Novartis-partnered TrialSpark pens 'digital' trial collab with Limbix

Clinical study tech company TrialSpark teamed up with digital mental health firm Limbix to work on a new “digital therapeutic” for adolescent depression.

Limbix, which works on mobile apps and virtual reality (VR) focused on helping solve mental health issues, is combining with TrialSpark for a so-called Limbix Spark five-week program that uses mobile and VR tech.

“The program uses cognitive behavioral therapy (CBT) to treat adolescent depression by helping teens understand their depressive patterns, identify behaviors and activities that can positively affect their mood, and help reduce symptoms of depression,” the pair said in a joint statement.

The program focuses on behavioral activation and guides teens through tasks that teach coping skills and mindfulness. They can also tap into additional resources for this, including after the five-week program ends.

“Access to mental health treatment is a global problem and long waitlists often prevent patients from receiving adequate care. Digital therapeutics like Limbix Spark can improve access to, and outcomes of, mental healthcare by being a first line of defense before a patient sees a provider,” said Jon Sockell, chief operating officer and co-founder of Limbix.

“Working with TrialSpark to conduct a rigorous, community-based clinical trial will allow us to generate robust evidence that prescription digital therapeutics like Limbix Spark can be used for treatment.”

TrialSpark will use its ability to recruit the best-placed patients to fit the enrollment criteria for the Limbix Spark clinical trial.

TrialSpark’s approach addresses issues with trial participants who don’t live near large academic centers or hospital-based trial sites by allowing them to participate at their local doctor’s office. The new model is designed to accelerate clinical trials by expanding the pool of patient participants.

To support its approach, the company built an end-to-end tech platform that includes precision-targeted recruitment, algorithmically prioritized queues, risk-based quality monitoring and cloud-based CTMS/eSource data capture.

By sifting through large data sets of de-identified health records, the company is able to find high-potential “hot spots” where likely trial participants can be found. Those patients/sites are usually overlooked due to their distance from large institutions and specialist centers.

Just over a year ago, New York-based tech CRO TrialSpark launched its first clinical trial sites as part of a partnership with Novartis, and it now adds Limbix to its workload.

“Digital therapeutics hold the potential to revolutionize mental healthcare. They can provide a new dimension of treatment for millions of people living with mental health conditions but without accessible and high-quality care," added Jeff Yuan, head of client growth at TrialSpark.

“TrialSpark is uniquely positioned to support clinical research of digital therapeutics by leveraging direct feedback from our network of community physicians; and the enablement of trials in real-world doctor's offices, often within traditionally underserved communities across diverse geographies. In addition to generating robust clinical evidence, we hope this collaboration extends the uptake of Limbix Spark among community practices particularly in areas where treatment gaps exist in mental health care.”