Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000571976
Ethics application status
Approved
Date submitted
4/05/2020
Date registered
15/05/2020
Date last updated
17/09/2020
Date data sharing statement initially provided
15/05/2020
Date results information initially provided
17/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Shift, a smartphone application for Junior Medical Officers in New South Wales during the COVID-19 epidemic.
Scientific title
Evaluation of Shift, a smartphone application for New South Wales Junior Medical Officers, on depression and anxiety during the COVID-19 epidemic.
Secondary ID [1] 301164 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 317288 0
Anxiety 317289 0
COVID-19-related anxiety 317466 0
Condition category
Condition code
Mental Health 315420 315420 0 0
Depression
Mental Health 315421 315421 0 0
Anxiety
Public Health 315426 315426 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this project is to conduct a preliminary (uncontrolled) quasi-experimental before and after study of a novel smartphone application designed to support the mental health and wellbeing of Junior Medical Officers across New South Wales. In response to the latest developments with regards to the coronavirus outbreak, the app will contain a dedicated session providing guidance for junior doctors who have pandemic-related anxieties and concerns.

The Shift app's conceptual design was modelled after HeadGear, an evidence-informed app delivered by the Black Dog Institute that has been shown to alleviate mental health concerns in working populations (Deady et al., 2018). The prototype and the current version of the Shift app have been adjusted in close collaboration with medical doctors, NSW Health, external digital project designers, and in-house IT developers, user experience, digital learning, and marketing and communication experts within the Black Dog Institute. Initial pilot testing of the Shift app prototype [approved by the South Eastern Sydney Local Health District HREC protocol number 2019/ETH00318, N = 22] resulted in design, content, and user experience updates of the app.

Shift is a smartphone application compatible with Apple and Android operating systems. Shift delivers its contents through text, audio, and video addressing topics such as depression, anxiety, traumatic stress, burnout, alcohol and drug use, sleep health, shift work, exams and interviews, work/life balance, diet, exercise, rural and regional placements, bullying, grief, calling for a consult, feeling inadequate, and anxieties related to the coronavirus pandemic. Shift incorporates general therapeutic elements from cognitive behavioural therapy such as thought evaluation (i.e., identification, evaluation, and modification of unhelpful thoughts) and engagement in valued action (i.e., values-consistent patterns of action). Shift further incorporates relaxation techniques (e.g., progressive muscle relaxation) based in mindfulness and stress-management practice that are intended to lessen the impact of stressful life events or daily stressors. Each of the 51 activities delivered in the app takes about 2 to 5 minutes to complete and users are able to set their own targets (between two to five activities per week). The app collects standard usage metrics such as number of logins, number of sessions completed, and time spent on the app.

