High anxiety calls for innovation in digital mental health

Are you feeling depressed or anxious? There’s an app for that. Globally, there are more than 400 million annual downloads of mobile health apps, which suggests that consumers are eagerly seeking technology to manage their health.

In the past few months alone, mental health surveys, tips, and counselling services have become available through social media sites and apps in response to the COVID-19 outbreak. For mental health professionals, the opportunity to provide help in this time of crisis – without an in-person consultation – is very desirable.

Mental health is one of the fastest-growing sectors in the global digital health market with more than 10,000 apps that claim to boost your mood, help you sleep, and even help you overcome an addiction.

Earlier this year, researchers reported findings from a mental health survey that helped gauge the prevalence of psychological distress among Chinese citizens during the COVID-19 pandemic – data that could help shape targeted interventions. Moving into the future, there’s no question that mobile apps could play important roles in tracking and treating mental illnesses. But do these apps really work? And is there any harm in trying them?

If your favourite gaming app crashes, you might moan and groan, but you’ll move on. If your photo editing app goes awry, you can start again from scratch. But what happens when a depression chat app fails to give appropriate guidance? The consequences may be severe. Lost in the headlong rush to develop and market mental health tools is the need to ensure that these technological solutions are safe, evidence-based, and effective.

Today, no-one really knows how many people have been misled or suffered a serious ill effect due to a mental health app. But studies have revealed a serious efficacy problem with many of these products. A study of 73 mental health apps, targeting a range of mental health outcomes, found that, while many claimed effectiveness and used science to sell the apps, only two apps provided evidence from research that examined the app in question.

Another evaluation of apps aimed at individuals at risk of depression and suicide concluded that “non-existent or inaccurate suicide crisis helpline phone numbers were provided by mental health apps downloaded more than 2 million times. This demonstrates a failure of the health app industry in self-governance, and quality and safety assurance”.

When it comes to mental healthcare solutions prescribed by clinicians, rigorous testing is required to ensure that people aren’t given drugs or other therapies that do more harm than good. For example, cognitive behavioural therapy went through extensive standardization and many clinical trials before it was considered an evidence-based intervention.

In the United States, the Food and Drug Administration (FDA) has put similar procedures in place for evaluating some mental health and wellbeing apps. Any app that is intended to diagnose, prevent, or treat a mental illness must undergo efficacy and safety studies to gain pre-market clearance from the FDA.

Most mental wellbeing/health apps, however, fall into a grey zone; they don’t make overt medical claims and are therefore able to avoid the need for efficacy studies or FDA scrutiny. Extreme circumstances – such as a pandemic – can also give regulatory agencies some leeway to push forward therapeutics and technologies faster than usual.

While the lack of rigorous evaluation may be disheartening, the good news is that the situation is changing. There is an increasing number of studies that aim to provide real data on the effectiveness of mental health apps.

For example, a recent analysis of 18 randomized controlled trials of mobile apps for people with depression showed that the use of apps was associated with a decrease in users’ symptoms, with the greatest benefits seen among users who had milder forms of depression.

A major initiative led by 23 partner organizations in Europe and the US, called RADAR-CNS, is rigorously evaluating the utility of a smartphone app for monitoring people with recurrent major depressive disorder. Mindfulness apps are also being studied in innovative ways: in a joint partnership, five University of California campuses and the mindfulness app Headspace are carrying out an eight-week randomized controlled trial examining the effects of the mindfulness app on stress, depression, sleep, heart health, and physical wellbeing in more than 1,000 individuals.

For consumers, it’s critical that the safety and efficacy of mental health apps come before flashy design and marketing. We need app makers and regulatory agencies to work together to collect data in both controlled clinical trials and in patients’ daily lives outside of rigorous clinical settings.

For example, China has established free, 24/7 online psychological counseling services, prioritizing patients who have concerns related to COVID-19. Outcomes are being collected and studied. Insights into the quality and effectiveness of these programmes could help people all over the world. Funders, including the US National Institute of Mental Health are already eager to support both early-phase and post-marketing outcomes research that will help ensure safety and efficacy. It’s now up to researchers and app developers to push studies forward.

Effective apps have the potential to change the face of mental health care – not only during pandemics but also in routine daily life. Now is the time to invest and innovate in digital mental health to ensure that anyone, anywhere, can get the help they need.