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Big Health | Date: 2016-04-28

Pain relief medication; Pharmaceutical products for the treatment of joint disease.

News Article | September 18, 2014
Site: thenextweb.com

It’s all very well tracking your sleep patterns with a device like the Jawbone Up, but if you’re struggling to get a good night’s rest, how do you actually improve the situation? UK startup Big Health has today brought its Sleepio sleep therapy service to iOS. Previously available only on the Web, Sleepio is based on cognitive behavioral therapy and supported by peer-reviewed research. The app was originally supposed to support Apple’s new HealthKit SDK, allowing it to pull data from compatable sleep tracking devices. However, the last-minute postponement of HealthKit compatability in iOS 8 yesterday forced Big Health to rush out a revised version that misses out that feature. Sleepio for iOS can import data about your sleep from the Jawbone Up but full HealthKit compatability will come later. From there, ‘the Prof’, a virtual sleep therapist in the app, gives you advice to improve your sleep schedule, thoughts and lifestyle. Big Health is backed by Index Ventures and Forward Parnters, and cofounder Peter Hames tells us that he sees Sleepio as a form of scalable ‘digital medicine’ that takes pressure off doctors while providing genuine results. While I haven’t been able to test Sleepio yet, Big Health says that in its own tests 75 percent of people with persistent sleep problems improved their sleep to healthy levels, compared with a placebo or no treatment. The app is free to download and try for a week, but then you’ll have to pay $4.99 per month or $149 for 12 weeks’ access depending on the amount of help you need. Even after the first week, the sleep diary and schedule features remain free.

News Article | September 17, 2014
Site: www.techworld.com

UK startup Big Health today launched a smartphone app called Sleepio - one of the first apps to be integrated with Apple's new health APIs. Sleepio, available in the App Store from today, is designed to help people to get to sleep by providing them with on-the-spot Cognitive Behaviour Therapy (CBT). The app, created by world sleep expert Professor Colin Espie from Oxford University and ex-insomnia sufferer Peter Hames, has been integrated with Apple’s new HealthKit. On the Apple Developer Library, Apple describes its HealthKit as a new framework for managing a user’s health-related information. "With the proliferation of apps and devices for tracking health and fitness information, it's difficult for users to get a clear picture of how they are doing," the company tells developers. "HealthKit makes it easy for apps to share health-related information, whether that information comes from devices connected to an iOS device or is entered manually by the user. The user’s health information is stored in a centralised and secure location. The user can then see all of that data displayed in the Health app. "When your app implements support for HealthKit, it gets access to health-related information for the user and can provide information about the user, without needing to implement support for specific fitness-tracking devices. The user decides which data should be shared with your app. "Once data is shared with your app, your app can register to be notified when that data changes; you have fine-grained control over when your app is notified. For example, request that your app be notified whenever users takes their blood pressure, or be notified only when a measurement shows that the user’s blood pressure is too high." Sleepio imports sleep data from fitness tracking devices such as the Jawbone UP or HealthKit in iOS 8 to provide users with an overview of their sleep profile. This data, with user permission, is used to create a personalised sleep programme that is designed to help promote better thoughts and behaviours. The programme is delivered to the user by a virtual animated sleep expert known as "The Prof" and his narcoleptic dog "Pavlov". According to Big Health, The Prof is there whenever you need him and a “Help Me Now” feature provides moment-by-moment help for those who are struggling to get to sleep. "Millions of people experience sleep problems – whether that’s falling asleep, staying asleep or with the quality of their sleep," said Espie. "Sleepio is a ground-breaking, clinically-proven digital sleep improvement programme that uses proven CBT techniques to help users with persistent sleep problems." In a clinical trial, the course featured in the Sleepio app was shown to be comparable in effect to face-to-face therapy, on average helping long-term poor sleepers: Free to download from the App Store, the app includes seven days free access after which users with a long term sleep problem can get unlimited access to the full CBT programme plus Help Me Now for £99.99 for 12 weeks. For those with short term sleep problems, one month’s access to the Help Me Now feature is available for £2.99. Tech investors appear to be keen on Sleepio and other apps that Big Health is working on. Indeed, a total of $3.3 million (£2.02 million) was invested in the company earlier this year when it was backed by Index Ventures, Forward Partners and several Angel investors, including Esther Dyson, Rob Taylor and Peter Read. Update: Apple found a bug in its HealthKit platform that prevented Sleepio from launching its intended app. However, Big Health has informed Techworld that a non-HealthKit-compatible version of the app can still be downloaded.

