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Mental health: Time for a new kind of therapy?

Published on 27/04/17 at 10:37am

It’s no secret that mental health is not taken as seriously as its physical counterpart. It has been an uphill battle to arrive at where we are stood today, where awareness of the many illness which make up that collective term is at a high. Stigma too – arguably one of the biggest obstacles which stops patients seeking treatment – has been tackled significantly in recent years. But as any medical professional working on the front lines will tell you, there is still much more work to be done.

In the UK, it is also no secret that the NHS is struggling against the tide when it comes to funding – a key element lacking from the current battle against mental health. In January, Prime Minister Theresa May announced that the government would be launching new initiatives to tackle the issue of mental health in the country, but despite the cries of many a health professional, the plan shuns a focus on funding in favour of providing support and visibility.

May herself stated: “It is always wrong for people to assume that the only answer to these issues is about funding,” claiming the crux of failing mental health treatment is “more about the stigma that still attaches to mental health”.

While the stigma attached to mental health is indeed a very real problem, there is very little that can be achieved without the money to fuel the engines of change. In terms of raw funding, the plan offers a paltry £15 million with an aim of creating ‘places of safety’.

Luciana Berger, Head of the Labour Party’s mental health campaign, responded to the plans by saying: “We have a mental health crisis in our country and we need tangible action from the government, at the very least to deliver on the promises they’ve made thus far. We’ve seen a measurable reduction around the stigma, taboo around mental health. That is an important goal, but it’s not going to solve our nation’s mental health crisis.

“There needs to be a shift in how we look after people to how we keep people well; to how we prevent mental ill health,” she continued. “All the focus, attention and resource goes into what we do when individuals are in a crisis. That doesn’t help them, it’s incredibly expensive, and it’s one of the reasons I believe we’re seeing people taking their own lives.”

Is this a thinly-veiled manoeuvre from the government to distract from a lack of dedication to the cause on the part of the government, and smokescreen to conceal a financial wound caused by relentless cuts in the name of austerity? Most probably. Data released by the Mental Health Confederation shows that over the course of the last parliament, funding to mental health in the UK has actually been cut by a total of £600 million, or 8.25%, rendering the government’s recent extension of a wilted olive branch as an impotent gesture. Think tank the Health Foundation corroborates these claims, finding that funding to mental health trusts has been cut overall despite government claims that national health spending had been augmented by £8 million, though this was disputed by the government itself.

Mental health is widely recognised as a crucial treatment area, with medicine for such conditions included on the WHO’s Essential Medicines List. According to a report from the organisation, untreated mental health issues are responsible for 13% of the world’s total disease burden, and they will become the primary cause of mortality and morbidity across the world by 2030.

Beyond this, the total worldwide costs of depression and anxiety disorders total more than $1 trillion annually. Yet, according to the WHO, investing in tackling this huge issue is a no-brainer: “Treating depression with therapy or antidepressants, or a combination of both, is cost-effective and even cost-saving: every $1 invested leads to a return of $4 in better health outcomes and work ability”.

This presents a tremendous market to drug researchers and manufacturers. So why has development in the field stagnated in recent years?  The big players in the industry have cut funding into research on psychiatric drug treatments by 70% over the past decade, leaving the leagues of those suffering from mental health issues with no effective treatment options since the wave of selective serotonin reuptake inhibitors such as Prozac (fluoxetine) hit the market in the 80s and 90s.

Medical treatments have ceased to evolve to requirements of today’s patients, with the most modern of mental health drugs failing to even adequately affect the majority of people who use them; the highest-grossing treatment for depression in the US, Cymbalta (duloxetine), only actually garners a reaction in around one out of nine users. It is estimated that only 30-70% of patients respond to medication, particularly within the poorly understood field of mental health. Even when such drugs do work with their intended purpose, they medications bring a slew of adverse side-effects which can cause further complications in everyday life. 

