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Trial registered on ANZCTR


Registration number
ACTRN12620000561987
Ethics application status
Approved
Date submitted
26/02/2020
Date registered
14/05/2020
Date last updated
14/05/2020
Date data sharing statement initially provided
14/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot evaluation of Workable by Uprise
Scientific title
A pilot trial of the Workable return-to-work program in people currently on leave from work due to a work-related physical or psychological injury.
Secondary ID [1] 300643 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Duration of sickness absence 316426 0
Condition category
Condition code
Mental Health 314686 314686 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is "Workable" by Uprise - a 6-week digital mental resilience program designed to assist injured workers return to work earlier. Workable involves:

i) Weekly self-administered online skills modules with videos, of approximately 10 minutes duration. The modules are all availabile at once, but users are recommended to complete them in the following order:
Weeks 1 and 2: Thoughts about work
Weeks 3 and 4: Problem Solving
Weeks 5 and 6: Relapse Prevention
Optional at any time: Pain and fatigue management
Participants are able do modules on more than one occasion.

ii) Homework exercises, such as
- creating a list of problems that the user is currently facing for returning to work
- creating a list of current thoughts about returning to work
- creating a list of solutions that the user has already tried for returning to work
- daily practice of controlled breathing (with a guided audio exercise)

iii) Weekly coaching telephone calls of up to 60 minutes duration. Coaching calls are conducted by registered psychologists with a minimum of 5 years experience post graduation. The psychologists will receive supervision from a senior clinical psychologist.

Workable teaches a recently injured worker (whether physical or psychological injury) an evidence-based problem solving process and focuses on participant autonomy to generate solutions, take action and evaluate outcomes. Additionally, the worker is taught how to identify and modify cognitions related to returning to work while still experiencing mental health symptoms. The intervention is tailored to address specific domains known to influence return to work (RTW) outcomes such as peer and family connections, social functioning, workplace relationships, pain and health factors. It is a modified version of a program evaluated in the Netherlands that has demonstrated a reduction in time to return to work (RTW) compared to care as usual.

Adherence will be monitored by recording the number of online modules of the Workable program completed by the participant and the number of coaching telephone calls participated in. Participants are also asked to complete online questionnaires at baseline, post-intervention (6 weeks) and at 12-week post-intervention (18 weeks).
Intervention code [1] 316974 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323012 0
Acceptability of the Workable program according to mean scores on the Client Satisfaction Questionnaire (CSQ-8)
Timepoint [1] 323012 0
Post-intervention (6 weeks)
Primary outcome [2] 323013 0
Feasibility of the Workable program, which will be assessed by the recruitment rate, attrition, (ie the proportion of participants who consent and drop out of the study) and adherence to the intervention (ie the number of modules completed and the number of coaching telephone calls participated in).
Timepoint [2] 323013 0
Post-intervention (6 weeks) and 12-weeks post-intervention (18 weeks). Primary timepoint is post-intervention (6 weeks).
Secondary outcome [1] 380519 0
Changes in duration of sick leave, which will be assessed by responses to two items (adapted from the Sheehan Disability Scale) assessing the number of days in the past four weeks that the participant has been absent from work because of their symptoms::
i) for the full working day
ii) for part of the working day
Timepoint [1] 380519 0
Baseline, post-intervention (6 weeks) and 12-weeks post-intervention (18 weeks).
Secondary outcome [2] 380520 0
Changes in self-reported productivity at work, according to responses on one item adapted from the Sheehan Disability Scale.
Timepoint [2] 380520 0
Baseline, post-intervention (6 weeks) and 12-weeks post-intervention (18 weeks).
Secondary outcome [3] 380521 0
Changes in self-reported work ability, assessed by four items from the Work Ability Index.
Timepoint [3] 380521 0
Baseline, post-intervention (6 weeks) and 12-weeks post-intervention (18 weeks).
Secondary outcome [4] 380522 0
Changes in depression symptoms according to mean scores on the Patient Health Questionnaire (PHQ-9)
Timepoint [4] 380522 0
Baseline, post-intervention (6 weeks) and 12-weeks post-intervention (18 weeks).
Secondary outcome [5] 380523 0
Changes in anxiety symptoms according to mean scores on the Generalised Anxiety Disorder 7-item scale (GAD-7).
Timepoint [5] 380523 0
Baseline, post-intervention (6 weeks) and 12-weeks post-intervention (18 weeks).
Secondary outcome [6] 380525 0
Changes in perceived stress, according to mean scores on the Perceived Stress Scale 4 (PSS-4).
Timepoint [6] 380525 0
Baseline, post-intervention (6 weeks) and 12-weeks post-intervention (18 weeks).
Secondary outcome [7] 380526 0
Changes in well-being, according to mean scores on the WHO-5 Well-being Index.
Timepoint [7] 380526 0
Baseline, post-intervention (6 weeks) and 12-weeks post-intervention (18 weeks).
Secondary outcome [8] 380527 0
Changes in health service utilization, according to the frequency of use of 19 different health services over the past month (sourced from Drummond et al, 2005).
Timepoint [8] 380527 0
Baseline, post-intervention (6 weeks) and 12-weeks post-intervention (18 weeks).
Secondary outcome [9] 381003 0
Usability of the Workable program, accoriding to one item assessing ease of use and qualitative feedback regarding the most and least helpful parts of the program and suggestions for improvement.
Timepoint [9] 381003 0
Post-intervention (6-weeks)

