Authors
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UNSW Sydney -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2023
INTERVENTION: 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 CONDITION: Depression; ; Depression Mental Health ‐ Depression PRIMARY OUTCOME: 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. [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: 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. [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.] 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. [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.] 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. [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.] 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. [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.] 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. [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).] 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. [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.] 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
Epistemonikos ID: 79e5e3b9382e144a3279952fc38bd435db3b2627
First added on: Feb 20, 2024