News Article | October 16, 2014
Site: www.newyorker.com

Recently, a San Francisco-based start-up called Big Health launched an iOS app, Sleepio, that features an animated psychotherapist named the Prof. The avuncular, grey-templed Scotsman guides users through a course, based on the principles of cognitive-behavioral therapy (C.B.T.), that is designed to treat insomnia. C.B.T’s basic principles are simple enough that patients can follow them with a book, but the company hopes to capture some of the dynamics of in-person therapy, which means encouraging its users to bond emotionally with its digital shrink­. When the Prof first appears, he’s waving hello in silhouette against the sun. He has a stocky body and skinny legs—proportions that suit an iPhone screen—and he’s dressed in a natty red sports jacket and a black tie. Users eventually learn that he rides in a hot-air balloon and that he has a narcoleptic hound named Pavlov. His gestures—for example, swinging his arms and grabbing his lapels—project an appealing vigor. Like a sportscaster, the Prof is frequently offscreen, so his voice is probably the most crucial aspect of the experience. Big Health tested regional British accents before settling on an optimistic but gentle brogue. “It combined authority with approachability, but yet with a sort of a no-nonsense streak that can nudge you towards doing a bit better,” the company’s C.E.O., Peter Hames, told me. The role ultimately went to a voice actor who lives in Glasgow. Hames added that the company is open to creating a figure with a more familiar voice—perhaps a woman. Though he says that the app is equally effective in treating insomnia in both men and women, anecdotal evidence suggests that the sexes don’t respond to the Prof in the same way. Men tend to absorb lessons without noticing him, while women are more inclined to form a bond. According to Hames, one woman reported, “When he congratulates me I feel great.” Sleepio costs a hundred and forty-nine dollars for twelve weeks—expensive by app-store standards, but a bargain compared with traditional therapy. In face-to-face therapy, Hames says, “there’s some kind of dark-matter effect that people really like, and that has a really positive effect on outcomes.” Though the Prof is animated, Hames has found that the character keeps users coming back. A paper he co-authored in the medical journal Sleep found that a placebo group encountering a version of the Prof who spoke “convincing nonsense” stuck with the course at almost the same rate as subjects who received the Prof’s real C.B.T. course. The idea that people can become invested in a non-human figure like the Prof or Apple’s Siri is not radically new; sometimes, at least in Hollywood, they even fall in love. But, outside of the entertainment industry, fully animated guides have struggled to take hold. Timothy Bickmore, a professor of computer science at Northeastern University, studies the use of digital agents (his preferred term) in health care. His research has shown that some groups who are traditionally less familiar with technology—older people and those on the lower end of the socioeconomic ladder—will adapt to agents. For instance, he conducted a study revealing that some hospital patients prefer to have a virtual nurse discharge them, and he has co-written papers showing that having a virtual coach can increase the amount seniors exercise in the short term and can reduce their loneliness. Bickmore identified agents’ slowness of speech and repetition of gestures as features that tend to turn users off. The larger issue, of course, is that digital agents simply aren’t as smart as humans. The Prof, for example, mostly learns about users’ sleep habits and goals by asking them multiple-choice questions. (It can also sync with several wearable sleep trackers on the market.) To improve the diagnostic abilities and responsiveness of digital agents, researchers are starting to build far more sensitive data-gathering tools. The Institute for Creative Technologies at the University of Southern California has developed a platform, known as SimSensei, that is equipped with a microphone, a webcam, sensors, and a screen showing an image of a woman named Ellie. As Ellie asks questions of subjects and they respond, she accumulates data on their speech patterns and motions in order to assess their mental condition. Albert (Skip) Rizzo, a psychologist who’s co-leading the project, told me, for example, that people with post-traumatic stress disorder often touch their faces. In one ongoing study, soldiers in the Colorado National Guard met with Ellie before combat deployment to Afghanistan, and will meet with her at least once more when they return. The goal is to determine whether the data Ellie gathers can be used to predict mental-health difficulties. (The project has received funding from the Defense Advanced Research Projects Agency.) Although this kind of therapeutic interaction introduces privacy concerns and other potential for abuse, there are reasons why people might prefer the help of a properly calibrated digital agent. A study that ran earlier this year in the journal Computers in Human Behavior, using Ellie, found that subjects talking to a “virtual human” felt more at ease disclosing sensitive information if they trusted that it was acting autonomously rather than masking a real person—because, they said, they believed that the machine was less likely to judge them. Mind you, that may change as agents become more intelligent and responsive. Using the desktop version of Sleepio, I rushed through a few sessions without doing the required homework. The Prof betrayed an edge of irritation—“Agaiiin, we’re missing diaries for most days”—before reverting to his upbeat tone. The mild scolding left me feeling inexplicably ashamed.

