Category Archives: Blog

New UK Guidance For Medical Device Regulation to Protect Users of Digital Mental Health Technologies.

February 3, 2025Blog, NewsArtificial Intelligence, mental health app, smartphone app, UK guidance on mental health app developmentadmin

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK today published new guidance to help manufacturers meet UK medical devices regulations and ensure that digital mental health technologies are effective, reliable and acceptably safe.

Just as technology has become a diagnostic, clinical and administrative “partner” in medical care and healthcare, it is also being increasingly used in mental health care. A variety of mental health apps, AI-powered assesssments, virtual and augmented reality programs and wearable technologies are becoming a new array of available mental health tools.

The prime directive of digital mental health technologies that diagnose, prevent, or treat conditions using complex software must meet medical device standards to ensure they are effective and acceptably safe, just like any other medical device.

Many manufacturers may be unsure how medical devices regulations apply to software, which products are regulated, how they are evaluated, and what evidence is required. The new MHRA guidance explains:

How to define and communicate the intended purpose of a digital mental health technology
When a digital mental health technology is considered a medical device under UK law.
How risk classification is determined, ensuring proportionate regulation for different types of technologies.

For the end users of these mental health apps, this means greater confidence in the tools they rely on.

Development

The UK MHRA Guidance was developed over the last two years to assist in the development of digital mental health technologies (DMHT) with the goal to create safe digital and software products that support mental health and wellbeing. The types of DMHTs can take many forms or approaches including: websites, internet-based platforms or applications (apps) to be used with non-medical technology, such as computers, mobile phones, fitness wearables, and virtual reality (VR) headsets, or medical technolog y, such as transcranial direct current stimulation (tDCS) headsets. They can be available as direct-to-consumer products intended for patients and the public, often accessible through app stores for free or for a fee, or used with a referral or supervision from healthcare or educational professionals, as part of the blended delivery of mental health care.

Figure 1 from the guidance illustrates some of the key steps in developing safe and effective DMHTs and emphasizes that these steps are iterative across the lifecycle of the product.

The complete MHRA Guidance is available online.

Link to New UK Guidance For Medical Device Regulation

Study Of Virtual Avatars in Mental Health Care

January 28, 2025Blog, NewsAI, avatars, CBT, motivational interviewingadmin

New research from Cedars-Sinai Medical Center in Los Angeles describes the use of AI driven avatars programmed for motivational interviewing and cognitive behavioral therapy can be accepted by patients and considered helpful in counseling sessions.

Patients reported that after 30 minute sessions using virtual reality goggles, 85% of participants said they found the experience to be helpful, and 90% expressed interest in doing it again.

The patients were individuals who were awaiting liver transplants for cirrhosis and according to Dr. Brennan Spiegel, director of health services research at Cedars-Sinai, ‘alcohol addiction remains a high-risk factor.’ “We see VR as a way to augment traditional interventions, which often fall short due to a shortage of mental health professionals, societal stigmatizing of alcoholism and other factors.”

In the US, over 29 million individuals were identified with alcohol use disorder (AUD) in 2019 and is projected to increase further by 2030. Despite this, treatment access is low, with only 7.6% of affected individuals receiving AUD-related treatment in 2021. Furthermore, only 16% of individuals receiving AUD-directed therapy achieved abstinence. Relapse prevention treatment remains a challenge, with more than 60% relapsing within the first year of treatment

Treatment modalities for AUD encompass both pharmacotherapy and psychotherapeutic approaches, with increasing emphasis on combination therapy. Psychotherapeutic approaches, such as motivational interviewing (MI) and cognitive behavioral therapy (CBT), are widely disseminated evidence-based interventions for AUD and recommended by professional societies as they serve to address harmful drinking patterns. Unfortunately, treatment access is limited and aggravated by a scarcity of mental health professionals, pervasive societal stigma, financial, attitudinal, and geographic barriers.

