Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001410741p
Ethics application status
Not yet submitted
Date submitted
27/10/2022
Date registered
4/11/2022
Date last updated
4/11/2022
Date data sharing statement initially provided
4/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Shift, a novel smartphone application to support the mental health and wellbeing of UNSW Senior Medical Students
Scientific title
Evaluation Study of a Smartphone Application effect on the Mental Health and Wellbeing of Medical Students and Junior Medical Officers
Secondary ID [1] 308278 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This record is a sub-study of ACTRN12620000571976

Health condition
Health condition(s) or problem(s) studied:
Depression 328062 0
Anxiety 328063 0
Condition category
Condition code
Mental Health 325123 325123 0 0
Depression
Mental Health 325124 325124 0 0
Anxiety

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 of Junior Medical Officers. In this evaluation study, we will replicate an earlier study described under ACTRN12620000571976 to examine whether this app is also suitable for senior medical students who are about to transition into their junior doctor roles.

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 subsequent versions 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], further examination among Junior Medical Officers in New South Wales [UNSW HREC protocol number HC200212], and consultations with medical students, 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, burnout, alcohol and drug use, sleep health, shift work, exams and interviews, diet, exercise, rural and regional placements, bullying, grief, and calling for a consult. 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 activities delivered in the app takes about 2 to 5 minutes to complete and users are able to set their own targets (between 2-5 activities per week). The app collects standard usage metrics such as number of logins, number of sessions completed, and time spent on the app.

We are aiming to recruit 200 medical students in their 4th, 5th, and 6th years of study 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, 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] 324739 0
Behaviour
Intervention code [2] 324740 0
Prevention
Intervention code [3] 324741 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332953 0
Depression symptom change:
Depression will be measured using the Patient Health Questionnaire (PHQ-9), a reliable and valid 9-item screening tool to assess depression severity over the past fortnight.
Timepoint [1] 332953 0
Depression symptoms will be assessed at baseline and post intervention (occuring between 4 and 6 weeks post baseline)
Primary outcome [2] 332954 0
Anxiety symptom change:
The Generalised Anxiety Disorder scale (GAD-7) is a reliable and valid 7-item screening tool for generalised anxiety symptoms.
Timepoint [2] 332954 0
Anxiety symptoms will be assessed at baseline and post intervention (occurring between 4 and 6 weeks post baseline).
Secondary outcome [1] 415290 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 [1] 415290 0
Work and social functioning will be assessed at baseline and post intervention (occurring between 4 and 6 weeks post baseline)
Secondary outcome [2] 415291 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 [2] 415291 0
Help seeking will be assessed at baseline and post intervention (occurring between 4 and 6 weeks post baseline)
Secondary outcome [3] 415292 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 [3] 415292 0
Shift app user experience will be assessed at the post intervention questionnaire (occurring between 4 and 6 weeks post baseline).
Secondary outcome [4] 415293 0
Reasons for study participation: An optional item will seek clarification on the reasons why participants chose to engage with the Shift study.
Timepoint [4] 415293 0
Reasons for study participation will be assessed at the post intervention questionnaire.
Secondary outcome [5] 415294 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 (to gauge user engagement and technical feasibility of the app).
Timepoint [5] 415294 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 4th, 5th, or 6th-year medical student at UNSW, Sydney, 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 4th, 5th, or 6th-year medical student at UNSW, Sydney, 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)
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
Not applicable
Phase
Not Applicable
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/02/2023
Actual
Date of last participant enrolment
Anticipated
17/03/2023
Actual
Date of last data collection
Anticipated
31/05/2023
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 312526 0
University
Name [1] 312526 0
UNSW Education Focussed School Grants Program
Country [1] 312526 0
Australia
Funding source category [2] 312536 0
Government body
Name [2] 312536 0
NSW Ministry of Health
Country [2] 312536 0
Australia
Funding source category [3] 312537 0
Government body
Name [3] 312537 0
Australian Government Department of Health
Country [3] 312537 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] 314126 0
None
Name [1] 314126 0
Address [1] 314126 0
Country [1] 314126 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 311861 0
UNSW Human Research Ethics Committee A
Ethics committee address [1] 311861 0
Ethics committee country [1] 311861 0
Australia
Date submitted for ethics approval [1] 311861 0
15/11/2022
Approval date [1] 311861 0
Ethics approval number [1] 311861 0

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

Contacts
Principal investigator
Name 122630 0
Dr Megan Kalucy
Address 122630 0
School of Psychiatry
UNSW Sydney
Level 1, AGSM Building Gate, 11 Botany St, Kensington NSW 2033
Country 122630 0
Australia
Phone 122630 0
+61 02 9065 7500
Fax 122630 0
Email 122630 0
[email protected]
Contact person for public queries
Name 122631 0
Megan Kalucy
Address 122631 0
School of Psychiatry
UNSW Sydney
Level 1, AGSM Building Gate, 11 Botany St, Kensington NSW 2033
Country 122631 0
Australia
Phone 122631 0
+61 02 9065 7500
Fax 122631 0
Email 122631 0
[email protected]
Contact person for scientific queries
Name 122632 0
Samineh Sanatkar
Address 122632 0
Black Dog Institute Hospital Road, Prince of Wales Hospital, Randwick NSW 2031
Country 122632 0
Australia
Phone 122632 0
+61 2 9065 9179
Fax 122632 0
Email 122632 0
[email protected]

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?

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.