歐美治療指引建議常見身心疾病第一線治療是心理介入，2023年英國NICE指引強調，治療輕中度憂鬱症不要以「開藥」做為常規，要和病人討論非藥物療法。台灣健保資源有限，提供的是符合成本效益和社會公平的服務，無法根據臨床需求增加合理成本，來達到更好品質和效果的醫療服務。結果造成台灣精神疾病治療多以藥物為主，加上健保限制用藥成本，導致病人的治療常以最落伍的抗憂鬱劑、併用最便宜的安眠藥和鎮靜劑，以及於憂鬱症病人合併BZD使用的風險是國外2到6倍。
二十一世紀人工智慧時代即將來臨，隨著人工智能進步和科技的創新，精神醫療服務的數位化是不可避免之趨勢，線上診療作為預防或治療輕度精神疾病應成為常規。英國的公醫健保和台灣一樣，即使治療指引強調非藥物治療，但面臨經費成本壓力，所以仍有70%的憂鬱症病人只以用藥為主。為了提高心理治療的普及、改善醫療資源不均的公平性、因應年輕族群最熟悉的求助方式、並減低個案求助專業的阻力，新版英國NICE指引推薦八種數位化、線上心理治療的App，在國民保健署 (NHS) 的治療師的支持下提供，用來治療憂鬱症和焦慮症。未來的「情緒辨識科技、精神病理數位表徵、睡眠和腦部活動等資料常模建立」、「系統性、連續性、即時性、動態性數據型態」…，將把心靈健康的促進提升到不同的境界。台灣有一流的醫療水準、大量臨床個案、完整健保資訊，若結合人工智能，推動精神醫療線上診斷和治療、以及健康資訊科技產業發展，以提供更完整的精神健康資訊，加速產業創新和技術轉移，促進精神健康醫療的升級和轉型。
Rejoyn的上世代表重度憂鬱症治療邁入新紀元。Rejoyn的核准是基於一項名為Mirai的大型臨床試驗數據。該試驗為期 13 週，多中心、遠距、雙盲、隨機對照試驗，納入 386 名正在服用抗憂鬱藥物治療憂鬱症的成年患者 (22-64 歲)。 試驗中，患者被隨機分配接受 Rejoyn 或安慰劑應用程式。 接受Rejoyn 治療的患者在憂鬱症狀嚴重程度方面在多個臨床評估量表上均觀察到優於對照組症狀改善的一致性。 在完成六週的療程後一個月，Rejoyn治療組的患者仍持續展現改善。試驗期間未觀察到任何與 Rejoyn 相關的副作用。
FDA approves first prescription-only digital treatment for depression
傳統的重度憂鬱症治療通常著重於改善腦內神經化學失衡，例如使用抗憂鬱藥物。 然而，近年研究發現，憂鬱症患者的大腦中負責情緒辨識、處理以及認知功能的區域之間的連結可能會出現異常，導致情緒調節更加困難。 Rejoyn透過設計特定的腦部訓練練習，靶向受憂鬱症影響的神經網絡，利用大腦本身俱有的可塑性來改變這些連接，從而達到減輕症狀的效果。
Rejoyn: A Fundamental Change in How Clinicians Can Treat MDD Symptoms
ReplyDeletehttps://www.psychiatrictimes.com/view/rejoyn-a-fundamental-change-in-how-clinicians-can-treat-mdd-symptoms
April 11, 2024 Leah Kuntz John Kraus, MD, PhD News Article
CLINICAL CONVERSATIONS
Rejoyn (CT-152) recently became the first prescription digital therapeutic authorized for the treatment of major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older who are on antidepressant medication. Rejoyn is expected to be available for download later in 2024. In the meantime, Psychiatric Times sat down with John Kraus, MD, PhD, executive vice president and chief medical officer at Otsuka, to learn more.
PT: Can you describe Rejoyn in your own words? How and why is it effective?
John Kraus, MD, PhD: Rejoyn (developed as CT-152) is a 6-week treatment intended to reduce MDD symptoms, delivered via smartphone app.