News Article
Site: www.nature.com

Type 'depression' into the Apple App Store and a list of at least a hundred programs will pop up on the screen. There are apps that diagnose depression (Depression Test), track moods (Optimism) and help people to “think more positive” (Affirmations!). There's Depression Cure Hypnosis (“The #1 Depression Cure Hypnosis App in the App Store”), Gratitude Journal (“the easiest and most effective way to rewire your brain in just five minutes a day”), and dozens more. And that's just for depression. There are apps pitched at people struggling with anxiety, schizophrenia, post-traumatic stress disorder (PTSD), eating disorders and addiction. This burgeoning industry may meet an important need. Estimates suggest that about 29% of people will experience a mental disorder in their lifetime1. Data from the World Health Organization (WHO) show that many of those people — up to 55% in developed countries and 85% in developing ones — are not getting the treatment they need. Mobile health apps could help to fill the gap (see 'Mobilizing mental health'). Given the ubiquity of smartphones, apps might serve as a digital lifeline — particularly in rural and low-income regions — putting a portable therapist in every pocket. “We can now reach people that up until recently were completely unreachable to us,” says Dror Ben-Zeev, who directs the mHealth for Mental Health Program at the Dartmouth Psychiatric Research Center in Lebanon, New Hampshire. Public-health organizations have been buying into the concept. In its Mental Health Action Plan 2013–2020, the WHO recommended “the promotion of self-care, for instance, through the use of electronic and mobile health technologies.” And the UK National Health Service (NHS) website NHS Choices carries a short list of online mental-health resources, including a few apps, that it has formally endorsed. But the technology is moving a lot faster than the science. Although there is some evidence that empirically based, well-designed mental-health apps can improve outcomes for patients, the vast majority remain unstudied. They may or may not be effective, and some may even be harmful. Scientists and health officials are now beginning to investigate their potential benefits and pitfalls more thoroughly, but there is still a lot left to learn and little guidance for consumers. “If you type in 'depression', its hard to know if the apps that you get back are high quality, if they work, if they're even safe to use,” says John Torous, a psychiatrist at Harvard Medical School in Boston, Massachusetts, who chairs the American Psychiatric Association's Smartphone App Evaluation Task Force. “Right now it almost feels like the Wild West of health care.” Electronic interventions are not new to psychology; there is robust literature showing that Internet-based cognitive behavioural therapy (CBT), a therapeutic approach that aims to change problematic thoughts and behaviours, can be effective for treating conditions such as depression, anxiety and eating disorders. But many of these online therapeutic programmes are designed to be completed in lengthy sessions in front of a conventional computer screen. Smartphone apps, on the other hand, can be used on the go. “It's a way of people getting access to treatment that's flexible and fits in with their lifestyle and also deals with the issues around stigma — if people are not quite ready to maybe go and see their doctor, then it might be a first step to seeking help,” says Jen Martin, the programme manager at MindTech, a national centre funded by the United Kingdom's National Institute for Health Research and devoted to developing and testing new mental-health technologies. One of the best-known publicly available apps was devised to meet that desire for flexibility. In 2010, US government psychologists conducting focus groups with military veterans who had PTSD learned that they wanted a tool they could use whenever their symptoms flared up. “They wanted something that they could use in the moment when the distress was rising — so when they were in line at the supermarket,” says Eric Kuhn, a clinical psychologist and the mobile apps lead at the US Department of Veterans Affairs' National Center for PTSD. The department joined up with the US Department of Defense to create PTSD Coach, a free smartphone app released in early 2011. Anyone who has experienced trauma can use the app to learn more about PTSD, track symptoms and set up a support network of friends and family members. The app also provides strategies for coping with overwhelming emotions; it might suggest that users distract themselves by finding a funny video on YouTube or lead users through visualization exercises. In its first three years in app stores, PTSD Coach was downloaded more than 150,000 times in 86 different countries. It has shown promise in several small studies; in a 2014 study of 45 veterans, more than 80% reported that the app helped them to track and manage their symptoms and provided practical solutions to their problems2. More results are expected soon. Kuhn and his colleagues recently completed a 120-person randomized trial of the app, and a Dutch team is currently analysing data from a 1,300-patient trial on a similar app called SUPPORT Coach. Smartphone apps can also interact with users proactively, pinging them to ask about their moods, thoughts and overall well-being. Ben-Zeev created one called FOCUS, which is geared towards patients with schizophrenia. Several times a day, the app prompts users to answer questions such as “How well did you sleep last night?” or “How has your mood been today?” If users report that they slept poorly, or have been feeling anxious, the app will suggest strategies for tackling that problem, such as limiting caffeine