New Technology Solutions

Technological solutions, such as telemedicine and mobile applications, have begun to address barriers to access. Including advancements in virtual reality (VR) is emerging as a valuable supplementary tool for AUD assessment and treatment. Current, traditional cognitive behavior therapy (CBT) and VR-assisted CBT have involved preprogrammed or scripted methods. Recently, advancements in artificial intelligence (AI) have introduced large language models (LLMs) capable of generating more dynamic and responsive interactions. LLMs have shown a remarkable ability to facilitate personalized treatment plans and enhance patient engagement in the fields of medicine. The applications of VR with integrative, interview-based therapies enabled through LLMs have been unexplored.

Results

The new study introduces a novel program that combines spatial computing with AI to deliver self-administered mental health support for patients with AUD. In earlier research, the researchers found this program to be feasible, safe, and acceptable for patients experiencing mild-to-moderate depression or anxiety. Building on this foundation, the study aimed to adapt the program to integrate motivational interviewing (MI) techniques, as well as to assess its feasibility, safety, and efficacy in delivering combined CBT and MI in VR to address persisting gaps in psychotherapeutic care delivery for patients with alcohol-associated cirrhosis.

Building upon the insights drawn from the thematic content analysis with 20 socioeconomically diverse participants, our study evaluated a program combining spatial computing and AI to deliver self-administered, immersive mental health support targeting alcohol craving reduction. The participants offered mostly positive feedback on their interaction with the virtual AI therapist.

Patient Assessment

Patients highlighted the program’s usability and acceptability, its personalized engagement, as well as the empathetic, private, and nonjudgmental therapeutic alliance it fostered. Participants described the AI avatar as realistic and engaging in its communication style, which many reported to be comparable with a human therapist. Most participants expressed a willingness to recommend this form of self-administered psychotherapy to others. These findings are notable given that three-quarters of participants reported minimal prior experience with VR.

Source:

Yeo YH, Clark A, Mehra M, Danovitch I, Osilla K, Yang JD, Kuo A, Kim H-S, Vipani A, Wang Y, Ayoub W, Trivedi H, Samaan, Wu T, Shah, Liran O, and Spiegel B. (2024) The feasibility and usability of an artificial intelligence-enabled conversational agent in virtual reality for patients with alcohol-associated cirrhosis: A multi-methods study, Journal of Medical Extended Reality 1:1, 257–270, DOI: 10.1089/jmxr.2024.0033.

[Link to virtualmedicine.org]

Link Between Social Media Use and Irritability

January 23, 2025Blog, Newsanxiety, depression, irritabilityadmin

A new survey led by researchers from the Center for Quantitative Health at Massachusetts General Hospital and Harvard Medical School has analyzed the association between self-reported social media use and irritability among US adults. Data suggests that frequent social media use, especially among active posters, was correlated with higher levels of irritability.

Previous research on social media use has demonstrated connections to increased depressive symptoms, but how much social media engagement is associated with irritability or its influence on depression and anxiety has remained unclear.

Symptom Measurements

The survey collected sociodemographic data, self-reported social media usage, and measures of irritability from 42,597 participants (mean age of 46 years, with 58.5% identifying as women, 40.4% as men, and 1.1% as nonbinary). The Brief Irritability Test (BITe), was used, which consists of five statements evaluating irritability symptoms over the previous two weeks. Scores range from 5 to 30, with higher scores indicating higher levels of irritability. The analysis also included depression and anxiety metrics to account for overlapping psychological symptoms.

Social Media Assessment

Social media use was categorized based on frequency: never, less than once per week, once per week, several times per week, once per day, several times per day, or most of the day. Platforms analyzed included Facebook, Instagram, TikTok, and Twitter/X. Frequency of active posting, political engagement, and political affiliation were also examined to identify potential confounding factors.

Results

Frequent social media use correlated with higher irritability scores, even after adjusting for anxiety and depression.
Participants using social media most of the day scored higher on the BITe in unadjusted models. After adjusting for anxiety and depression, the increase remained significant.
Platform-specific analyses revealed a dose-response relationship between posting frequency and irritability. Posting multiple times per day was associated with the highest irritability levels across all platforms, with TikTok users showing the largest increase.
High social media engagement levels, particularly frequent posting, were associated with greater irritability in US adults. Although the study could not establish direct causation, findings suggest a potential feedback loop relationship, where irritability may both influence a desire to engage and increase irritation from social media use.

