Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000664640
Ethics application status
Approved
Date submitted
5/06/2023
Date registered
20/06/2023
Date last updated
24/04/2024
Date data sharing statement initially provided
20/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial testing the efficacy of a smartphone application designed to improve the mental health and wellbeing of doctors in training
Scientific title
Randomised controlled trial testing the efficacy of a smartphone application designed to improve the mental health and wellbeing of doctors in training
Secondary ID [1] 309548 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This link is an RCT following the evaluation trial of Shift: ACTRN12620000571976

Health condition
Health condition(s) or problem(s) studied:
Depression 329943 0
Condition category
Condition code
Mental Health 326909 326909 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this project is to conduct a randomised controlled trial of a novel smartphone application designed to support the mental health and wellbeing of junior doctors in Australia.

Participants will be randomly allocated to one of two groups: (1) the experimental group, in which they will be provided with a link to download the app, and will be asked to use it for a period of 30 days; or (2) the control group, in which they will be placed on a waitlist to use the app. After a period of 3 months, the participants in the control group will also gain access to the app, and will be asked to use it for 30 days.

After participants are provided with a link to download the Shift app on their smartphone, they will be able to use the app freely. The intervention is completely remote, meaning that the researchers will not physically contact the participants in any way. The Shift modules include content covering topics on Mental Health, Getting Help, Lifestyle and Work. Other components of the Shift app include a tracking function for monitoring mood, physical activity, work-life balance and sleep. The contents of the app are delivered through video, audio, graphical representation, and text displays. These modules are based on recognised, evidence-based psychological approaches including cognitive behavioural therapy (CBT), acceptance and commitment therapy (ACT), mindfulness, and stress-management. Thus, the app provides therapeutic, psychoeducational content and strategies contextualised for the specific needs of doctors in training.

The app will automatically record generic usage data such as number of logins, time spent on app contents, and how many times the tracker function was used (to track mood, exercise, sleep and/or work-life balance). Data will be stored on the Black Dog Institute’s Research Engine, which is part of UNSW-owned and run secure servers.

30 days after registration, the participant will be asked to complete a post-intervention questionnaire, regardless of whether they were placed in the experimental group or the control group. All participants will also be asked to complete a follow-up questionnaire at 3 months after registration.
Intervention code [1] 326095 0
Prevention
Comparator / control treatment
Participants placed in the control group will be allocated to a waitlist control condition. Those in the control will not receive the intervention app, but will be asked to complete the post-intervention questionnaire (30 days after registration) and follow-up questionnaire (three months after registration). Waitlist control participants will gain access to the app after completion of the three month questionnaire, and will be asked to complete a post-study questionnaire at four months.
Control group
Active

Outcomes
Primary outcome [1] 334747 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] 334747 0
Depression symptoms will be assessed at baseline, at post-completion of intervention (the post-completion of intervention questionnaire becomes available 1 month post-baseline for intervention group participants and 4 months post-baseline for waitlist control participants), and at 3 months post-baseline. The primary timepoint will be at 1 month post-baseline, which both the experimental and waitlist control participants will be asked to respond to.
Secondary outcome [1] 421940 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 [1] 421940 0
Anxiety symptoms will be assessed at baseline, at 1 month post-baseline, and at 3 months post-baseline. The waitlist control group will additionally complete a post-intervention questionnaire 1 month after they have gained access to the intervention, at 4-months post-baseline.
Secondary outcome [2] 421992 0
Work and social functioning:
The 6-item Work and Social Adjustment Scale is a valid and reliable tool to measure the 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 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] 421992 0
Work and social functioning will be assessed at baseline, at 1 month post-baseline, and at 3 months post-baseline. The waitlist control group will additionally complete a post-intervention questionnaire 1 month after they have gained access to the intervention, at 4-months post-baseline.
Secondary outcome [3] 421993 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 on a simple yes or no response scale whether they sought help from a mental health professional in the previous month.
Timepoint [3] 421993 0
Help seeking will be assessed at baseline, at 1 month post-baseline, and at 3 months post-baseline. The waitlist control group will additionally complete a post-intervention questionnaire 1 month after they have gained access to the intervention, at 4-months post-baseline.
Secondary outcome [4] 421994 0
Quality of life:
The 5-item Quality of Life Linear Analog Scale Assessment is a reliable and valid tool to measure quality of life in a number of domains (physical, emotional, spiritual, intellectual, and overall). Respondents are asked to rate their wellbeing over the past week on a scale ranging from 1 (as bad as it can be) to 10 (as good as it can be). The scale has been validated in physician populations.
Timepoint [4] 421994 0
Quality of life will be assessed at baseline, at 1 month post-baseline, and at 3 months post-baseline. The waitlist control group will additionally complete a post-intervention questionnaire 1 month after they have gained access to the intervention, at 4-months post-baseline.
Secondary outcome [5] 421995 0
Burnout:
The 16-item Oldenburg Burnout Inventory is a valid and reliable tool to measure the two main dimensions of burnout: exhaustion and disengagement from work. Respondents use a 4 point Likert-type scale to indicate their degree of agreement with a number of questions relating to their level of burnout at work. Higher scores indicate a greater level of burnout.
Timepoint [5] 421995 0
Burnout will be assessed at baseline, at 1 month post-baseline, and at 3 months post-baseline. The waitlist control group will additionally complete a post-intervention questionnaire 1 month after they have gained access to the intervention, at 4-months post-baseline.
Secondary outcome [6] 421996 0
Usability, feasibility and acceptability of Shift:
The user experience of the Shift app will be assessed using self-report measures and automatically collected app usage data. In-app data collected will include frequency of use, time spent using the app, and which modules were accessed. At the post-study assessment, participants will be asked to respond to 12 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. Additionally, one optional item will seek clarification on the reasons why participants chose to engage with the overall Shift study.
Timepoint [6] 421996 0
Usability, feasibility and acceptability will be assessed at post-completion of intervention (the post-completion of intervention questionnaire becomes available 1 month post-baseline for intervention group participants and 4 months post-baseline for waitlist control participants).