Rejoyn is designed to help enhance cognitive control of emotion through a combination of clinically-validated cognitive emotional training exercises for the brain and brief therapeutic lessons. In the Mirai study, individuals treated with Rejoyn showed an improvement in depression symptoms from baseline. Symptom improvement was observed across multiple patient and clinician-reported scales, including the Montgomery-Åsberg Depression Rating Scale (MADRS), Patient Health Questionnaire nine-item depression scale (PHQ-9), and the Clinical Global Impression – Severity scale (CGI-S). One month after completing the 6-week treatment program, Rejoyn participants’ symptoms showed continued improvement. No side effects were assessed as related to Rejoyn during the trial.
PT: Tell us a bit about the cognitive emotional training exercises included in Rejoyn’s 6-week program. Why is this approach novel?
Kraus: Rejoyn offers a novel approach to the treatment of depression symptoms as it is designed to target neural networks affected by depression and is hypothesized to leverage the brain’s inherent neuroplasticity to alter those connections leading to symptom reduction over time. It introduces clinically-validated cognitive emotional brain training exercises (“Emotional Faces Memory Task” or “EFMT”) that were conceived and conceptually proven by a team of psychologists, psychiatrists, and neuroscientists. These brain exercises are designed to target and help alter those neural connections necessary to appropriately process emotions with the goal of reducing symptoms of depression.
For your reference, Rejoyn’s 6-week treatment program is composed of:
1. Clinically-validated cognitive emotional training exercises for the brain, which are designed to target and help alter the neural connections necessary to appropriately process emotions with the goal of reducing symptoms of depression. A neuromodulatory mechanism acts like physical therapy for the brain by delivering personalized, consistent brain-training exercises designed to help improve connections in the brain regions affected by depression symptoms. By creating stronger connections, the parts of the brain responsible for emotions and regulating emotions are better able to work together to process those emotions more appropriately.
2. Brief therapeutic lessons to teach skills that can help manage depression symptoms, including handling strong emotions, reframing negative thinking, and engaging in positive actions.
3. In-app notifications and SMS messages to reinforce lesson content and encourage engagement with the treatment program.
First Digital Treatment for Generalized Anxiety Disorder Cleared by the FDA
ReplyDeleteSeptember 5, 2024
By Leah Kuntz
News
Article
DaylightRx becomes the very first FDA-cleared digital treatment for generalized anxiety disorder.
anxiety
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The US Food and Drug Administration (FDA) has granted clearance to Big Health’s DaylightRx, a prescription digital therapeutic that delivers cognitive behavioral therapy to treat generalized anxiety disorder (GAD) in patients aged 22 and older. DaylightRx is the very first FDA-cleared digital treatment for GAD. This digital therapeutic can be ordered by a licensed health care provider and is meant to be an adjunct to usual care.1
In randomized controlled trials, DaylightRx demonstrated efficacy in treating GAD with rates of remission of over 70% and significantly reduced anxiety in patients for up to 6 months or more.2 Specifically, in an online, 2-arm parallel-group superiority randomized controlled trial of 256 participants with moderate-to-severe symptoms of GAD, the digital therapeutic reduced symptoms of anxiety compared with waitlist control at postintervention, reflecting a large effect size (adjusted difference [95% CI]: 3.22 [2.14, 4.31], d = 1.08). Significant improvements were found in several domains: worry, depressive symptoms, sleep difficulty, well-being, and participant-specific quality of life. DaylightRx was delivered using the participants' personal smartphones. Online assessments took place at baseline, mid-intervention (week 3; from randomization), postintervention (week 6; primary endpoint), and follow-up (week 10).
“For too long, patients seeking non-drug treatment options for anxiety have had limited choices. Now, with our FDA-cleared treatment, we are offering a powerful alternative with remission rates of over 70%. With this clearance, there is now an accessible non-medication option that patients can trust," said Big Health CEO Yael Berman in a press release.
