Oct 30,2024 TOP STORY

Click Therapeutics Launches Software-Enhanced Drug™ Therapies as part of new Click SE™ Offering

Click Therapeutics has launched Click SE™, a new line of Software-Enhanced Drug™ therapies combining digital therapeutics with traditional medications, marking a pioneering step in digital health. These innovative therapies integrate Click’s AI-driven digital platforms with pharmacotherapy to enhance drug efficacy, targeting specific patient needs. The Click SE™ offerings align with recent FDA guidance encouraging software applications that support drug effectiveness, potentially improving patient outcomes. By adding a digital layer, these "smart" medications could become a standard in healthcare, enabling physicians to choose between traditional or software-enhanced versions of drugs for personalized patient care.

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Sep 05,2024

New Clinical Study Finds Sword Saves Employers $2,900 per Member in MSK-Related Productivity Loss Annually

The study aimed to evaluate the economic impact of Sword's digital musculoskeletal (MSK) care platform on employee productivity and healthcare savings for employers. The study involved over 5,000 employees from various industries across the United States, all of whom had suffered from chronic MSK pain for at least 12 weeks. Participants were enrolled in a 12-week digital MSK care program called "Thrive," which included several key components: home-based exercises, educational materials, cognitive behavioral therapy (CBT), and ongoing support from a Doctor of Physical Therapy. On average, the program resulted in savings of $243 per participant per month, which could be projected to nearly $2,916 per participant annually. These savings were consistent across different industries, although sectors such as finance and information saw the highest savings at around $300 per participant per month. Participants reported significant enhancements in their non-work-related daily activities, indicating an overall improvement in quality of life.

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Aug 14,2024 TOP STORY

Otsuka Precision Health launches first digital therapeutic for depression

Otsuka Precision Health has launched its first digital therapeutic for major depressive disorder, an app-based treatment called Rejoyn. The six-week program, available by prescription, is designed to supplement medication. It features cognitive behavioral therapy-based video lessons and exercises that help users identify and recall emotions from facial expressions, targeting neural connections involved in emotional processing. Rejoyn, developed with Click Therapeutics, received FDA clearance in March and has shown statistically significant improvement in depression symptoms during clinical trials. The app will initially be available for $50 on a cash-pay basis, with a future price of $200 for insurers.

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Aug 27,2024

The results of the ELAINE study, published in Epilepsia Open, confirm the positive impact of emyna from GAIA Group

Despite the availability of pharmacological treatment for seizures, people with epilepsy (PwE) commonly experience impairments in quality of life (QoL). The objective of this study was to examine the effectiveness of emyna, a fully automated digital intervention based on cognitive behavioral therapy (CBT) techniques, in improving health-related QoL among PwE who reported impairments in QoL. A pragmatic randomized controlled trial was conducted with N = 438 PwE who were assigned to the intervention group (n = 216), which used emyna alongside treatment as usual (TAU), or the control group (n = 222), which received TAU only. Findings from the intent-to-treat analyses showed that after 3 months, participants in the intervention group experienced significant and clinically relevant improvements in health-related QoL compared to the control group. This study extends previous research by demonstrating that emyna facilitates improvements in QoL in a diverse group of PwE treated in routine care settings. This CBT-based digital intervention therefore presents a convenient and cost-effective addition to healthcare providers' treatment repertoire.

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Sep 04,2024

Click Therapeutics Announces CT-132 Met Primary Endpoint for the Reduction of Monthly Migraine Days in ReMMi-D Pivotal Trial

Click Therapeutics announced meeting the primary endpoint in the pivotal randomized, double-blind, controlled, decentralized, study of CT-132 for the preventive treatment of migraine, ReMMi-D (Reduction in Monthly Migraine Days, NCT05853900). At completion of the study, CT-132 showed a statistically significant reduction in monthly migraine days (MMDs) following 12 weeks of treatment compared to sham, (n=568, ITT population, -0.9 MMDs, p=0.005), with the treatment arm experiencing -3.04 MMDs by end of treatment. Engagement and adherence were high and sustained over the full 12-week duration of the treatment. Both the intervention and sham groups demonstrated nearly 100% median completion of daily tasks.