A minimum of 75 Junior Medical Officers working in New South Wales will be recruited to complete an app-based intervention. The proposed study will employ a pre-post design without a control group and will take place entirely online. The overall trial period is four weeks. Baseline and post-study measures assess participants' levels of depression, anxiety (general and COVID-19-specific), work and social functioning, and help-seeking behaviours. Participants will further be asked to indicate their user experience with the app at the post-study assessment.
Intervention code [1] 317475 0
Behaviour
Intervention code [2] 317480 0
Prevention
Intervention code [3] 317481 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323668 0
Depression symptom change:
Depression will be measured using the Patient Health Questionnaire (PHQ-9), a reliable and valid nine-item screening tool to assess depression severity over the past fortnight. The PHQ-9 also includes a single item assessing level of difficulty in daily functioning due to depressive symptoms.
Timepoint [1] 323668 0
Depression symptoms will be assessed at baseline and post intervention (occurring between 4 and 6 weeks post baseline)
Primary outcome [2] 323669 0
Anxiety Symptom change:
The Generalised Anxiety Disorder scale (GAD-7) is a reliable and valid seven-item screener for generalised anxiety symptoms. The GAD-7 also includes a single item assessing level of difficulty in daily functioning due to anxiety-related symptoms.
Timepoint [2] 323669 0
Anxiety symptoms will be assessed at baseline and post intervention (occurring between 4 and 6 weeks post baseline)
Secondary outcome [1] 382538 0
Corona virus related concerns:
Three items developed by UNSW researchers will assess participants’ level of concern surrounding the coronavirus pandemic and whether respondents had contact with a person who has been diagnosed with COVID-19 or is possibly infected. Respondents indicate on a response scale ranging from 0 (not at all) to 4 (extremely) how concerned they are for their personal safety and the safety of their family and friends to contract COVID-19. Respondents further indicate with a simple yes or no response, whether they have been in contact with somebody with observed or covert COVID-19.
Timepoint [1] 382538 0
Corona virus related concerns will be assessed at baseline and post intervention (occurring between 4 and 6 weeks post baseline)
Secondary outcome [2] 382539 0
Composite measure of work and social functioning:
The 6-item Work and Social Adjustment Scale is a valid and reliable tool to measure functional impairment in private and professional areas of life. Respondents indicate on a scale ranging from 0 (not at all) to 8 (very severely) to which degree their ability to perform in social and work domains is impaired due to their mental health problems. Higher scores indicate greater impairment in respondents’ ability to perform in their usual capacity.
Timepoint [2] 382539 0
Work and social functioning will be assessed at baseline and post intervention (occurring between 4 and 6 weeks post baseline)
Secondary outcome [3] 382540 0
Help seeking:
A brief 2-item measure modelled after the General Help Seeking Questionnaire will assess participants’ willingness to seek help for mental health concerns and will assess whether participants’ recently sought help for mental health-related issues. Respondents indicate their willingness to seek help on a Likert-type response scale ranging from 1 (extremely unlikely) to 7 (extremely likely) and indicate with on a simple yes or no response scale whether they sought help from a mental health professional in the previous month.
Timepoint [3] 382540 0
Help seeking will be assessed at baseline and post intervention (occurring between 4 and 6 weeks post baseline)
Secondary outcome [4] 382541 0
Shift app user experience:
The user experience of the Shift app will be assessed using 13 open- and closed-ended questions developed by the Black Dog Institute’s user experience personnel to identify areas of improvement in the functionality, design, and satisfaction with the app components.
Timepoint [4] 382541 0
Shift app user experience will be assessed at the post intervention questionnaire (occurring between 4 and 6 weeks post baseline).
Secondary outcome [5] 382954 0
Reasons for study participation:
Two optional items will seek clarification on the reasons why participants chose to engage with the overall Shift study and whether the coronavirus pandemic influenced their decision to take part in this research.
Timepoint [5] 382954 0
Reasons for study participation will be assessed at the post intervention questionnaire.
Secondary outcome [6] 382955 0
Shift app usage:
In-app usage data will be automatically collected and includes frequency of use, time spent using the app, and which modules were accessed.
Timepoint [6] 382955 0
Shift app usage data collected during the 4-week trial period will be assessed.

Eligibility
Key inclusion criteria
The inclusion criteria requires participants to be:
- Willing to provide consent to participate, and
- Currently employed as a Junior Medical Officer (Intern, Resident, Registrar or Junior Career Medical Officer) in New South Wales, and
- Own an internet-enabled smartphone with an Apple or Android operating system
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Candidates will be excluded from the study if they:
- Do not provide consent to participate, or
- Are not currently employed as a Junior Medical Officer in New South Wales, or
- Do not own an internet-enabled smartphone with an Apple or Android operating system

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
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mental health and help-seeking trajectories will be analysed using non-parametric tests of repeated-measures if n < 30 (e.g., Mann Whitney U test) and standard statistical procedures (e.g., paired-samples t-test) if n > or equal 30.

App usage count data will be examined with regards to which app components were used and which usage patterns emerged (using explorative approaches such as cluster analysis).

Qualitative open-ended responses will be assessed for feedback to incorporate to aid subsequent app changes and study design considerations.

