HeadGear – A mental health smartphone application for those with elevated symptoms of depression

INTERVENTION: 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. CONDITION: Anxiety Depression PRIMARY OUTCOME: The relative change in depression symptomatology from baseline at each follow‐up point. measured by the Patient Health Questionnaire (PHQ‐9). SECONDARY OUTCOME: 4‐Item Self‐determination Measure Anxiety symptomatology as measured by the Patient Health Questionnaire ‐ 2 (PHQ‐2) Demographic information, using standard demographic items which include; age, gender, industry and job information Levels of wellbeing measured by the World Health Questionnaire‐5 (WHO‐5) Wellbeing Index. Service utilisation, using health service use items based on those used in the National Health Survey of Australia (NHS). To measure resilience, the Connors‐Davidson Resilience Scale (CD‐RISC10) Work performance and absenteeism measured by the Health and Work Performance Questionnaire (HPQ). 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. Participants will also be included in this trial if they score >14 on the PHQ‐9 or meet MDD diagnosis using the PHQ‐9 algorithm. This change was made prior to recruitment.