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Trial registered on ANZCTR


Registration number
ACTRN12617000290392
Ethics application status
Approved
Date submitted
15/02/2017
Date registered
24/02/2017
Date last updated
24/02/2020
Date data sharing statement initially provided
24/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Doctors Working Well: A Study Evaluating an Online Stress Management Program for Doctors
Scientific title
A Randomised Controlled Trial of an Online Intervention on Resiliency, Occupational Stress, and Burnout among Junior Medical Doctors
Secondary ID [1] 291127 0
Nil known
Universal Trial Number (UTN)
U1111-1192-6608
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stress 301952 0
burnout 301953 0
Condition category
Condition code
Mental Health 301605 301605 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Doctors Working Well is an online program designed to target occupational stress and burnout. The intervention will consist of 6 online modules (each of approximately 30-45 minutes duration) that focus on stress management techniques, emotion monitoring and regulation techniques, and self-care. Participants will have access to one module per week over a six week period. At the start of each module they will also be asked to answer a small number of questions relating to their mood and engagement with skills learnt in the previous module.

Each module contains a mixture of didactic and interactive learning activities, such as readings, quizzes, videos, and personal reflections. Development of the program was led by a clinical psychologist with six years treatment experience, with input also received from two other research team members, who are both also psychologists. Intervention adherence will not be assessed as the program content will be delivered consistently across participants, due to the electronic format of the intervention. Participant adherence to the intervention will be assessed through examination of number of log ins, time spent using program, modules completed, and activities completed within each module. Participants will be sent a reminder email if a module hasn't been completed within 2 days of it becoming available on the weekly cycle.
Intervention code [1] 297109 0
Behaviour
Comparator / control treatment
An active control condition will be utilized at the end of a six week intervention period, control participants will complete an assessment. After completing the three month follow up assessment, those participants allocated to the control condition will then receive access to the online program. This change was made prior to commencement of the trial and prior to any recruitment of participants.
Control group
Active

Outcomes
Primary outcome [1] 301007 0
Stress as measured by the stress subscale of the Depression and Anxiety Stress Scales - 21 item version
Timepoint [1] 301007 0
pre intervention, post intervention (end of week 6 module), 3 months following intervention
Primary outcome [2] 301008 0
Burnout as measured by the Copenhagen Burnout Inventory
Timepoint [2] 301008 0
pre intervention, post intervention (end of week 6 module), 3 months following intervention
Secondary outcome [1] 331418 0
depression as measured by the depression subscale of the Depression, Anxiety, and Stress Scales - 21 item version
Timepoint [1] 331418 0
pre intervention, post intervention (end of week 6 module), 3 months following intervention
Secondary outcome [2] 331419 0
anxiety as measured by the anxiety subscale of the Depression, Anxiety, and Stress Scales - 21 item version
Timepoint [2] 331419 0
pre intervention, post intervention (end of week 6 module), 3 months following intervention
Secondary outcome [3] 331420 0
resilience as measured by the Brief Resilience Scale
Timepoint [3] 331420 0
pre intervention, post intervention (end of week 6 module), 3 months following intervention
Secondary outcome [4] 331421 0
Patient care attitudes as measured by The Patient Care Attitudes and Practices Scale.
Timepoint [4] 331421 0
pre intervention, post intervention (end of week 6 module), 3 months following intervention
Secondary outcome [5] 331422 0
psychological distress as measured by the Kessler-10 scale
Timepoint [5] 331422 0
pre intervention, post intervention (end of week 6 module), 3 months following intervention
Secondary outcome [6] 331423 0
mindfulness as measured by the Cognitive and Affective Mindfulness Scale - Revised
Timepoint [6] 331423 0
pre intervention, post intervention (end of week 6 module), 3 months following intervention
Secondary outcome [7] 331424 0
Quality of Life as measured by The Assessment of Quality of Life Scale - 8D
Timepoint [7] 331424 0
pre intervention, post intervention (end of week 6 module), 3 months following intervention
Secondary outcome [8] 331425 0
stigma as measured by the Stigma of Occupational Stress Scale for Doctors
Timepoint [8] 331425 0
pre intervention, post intervention (end of week 6 module), 3 months following intervention
Secondary outcome [9] 331426 0
satisfaction with the program as measured by the Client Satisfaction Questionnaire - 8 item version
Timepoint [9] 331426 0
post intervention (end of week 6 module)
Secondary outcome [10] 380466 0
Job Satisfaction as measured by the Copenhagen Psychosocial Questionnaire - COPSOQ II Job satisfaction scale
Timepoint [10] 380466 0
pre intervention, post intervention (end of week 6 module), 3 months following intervention
Secondary outcome [11] 380467 0
Self-efficacy as measured by the General Self-Efficacy Scale
Timepoint [11] 380467 0
Useful outcome measure for the population