Eligibility
Key inclusion criteria
Inclusion criteria for participants taking part in this study includes:

1. Willing to provide consent to participate
2. Currently employed as a doctor in training in Australia (interns, hospital medical officers, resident medical officers, non-accredited trainees, postgraduate trainees, principal house officers, registrars, and specialist trainees. Career medical officers who intend to undertake further postgraduate training in medicine can also participate.)
3. Ownership of an internet-enabled smartphone that has 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 doctor in training in Australia, 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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes. Participants will be randomly allocated to groups using a computer program when they register for the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using research computer software.
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
We expect to randomise a total of N = 778 participants to conditions. This number is comprised of the expected effect size of Cohen's d = 0.25 and drop-out rate of 48%, as per established knowledge from review studies and similar preceding research.

Analyses will be undertaken on an intention-to-treat basis and will include all participants in the group to which they were randomized (regardless of actual receipt or uptake of the intervention or withdrawal from the study). Mixed-model repeated measures analysis will be used for the primary outcome and continuously scaled secondary outcome variables. Models will include factors of study condition (intervention or control group), occasion of measurement (baseline, post intervention, and 3 months follow up), and their interaction.

Primary outcome
The primary outcome will be assessed by a planned comparison of the difference between groups in change of the primary outcome variable (PHQ-9) from baseline to post intervention. This test will be undertaken with an alpha of .05. An unstructured residual variance-covariance matrix will accommodate within-participant dependency. Tests of significance will use the Kenward-Roger method of degrees of freedom adjustment based on the observed information matrix. Where necessary, transformation of the outcome variable will be undertaken to ensure distributional assumptions of the model are met. A per-protocol analysis will also be conducted. This is to examine the pattern of results when only intervention group participants who used the intervention are included in the analysis.

Secondary outcomes
Analyses of continuous secondary outcome variables (GAD-7, WSAS, modified GHSQ, LASA, OLBI) will follow the same methods as the primary outcome. Analysis of the proportion of participants meeting the clinical threshold for caseness on the diagnostic measures. For categorical secondary outcome measures (modified GHSQ), analogous generalized mixed models will be used. Odds ratios and predicted probabilities from the mixed model for self-reported depression caseness (threshold for moderate depressive symptoms on the PHQ-9 is 10) for control and intervention group participants will be assessed and compared at each time point.

A priori-defined subgroup analyses (age, gender, specialty, training level, location) will be conducted to explore the effect of app usage, baseline symptoms patterns, and related factors, including across all examined time points (baseline, post, and 3 months follow up) to inspect group and subgroup trajectories.

Secondary analyses will also include change in the primary and other outcome variables from baseline (T1) to follow-up (T3) to inform the outcome pertaining to retention of benefit. The waitlist group will be provided with access to the intervention post follow up at T3. Post-intervention outcomes in the waitlist group (T4) will be compared to the intervention group’s post-intervention (T2) scores in order to estimate change after they have accessed the intervention. Subject to qualifications arising due to attrition and any natural drift over time, this analysis will stand as a quasi-replication of the primary outcome of the trial.

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/01/2024
Actual
15/01/2024
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
778
Accrual to date
652
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313740 0
Government body
Name [1] 313740 0
Australian Government Department of Health
Country [1] 313740 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Grants Management Office UNSW Australia
Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 315689 0
None
Name [1] 315689 0
None
Address [1] 315689 0
None
Country [1] 315689 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312911 0
UNSW Human Research Ethics Committee C
Ethics committee address [1] 312911 0
Ethics committee country [1] 312911 0
Australia
Date submitted for ethics approval [1] 312911 0
05/06/2023
Approval date [1] 312911 0
Ethics approval number [1] 312911 0
Ethics committee name [2] 314723 0
Sydney Local Health District Ethics Review Committee (RPAH Zone) EC00113
Ethics committee address [2] 314723 0
Ethics committee country [2] 314723 0
Australia
Date submitted for ethics approval [2] 314723 0
06/11/2023
Approval date [2] 314723 0
29/11/2023
Ethics approval number [2] 314723 0
X23-0424

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

Contacts
Principal investigator
Name 126306 0
Prof Samuel Harvey
Address 126306 0
Black Dog Institute
Hospital Road, Prince of Wales Hospital
Randwick NSW 2031
Country 126306 0
Australia
Phone 126306 0
+61 0293828356
Fax 126306 0
Email 126306 0
[email protected]
Contact person for public queries
Name 126307 0
Lauren Lai
Address 126307 0
Black Dog Institute
Hospital Road, Prince of Wales Hospital
Randwick NSW 2031
Country 126307 0
Australia
Phone 126307 0
+61 466063592
Fax 126307 0
Email 126307 0
[email protected]
Contact person for scientific queries
Name 126308 0
Samineh Sanatkar
Address 126308 0
Black Dog Institute
Hospital Road, Prince of Wales Hospital
Randwick NSW 2031
Country 126308 0
Australia
Phone 126308 0
+61 0293824368
Fax 126308 0
Email 126308 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 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.