The pipeline is looking bleak, at least from a pharmaceutical perspective. But in this developmental void, other alternatives methods have seen a rise to meet this unmet need. Recently, scientific interest has peaked surrounding the promise and potential of controlled substances in generating innovative treatments – in this case, ketamine as a depression therapy. The role of medication when used in tandem with more psychiatric methods is continually being questioned, and perhaps most notably, the industry’s interest in increasingly focused not on conventional medical treatments, but on digital, technological ones, and leading this new charge is the app. Mobile devices allow for remote, novel and alternative treatment methods, all backed up by continuous data collection which can be stored in databases to be potentially fed back into drug development and refining therapy effectiveness.

Even contained within the government’s limp offering lies a focus on digital solutions; the plan promises the instigation of “digitally assisted therapies”, which refers to treatments delivered via the internet or digital device. Whether unwitting or not, this focus is also indicative of the wider move towards such solutions where drug development has failed to keep pace with medical need.

In light of these fascinating trends, we spoke to three professionals to discover the core issues behind the industry’s lagging dedication to the development of further mental health therapies, and how these new alternative methods are changing the face of treatment for today’s patients.

Jennifer Barnett, CSO of Cambridge Cognition

Following the news that Japanese pharma giant Takeda was joining forces with cognitive assessment tool developer Cambridge Cognition to trial the use of an app for monitoring patients suffering from major depressive disorder,Pharmafocus spoke to CSO Jennifer Barnett to discuss what this new tool could mean for the field. 

How did your partnership with Takeda come about?

We’re known for our ability to do cognitive testing in clinical trials, and Takeda have a drug in market that they’re interesting in exploring the cognitive properties of, so we were a natural place for them to start when they were interested in working with mobile and wearable technologies in the space.

Cognition Kit is the mobile and wearables venture, and it’s a joint venture between Cambridge Cognition, who I work for, and Control Group, which is a design agency. They make mobile apps in particular; we make cognitive tests in particular, and Cognition Kit is the overlap between those two things: apps for mobile and wearable devices that involve measuring cognition and aspects of the brain’s health or mental health.

How does the technology work?

The app that’s being used in Takeda’s pilot study runs on an Apple Watch, and we’ve experimented with using a number of different wearable technologies. At the moment the Apple Watch is one of the most robust – it’s one of the most mature technologies out there, and very important: it has a nice screen. Cognitive tests work by presenting people with things on the screen and having them make decisions about what you’re doing. This app is giving people a memory test – it pops up on their watch three times a day and they can tell it to go away or they can take part in it. What happens in the test is that patterns appear on the screen and you’re asked to keep track of where the patterns are, and you respond if you see the pattern in the same place as it was two patterns ago, so you’re constantly having to update your memory with where these patterns are appearing.

How do these tests produce a metric which can be used to measure improvements in the illness?

We’re measuring two things with the wearable app. The first is how people feel – their mood and how much interest they have in their day-to-day life. We’re measuring that every day, and these are brief, cut-down versions of the way we’d normally measure mood in a doctor’s office or clinical trial. It’s a standardised assessment that you would normally ask someone ‘how have you been feeling over the past two weeks?’

Then we’re also measuring their cognitive function, and the reason we’re doing this is essentially because one the big barriers in mental health and one of things that stops people being treated as well as they can be is that the normal interview that goes on between a doctor and a patient is really a very subjective thing. The doctor says ‘how have you been feeling since I saw you last?’ The patient then has to remember how they’ve been doing and explain that to the doctor, and if you have depression, it’s inherently harder to give an objective answer to those questions. So we think the app will improve patient treatment by essentially giving them real data to work with their doctor on. If we could look back over six weeks of data that gives a report of how mood and cognitive function was every day, then that’s a much more useful way of measuring whether a patient is getting better or worse, or if we should consider increasing your dose or switching you to another treatment. So having this data set and visualising it and giving it back to patients and doctors is a better way to be doing mental health treatment than the standard, very subjective approach.

When you’re measuring these metrics, are they good indicators of the illness, and can they accurately measure improvements?

