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Trial registered on ANZCTR


Registration number
ACTRN12619001311145
Ethics application status
Approved
Date submitted
6/09/2019
Date registered
25/09/2019
Date last updated
14/01/2021
Date data sharing statement initially provided
25/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Usability, feasibility and acceptability of a smartphone application to support the mental health of Junior Medical Officers in NSW: A pilot trial
Scientific title
Usability, feasibility and acceptability of a smartphone application to support the mental health of Junior Medical Officers in NSW: A pilot trial
Secondary ID [1] 299177 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 314270 0
anxiety 314271 0
willingness to seek help for mental health problems 314272 0
Condition category
Condition code
Mental Health 312624 312624 0 0
Depression
Mental Health 312625 312625 0 0
Anxiety
Public Health 312626 312626 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The pilot trial will examine the usability, acceptability and feasibility of a smartphone application (“Shift”) that aims to support the mental health and well-being of Junior Medical Officers (JMOs) in NSW.

Due to doctors’ job demands and their specific work environment, evidence suggests that doctors are at risk of developing mental health problems, avoiding seeking help for these problems, and suicide. JMOs in particular report high levels of distress and stressors such as long working hours, sleep difficulties and the pressure to pass exams.

In response to the mental health needs of JMOs, the NSW Ministry of Health has partnered with the Black Dog Institute's Workplace Mental Health team lead by A/Prof and Chief Psychiatrist Dr Samuel Harvey to develop Shift to support the mental health and wellbeing of JMOs. This project is an initiative of the NSW Health JMO Wellbeing and Support Plan (https://www.health.nsw.gov.au/workforce/culture/Pages/jmo-support-plan.aspx).

Shift is designed for self-guided use by JMOs on Android or Apple smartphone devices. The app is modeled after a previously evaluated workplace mental health app called “HeadGear”, which follows a 30-day intervention format. The principal components of HeadGear were modified following one-on-one interviews with JMOs who identified their specific needs to overcome work-related stressors. At its core, Shift contains 30 "challenges" featuring evidence-based therapeutic techniques such as cognitive restructuring and mindfulness. Other components provide psycho-educational contents such as adjusting to shift work and adjusting to placements in remote or rural areas. Participants are asked to use Shift daily for approximately 5-10 minutes for the duration of 4 weeks. Each day, participants can complete a new exercise. These include generating lists of values and goals, watching short instructional videos, or listening to mindfulness audios. Basic usage statistics are being collected such as number of days the app was accessed and the number of challenges completed. It is hoped that delivering mental health support directly to JMOs via an app will overcome some of the barriers to help-seeking, such as time constraints and concerns about confidentiality.

Up to 30 JMOs will be recruited from two NSW Local Health Districts to complete an app-based intervention for 1 month. This study will use a pre-post intervention design with no control group. The app will be evaluated by baseline and follow-up measures assessing usability and acceptability and app usage data (e.g., number of days accessed). As a secondary outcome of interest, depression and anxiety will be assessed for within-group changes in effect size. The results of this study will inform any modifications to the app, prior to a randomised controlled trial to evaluate the effectiveness of the app-based intervention in a larger sample of JMOs.
Intervention code [1] 315471 0
Behaviour
Intervention code [2] 315472 0
Prevention
Intervention code [3] 315608 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321280 0
Usability, feasibility and acceptability of Shift (measured using self-generated items and The Systems Usability Scale).
Timepoint [1] 321280 0
At 5-weeks post baseline.
Secondary outcome [1] 374523 0
Depression symptom change as measured by the Patient Health Quesionnaire (PHQ-9).
Timepoint [1] 374523 0
Measurements will be collected at baseline and at 5-weeks post-baseline.
Secondary outcome [2] 374524 0
Anxiety symptom change as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale.
Timepoint [2] 374524 0
Measurements will be collected at baseline and at 5-weeks post-baseline.
Secondary outcome [3] 374525 0
Willingness to seek help will be collected using purpose-built, self-generated items (e.g., "If you were to develop a mental health issue, how likely would you be to seek help from a GP or mental health professional (e.g. psychologist/psychiatrist)?" with response options ranging from Not at all likely to Very likely).
Timepoint [3] 374525 0
Measurements will be collected at baseline and at 5-weeks post-baseline.