DaylightRx works by teaching patient users evidence-based techniques to alter the thoughts and behaviors that exacerbate chronic worry and anxiety via 90-day treatment. There are interactive lessons on applied relaxation to reduce tension, stimulus control to decrease worry frequency, cognitive restructuring to break the spiral of anxious thoughts, and exposure to reduce intensity of worry. DaylightRx also includes guided practice exercises to show patients how to integrate these techniques into their daily lives.
Big Health also had a product cleared by the FDA earlier year: SleepioRx for insomnia disorder. It is worth noting that the 2025 Medicare Physician Fee Schedule includes a proposal to pay for FDA-cleared digital mental health treatments, which would establish a pathway to scale access to DaylightRx, SleepioRx, and other digital therapeutics.
What digital therapeutics do you use in your practice? Let us know at PTEditor@MMHGroup.com!
References
1. US FDA Grants Clearance for DaylightRx. Big Health. News release. September 4, 2024. Accessed September 5, 2024. https://www.bighealth.com/news/us-fda-grants-clearance-for-daylightrx
2. Carl JR, Miller CB, Henry AL, et al. Efficacy of digital cognitive behavioral therapy for moderate-to-severe symptoms of generalized anxiety disorder: a randomized controlled trial. Depress Anxiety. 2020;37(12):1168-1178.
Rejoyn: First App Cleared by FDA for Depression; Cost, Efficacy Unclear
ReplyDeleteLinda M. RichmondAuthors Info & Affiliations
Publication: Psychiatric News Volume 59, Number 06
https://doi.org/10.1176/appi.pn.2024.06.6.15
A new smartphone app promises to help treat people who don’t fully respond to their antidepressant. Whether insurance will cover it and whether apps that go through the FDA clearance process will ultimately reach patients remains unclear.
Getty Images/iStock/Dilok Klaisataporn
A novel smartphone-delivered treatment, Rejoyn, has become the first app to gain clearance from the Food and Drug Administration for the treatment of major depressive disorder (MDD), and is expected to be available for patient downloads starting this summer.
Marketed by Otsuka Pharmaceutical Co. and Click Therapeutics Inc., Rejoyn was cleared as an adjunct to clinician-managed outpatient care for adults aged 22 and older who are already taking antidepressants. However, its clinical trial results have left some digital psychiatry experts who spoke to Psychiatric News questioning its potential efficacy.
The bulk of the app’s treatment is a novel training exercise for which users view a series of faces depicting several different emotions; users then must recall the sequence in which they appeared. The exercises are aimed at improving deficits in working memory for emotional material that is theorized to play a role in MDD. The app also offers brief animated cognitive-behavioral therapy lessons of 3-4 minutes each and personalized reminders and messages.
Rejoyn secured FDA clearance after a trial involving 354 adults with current MDD who had experienced only partial remission from their current antidepressant, according to Otsuka’s clinician summary. Participants scored an average of 28 on the Montgomery-Asberg Depression Rating Scale (MADRS) at baseline, indicating moderate depression. Participants were randomly divided into two groups; one group was treated with the Rejoyn app and the other was given a sham (placebo) app with a working memory task involving shapes.
After six weeks of app use, average MADRS scores dropped to 19 among Rejoyn users and 21 for sham app users, a group difference deemed “not statistically significant,” according to the study’s primary outcome. There were no patient safety incidents related to use of the app.
“There were several analyses, but in one of the key analyses, the improvement in depression symptoms for participants using Rejoyn was equivalent to the changes among those using the placebo,” explained John Torous, M.D., director of digital psychiatry at Beth Israel Deaconess Medical Center in Boston. Yet both groups of patients did improve their MADRS scores by several points. “So perhaps one thing this study shows us is that apps can be effective in helping patients with major depression.”
Torous added, “The results raise questions about what is the active ingredient here? What is making people feel better?” The “digital placebo effect,” due in part to people’s high levels of expectation and trust for their smartphones, might offer some explanation, he said. Both groups also received weekly telehealth visits; and they were contacted by an investigator to make up missed app sessions.
