Background
Depression is now recognised as one of the leading causes of disability worldwide [
1]. As well as being relatively common [
2], depression can also be very debilitating [
3], with core symptoms inclusive of; an absence of positive affect, persistent low mood, and low activity [
4]. Persons with severe depressive symptoms report serious difficulties in all aspects of their life, including work, home, and social activities [
5]. In response to the increased identification and recognition of depression [
6], there has been greater emphasis on the development of innovative and effective psychological treatments.
The treatment of depression, both pharmacologically and with non-pharmacological interventions, remains a critical area of ongoing clinical research. There is substantial evidence supporting the efficacy of psychotherapy in the treatment of both sub-clinical [
7] and clinical levels of depression [
8]. Whilst cognitive behaviour therapy (CBT) remains the most empirically supported treatment [
9], other therapies such as behavioural activation therapy (BAT) has been shown to be equally effective and also less complex to administer [
10]. Service use statistics indicate that despite the effectiveness of such treatments, few people readily access these services [
11]. Overcoming identified barriers to accessing psychotherapy such as cost, convenience and accessibility [
12] may enhance people’s ability to access evidence based treatments.
Despite experiencing depression many people still remain as active participants in the workforce [
13]. Ongoing employment is associated with numerous individual benefits such as economic, psychosocial, and emotional wellbeing [
14]. Given its immediacy and core role in the lives of individuals, the workplace may be an avenue for providing psychological interventions to those who might not otherwise access mental health services in a conventional manner [
15]. Interventions implemented in the workplace have been found to be effective in improving both mental health and occupational outcomes [
16]. This highlights an added benefit of workplace interventions as medical interventions in isolation have not shown as positive an effect on work-related outcomes when compared to workplace interventions [
17]. To date, most workplace interventions face accessibility and scalability issues, thus limiting the opportunity for employees to access these services. This issue appears to be particularly prevalent in workers employed in industries where roles are mobile and/or isolated; work hours are often intermittent or excessive; and tasks may be repetitive and high-risk (e.g. such as construction, transport and mining). These industries tend to be male-dominated (males > 70% of workforce) [
18] and are associated with higher rates of mental health concerns [
18]. Technological innovations, namely smartphones, provide an opportunity for individuals in such roles to learn how to manage their wellbeing and seek further support if required [
19].
Mobile health (mhealth) technologies are increasingly being recognised as an effective means through which mental health interventions can be disseminated in the population [
20,
21]. Such interventions overcome numerous barriers associated with treatment seeking, including stigma, cost, and accessibility [
20]. Encouragingly, there is preliminary support that mhealth interventions can effectively treat symptoms in adults with depression [
22]. Moreover, mhealth interventions offer the opportunity for an autonomous, user-directed approach that motivates and offers personalised support by allowing the delivery of content to be tailored to an individual’s interests and needs [
23]. This may be particularly advantageous to workplace contexts where, individualised interventions are associated with more consistent outcomes than organisational wide interventions [
24]. However, of the many mhealth interventions available on the market, few have been trialled [
20] and even fewer have been specifically tailored to a workplace setting.
The proposed HeadGear trial aims to evaluate the effectiveness of a new smartphone app in treating depressive symptoms in a workplace context.
Discussion
This study is planned to be the largest randomised controlled trial of a smartphone intervention for depression. By targeting the workers, this trial will provide valuable evidence regarding the effectiveness of mhealth interventions in treating depressive symptoms in a workplace context. Given the substantial impact that depression has on the individual and the employer, if shown to be effective, this program would allow for a simple and economical means by which an organisations or governments could disseminate a tailored intervention for workers. Given the proliferation of untested smartphone applications, the dissemination of evidence based products into the workplace, and indeed the wider community, remains a pressing need.
Employees with significant depressive symptoms have higher rates of absenteeism, presenteeism and job turnover [
59]. Remaining in the workforce is important as it offers structure, empowerment, financial security and protection from the psychological impacts of unemployment [
14]. Using the workplace as a means to dispense or promote an intervention may not only be protective for the individual concerned, but may also assist in overcoming the issue of individuals delaying or not receiving treatment [
60]. From an economic standpoint, it is has been established that, for the workplace, such an approach is more cost-effective for the organisation [
61]: utilising smartphone technologies would improve upon this cost-effectiveness. It is also hoped that dissemination via workplaces and social media will help engage individuals who would not usually access help via the health care system.
This study will provide valuable evidence regarding the effectiveness of mhealth tools in the treatment of depressive symptoms. Despite the proliferation of mental health apps, there is scarce research on the effectiveness of such apps. Indeed, in a systematic review of the literature on smartphone interventions, only five mental health apps were empirically tested and only one of these did not require the input from a mental health professional [
20]. mHealth interventions offer advantages in that they increase user autonomy and anonymity, which may be important as stigma [
62] and lack of knowledge of services [
63] can impact upon help-seeking behaviour in the workplace. An intervention developed for the workplace also carries the benefit in that it could ameliorate some of the financial burden placed solely on the healthcare system.
The proposed trial does carry with it a number of limitations. The use of a smartphone app as a delivery modality does mean that the intervention is unguided and that the user is responsible for managing their interaction with the program. Thus, trial attrition and disengagement are expected issues [
64,
65]. It is worth noting, however, that this has also been an issue for face-to-face psychotherapy trials [
66]. The reason for drop out in both mhealth and face-to-face trials is often multi-faceted, and whilst can be related to engagement with the program, it is rarely only due to dissatisfaction [
67].To account for potential drop out, two procedures were put into place. Firstly, all follow-up communication would occur via phone numbers to ensure that if the participant uninstalled the app before the follow-up period, the participant could still be reached. Secondly, conservative drop-out estimation and the use of statistical methods robust to data missing at random, it is believed that this limitation will be minimised.
Another limitation of the present trial is related to the reliance on self-reported depressive symptoms, rather than a diagnosis of depression achieved through a structured diagnostic interview. This is a common issue faced by most similar trials given the constraints around time and resources. To overcome this issue, we will use a well-validated measure (PHQ-9) that contains two methods for classifying depression: 1) threshold total score above 14 (sensitivity = 67%; specificity = 95%) [
68] or 2) meeting the depression algorithm’s criteria (sensitivity = 0.53; specificity = 0.94) [
69]. By using both methods, we are confident that participants without significant symptomatology will be excluded and those with significant symptomatology will be included.
The treatment of depression utilising evidence based mhealth interventions remains an important area of clinical research. The Headgear trial will be the largest trial of a smartphone application that seeks to offer an alternate or augmentation to traditional face-to-face therapy through which working adults can manage their mental health and wellbeing. This trial will be unique in that it is advertising a treatment via a workplace setting, and allowing for the assessment of clinical and occupational outcomes. Finally, the Headgear Trial will provide much needed information on the general effectiveness of evidence-based interventions (BAT and mindfulness) delivered through smartphone technology.