Conclusion

Researchers suggest that there is an association between high levels of social media use, particularly posting on social media, and irritability among US adults. The implications of this irritability and the potential for interventions to address this association require additional investigation.

Source: Roy H. Perlis et al, Irritability and Social Media Use in US Adults, JAMA Network Open (2025). DOI: 10.1001/jamanetworkopen.2024.52807

Teletherapy Has Not Improved Access to Mental Health Care for Those Who Cannot Pay

January 18, 2025Blog, Newsaffordability of treatment, psychotherapy, teletherapyadmin

A recent study published in the American Journal of Psychiatry has demonstrated that while the use of teletherapy has become more widespread over the last few years, access to such care has not increased for those who cannot afford it.

The researchers, from Columbia University, note that since the pandemic, the percentage of Americans seeking psychotherapy has more than doubled and has remained at higher levels since then, primarily due to the ease of access online.

For this study, the research team looked at previous research that focused on highlighting trends in patients seeking outpatient care in the U.S.— this earlier study involved 89,619 psychotherapy patients. A comparison of previous versus current data found that despite the hope that increasing the use of teletherapy would lead to more help for low-income people, there was no noticeable improvement. Patients using such services tended to be young, well educated and in higher income brackets.

The researchers also looked at data from another study focused on the use of telehealth by children and adolescents and found similar results. Most were members of high-income families, especially those with good health insurance.

The research team concluded that it appears that teletherapy has done little to improve access to mental health care for low-income people, primarily because those who offer such services expect to be paid the same as for in-office sessions, either by clients or their insurance companies.

Source: Mark Olfson et al, Use of Telemental Health Care by Children and Adolescents in the United States, American Journal of Psychiatry (2025). DOI: 10.1176/appi.ajp.20240193

New Pew Research Reveals High Usage of Social Media Among Teens

December 13, 2024Blog, NewsChildren & Adolescents, overuse, smartphone app, Social Mediaadmin

A recent survey published this week from the Pew Research Center reveals some eye-catching statistics about teen online habits. Nearly half of the surveyed teens, aged 13 to 17, report spending almost all their time online, which is up from about 24% just ten years ago.

While parents, teachers, healthcare professionals and politicians have expressed serious concerns about the impact of technology and social media on the mental health of today’s youth, many teens remain digitally more connected than ever. Pew Research Center survey of U.S. teens ages 13 to 17 conducted Sept. 18-Oct. 10, 2024 demonstrates that nearly half of the teens describe that they are online almost constantly.

It is interesting to note that these findings show just how integral the internet has become for this age group, reflecting both its pervasive role and the uncertainties around its impact on mental health. A staggering 96% of these teens claim to use the internet every day, and 95% have access to smartphones. These devices have become almost compulsory tools for socialization, entertainment, and information.

Choice and interest in the various social media platforms has changed for this age group in the last two years, according to Pew. The survey asked about the platforms and regularity of usage.

YouTube remains the most popular but usage has reduced by 5 percent in 2024.

TikTok, Instagram and Snapchat remain widely used among teens. Roughly six-in-ten teens say they use TikTok and Instagram, and 55% say the same for Snapchat.

Facebook and X use have steeply declined over the past decade. Today, 32% of teens say they use Facebook. This is down from 71% in 2014-15, though the share of teens who use the site has remained stable in recent years. And 17% of teens say they use X (formerly Twitter) – about half the share who said this a decade ago (33%), and down from 23% in 2022.

Roughly one-quarter of teens (23%) say they use WhatsApp, up 6 percentage points since 2022.

And 14% of teens use Reddit, a share that has remained stable over the past few years.

The survey asked about Threads, launched in 2023 by Meta, currently shows that only 6% of teens report using it.

How often do teens visit online platforms?

Time that teens (and everyone) spends on social media has been a major concern in the US. This new survey asked teens how often they use five platforms: YouTube, TikTok, Instagram, Snapchat and Facebook.

Overall, 73% of teens say they go on YouTube daily, making YouTube the most widely used and visited platform we asked about. This share includes 15% who describe their use as “almost constant.”

The share of teens who say they use Instagram almost constantly has increased slightly, from 8% in 2023 to 12% today.

Relatively few teens report using Facebook daily (20%).

