Dec 13,2023 TOP STORY

PursueCare Acquires Three Software-Based Products of Pear Therapeutics

The Middletown, Connecticut-based PursueCare acquired three software-based digital therapeutics developed by Pear Therapeutics, which filed for bankruptcy in April 2023. PursueCare previously offered digital therapeutics reSET, reSET-O and reSET-A to its patients before Pear’s bankruptcy. The products can now be used as self-guided cognitive behavioral therapy (CBT) tools or integrated into a treatment plan. reSET is designed for general SUD, reSET-O for opioid use disorder (OUD) and reSET-A for alcohol use disorder (AUD). PursueCare, which has treated approximately 10,000 patients this year, plans also to keep the costs of the therapeutics low for both patients and health plans. “Core to the offering is this 12-week curriculum,” Nick Mercadante, the CEO and Founder of PursueCare, said. “Behind the 12-week curriculum is a contingency management program, which is basically a reward system. We plan to rebate any cost of care. If patients stick with treatment, they’re rewarded, and over time, it might become free for them.” For health plans, the products are included as part and parcel with PursueCare’s value-based arrangements or be reimbursed as a product contract covered for members by their plan. PursueCare has been working “behind the scenes” to seamlessly integrate the reSET products into its infrastructure and incorporate its data flow into the company’s electronic medical record (EMR). Once fully incorporated, PursueCare plans to offer the products to other providers.

COLLABORATION MERGERS & ACQUISITION

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Dec 13,2023

Addiction Startup PursueCare Raises $20M

Virtual substance use disorder (SUD) provider PursueCare netted $20 million in a series B fundraising round. T.Rx Capital and Yamaha Motor Ventures led the funding round with participation from Seyen Capital and OCA Ventures. The company has also announced the acquisition of three software products of Pear Therapeutics following its bankruptcy.

FUNDING SERIES B

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Dec 05,2023

PCMIS Health Technologies Contracted to Support Silvercloud® By Amwell® Delivery of National Digital Mental Health Program for Ireland

PCMIS Health Technologies’ patient record system will provide effective, evidence-based case and risk management and outcome monitoring through a seamless integration with SilverCloud by Amwell. In addition, PCMIS will facilitate comprehensive national reporting as part of the next phase of the SilverCloud and Ireland Health Service Executive (HSE) partnership. PCMIS and Amwell have a history of collaboration and integration, having been the first to offer a “Digital First” referral and treatment pathway for NHS England Talking Therapies services in 2019. This is the first time the companies have worked together on a national health programme and as such, marks a new phase in their integrated approach to deliver tech solutions that drive service efficiencies and improve treatment outcomes. “The SilverCloud platform has seen a significant increase in use since working with the HSE. Our ongoing collaboration with PCMIS will play a key role in maintaining the efficient delivery of services on the platform through this growth." said Elaine Martin, Director of SilverCloud Clinical Operations at Amwell.

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Nov 14,2023 TOP STORY

Swing Therapeutics Announces Positive Results from Pivotal Phase 3 Trial of Stanza, a Digital Therapy for Fibromyalgia Symptoms

Swing Therapeutics, a leading developer of digital therapies for chronic pain conditions, announced the successful completion of and positive results from its pivotal Phase 3 PROSPER-FM trial on Stanza, a self-guided smartphone-based behavioral therapy for the treatment of fibromyalgia symptoms in adult patients. Swing received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for Stanza in May 2023, making it the first prescription digital therapeutic indicated for treating fibromyalgia symptoms. In this 12-week trial, 275 participants were randomized to receive either Stanza treatment or a digital symptom tracker control. The primary outcome measurement was the response rate on the Patient Global Impression of Change (PGIC) Scale. The key secondary endpoint measured fibromyalgia severity using the Revised Fibromyalgia Impact Questionnaire (FIQ-R). Analysis of the intention-to-treat population demonstrated significant clinical benefits of Stanza. At week 12, 70.6% of participants in the Stanza arm reported an improvement on PGIC. Stanza exhibited statistically greater improvement compared to the control on the FIQ-R total score.

CLINICAL STUDY

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Oct 30,2023

A Digital Therapeutic to Improve Insomnia in Multiple Sclerosis: A Randomized Controlled Trial (NorseMS)

A new randomized controlled trial is registered, aiming to test the effectiveness of digital cognitive behavioral therapy for insomnia (dCBT-I) compared with digital patient education about insomnia for people with Multiple Sclerosis (MS). The main questions it aims to answer are whether dCBT-I is effective in reducing insomnia severity in people with MS, whether dCBT-I is effective in reducing daytime fatigue, psychological distress, cognitive problems, medication use (hypnotic, sedative/anxiolytic and antidepressant), resource utilization and if these changes are mediated by improvements in insomnia severity and whether dCBT-I is feasible for people with MS. The treatment group is designed to receive dCBT-I during 9 weeks including psychoeducation about sleep, sleep hygiene, sleep restriction therapy, stimulus control and challenging beliefs and perception about sleep via Sleep Healthy Using The internet (SHUTi). Teh control group is going be receiving digital patient education about insomnia (PE). The primary outcome measure is between-group difference in insomnia severity at week 9 after randomization assessed with the Insomnia Severity Index (ISI)

