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
ACTRN12616000704493
Ethics application status
Approved
Date submitted
24/05/2016
Date registered
27/05/2016
Date last updated
27/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Measuring Individual Stress Levels In A Workplace Environment Using The Circadian Heart Rate
Scientific title
Measuring Individual Stress Levels In A Workplace Environment Using The Circadian Heart Rate
Secondary ID [1] 289286 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 298874 0
Condition category
Condition code
Mental Health 298945 298945 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of this study is to assess whether measures of circadian heart rate (CHR) can provide objective indications of stress and distress in the workplace. CHR is monitored at baseline and after a period of 8 weeks with a ‘Zephyr BioHarness 3 BTLE’ monitor worn with a strap around the participant's torso. At each assessment point 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). Measures of CHR will be compared with data obtained from self-report questionnaires and clinician interview (M.I.N.I.) to evaluate cross-sectional and predictive validity.
Intervention code [1] 294838 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298415 0
Stress will be measured with the circadian heart pattern derived from the participant ECG data file recorded on the ‘Zephyr BioHarness 3 BTLE’ monitor. This device records the participant’s body temperature, respiration rate, actigraphy and ECG signal. 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). Overnight recordings are commonly used to measure CHR due to limited external confounds when sleeping (e.g., rigorous exercise). The target population are mining workers who we are going to recruit and assess onsite.
Timepoint [1] 298415 0
Baseline and 8 week follow-up
Secondary outcome [1] 324077 0
Physical Activity assessed using Brief Physical Activity Assessment Scale (Marshall et al., 2005)
Timepoint [1] 324077 0
Baseline and 8 week follow-up
Secondary outcome [2] 324078 0
Sleep Quality assessed using Bergen Insomnia Scale (Pallesen et al., 2008)
Timepoint [2] 324078 0
Baseline and 8 week follow-up
Secondary outcome [3] 324079 0
Alcohol drinking behaviour assessed using AUDIT-C (Bush et al., 1998)
Timepoint [3] 324079 0
Baseline and 8 week follow-up
Secondary outcome [4] 324080 0
Participant's coping strategies assessed using a list of strategies that people have previously identified to regularly use to prevent and manage depression. These strategies have been specifically nominated by men in a previous qualitative study (Fogarty et al 2015) and have been used in a national online survey investigating Australian men’s use of positive coping strategies (Proudfoot et al., 2015).
Timepoint [4] 324080 0
Baseline and 8 week follow up
Secondary outcome [5] 324081 0
Self-report measure of depression using Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)
Timepoint [5] 324081 0
Baseline and 8 week follow-up
Secondary outcome [6] 324082 0
Self-report measure of anxiety using Generalized Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006)
Timepoint [6] 324082 0
Baseline and 8 week follow-up
Secondary outcome [7] 324083 0
General wellbeing assessed using WHO-5 Well-being Index (WHO, 1998)
Timepoint [7] 324083 0
Baseline and 8 week follow-up
Secondary outcome [8] 324084 0
Workplace discrimination assessed using the Everyday Discrimination Scale (Williams et al., 1997).
Timepoint [8] 324084 0
Baseline and 8 week follow-up
Secondary outcome [9] 324085 0
Job satisfaction using the 12-item short Job Content Questionnaire (as used in HILDA study)
Timepoint [9] 324085 0
Baseline and 8 week follow-up
Secondary outcome [10] 324086 0
Emotional resilience assessed using the Brief Resilience Scale (Smith et al., 2008)
Timepoint [10] 324086 0
Baseline and 8 week follow-up
Secondary outcome [11] 324087 0
Work-life balance assessed using Work-Family Balance Scale (Hill et al., 2001)
Timepoint [11] 324087 0
Baseline and 8 week follow-up
Secondary outcome [12] 324088 0
Screening for major depressive disorder, panic disorder, psychotic disorders, generalised anxiety disorder and posttraumatic stress disorder with the M.I.N.I. International Neuropsychiatric Interview (M.I.N.I.).
Timepoint [12] 324088 0
Baseline and 8 week follow-up
Secondary outcome [13] 324089 0
Workplace satisfaction assessed using the Physical Work Environment Satisfaction Questionnaire (Carlopio, 1996)
Timepoint [13] 324089 0
Baseline and 8 week follow-up
Secondary outcome [14] 324156 0
Workplace bullying assessed using the Workplace Bullying Question (Kivimaki et al., 2000).
Timepoint [14] 324156 0
Baseline and 8 week follow-up