Eligibility
Key inclusion criteria
Over 18 years of age, own a smartphone with either Android or Apple operating systems, are currently employed as a JMO (including Interns, Residents, Registrars, and Junior Career Medical Officers), and are proficient in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under 18 years of age, no access to a smartphone with either Android or Apple operating systems, not currently employed as a JMO, and not proficient in English.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
There is no allocation and no concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Not applicable.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Usability, feasibility and accessibility items will be assessed according to their mean scores. Any scores below the midpoint of the response scale is interpreted as unsatisfactory and will prompt the research team to make improvements to the specific aspect of the app. Similarly, a general System Usability Scale score of 68 or above is deemed acceptable (see Brooke, 2013), whereas a score below 68 is indicative of a need to further improve the app. Participants' open-ended text responses will guide researchers as to how the app needs to be modified to meet JMO's expectations. Paired samples t-test will be used to test for differences between pretrial and post-trial clinical and help-seeking outcomes.
Following recommendations of pilot and feasibility assessments (see, e.g., Johanson et al., 2010), we are aiming for a sample size of N = 30. However, we deem a lower end of 20 participants acceptable as our initial trial's primary aim is to collect feedback on the app features, which are more akin to qualitative assessments and thus do not require sample sizes of the magnitude required in quantitative research (i.e., simulation studies suggest that 20 users will identify 95% of problems with a technology, see O'Cathain et al., 2015).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2019
Actual
21/10/2019
Date of last participant enrolment
Anticipated
30/10/2019
Actual
25/11/2019
Date of last data collection
Anticipated
11/12/2019
Actual
10/12/2019
Sample size
Target
30
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14728 0
Gosford Hospital - Gosford
Recruitment hospital [2] 14729 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 27770 0
2250 - Gosford
Recruitment postcode(s) [2] 27771 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 303720 0
Government body
Name [1] 303720 0
Health Administration Corporation
Country [1] 303720 0
Australia
Funding source category [2] 303747 0
Commercial sector/Industry
Name [2] 303747 0
Insurance And Care NSW
Country [2] 303747 0
Australia
Funding source category [3] 303748 0
Government body
Name [3] 303748 0
Australian Government Department of Health
Country [3] 303748 0
Australia
Primary sponsor type
Other
Name
Black Dog Insitute
Address
Hospital Rd, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 303835 0
None
Name [1] 303835 0
Address [1] 303835 0
Country [1] 303835 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304245 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 304245 0
Ethics committee country [1] 304245 0
Australia
Date submitted for ethics approval [1] 304245 0
15/02/2019
Approval date [1] 304245 0
21/06/2019
Ethics approval number [1] 304245 0
2019/ETH00318

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

Contacts
Principal investigator
Name 96266 0
A/Prof Samuel Harvey
Address 96266 0
Black Dog Institute
Hospital Road, Prince of Wales Hospital, Randwick NSW 2031
Country 96266 0
Australia
Phone 96266 0
+61 0293828356
Fax 96266 0
Email 96266 0
s.harvey@unsw.edu.au
Contact person for public queries
Name 96267 0
Isabelle Counson
Address 96267 0
Black Dog Institute
Hospital Road, Prince of Wales Hospital, Randwick NSW 2031
Country 96267 0
Australia
Phone 96267 0
+61 0293824515
Fax 96267 0
Email 96267 0
i.counson@unsw.edu.au
Contact person for scientific queries
Name 96268 0
Samineh Sanatkar
Address 96268 0
Black Dog Institute
Hospital Road, Prince of Wales Hospital, Randwick NSW 2031
Country 96268 0
Australia
Phone 96268 0
+61 0293824368
Fax 96268 0
Email 96268 0
s.sanatkar@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
As this is a pilot version of the Shift app, individual participant data will be used to establish feasibility and acceptability, and to inform modifications to the app before it is implemented in a large-scale trial. As stated in the Participant Information Statement of this research, no individual data from the present study will be made public.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4601Ethical approval    378302-(Uploaded-06-09-2019-12-06-58)-Study-related document.docx



Results publications and other study-related documents

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