We can measure changes in cognition very reliably. What happens in depression is that antidepressant medications are designed to treat just the mood symptoms – we consider it successful treatment if you feel a little less sad, or if that experience of low mood or sad mood or depression is getting better. Even though we can treat that, we know there are other aspects of depression that are much harder to treat, and that some of these aspects are very important to patients because they stop them getting on with their life; they stop them functioning at work and functioning in their social relationships. There are a number of aspects to that: things like sleep, social activity and physical activity, but cognition is one that seems particularly important in predicting whether people manage to maintain their education or employment. If you’ve got really bad problems with your memory and you’re finding it hard to concentrate, regardless of whether you’re experiencing low mood or not, it’s going to have a really bad effect on your life. This is something that doctor’s don’t necessarily ask patients about, and it isn’t always the first thing that people complain about to their doctor, but there’s quite a lot of data showing that standard antidepressant treatments don’t touch that aspect of depression – it’s a very important thing to be thinking about.

When do you plan on moving the technology into full testing?

The first trial is happening now, which is the first time the technology has been used in a clinical population. We’ve been working over the past year in iterative testing in healthy volunteers to create an app which we feel is both scientifically valid and as useable as possible so that it’s easy for patients to take part in the study.

This is a pilot study of 30 participants and what we’re really testing is can patients with major depression use this app? Is it acceptable to them? Is it producing data in them? Is it behaving the same way in this patient population as it did in our validation studies and healthy volunteers? All being well we plan to expand this into larger populations of patients.

Is there any scope for this to be combined with other technologies, such as databasing and big data?

Yeah, I think so in the long term. These wearable devices collect enormous amounts of data; in the healthy volunteer studies we’ve been running you collect millions of data points within weeks if you start to combine these active assessments, where you’re asking questions of asking people to do things, with all the passive assessments that these devices can already measure. The Apple Watch can already measure your heart rate and how many steps you’re taking, so you can get to really large datasets really quickly. We think that the opportunity here is particularly in diseases like depression where the biology is quite poorly understood; quite a lot people have depression and we don’t really know whether that is because lots of people have the same underlying biology or that there are sub-types of depression, such as life events or changes in underlying neurochemistry.

Depression is a multi-faceted illness because you have the mood symptoms but you also have the cognitive symptoms; if we can measure all those aspects we can start to build up the size of datasets that will allow us to pick apart whether there are different kinds that ought to be treated in different ways, so I think there is huge potential there.

The next steps on this project are to finish this patient study; we’re evaluating that in two ways: qualitatively, is the science correct? And how do patients feel about using this device? Do we need to make any changes on the basis of that? And then we’ll be working with Takeda to determine what the next study is.

More broadly, Cognition Kit is taking what we’ve learnt from this and other works that we’re doing and looking for new opportunities where we think we can solve other pharmaceutical industry problems, by collecting high-frequency data, real-world data to answer either scientific problems during the clinical development process, or commercial challenges during post-approval phases of the drug life cycle.

Will the technology be affected by feedback?

The long-term goal of these technologies in general, and why Takeda want to work with us, is that we’re trying to produce tools that help patients manage their disease better and help patients and doctors communicate better. The goal is to make technologies that can be used by patients in the wild; the necessary steps to doing that in a responsible way are doing control studies in an iterative manner where we learn from increasingly larger studies, both about the usability of these technologies and concerns that patients have around level of comfort with data privacy and sharing, whilst continuing to make sure that the tests are scientifically acceptable and measuring what we think they’re measuring.

Would you agree that development of mental health treatments within the pharmaceutical industry has stagnated in recent years? Why do you think this could be?

“The last few years have been a period in which we’ve seen people withdrawing from psychiatry as a field. Cambridge Cognition works right across the therapeutic area space; we do a lot of work in neurological disorders in areas like Alzheimer’s, where we see periods of uplift and excitement and then periods of more pessimism. I think it’s fair to say there hasn’t been a great deal of good news in psychiatry for a while. One of the reasons we’re excited about this new project is because I think its proof of concept of how digital technologies may be able to work with psychiatry to make existing compounds more effective or more useful for patients. It may be that it’s easier to make patient health better by helping them to adhere to medications and feel empowered, and understand why they’re taking them and they’re taking an active part in treatment. That area of supporting patients might be one way to help the mental health sphere in the absence of any chemical breakthroughs.