Eligibility
Key inclusion criteria
Participants will be registered medical doctors practicing in the West Moreton Hospital and Health Service district (Queensland, Australia), aged 18 years or older.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Aged younger than 18 years, not a medical doctor, or practicing outside the West Moreton Hospital and Health Service area.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
individual, sequential, simple randomisation, using a computer generated string
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Multilevel statistical modelling will be used to analyse the data. The multilevel models will be fitted with the MIXED procedure in SPSS and alpha criterion set at .05. As such, data from all randomised participants will be used in analyses. Time (two levels, pre- and post-) will be entered with each outcome variable and the interaction term of each outcome variable x time. A similar set of analyses using multilevel modelling will be conducted to assess maintenance of treatment gains between post and follow up time points.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7448 0
Ipswich Hospital - Ipswich
Recruitment postcode(s) [1] 15274 0
4305 - Ipswich

Funding & Sponsors
Funding source category [1] 295565 0
University
Name [1] 295565 0
University of Southern Queensland
Address [1] 295565 0
37 Sinnathamby Boulevard, Springfield Central, 4300, QLD
Country [1] 295565 0
Australia
Funding source category [2] 295568 0
Hospital
Name [2] 295568 0
West Moreton Hospital and Health Service
Address [2] 295568 0
21 Bell St, Ipswich, QLD, 4305
Country [2] 295568 0
Australia
Funding source category [3] 305056 0
Charities/Societies/Foundations
Name [3] 305056 0
HCF Research Foundation
Address [3] 305056 0
GPO Box 4242
Sydney NSW 2001
Country [3] 305056 0
Australia
Primary sponsor type
University
Name
University of Southern Queensland
Address
37 Sinnathamby Boulevard, Springfield Central, 4300, QLD
Country
Australia
Secondary sponsor category [1] 294391 0
Hospital
Name [1] 294391 0
West Moreton Hosptial and Health Service
Address [1] 294391 0
21 Bell St, Ipswich, QLD, 4305
Country [1] 294391 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296884 0
West Moreton Hosptial and Health Service Human Research Ethics Committee
Ethics committee address [1] 296884 0
The Park - Centre for Mental Health, Level 2 Dawson House, Locked Bag 500, Archerfield, QLD, 4108
Ethics committee country [1] 296884 0
Australia
Date submitted for ethics approval [1] 296884 0
29/11/2016
Approval date [1] 296884 0
01/02/2017
Ethics approval number [1] 296884 0
HREC/16/QWMS/51
Ethics committee name [2] 296889 0
University of Southern Queensland Human Research Ethics Committee
Ethics committee address [2] 296889 0
PO Box 4196, Springfield Central, QLD, 4300
Ethics committee country [2] 296889 0
Australia
Date submitted for ethics approval [2] 296889 0
01/02/2017
Approval date [2] 296889 0
02/02/2017
Ethics approval number [2] 296889 0
H17REA025

Summary
Brief summary
Participants will be randomly allocated to either treatment or control conditions. All participants will be asked to complete a number of pre-treatment questionnaires. These questionnaires will measure stress, burnout, resilience, mood, and related factors. Those participants allocated to the treatment condition will then be provided with access to the online intervention. The intervention will consist of 6 online modules (each of approximately 30-45 minutes duration) that focus on stress management techniques, emotion monitoring and regulation techniques, and selfcare.

Participants will have access to one module per week over a six week period. At the start of each module they will also be asked to answer a small number of questions relating to their mood and engagement with skills learnt in the previous module. Participants allocated to the control condition will not be given access to the intervention at commencement of the study. At the end of the six week intervention period, and again three months following the intervention, both control and intervention participants will be asked to complete a small number of questionnaires measuring the same constructs as at pre-intervention, with the addition of a small number of questions relating to satisfaction and experience with the program.
Trial website
https://workingwell.usq.edu.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72330 0
Dr Michael Ireland
Address 72330 0
Institute for Resilient Regions, University of Southern Queensland, 37 Sinnathamby Boulevard, Springfield Central, QLD, 4300
Country 72330 0
Australia
Phone 72330 0
+61 734704497
Fax 72330 0
Email 72330 0
michael.ireland@usq.edu.au
Contact person for public queries
Name 72331 0
Dr Michael Ireland
Address 72331 0
Institute for Resilient Regions, University of Southern Queensland, 37 Sinnathamby Boulevard, Springfield Central, QLD, 4300
Country 72331 0
Australia
Phone 72331 0
+61 734704497
Fax 72331 0
Email 72331 0
michael.ireland@usq.edu.au
Contact person for scientific queries
Name 72332 0
Dr MIchael Ireland
Address 72332 0
Institute for Resilient Regions, University of Southern Queensland, 37 Sinnathamby Boulevard, Springfield Central, QLD, 4300
Country 72332 0
Australia
Phone 72332 0
+61 734704497
Fax 72332 0
Email 72332 0
michael.ireland@usq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participation in this study is confidential and data will be de-identified
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7057 0
Study protocol
Citation [1] 7057 0
Link [1] 7057 0
Email [1] 7057 0
michael.ireland@usq.edu.au
Other [1] 7057 0
Attachment [1] 7057 0
Type [2] 7058 0
Informed consent form
Citation [2] 7058 0
Link [2] 7058 0
Email [2] 7058 0
michael.ireland@usq.edu.au
Other [2] 7058 0
Attachment [2] 7058 0
Type [3] 7059 0
Ethical approval
Citation [3] 7059 0
Link [3] 7059 0
Email [3] 7059 0
michael.ireland@usq.edu.au
Other [3] 7059 0
Attachment [3] 7059 0
Summary results
No Results