Rejoyn: First App Cleared by FDA for Depression; Cost, Efficacy Unclear
ReplyDeleteLinda M. RichmondAuthors Info & Affiliations
Publication: Psychiatric News Volume 59, Number 06
https://doi.org/10.1176/appi.pn.2024.06.6.15
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“It’s less clear what constitutes a good placebo or ‘sham’ arm in a [randomized clinical trial] for a digital therapeutic, which might have complicated the trial results,” pointed out Julia Tartaglia, M.D., a PGY-4 resident at the Department of Psychiatry at Zucker Hillside Hospital/ Northwell Health. Tartaglia has a special interest in digital psychotherapeutics and is a member of the expert panel that developed APA’s updated app evaluator.
Tartaglia said it’s important for clinicians to remember that Rejoyn was tested only in a narrow subset of patients: those with unipolar depression who have not tried other treatments. “Also not included were those with treatment-refractory depression, bipolar disorder, or even those at high risk of suicide.”
Apps’ Insurance Coverage Unclear
Rejoyn joins only a handful of digital therapeutics that have been cleared by the FDA, and that should account for something, noted Dror Ben-Zeev, Ph.D., a psychologist and professor of psychiatry and behavioral sciences at the University of Washington.
Clinicians advocated for the creation of a regulatory framework to enhance patient safety and provide insight into efficacy of digital mental health tools, to help tame the “wild west” of thousands of digital offerings, pointed out Ben-Zeev, who is also the editor for the Technology in Mental Health section of Psychiatric Services.
“I don’t know if we want to look through the weeds of cleared apps and say ‘Well, it’s promising, but not promising enough,’” Ben-Zeev said. “We are in the midst of such a mental health crisis that digital interventions that prove to be safe and demonstrate clinical usefulness for at least some people should certainly be considered.”
Depression is one of the most common mental illnesses, with about 21 million U.S. adults experiencing major depressive episodes in the past year, according to the National Institute of Mental Health. Yet nearly two-thirds don’t seek professional help, mostly due to stigma and cost. At least one third of those treated still experience significant residual symptoms.
However, FDA clearance has not necessarily guaranteed previous apps a path to coverage by insurance.
Pear Therapeutics Inc. secured clearance for its reSET line of CBT-based apps for substance use disorders but declared bankruptcy in 2023 after payors refused to cover them. It is unclear how many insurers cover the FDA-authorized video game EndeavorRx, designed to improve the attention span of children with ADHD. Creator Akili Interactive Labs Inc. now markets a less expensive “over the counter” version for adults.
NightWare was cleared by the FDA in 2020 for its ability to detect and gently interrupt patients’ recurring nightmares, but not their sleep. Yet it has not secured coverage by Medicare or private insurance companies, according to the company’s website. It is offered through the Department of Defense and the Veteran’s Administration.
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ReplyDeleteRejoyn: First App Cleared by FDA for Depression; Cost, Efficacy Unclear
Linda M. RichmondAuthors Info & Affiliations
Publication: Psychiatric News Volume 59, Number 06
https://doi.org/10.1176/appi.pn.2024.06.6.15
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Torous said it remains to be seen whether insurance will cover Rejoyn, given the results. “Or if not, will people want to pay for it? What price point will manufacturers’ set?” At least one major insurer, UnitedHealth Care, wrote last year that its pharmacy benefit manager OptumRx would deny claims for all FDA-approved digital apps, effective September 2023.
“Rejoyn adds to the landscape of potential treatments for depression. There are very few digital therapeutics with an evidence-based intervention,” said Kunmi Sobowale, M.D., an assistant professor of child and adolescent psychiatry at UCLA Health with a special interest in digital technology for the prevention and intervention of mental illness. “Whether it improves the quality of care remains to be seen based on the study results. … However, I don’t think [the Rejoyn app] really moves the needle in terms of improving access or decreasing the cost of care, since it still requires a physician to prescribe it. Only some patients will be able to afford it.