Eligibility
Key inclusion criteria
• Aged over 18 years
• Employed, but currently on leave from work due to a work-related physical or
psychological injury (leave duration at recruitment to be between 2 and 26 weeks)
• Not engaged in legal action against their employer
• Good understanding of English


Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Severe depression (indicated by a PHQ-9 score >19)
• Current psychotic episode or
• Active suicidal intent or current plan to harm themselves or others

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)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet 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)
NSW

Funding & Sponsors
Funding source category [1] 305067 0
Charities/Societies/Foundations
Name [1] 305067 0
iCare
Address [1] 305067 0
Level 15, 321 Kent Street
Sydney, NSW, 2000
Country [1] 305067 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Uprise Services Pty Ltd
Address
11 York Street
Sydney, NSW, 2000
Country
Australia
Secondary sponsor category [1] 305436 0
Charities/Societies/Foundations
Name [1] 305436 0
Black Dog Institute
Address [1] 305436 0
Black Dog Institute
Hospital Road, Randwick, NSW, 2031
Country [1] 305436 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305456 0
University of New South Wales Human Research Ethics Committee (UNSW HREC)
Ethics committee address [1] 305456 0
Human Research Ethics
University of New South Wales
Sydney NSW 2052
Ethics committee country [1] 305456 0
Australia
Date submitted for ethics approval [1] 305456 0
22/02/2019
Approval date [1] 305456 0
16/04/2019
Ethics approval number [1] 305456 0
HC190114

Summary
Brief summary
Uprise is a mental health tech company that provides mental health and employee assistance programs to organisations for their employees. iCare has awarded Uprise funding through their WorkUp initiative that aims to help injured workers across New South Wales. In partnership with the Black Dog Institute, Uprise aims to conduct a pilot trial of Workable, in order to examine the feasibility and acceptability of the program. Feasibility of the program will be assessed by the recruitment rate, attrition, (ie the proportion of participants who consent and drop out of the study) and adherence to the intervention (ie the number of modules completed). In addition, a secondary aim of the pilot study is to conduct a preliminary examination of the efficacy of the Workable program in improving mental health and return to work (RTW) outcomes. Participants in the pilot trial will be approximately 20 workers currently on leave due to a work-related physical or psychological injury.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100442 0
A/Prof Samuel Harvey
Address 100442 0
Black Dog Institute
Hospital Road, Randwick, NSW 2031
Country 100442 0
Australia
Phone 100442 0
+61 2 93824517
Fax 100442 0
Email 100442 0
s.harvey@unsw.edu.au
Contact person for public queries
Name 100443 0
Dr Jay Spence
Address 100443 0
Uprise Services Pty Ltd
11 York Street
Sydney, NSW, 2000
Country 100443 0
Australia
Phone 100443 0
+61 1300209371
Fax 100443 0
Email 100443 0
team@uprise.co
Contact person for scientific queries
Name 100444 0
Dr Mark Deady
Address 100444 0
Black Dog Institute
Hospital Road, Randwick, NSW 2031
Country 100444 0
Australia
Phone 100444 0
+61 2 93824517
Fax 100444 0
Email 100444 0
m.deady@unsw.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
What supporting documents are/will be available?
No other documents available
Summary results
No Results