Social Media Usage by Gender and Race/Ethnicity

Additional Data

The Pew Report also offers additional data and other demographics that describe how teens engage with online platforms by gender, race and ethnicity, age, and household income. It also highlights time spent online and teen access to smartphones at home.

Source: Teens, Social Media and Technology, December 12, 2024, Pew Research Center

Browsing Negative Content Online Linked to Poor Mental Health

November 21, 2024Blog, NewsSocial Mediaadmin

According to the study published in Nature Human Behaviour, the relationship between mental health and web-browsing is causal and bi-directional.

Self-guided browsing of negative content online is associated with poorer mental health and continued browsing of negative content. Study results “show that browsing negatively valenced content not only mirrors a person’s mood but can also actively worsen it. This creates a feedback loop that can perpetuate mental health challenges over time.”

Browsing and Mood Symptoms

Approximately 1,000 study participants shared their web browsing history with the researchers and answered questions about their mental health. Using natural language processing methods, the researchers analyzed the emotional tone of the webpages participants visited. Interestingly, perticipants rather than taking a break from negative or depressing content, the study found that participants with worse moods and mental health symptoms were inclined to browse more negative content online, and after browsing, those who browsed more negative content felt worse.

In another study, the researchers manipulated the websites people visited, exposing some participants to negative content and others to neutral content. They found that those exposed to negative websites reported worse moods afterward, demonstrating a causal effect of browsing negative content on mood. Afterwards, when these participants were then asked to browse the internet freely, those who had previously viewed negative websites—and consequently experienced a worse mood—chose to view more negative content.

This finding highlights that the relationship is bi-directional: negative content affects mood, and a worsened mood drives the consumption of more negative content.

Previous research on browsing focused on screen time or quantity of use which let to mixd conclusions. To evaluate if an intervention could change participants web-browsing choices, researchers conducted a further study.

Can an intervention help?

To evaluate if a break in the “negative browsing /negative mood” loop might change things, researchers added content labels to the results of a Google search, which informed participants whether each search result would likely improve their mood, make it worse, or have no impact. Results showed that participants were then more likely to choose the positively-labeled sites deemed likely to improve their mood—and when asked about their mood afterward, those who had looked at the positive websites were indeed in better moods than other participants.

Researchers developed helpful software

In response to the results of their intervention, the researchers have developed a free browser plug-in that adds labels to Google search results, providing three different ratings of how practical a website’s content is, how informative it is, and how it impacts mood.

Co-author Professor Tali Sharot said, “We are accustomed to seeing content labels on our groceries, providing nutritional information such as sugar, calories, protein, and vitamins to help us make informed decisions about what we eat. A similar approach could be applied to the content we consume online, empowering people to make healthier choices online.”

Source:
Kelly, C.A., Sharot, T. Web-browsing patterns reflect and shape mood and mental health. Nat Hum Behav (2024). https://doi.org/10.1038/s41562-024-02065-6

Ultrasound: Potential Use as Search and Treatment Tool for the Brain

November 1, 2024Blog, Newsadmin

Traditionally, health professionals across the world have used ultrasound as a means of monitoring the development of unborn babies and assessing the health of patients’ internal organs. Over the decades, its uses have expanded to evaluate blood flow and check for blockages in arteries and veins, assess joint inflammation and metabolic bone disease, help diagnose abnormal growths, blood clots, gallstones, kidney or bladder stones, and more.

As a tool for interventional therapies, ultrasounds can guide needles for biopsies or tumor treatments, and can image the location of a catheter as it’s inserted into a blood vessel. Ultrasound scans are generally non-invasive and painless, and can take about 30 minutes. There are some limitations however, such as the fact that ultrasound waves can be disrupted by air or gas, and that ultrasound cannot penetrate bone.

A new article in the journal PLOS Biology, by researchers from Stanford University, the University of Plymouth, and Attune Neurosciences describe that it has now been demonstrated to offer a non-invasive and precise way of targeting specific areas of the human brain.

Dr Elsa Fouragnan Brain Research & Imaging Centre (BRIC) Computational Neuroscience

Using a technique known as transcranial ultrasound stimulation (TUS) offers the potential to help people with conditions ranging from pain, alcoholism, obsessive-compulsive disorder (OCD), and Parkinson’s disease, all without the use of drugs or surgery.

