Limbix Partners with the Children's Hospital Los Angeles to Study SparkRx

SAN FRANCISCO , Sept. 6, 2022 /PRNewswire/ -- Limbix is excited to announce a partnership with Children's Hospital Los Angeles (CHLA) for a research study to evaluate SparkRx, an adjunct treatment for adolescents with symptoms of depression, in specialty medical care settings. SparkRx is a self-guided, cognitive behavioral therapy (CBT)-based digital therapeutic intervention for adolescents, aged 13-22 years old. Research indicates that CBT is an effective treatment option for depression in adolescents. SparkRx brings an engaging, evidence-based program directly to teens' smartphones. This digital therapeutic helps teens understand their depression and learn coping skills to manage their symptoms.

Limbix and CHLA are testing SparkRx's feasibility and efficacy among adolescents with elevated depressive symptoms that are being treated in the Cardiology and Gastroenterology programs at CHLA. Teens that have chronic medical conditions, such as cardiovascular and gastrointestinal diseases, are often at higher risk for depression. Finding behavioral health care can be difficult and when left untreated, symptoms of depression can worsen other health conditions.

"At Limbix, we are committed to building digital therapeutics that are easily accessible to patients and give providers a safe and effective treatment option," said Aarthi Padmanabhan, PhD, Chief Research Officer at Limbix and Co-Principal Investigator of the study. "We are especially excited to partner with Children's Hospital Los Angeles to run this research study in specialty care settings to better understand the mental health needs of this patient population."

Eligible study participants complete interactive activities within the digital therapeutic intervention that are designed to help them learn the relationship between mood and behavior, identify activities that can help them feel better, and give them a sense of accomplishment. The goal of the study is to understand if these adolescents find SparkRx to be a convenient treatment option, if it can reduce the symptoms of depression in adolescents with chronic medical conditions, and to collect feedback on the participants' experience using SparkRx.

"We're excited about this opportunity to offer our patients a new resource for adolescent depression via a digital therapeutic that could help minimize barriers and increase access to mental health treatment," said Heather Bemis, PhD, Licensed Clinical Psychologist, Division of Comfort and Palliative Care, Department of Anesthesiology Critical Care Medicine at CHLA and Principal Investigator of the study.

To learn more about the study or to enroll as a participant, please visit https://project.limbix.com/sparkrx-study-a.

Limbix is on a mission to make mental health treatment accessible to young people who need it the most, when they need it the most. Limbix's diverse team of clinicians, product designers, researchers, and engineers are uniquely suited to developing mental health technology, as they understand the value of combining clinical expertise with technological innovation. The team is focused on giving all young people access to affordable, effective behavioral health care by building safe and evidence based treatment options that providers can offer to their patients. Through extensive research, Limbix built their first digital therapeutic, SparkRx, that delivers CBT-based treatment directly to each user's smartphone.

Intended Use: SparkRx is a digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy - Behavioral Activation) in patients 13 to 22 years of age as adjunct treatment for symptoms of depression.

‍SparkRx has not been cleared or approved by the U.S. Food and Drug Administration. During the COVID-19 public health emergency, SparkRx is being made available without a prescription under the FDA's emergency guidance for digital health devices treating psychiatric disorders.

Warnings: SparkRx is not for emergency use. Please instruct patients to dial 911 or go to the nearest emergency room in the event of a medical emergency.

‍Patients should be clearly instructed not to use SparkRx to communicate severe, critical, or urgent information to their health care provider. Patients should also be informed that text they enter into SparkRx will not be monitored or reviewed by a health care provider.

‍SparkRx is not meant to be used as treatment without supervision of a health care provider. Please instruct your patients to contact you should they notice a worsening of symptoms or an increase in thoughts of suicide or self-harm.

‍SparkRx is not meant to be a substitution for any treatment or medication.

‍SparkRx is intended for patients whose primary language is English with a reading level of 5th grade or above, and who have access to an Android/iOS smartphone or tablet. SparkRx is intended only for patients who own a smartphone or tablet and are familiar with use of smartphone or tablet apps (applications).

‍SparkRx contains sensitive medical information. Please instruct patients to protect their information by password protecting their smartphone or tablet, and ensuring no one else may access their device.

‍SparkRx does not address concerns of active suicidal ideation with intent. SparkRx is not intended for the prevention of suicide attempts or self-harm behaviors. Patients with active suicidal ideation with intent or those who have had a past suicide attempt may still be given SparkRx to help treat depression but should not be given SparkRx to prevent, treat or mitigate active suicidal ideation with intent.

‍Patients with posttraumatic stress disorder (PTSD) who are currently experiencing marked alterations in arousal or reactivity associated with traumatic events may find that the level of exposure related to guided behavioral activation exacerbates symptoms.

SOURCE Limbix