intake or doing some deep-breathing exercises. Some apps help people to stay connected to health-care professionals, too. ClinTouch, a psychiatric-symptom-assessment app designed by researchers at the University of Manchester, UK, analyses users' responses for signs that they may be experiencing a relapse; it can even notify a clinical-care team. Small feasibility studies — which are generally designed to determine whether an intervention is practical, but do not necessarily evaluate its efficacy — have shown that patients use and like both apps, and a 2014 study found that those who used FOCUS for a month experienced a reduction in psychotic symptoms and depression3. FOCUS and ClinTouch are both now being evaluated in randomized, controlled trials. Some researchers see opportunities in the data that smartphones collect about their users' movement patterns or communication activity, which could provide a potential window into mental health. “Your smartphone is really this interesting diary of your life,” says Anmol Madan, the co-founder and chief executive of Ginger.io, a digital mental-health company based in San Francisco, California. Studies have now shown that certain patterns of smartphone use can predict changes in mental-health symptoms4; a drop in the frequency of outgoing text messages, for instance, may suggest that a user's depression is worsening. The Ginger.io app, which is still in beta, monitors these sorts of patterns and alerts each user's assigned mental-health coach if it detects a worrying change. The evidence supporting the use of such apps is building5, 6, 7. But this is a science in its infancy. Much of the research has been limited to pilot studies, and randomized trials tend to be small and unreplicated. Many studies have been conducted by the apps' own developers, rather than by independent researchers. Placebo-controlled trials are rare, raising the possibility that a 'digital placebo effect' may explain some of the positive outcomes that researchers have documented, says Torous. “We know that people have very strong relationships with their smartphones,” and receiving messages and advice through a familiar, personal device may be enough to make some people feel better, he explains. But the bare fact is that most apps haven't been tested at all. A 2013 review8 identified more than 1,500 depression-related apps in commercial app stores but just 32 published research papers on the subject. In another study published that year9, Australian researchers applied even more stringent criteria, searching the scientific literature for papers that assessed how commercially available apps affected mental-health symptoms or disorders. They found eight papers on five different apps. The same year, the NHS launched a library of “safe and trusted” health apps that included 14 devoted to treating depression or anxiety. But when two researchers took a close look at these apps last year, they found that only 4 of the 14 provided any evidence to support their claims10. Simon Leigh, a health economist at Lifecode Solutions in Liverpool, UK, who conducted the analysis, says he wasn't shocked by the finding because efficacy research is costly and may mean that app developers have less to spend on marketing their products. A separate analysis11 found that 35 of the mobile health apps originally listed by the NHS transmitted identifying information — such as e-mail addresses, names and birthdates — about users over the Internet, and two-thirds of these did not encrypt the data. Last year, the NHS took this apps library offline and posted a smaller collection of recommended online mental-health services. The NHS did not respond to e-mailed questions or make an official available for interview, but it did provide this statement: “We are working to upgrade the Health Apps Library, which was launched as a pilot site in 2013 to review and recommend apps against a defined set of criteria which included data protection.” The regulation of mental-health apps is opaque. Some apps designed to be used in a medical context can be considered medical devices and therefore may be regulated by the UK Medicines and Healthcare Products Regulatory Agency, the US Food and Drug Administration (FDA) or equivalent bodies elsewhere. But the lines are fuzzy. In general, an app that claims to prevent, diagnose or treat a specific disease is likely to be considered a medical device and to attract regulatory scrutiny, whereas one that promises to 'boost mood' or provide 'coaching' might not. The FDA has said that it will regulate only those health apps that present the highest risks to patients if they work improperly; even mental-health apps that qualify as medical devices might not be regulated if the agency deems them to be relatively low risk. But the potential risks are not well understood. “At the low end, people might waste their money or waste their time,” says Martin, “and at the higher end, especially with mental health, they might be actively harmful or giving dangerous advice or preventing people from going and getting proper treatment.” When a team of Australian researchers reviewed 82 commercially available smartphone apps for people with bipolar disorder12, they found that some presented information that was “critically wrong”. One, called iBipolar, advised people in the middle of a manic episode to drink hard liquor to help them to sleep, and another, called What is Biopolar Disorder, suggested that bipolar disorder could be contagious. Neither app seems to be available any more. Martin says that in Europe, at least, apps tend to come in two varieties, those that are commercially developed and come with little supporting evidence or plans for evaluation, and those with academic or government backing that take a more rigorous