 71484 0
+61 2 9515 1439
Fax 71484 0
Email 71484 0
[email protected]

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.