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Aug 08,2024 TOP STORY

U.S. Food and Drug Administration Grants Clearance for Big Health's SleepioRx

Big Health, a developer of digital mental health treatments, received FDA clearance for its flagship digital therapeutic, SleepioRx, designed to treat chronic insomnia in adults. SleepioRx, which delivers Cognitive Behavioral Therapy for Insomnia (CBT-I), can now be prescribed by licensed healthcare providers. The 90-day treatment has been proven effective in reducing sleep issues, with benefits lasting up to three years. With the proposed 2025 Medicare rule to reimburse FDA-cleared digital treatments, SleepioRx could see broader adoption.

REGULATORY FDA

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Jul 18,2024

Comparative Effectiveness of Three Digital Interventions for Adults Seeking Psychiatric Services

There is a substantial gap between demand for and availability of mental health services. Digital mental health interventions (DMHIs) are promising tools for bridging this gap, yet little is known about their comparative effectiveness. In this study, researchers aimed to assess whether patients randomized to a cognitive behavioral therapy (CBT)–based or mindfulness-based DMHI had greater improvements in mental health symptoms than patients randomized to the enhanced personalized feedback (EPF)–only DMHI. Participants were randomized to 1 of 5 intervention arms: (1) EPF only; (2) Silvercloud only; (3) Silvercloud plus EPF; (4) Headspace only; and (5) Headspace plus EPF. The results showed that the magnitude of change was not significantly different across the 5 arms. Additionally, the groups did not differ in decrease in anxiety or substance use symptoms. However, the Headspace arms reported significantly greater improvements on a suicidality measure subscale compared with the Silvercloud arms. The findings suggest that DMHIs may provide support for patients during waiting list–related delays in care. 

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Jul 29,2024

Breakthrough study shows AI digital program as effective as human therapy for anxiety

A new study by ieso Digital Health in collaboration with the NHS and NIHR BioResource reveals that its AI-driven digital programme delivered results comparable to traditional human-led therapy for generalized anxiety.  Developed by expert clinicians and using the latest advances in AI, the ieso Digital Programme offers a six-module course facilitated by a conversational agent. It provides real-time, tailored interactions to teach users skills to manage their anxiety based on Cognitive Behavioral Therapy (CBT) principles. In ieso’s landmark study of 300 volunteers with mild to severe anxiety, 82% of participants who used the programme for up to nine weeks showed a clinically meaningful decrease in anxiety symptoms, which can include worry, sleeplessness and fatigue. Even those with severe anxiety benefited from marked improvements, and over half experienced a reduction in symptoms within two weeks, on average. The programme, benchmarked against carefully matched NHS patient data (n=767), proved as effective as human-led therapy. In the US, variants of the ieso digital programme are being piloted with payers and health systems. The program will be rolled out with selected UK partners in late 2024.

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Jul 29,2024 TOP STORY

Otsuka and Oxford HIN collaborate to gather insights into digital therapeutics for mental health

Otsuka and Health Innovation Oxford & Thames Valley (Oxford HIN) have announced a collaboration to evaluate the implementation and integration of a new digital therapeutic (DTx), CARE for MDD, intended to treat major depressive disorder. The companies will combine Oxford HIN’s network and expertise in mental health treatment, with Otsuka’s experience in developing therapies for patients living with mental illness. Together, Otsuka and Oxford HIN intend to evaluate patient and healthcare practitioner feedback on real-world implementation of the DTx through a pilot that will initially run across four Primary Care sites in England. CARE for MDD is a regulated medical device delivered as a smartphone app, and was co-developed by Otsuka alongside Click Therapeutics.

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Jul 11,2024

Swing publishes Phase III data for fibromyalgia digital therapy

Swing Therapeutics has published positive Phase III trial results for its digital therapeutic, Stanza, which treats fibromyalgia symptoms through self-guided acceptance and commitment therapy (a form of CBT). The 12-week, randomized PROSPER-FM study (NCT05243511) showed that 71% of Stanza users reported improved well-being, compared to 22% in the control group. Stanza also significantly improved fibromyalgia-related symptoms, pain, fatigue, sleep disturbance, and depression. No safety issues were reported. The study's results, published in the Lancet, validate Stanza as an effective, non-drug treatment option for fibromyalgia, addressing the limitations of traditional pharmacological treatments.

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