None listed
Conditions
Brief summary
Our research team has recently been awarded an Australian Mental Health Award by Beyondblue and the Movember Foundation that will fund a program of research aimed at developing and evaluating a range of new e-health interventions for Australian workers. This is intended to cover the evaluation via a multisite randomised controlled trial (RCT) of a smartphone intervention aimed at promoting mental health and well-being. Specifically, this study aims to evaluate the efficacy of a smartphone application (‘app’) designed to prevent depression in workers, with an intervention condition (‘HeadGear’ app) and attention-matched control condition (‘HeadGear lite’ app). Specifically, the relative efficacy of the application as a tool for primary prevention of common mental disorders will be evaluated. All employees of several partner organisations will be invited to participate, and directed to their app store via advertisements or via visiting the trial website. Upon downloading the app, participants will undergo initial screening, provide informed consent, and complete baseline assessments of outcomes including: depression (PHQ-9) and anxiety (PHQ-2) symptomatology, wellbeing (WHO-5 Well-being Index) and work performance (HPQ). Participants scoring below 9 on the PHQ-9 at baseline will then be randomised to receive either the intervention ‘HeadGear’ application or the attention-matched control version of the app. Those scoring above 9 or meeting MDD diagnosis using the PHQ-9 algorithm will be provided with appropriate referral information to health services and crisis lines, and will be encouraged to seek help from their GP. Participants are encouraged to use the smartphone application for 30 days. Post-intervention assessment will occur at 5 weeks post-baseline, and 3 and 12 months later at follow-up, with measures similar to those assessed at baseline. All assessment (apart from diagnostic interviews) will be completed online. Individuals whose results indicate depressive symptomatology or diagnosis (via PHQ-9); and a random sample of 10% of participants at 3 months, will receive a follow-up diagnostic telephone calls from trial staff. Researchers will be evaluating the relative impact of the smartphone application intervention on the prevention of common mental disorders, primarily depression, and its effects on health and wellbeing outcomes, immediately after trial participation, and 3 and 12 months later.
Interventions
The intervention condition takes the form of a smartphone application (app) called Headgear. Headgear is designed for self-directed use by an individual on a smartphone device. The application features interactive content, delivered on-screen and by audio using text, static and interactive image displays and videos. The app software is compatible with both Apple and Android operating systems and available for download online via the user’s respective app store (iTunes or Google Play) or the Trial website. The application can be accessed by the participant on their smartphone /mobile phone at a time and location of their choosing. The app monitors usage data including time (amount of time spent in-app) and frequency of use, number of log-ins and 'challenge' completion rates. This data will be used to examine program engagement. Participants will have access to the application indefinitely. The intervention application is designed around a 30-day timeframe. However, the active phase of this trial during which the experimental condition will be delivered and monitored is 30 days from baseline, with follow-up assessments at 5-weeks post-baseline, 3 months and 12 months. The intervention, HeadGear, is a smartphone application (‘app’)-based intervention centered on behavioural activation and mindfulness therapy. The main therapeutic component of the HeadGear app takes the form of a 30-day challenge in which users’ complete one ’challenge’ daily (approximately 5-10 minutes per day, for 30 days). These ‘challenges’ include: psychoeducational videos on coping skills/resiliency, mindfulness, and behavioural activation; mindfulness exercises; value-driven activity planning, goal-setting, and review; and coping skill development (problem solving, sleep, grounding, alcohol use, assertiveness, and training in adaptive forms of coping). The first daily challenge will involve the completion of a risk calculator, which will assess and provide participants with personalised feedback regarding their risk for future mental health issues. The risk calculator consists of 20 items developed from the Household, Income and Labour Dynamics in Australia Survey (HILDA) derived risk algorithm.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 No limit
Healthy volunteers
Yes
Inclusion criteria
Key eligibility criteria include: participants must be: Be an Australian resident, have a valid email address and telephone number, own a smartphone, have a reasonable understanding of the English language, and are currently employed.
Exclusion criteria
Participants will be excluded if they do not own an Apple/Android-operating smartphone, do not have reliable Internet access at home or work, are unable to comfortably read and comprehend English, or are not in the workforce. Participants will also be excluded from this trial if they score >14 on the PHQ-9 or meet MDD diagnosis using the PHQ-9 algorithm at baseline assessment
Outcome results
None listed