Sample size:
The minimum target sample size for the project is N = 75. Considering drop-out rates similar to the pilot study of about 60%, an estimated 75 participants entering the study at baseline seems necessary to retain at least 30 participants at the post assessment. A minimum of 30 data points is recommended to perform basic parametric analyses (e.g., paired-samples t-test).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
20/05/2020
Actual
4/06/2020
Date of last participant enrolment
Anticipated
20/07/2020
Actual
5/08/2020
Date of last data collection
Anticipated
20/09/2020
Actual
Sample size
Target
75
Accrual to date
Final
221
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 305607 0
Government body
Name [1] 305607 0
NSW Ministry of Health
Country [1] 305607 0
Australia
Funding source category [2] 305624 0
Commercial sector/Industry
Name [2] 305624 0
Insurance and Care NSW
Country [2] 305624 0
Australia
Funding source category [3] 305636 0
Government body
Name [3] 305636 0
Australian Government Department of Health
Country [3] 305636 0
Australia
Primary sponsor type
University
Name
UNSW Sydney (University of New South Wales, Sydney)
Address
Grants Management Office, UNSW Sydney, Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 306020 0
None
Name [1] 306020 0
Address [1] 306020 0
Country [1] 306020 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305904 0
UNSW Human Research Ethics Committee A
Ethics committee address [1] 305904 0
UNSW Research Ethics and Compliance Support
The University of New South Wales,
Sydney NSW 2052
Ethics committee country [1] 305904 0
Australia
Date submitted for ethics approval [1] 305904 0
23/03/2020
Approval date [1] 305904 0
15/05/2020
Ethics approval number [1] 305904 0

Summary
Brief summary
The primary objective of this study is to evaluate Shift, a novel smartphone application designed to support the mental health and wellbeing of Junior Medical Officers in New South Wales. This will be the first app of its kind, in that it is specifically designed for doctors in training who would like to learn about how to improve or maintain their mental health while entering the workforce in the demanding medical profession. The app uses therapeutic elements (cognitive-behavioural, mindfulness, and psycho-educational contents) designed to alleviate or prevent the worsening of mental health symptoms and encourage help-seeking behaviours.
Trial website
https://shift.blackdoghealth.org.au

Trial related presentations / publications
Public notes
Since the recruitment phase has ceased, the website is now made unavailable for non-study participants. Study participants receive a unique link to complete any outstanding online questionnaires. The website was available for eligible candidates to register through between 4/6/20 and 5/8/20.

Contacts
Principal investigator
Name 102006 0
A/Prof Samuel Harvey
Address 102006 0
Black Dog Institute
Hospital Road, Prince of Wales Hospital,
Randwick NSW 2031
Country 102006 0
Australia
Phone 102006 0
+61 02 9382 8356
Fax 102006 0
Email 102006 0
s.harvey@unsw.edu.au
Contact person for public queries
Name 102007 0
Ms Isabelle Counson
Address 102007 0
Black Dog Institute
Hospital Road, Prince of Wales Hospital,
Randwick NSW 2031
Country 102007 0
Australia
Phone 102007 0
+61 02 9382 4515
Fax 102007 0
Email 102007 0
s.sanatkar@unsw.edu.au
Contact person for scientific queries
Name 102008 0
Dr Samineh Sanatkar
Address 102008 0
Black Dog Institute
Hospital Road, Prince of Wales Hospital,
Randwick NSW 2031
Country 102008 0
Australia
Phone 102008 0
+61 02 9382 4368
Fax 102008 0
Email 102008 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 an evaluation study, individual participant data will be used to establish feasibility, acceptability and initial effectiveness of this revised version of the app to inform any potential modifications before it is implemented in a large-scale clinical trial. As stated in the Participant Information Statement and Consent Form 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
7841Informed consent form    379737-(Uploaded-04-05-2020-20-57-23)-Study-related document.docx


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.