I think there is a range of ways that digital technology can be used in the mental health sphere, from what we’re doing here right through to digital interventions which we think might work synergistically with drug interventions. In theory it should be the case that if you had a drug which improved plasticity in the brain, for example, and you had a digital application which was training some aspect of brain function, that would be a better way of improving cognitive function than either of those things alone. There might be a similar logic in something like depression: we know that, broadly speaking, the gold standard in depression treatment is antidepressant therapy and talking therapy; the problem with that is that talking therapy is resource intensive. If there are digital applications that help support patients in the same way that talking therapy does, then the best time to be applying those might be while someone is taking an antidepressant and therefore in a better position to engage with certain aspects of the disease. 

I think the idea that assessing things objectively that we normally ask people about subjectively, there are loads of other areas where that would be really useful. Mental health really suffers compared with most physical conditions; we don’t have biomarkers, we don’t have assays, we don’t have blood tests that we can give people, and that’s partly contributed to the stigma. It’s part of the reason people don’t seek help, because there isn’t a test that you can give people, so one of the ways of normalising mental health and making it more equal with physical health is to have better ways of measuring, so it can become a discussion about objective data.

The other thing about digital health interventions and technologies is that, because of the stigma, giving people things that they can do in their own home, or they can do with a high degree of privacy – digital technologies seem like a really great fit as a way of delivering assessment, information or intervention. Mental health is such a huge problem that we need scalable solutions, and the only scalable solutions that are out there really are digital, so I think it’s got to be the way forward.

Dr Nihara Krause, Consultant Clinical Psychologist and Founder and CEO of stem4

With the launch of CalmHarm, an app targeted at helping patients manage and resist the urge to self-harm, Pharmafocus spoke to its primary designer Dr Nihara Krause on its impact and how its surprising range of benefits indicate a significant appetite for technology in the field.

What has been the reaction to CalmHarm since its launch?

“We launched CalmHarm about 16 or 17 months ago, and to date we’ve had 28,000 downloads, and that’s with minimal advertising because we haven’t had the budget to do that. We were picked up by various newspapers, but it’s really been relatively ad-hoc so there’s obviously a need. We’re also doing a large-scale evaluative study where we’re looking at bounce rates; whether it actually reduces the urgency to self-harm; what sort of tasks people like doing; what sort of age groups use it.

We’ve had a lot of qualitative information and interestingly, although we developed the app for the secondary school age group which is 11-18, we’ve had parents of children much younger write in saying their child is using the app. I think the youngest was eight. We’ve had a lot of university students and we’re on a lot of university websites, and we’ve had adults write in too. What’s nice is that there seems to be a cross-generation of use in that although it’s very much for self-harm, we’ve had young people say they use it to manage bulimia. We had another say that they’d used it to manage smoking, and they’d given up. We’ve had a few young people say they use it for anxiety.

That’s made us think we’d actually like to develop another app to help manage anxiety and make it more targeted. We conducted a study and asked about 200 students what they want, and anxiety and depression were top priorities for them in terms of an app. So we’re trying to gather our breath and get sponsorship on board to see whether somebody would help support us to develop another app.

How do you feel about the current effectiveness of medication versus tools such as CalmHarm in today’s treatment of mental health?

I think there is a real need to get good-quality interactive tools out. It’s very practical, it follows very good evidence-based principles, and it’s nice to give people tools that they can use either before they go in for treatment or alongside treatment. It can be used in a population that never will access treatment – they might want to try it and maybe that would increase their motivation to ask for treatment.

There’s always a place for people who need it to have medicine, but inevitably you have to have psychological treatments alongside medication. You wouldn’t necessarily just prescribe antidepressants to someone who is depressed without giving them some ways of managing the causes of what may have triggered it; even if it is something that is biochemical, they would still require some sort of psychological intervention to help them manage it. In that sense, it’s not one or the other – they both go absolutely hand in hand – but secondly I think for young people there aren’t that many antidepressants that are licensed; I think first treatment of choice would be something that was a little more behavioural or emotionally-managed. Young people are not very good with complying with treatment, so again, if they can have something that they can use alongside, then why not?

What more can be done to help people with collective mental health issues?