Eligibility
Key inclusion criteria
All Fortescue employees at three worksites (Cloudbreak, Port Hedland and the Perth administrative centre), in Western Australia, will be invited to participate
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Employees who have difficulty reading and understanding English
Employees who are currently suicidal (a score of 2 or more on question ix of PHQ-9)
Employees who do not meet any of the threshold scores in the self-report mental health/stress questionnaires will not be offered the intervention.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Statistical methods / analysis
Based on pilot results, we show that accuracy of the algorithm using a conservative approach is between 70 and 80%. So for further calculations we will use a conservative representative accuracy of 70%

If the accuracy is 70%, then for severe cases, in order to show with statistical confidence (in a 2 by 2 contingency table) that correctly estimating severe levels of stress with an accuracy of 70% is unlikely to occur due to chance, (i.e. 95% confidence interval does not include 50%), would require 15 participants who present with a severe level of stress.
It is important to note that the 2by2 contingency table is forcing the algorithm to make a choice between severe stress and not severe stress (which includes normal, mild and moderate stress).

Given that the point prevalence of severe stress in the general population is estimated to be around 10%, this would mean that we would require a sample of 150 people in order to recruit 15 participants suffering from severe levels of stress.

The CHR output metrics will be compared with self-report and clinician interview data as follows:

1. Cross-sectionally against the measures of depression and anxiety (quantitative discrete variables), and diagnoses (quantitative discrete variables) using agreement statistics for dichotomous variables and ROC curves for continuous variables. We will evaluate an interaction with coping responses
2. Cross sectional measures of ‘normals’ against those who consider themselves stressed, depressed, or anxious on self report scales.
3. Longitudinally by validating changes in the participant’s CHR status with changes in symptoms and stressors.
4. User acceptability, feedback response and comfort ratings will be collected through questions embedded in the App.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 293666 0
Commercial sector/Industry
Name [1] 293666 0
Medibio Ltd
Country [1] 293666 0
Australia
Primary sponsor type
Individual
Name
Nick Glozier
Address
Level 5, Professor Marie Bashir Centre
The University of Sydney
67-73 Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 292501 0
None
Name [1] 292501 0
None
Address [1] 292501 0
None
Country [1] 292501 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295105 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 295105 0
Ethics committee country [1] 295105 0
Australia
Date submitted for ethics approval [1] 295105 0
Approval date [1] 295105 0
15/03/2016
Ethics approval number [1] 295105 0
2016/113

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

Contacts
Principal investigator
Name 66142 0
Prof Nick Glozier
Address 66142 0
Level 5, Professor Marie Bashir Centre
The University of Sydney
67-73 Missenden Road
Camperdown NSW 2050
Country 66142 0
Australia
Phone 66142 0
+61 2 9515 1596
Fax 66142 0
Email 66142 0
[email protected]
Contact person for public queries
Name 66143 0
Ariane Dahlheimer
Address 66143 0
Level 5, Professor Marie Bashir Centre
The University of Sydney
67-73 Missenden Road
Camperdown NSW 2050
Country 66143 0
Australia
Phone 66143 0
+61 2 9515 1440
Fax 66143 0
Email 66143 0
[email protected]
Contact person for scientific queries
Name 66144 0
Michael Player
Address 66144 0
Level 5, Professor Marie Bashir Centre
The University of Sydney
67-73 Missenden Road
Camperdown NSW 2050
Country 66144 0
Australia
Phone 66144 0
+61 2 9515 1440
Fax 66144 0
Email 66144 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.