approach. The problem is that the former are generally more engaging for users and the latter take so long to make it to the market — if they even do — that they look out of date. “This is a generalization,” Martin says, “but it's broadly true.” Even well-intentioned apps can produce unpredictable outcomes. Take Promillekoll, a smartphone app created by Sweden's government-owned liquor retailer, designed to help curb risky drinking. While out at a pub or a party, users enter each drink they consume and the app spits out an approximate blood-alcohol concentration. When Swedish researchers tested the app on college students, they found that men who were randomly assigned to use the app ended up drinking more frequently than before, although their total alcohol consumption did not increase. “We can only speculate that app users may have felt more confident that they could rely on the app to reduce negative effects of drinking and therefore felt able to drink more often,” the researchers wrote in their 2014 paper13. It's also possible, the scientists say, that the app spurred male students to turn drinking into a game. “I think that these apps are kind of playthings,” says Anne Berman, a clinical psychologist at the Karolinska Institute in Stockholm and one of the study's authors. There are other risks too. In early trials of ClinTouch, researchers found that the symptom-monitoring app actually exacerbated symptoms for a small number of patients with psychotic disorders, says John Ainsworth at the University of Manchester, who helped to develop the app. “We need to very carefully manage the initial phases of somebody using this kind of technology and make sure they're well monitored,” he says. In a pilot trial published earlier this year, ten US veterans with PTSD were randomly assigned to use PTSD Coach on their own for eight weeks, while another ten used the app with the support and guidance of primary-care providers. At the end of the trial, seven of the ten patients using the app with support showed a reduction in PTSD symptoms, compared with just three of the patients who used the app on their own14. But if apps require medical supervision, that undermines the idea that they will serve as an easy and low-cost way to provide care to the masses. “People think there's an app for everything,” says Helen Christensen, the director of the Black Dog Institute at the University of New South Wales in Sydney, Australia, who has developed and studied mental-health apps. “It's actually about how we build systems around apps, so that people have health care.” Distributing mental-health apps in the developing world presents further challenges. Although mobile technology is spreading rapidly, there are many people who do not have — or cannot afford — smartphones or mobile Internet access. And the content of apps needs to be delivered in local languages and reflect local cultures. “The notion that you can take an intervention and just plop it down in a region where people might not even use the same terms for mental health as you're using is a little unrealistic,” says Ben-Zeev. “What we might call 'hearing voices' in the United States might be something like 'communicating with your elders' in a different region, depending on what label people attach to that experience.” At this point, the notion that apps can deliver quality health care in low-income regions remains largely theoretical. “This is generally where the mHealth field is,” says Natalie Leon, a scientist at the South African Medical Research Council in Cape Town. “It's a promise of potential effectiveness.” To make good on that promise, apps will have to be tested. Between 2013 and 2015, the number of mobile-health trials registered on ClinicalTrials.gov more than doubled, from 135 to 300. And the number of trials specifically focused on mental and behavioural health increased by 32%, according to a report by the IMS Institute for Health Informatics in Parsippany, New Jersey. One digital health company that has earned praise from experts is Big Health, co-founded by Colin Espie, a sleep scientist at the University of Oxford, UK, and entrepreneur Peter Hames. The London-based company's first product is Sleepio, a digital treatment for insomnia that can be accessed online or as a smartphone app. The app teaches users a variety of evidence-based strategies for tackling insomnia, including techniques for managing anxious and intrusive thoughts, boosting relaxation, and establishing a sleep-friendly environment and routine. Before putting Sleepio to the test, Espie insisted on creating a placebo version of the app, which had the same look and feel as the real app, but led users through a set of sham visualization exercises with no known clinical benefits. In a randomized trial, published in 2012, Espie and his colleagues found that insomniacs using Sleepio reported greater gains in sleep efficiency — the percentage of time someone is asleep, out of the total time he or she spends in bed — and slightly larger improvements in daytime functioning than those using the placebo app15. In a follow-up 2014 paper16, they reported that Sleepio also reduced the racing, intrusive thoughts that can often interfere with sleep. The Sleepio team is currently recruiting participants for a large, international trial and has provided vouchers for the app to several groups of independent researchers so that patients who enrol in their studies can access Sleepio for free. “We think this is the way forward for digital health,” says Espie. Mobile-phone-based treatments, he says, “should be tested and judged like any other intervention. We shouldn't treat people's health with any less respect because the treatment is coming through an app.”

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