Beyond the treatment, the researchers discuss in the new article how the technology can also be used to temporarily test areas before treating them, serving as a sort of “search and rescue tool for the brain”.

This enables them to find the sources of brain-related issues and disorders prior to treating them, which may be an added resource towards personalized treatments.

Challenges

However, the researchers acknowledge there are still a number of complex challenges that need to be addressed before TUS can be rolled out in healthcare settings – and maybe even homes – on a global scale. And while significant advances have been made to the technology, reaching a point where it can still be effective – but also sustainable from a cost perspective – is still some years away.

Currently, the researchers have developed and are testing a TUS device small and simple enough for people to use them at home following a series of clinical assessments, rather than having to continually go into hospitals or other healthcare settings. According to Dr Keith Murphy, co-founder of Attune Neurosciences and researcher at Stanford University School of Medicine, “There are countless reasons people can’t get to a clinic, whether it’s financial strain or simply not having the time. In the past few years, we’ve made substantial progress towards a device that leverages MRI precision guidance but may still be used safely at home. We’ve always believed that portability was a critical step towards making advanced brain therapies accessible to everyone and we’ve made great strides in demonstrating that it works.”

The researchers further discuss how focused ultrasound can also be integrated with other emerging technologies, for example improving the accuracy and effectiveness of interfaces that enable direct communication between the brain and external devices.

Source: Murphy K, Foragnan L. The future of transcranial ultrasound as a precision brain interface. PLoS Biol 22(10): e3002884. https://doi.org/10.1371/journal.pbio.3002884

Technoference

September 6, 2024Blog, Newsadmin

A recent ‘Letter to the Editor’ to MDEdge from a Maine Pediatrician reminds us that our use of technology that consumes so much of our attention is indeed taking a toll on our human interactions. Dr Willkoff describes two scenarios that troubled him but, as he points out, may also be so ubiquitous that perhaps too many of us accept these as the norm. In one scenario, a family is dining at a restaurant but the two teens were immersed texting with their smartphones and little else. The other vignette described a 3-year old playing with his toys in the sand and his father nearby was solidly ‘glued’ to his laptop and hadn’t said a word to his child.

These vignettes describe what is called “technoference,” a word coined by a doctoral student in human development and family studies at Penn State a decade ago “to describe the everyday intrusions and interruptions in couple interactions that take place due to technology devices and their always-on, ever-present nature.” Although, the original research that triggered the coinage was studying couples, clearly this phenomenon occurs whenever people of any age are together in social situations.

Recent Studies in Early Childhood and Adolescence

Early Childhood Studies

Dr W points out that “technoference in recent studies has been associated with decreased parent-child interaction during early childhood” including a reduced ability to notice and attend to children’s needs, less frequent and lower-quality joint play and conversational interactions, including more negative responses to children’s behavior, and higher risk of child injuries.

Adolescent Studies

In adolescence, adolescent-perceived parental technoference is associated with higher levels of parent-child conflict and lower levels of parental emotional support and warmth. When children’s emotional and physical needs are consistently ignored or inappropriately responded to, they are at risk of developing mental health difficulties, underscoring the need to investigate parental technoference as a potential precipitant of the development of mental health difficulties, such as depression, anxiety, hyperactivity, and inattention.

New JAMA Study

A recent study in JAMA Open Network Pediatrics (A Deneault, et al.) highlights the limitations of these previous studies of technoference in both children and adolescents in that this body of research has been primarily cross-sectional, which hinders the ability to understand the directionality of associations (ie, which comes first, parental technoference or child mental health difficulties?)

A. Deneault and colleagues studied over 1300 emerging adolescents aged 9 to 11 years across 3 assessments (anxiety, attention difficulties and hyperactivity) revealing that higher levels of anxiety symptoms were associated with higher levels of perceived parental technoference later in development. Higher levels of perceived parental technoference were associated with higher levels of inattention and hyperactivity symptoms later in development.

Meaning of Results: Parent digital technology use that interrupts routine parent-adolescent interactions may be instigated by the emerging adolescents’ levels of anxiety, and parent technoference may also have consequences for emerging adolescents’ inattention and hyperactivity.