CLINICAL STUDY

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Oct 24,2023 TOP STORY

HSE Shows Strong Mental Health Patient Outcomes Using Silvercloud® By Amwell® Digital Programmes

The Health Service Executive (HSE) shared a new report highlighting a key milestone in the technology partnership with SilverCloud® by Amwell®; more than 12,300 people have used the SilverCloud platform’s guided digital Cognitive Behaviour Therapy (iCBT) programmes, as of August 2023. The report, which follows November’s research report on the first 5,000 users to utilise the programmes, details the continued progress of the HSE partnership, and outlines the encouraging clinical success, uptake and effectiveness of the platform. 49% of users with clinical levels of depression showed clinically meaningful improvement and 59% of users with clinical levels of anxiety showed clinically meaningful improvement.

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Oct 09,2023 TOP STORY

New Research Demonstrates Clinical Effectiveness of Digital Treatment at Improving Insomnia and Comorbid Mental and Physical Health Issues

Big Health announced today the publication of two, peer-reviewed studies demonstrating the effects of its flagship digital insomnia treatment Sleepio in individuals with co-morbid insomnia and clinically significant anxiety as well as in stroke survivors. Published in the peer-reviewed Journal of Affective Disorders, researchers found that Sleepio’s clinically validated impact on insomnia also significantly reduced participants’ anxiety symptoms — 84% of improvements in anxiety were due to improvements in sleep. Also, the peer-reviewed Journal of Sleep Research published results from the INSPIRES study, a randomized controlled trial (RCT) comprising 84 stroke survivors demonstrating that Sleepio was effective at improving sleep, compared with sleep hygiene control, for at least eight weeks post-intervention. Results also showed that, among participants who had insomnia disorder at baseline, 71% in the Sleepio study arm achieved remission post-intervention compared to 30% of control participants.

CLINICAL STUDY

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Oct 06,2023

Curio Digital Therapeutics: Pivotal Trial for Postpartum Depression Digital Therapeutic Meets Efficacy Endpoints

Curio Digital Therapeutics today announced positive data from the Supporting Maternal Mental Health and Emotional Regulation (SuMMER) trial. SuMMER is a national, randomized, placebo (sham)-controlled pivotal trial evaluating MamaLift Plus for eight weeks in 141 patients (ITT population) randomized in a 2:1 ratio to the MamaLift Plus arm (N = 95) and control (sham digital) arm (N = 46). The SuMMER trial met its primary endpoint, a ?4-point improvement in Edinburgh Postnatal Depression Scale (EPDS) score. Preliminary results indicate that approximately 83% of participants in the intervention arm achieved a 4-point improvement in EPDS score, compared to only 22% in the control arm. Approximately 82% of patients in the intervention arm achieved an EPDS reduction to <13, compared to only 30% in the control arm.

CLINICAL STUDY

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Oct 05,2023

Better Therapeutics Announces Publication of LivVita Liver Disease Study Results in Gastro Hep Advances

Better Therapeutics today announced the pre-print publication of the LivVita study's results in Gastro Hep Advances. The feasibility study's authors conclude that the positive efficacy, safety, and usability data underscore the potential of Better Therapeutics' digitally delivered Cognitive Behavioral Therapy (CBT) to address the unmet clinical needs associated with metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NAFLD and NASH. This first-of-kind study (n=22) demonstrated improvements in multiple markers, including MRI-PDFF, FibroScan CAP score, weight, FastTM score, and ALT, suggesting therapeutic potential in a larger patient population. Additionally, there were no device-related adverse events, even in patients with a large number of comorbidities and background pharmacotherapy use. The company anticipates submitting a request to the FDA for Breakthrough Device Designation by the end of 2023.

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Sep 28,2023 TOP STORY

GAIA's New Depression Therapy for MS Shows Significant Results

In the study published in Lancet Digital Health, GAIA’s (digital) depression therapy “amiria” was able to show that it can significantly reduce depression symptoms and that the positive therapy effects were even detectable up to 1 year after the end of therapy. This parallel-group, randomised, controlled, phase 3 trial of an iCBT programme to reduce depressive symptoms in patients with multiple sclerosis was carried out at five academic centres with large outpatient care units in Germany and the USA. The predefined primary endpoint, which was analysed in the intention-to-treat population, was severity of depressive symptoms as measured by the Beck Depression Inventory-II (BDI-II) at week 12 after randomisation. 279 participants were enrolled, of whom 101 were allocated to receive stand-alone iCBT, 85 to receive guided iCBT, and 93 to the control condition. he dropout rate at week 12 was 18% (50 participants). Both versions of the iCBT programme significantly reduced depressive symptoms compared with the control group. The approval of amiria for the treatment of depression in MS patients in Germany (BfArM) is currently being prepared.

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