I think you have to look at it as a kind of holistic thing really. On the one hand I think we need to start to think about those people who do have mental ill health – I think there needs to be a range of interventions offered because no one size fits all. The NHS is struggling; private providers are stretched themselves, but keeping consistency in terms of approach is quite difficult.

I think treatment is important, and specifically early treatment, because what’s tended to happen with the medical model is to offer treatment to people who have developed full-blown symptoms to then deal with the issue, but there’s a lot we can do at very early stage that would then bring about enormous change. I think one of the things that research has shown is that if you can provide intervention early, you can bring about lots of change. 50% of adult mental health problems start at the age of 15, and 75% by the age of 23, so it’s a young person’s condition. But I think there’s a lot to do at the other end, which is prevention, before it even gets to ill health.

Amelia Mustapha, former Executive Director of European Depression Association and Current Director at Saint Mary Abbott’s Rehabilitation and Training

Pharmafocus reached out to Amelia Mustapha for a snapshot of the mental health support climate today, the significance of medication in treat and how the field is coping in the face of diminishing funding.

Where does mental health support stand in the UK today?

A few years ago, I would have said we were getting really good at supporting people with mental health in the UK; we had the Increasing Access to Psychological Therapies programme; there was an increasing awareness of the role of patient groups in providing social support; we were starting to have whole systems and whole personal approach to treatment, with GPs really starting to understand mental illness; we had early intervention programmes and evidence-based self-management programmes; we also had great awareness raising campaigns from organisations like SHIFT.

Over the last few years, we’ve seen funding increasingly cut, and although that’s led to some really creative new ways of working to meet needs, like pilot areas for whole systems in primary care, generally it means that services are understaffed, the people providing those services are overworked, and support is only available for people when they get really sick. The need is growing and the ability to meet that need is just not there.

The government is always promising extra money and then never delivering it, and if there is extra money, we won’t see it. We do need more money, we need more therapists, we need more charities that are supporting people. It’s really bad at the moment.

Besides funding, what else do you think can be done to support those with mental health issues?

What people often say to me is that the worst part of their illness is the stigma; tackling that is hugely important, because even if we can prescribe medicines and interventions that promote recovery, people still need to be able to recognise that they need help. They need to be able to seek it, get it, and once they’re well enough, get jobs and have meaningful relationships. We need to take a root and branch approach to tackling stigma so that mental health is a factor in health and safety legislation at work for example. We need better education at school so when a child experiences their first episode of mental illness we can recognise and intervene earlier.

I think it all comes down to stigma really because if you break down things like institutionalised stigma, you get better policy-making and better funding. With a properly funded mental health policy, you’re going to get community services that support and recognise people with mental health needs. If you break down stigma you’re going to get employers that reduce psychosocial stress risks in the workplace, so it all comes back to better information. Everything seems to go through this process – just think about cancer and how much stigma was against that, and then how that changed and how support has come into play, along with the medicines and the services that followed.

As individuals we need to recognise stigma and call it out for what it is, but collectively we need to have this whole systems approach to tackling it.

With so many drug developers withdrawing investment from the area, how do you feel about the importance of medication in treatment today?

Medication has its place. Personally I think that the process of getting a medicine licensed and to market is very rigorous, and there should be no doubt that they are lifesavers. Having said that, the evidence also shows that the package of care and information that takes into account the whole person, their preferences and circumstances works best.

But the industry just isn’t investing in R&D around psychiatric medicines. Bringing new medicines to market is tough: it’s risky, it’s expensive, and then when you consider the generics drugs market and the issues around getting approval, it’s no wonder really that people see oncology as low-hanging fruit. It’s terribly worrying.

How do you feel about the use of controlled substances as a new, more novel treatment option?

The use of controlled substances is really interesting and exciting stuff, because it’s got the potential to work very quickly, whereas traditional medicines take much longer to work. People see these things as magic bullets and they’re not, and I wonder what the long-term effects and the risks are, and they will still need to be evaluated. It’s good that they’ve grabbed headlines because it’s worth pursuing and I think media attention helps with that, but we’re a long way to go before things like that start getting onto the market.

Matt Fellows

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