Conclusions and Relevance

Higher levels of emerging adolescent anxiety symptoms were associated with higher levels of perceived parental technoference (but not vice versa). Higher levels of perceived parental technoference were associated with higher levels of emerging adolescent inattention and hyperactivity symptoms (but not vice versa). Substantial gender differences were not identified. It is possible that, despite experiencing different levels and onset of mental health difficulties, boys and girls similarly experience the effects of parental technoference.

This study highlights the complex relations between parental technoference and emerging adolescents’ mental health and highlights the need to address parental technology use when considering emerging adolescents’ well-being. The findings speak to the need to discuss digital technology use and mental health with parents and emerging adolescents as a part of routine care.

Citations

Deneault A, Plamondon A, Neville RD, et al. Perceived Parental Distraction by Technology and Mental Health Among Emerging Adolescents. JAMA Netw Open. 2024;7(8):e2428261. doi:10.1001/jamanetworkopen.2024.28261
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2822421

Wilkoff WG. Technoference. MDEdge. Pediatric News. Sept 2024.Available at :https://www.mdedge.com/pediatrics/article/270630/mental-health/technoference

New Studies: Teen Smartphone Problems Revisited

August 6, 2024Blog, Newsoveruse, smartphone app, Social Mediaadmin

New studies demonstrate that approximately one in five older British teenagers involved in one study displayed problematic phone use (PSU), which resembles an addiction. This can mean they feel panicky or upset when their phone is unavailable, find it difficult to control their screen time and use their phone to the detriment of other meaningful activities.

“Even if we could wave a magic wand and make all smartphones go away, these kids could still have problems overdoing other stuff.”

Research, from the Institute of Psychiatry, Psychology and Neuroscience at King’s College London, was published in two studies. One, in the journal Acta Paediatrica, surveyed 657 teenagers aged 16 to 18 at five schools across England. The second analysis, published in BMJ Mental Health, studied a smaller group of teenagers for a month: 62 pupils aged 13 to 16 from two London schools.

Teens with PSU were twice as likely to have anxiety, three times more likely to have depressive symptoms and 64 per cent more likely to be insomniacs. Instagram and TikTok were the social media accounts most strongly linked to PSU.

The studies also showed that that teens were keen to find ways to restrict their phone use. The most effective methods were putting their device on “do not disturb” or “airplane mode”, turning off notifications and keeping smartphones out of the bedroom.

Dr Nicola Kalk, senior author on both studies, said the work “does contribute to an accumulation of evidence that suggests that a proportion of teenagers use their smartphone in a way that is starting to look more and more like an addiction”.

Professor Ben Carter, professor of medical statistics at King’s, said: “By revealing the link between problematic use of smartphones and poorer mental health, and demonstrating that young people are aware of this problem and are eager to manage their use, these studies highlight the need for evidence-based interventions to help adolescents struggling with difficult behaviours around their smartphone use.”

Chris Ferguson, professor of psychology at Stetson University, who is quoted above said: “Even if we could wave a magic wand and make all smartphones go away, these kids could still have problems overdoing other stuff. Ultimately, I think this data suggests we do need to reframe our approach to technology.

“There’s little evidence here, or elsewhere, that restricting technology, putting age limits on social media or banning smartphones in schools is helpful in improving teen wellness or academic performance. Technology overuse is best understood as a new symptom of age-old disorders such as depression, anxiety or ADHD, not a new set of problems.

“Further indulging a moral panic over smartphones and social media is unlikely to help any youth.”

Sources:

Kalk NJ, Downs J, Clark B, Carter B. Problematic smartphone use: What can teenagers and parents do to reduce use? Acta Paediatrica. First published: 31 July 2024. https://doi.org/10.1111/apa.17365
Carter B, Armed, N, Cassidy O, Pearson O, Calcia M, et al. ‘There’s more to life than staring at a small screen’: a mixed methods cohort study of problematic smartphone use and the relationship to anxiety, depression and sleep in students aged 13–16 years old in the UK. BMJ Mental Health. July 2024. https://mentalhealth.bmj.com/content/27/1/e301115.

American Association for Technology in Psychiatry

AATP